Organovo is presenting the first data showing survival and sustained functionality of its 3D bioprinted human liver tissue when implanted into animal models. This data is being presented at the TERMIS-Americas Meeting in San Diego.

“With a critical shortage of donor organs and few alternatives to transplantation, Organovo is using its 3D bioprinting technology to develop novel therapeutic tissues for direct surgical implantation,” said Eric Michael David, M.D., J.D., chief strategy officer and executive vice president of preclinical development, Organovo.  “Our preclinical data show rapid vascularization and tissue engraftment, and evidence of function and durability of our 3D bioprinted human liver tissue over several weeks.  Most importantly, we see evidence of stable production of key human liver proteins in the animal bloodstream, and tissue staining for key human metabolic enzymes.  The presence of these enzymes provides an important first step in demonstrating the capability of this tissue to treat inborn errors of metabolism, a key indication we are targeting.”

Organovo implanted its 3D bioprinted human liver tissue patches onto the livers of NOD/SCID mice. The tissue was composed of human hepatocytes and select non-parenchymal cells. Function of the 3D bioprinted human liver tissue patches was seen via detection of human albumin, alpha-1-anti-trypsin and fibrinogen in the circulating blood of the mice as early as seven days and for at least 28 days post-implantation. Histopathologic evaluation of the implanted therapeutic tissue revealed retention of the bioprinted cellular organization through 28 days post-implantation, with robust staining for key human metabolic enzymes associated with inborn errors of metabolism, such as Fumarylacetoacetate Hydrolase (FAH) deficiency and Ornithine Transcarbamylase (OTC) deficiency. The tissues remained intact on the animal liver and were well tolerated by the animals. Taken together, these data support further preclinical development of Organovo’s 3D bioprinted liver tissue for therapeutic use.

Focusing first on acute-on-chronic liver failure and pediatric inborn errors of metabolism, both indications where a bioprinted liver patch may show therapeutic benefits, Organovo intends to submit an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for its therapeutic liver tissue in three to five years. As appropriate, Organovo will pursue breakthrough therapy designation, clinical development outside the United States, and other opportunities to help accelerate time to market.

Published in Organovo

At the 2nd International Conference on 3D Printing in Medicine in Mainz, Germany, the focus is on innovative deployment options for the 3D print process in medicine. Already, 3D printing is being applied in virtually all medical disciplines. So orthopaedic surgeons, oral and maxillofacial surgeons, vascular surgeons, ophthalmologists, urologists, dermatologists and ear, nose and throat doctors are now using individually adapted 3D implants.

Well-known international physicians, material scientists and engineers are involved with the opportunities that 3D printing opens up in oral and maxillofacial surgery, casualty surgery, orthopaedic surgery and vascular surgery, as presenters at the 2nd International 3D Print conference. Additionally, further medical disciplines such as ophthalmology, dentistry and neurosurgery will also be featured. The presenters will also be examining the influence 3D print has on regenerative medicine. Using the 3D print process, veins, nerves, breast tissue, bone replacement material or corneas can already be artificially produced today.

Last but not least, this cross-disciplinary conference will also be about new developments in materials science with reference to 3D print, as well as 3D bioprinting. 3D bioprinting technology, which supports the reproduction of organic tissue, enables the precise arrangement of living, human cells in three-dimensional structures. It is seen as a key technology for producing functional tissue or whole organs in future. The 2nd International 3D Print Conference in Mainz will also look into the question of which new and biocompatible materials can be optimised for many methods of treatment.

3D printing will be finding more medical areas of deployment. A study by the A.T. Kearney business consultancy has reached the conclusion that a growth rate of 20-25% is to be reckoned with in the medical sector by 2020. The production of individualized transplants is becoming more and more important, especially in prosthetic joints (for hips, shoulders, knees and jaws).

Some further questions that the conference will be addressing are: What are the developments and advances in medicinal 3D printing? Which medical disciplines already use 3D printing for individual solutions today? Which materials are used in the production of individual implants and how do these newly developed materials distinguish themselves? Which technologies are applied and how are they further developed? The conference also cultivates the promotion of cross-disciplinary dialogue between experts from medicine, materials science and engineering. This event is also intended to combine synergies among participants from different areas, to work out and support any national and international cooperation projects.

In consequence of the great international success of the first conference in Mainz in April 2016, there was soon a demand from the scientists for follow-up event. Mainz was chosen once more to be the location for the 2nd International Conference of 3D Printing in Medicine.

Published in boeld communication

Graham Engineering Corporation director of business development for extrusion, Steve Maxson, announces the first Spotlight™ Medical Extrusion & Secondary Operations Conference to be held November 10th in Irvine, California.

“The focus of our Spotlight conferences is on medical extrusion and secondary operations such as surface treatment, drilling, laser processing, over-molding, and braiding for catheters and delivery systems,” said Mr. Maxson, who is the confererence organizer.

“I am very excited that we were able to secure Dr. James Oberhauser, a medical device industry leader, as the keynote presenter,” Mr. Maxson said. “From 2007 to 2015 Dr. Oberhauser led the product development of Abbott Vascular’s Absorb™ Bioresorbable Vascular Scaffold (BVS), which was recently approved by the FDA. This is the biggest development in medical devices related to the treatment of coronary artery disease in many years.”

Graham Engineering Corporation intends to organize two Spotlight™ Conferences annually in varying locations to address important developments and new technologies in medical extrusion and secondary operations.

Steve Maxson’s background combines disciplines from the fields of medical extrusion technology and medical device manufacturing.  His career includes roles with Raumedic Inc., Vante, and American Kuhne, now a brand of Graham Engineering Corporation.

Published in Graham Engineering

3D metal printing enables incredible applications because it truly allows freedom of design. For the first time ever, a prosthetic titanium beak has been manufactured using 3D metal printing and implanted on Gigi, a blue macaw (a genus of the parrot family), in Brazil. This unusual prosthetic saved Gigi's very life, as macaws are unable to eat solid foods without a beak.

The illegal trade of wild birds is a sad story of greed, and it doesn't just happen in Brazil. The victims are magnificent creatures whose very beauty can end up being their downfall. During Gigi's captivity at the hands of illegal bird traders, poor housing conditions caused severe malformation of the bird's beak. Ultimately, Gigi was freed by the Brazilian police, but the magnificent bright blue and yellow feathered macaw could no longer be fed without a beak. A team of veterinarians, together with 3D printing experts from the Renato Archer Technology and Information Center (CTI) in Campinas, Brazil, developed an implant solution for the bird. The successful operation took place at the Animal Care Center in Ipiranga near Sao Paulo.

The artificial beak was created thanks to the cooperation of three specialists. The team, dubbed the "Avengers," was comprised of veterinarian Roberto Fecchio, 3D designer and facial-reconstruction specialist Cicero Moraes and veterinary dentist Paul Miamoto. The "Avengers" are pioneers in the use of 3D printing technology for saving the life of wild animals, having previously made a new shell for Freddy the turtle and a beak for an injured toucan. These prosthetics were made of plastic. In the case of Gigi, Plastic was not suitable. Macaws use their beaks to open seeds and break other hard shells, meaning that their beaks need to be extremely long-lasting and strong. This being the case, the team decided on titanium, known to be extremely durable. Titanium presented itself as the perfect solution, as it is biocompatible, lightweight and corrosion-resistant. Many prosthetics for people are produced using titanium today, so why not try using the material to help a wild bird?

Paul Miamoto began by taking a series of photographs of the malformed beak. From these, Cicero Moraes created a digital 3D model for the perfectly fitting prosthetic. The beak was then laser melted at the Renato Archer Technology and Information Center (CTI). Gigi's artificial beak was created using a Mlab cusing R from Concept Laser, with which especially delicate parts with high surface quality can be manufactured. The smallest system model from Lichtenfels proved to be the right choice for saving Gigi's life. The operation then took place at the Animal Care Center in Sao Paulo. Veterinarians Roberto Fecchio, Sergio Camargo, Rodrigo Rabello and Methus Rabello participated. The 3D-printed prosthetic was secured in place with bone cement and orthopedic screws. Just 48 hours after the operation, Gigi was able to try out the beak. She made a fantastic recovery at the Center for Research and Screening of Wild Animals (CEPTAS) at Unimonte University. Gigi is currently awaiting placement at a zoo, where visitors can marvel at the bird's one-of-a-kind beak secured in place with colorful rhinestone-styled screws.

All's well that ends well. Examples like Gigi show that 3D-printed medical technology isn't just capable of providing greater quality of life to people. The unlimited geometric freedom of the process enables the manufacture of perfectly fitting implants ideally suitable for each respective application. Ultimately, it was able to help a magnificent wild bird overcome injuries and deformities, so there is good news in our often uncertain and sometimes unsettling world.

Published in Concept Laser

Formlabs announced the release of Dental SG Resin, the first biocompatible resin in desktop 3D printing. Enabling professionals to push new boundaries in digital dentistry, Dental SG is a certified biocompatible Class 1 material designed primarily for surgical guide applications. The latest addition to Formlabs' material portfolio, Dental SG will allow applications never seen before in the desktop 3D printing space such as high-precision drill guides from digital scan data for implant surgeries. Dental professionals can now move from a 3D model to a directly printed surgical guide, at a quick turnaround and a tremendously affordable price.

“When practitioners and researchers have the ability and access to develop incredibly precise tools for surgical applications, it opens up a new range of possibilities for the dental industry and for the medical science industry at large,” said Dávid Lakatos, Head of Product at Formlabs. “Formlabs is leading the way in helping to advance patient care by introducing solutions that enable personalized surgical planning and mass customization. Material innovation, like with the introduction of Dental SG, is a key driver in growing the adoption of digital dentistry powered by 3D printing.”

In recent years, dental applications in desktop 3D printing have rapidly taken off. Formlabs products have become indispensable tools for dental innovation. Dentists use the Form 2 to create surgical guides, educational models, bleaching trays, retainers, aligners, and more. Some of the applications have transformed the medical field. At the Indiana University School of Dentistry, Dr. Travis Bellicchi, a resident specializing in maxillofacial prosthetics, is developing a new digital workflow with Formlabs 3D printers to create accurate prostheses for individual patients, inspired by his work with Shirley Anderson, a Vietnam veteran who suffered severe jaw loss as a result of cancer. Today’s introduction of Dental SG will continue to significantly expand the industry’s repertoire of dental applications.

The new resin has already drawn praise from leaders in the dental community like Dr. Michael Scherer, who has been using Formlabs 3D printers in his private dental office for almost two years. He will be adding Dental SG to the curriculum of his 3D printing training for dentists. “The addition of Dental SG Resin is a game-changer,” Dr. Scherer says. “Dental SG is poised to dramatically improve patient outcome of surgical procedures by making implant surgery faster, more precise, and ultimately more comfortable for the patient. Direct printing of surgical guides has traditionally required larger-scale 3D printers that are beyond the expense and comfort level of most dental laboratories and clinicians. The introduction of Dental SG Resin allows for benchtop surgical guide printing in dental offices and smaller dental labs.”

Compatible with the Form 2 3D printer, the Dental SG biocompatible resin will be available directly from the Formlabs web store. Dental SG joins Formlabs’ comprehensive library of advanced materials for its 3D printers, which includes a suite of Standard and Functional resins for a variety of capabilities.

For more information, visit: www.formlabs.com/products/materials/dental-sg

Published in Formlabs

Nexxt Spine, LLC announced the development of NanoMatrixx, a porous bioactive titanium material designed to actively participate in the intervertebral fusion process.

Nexxt Spine’s NanoMatrixx is manufactured to exacting specifications utilizing modern 3D printing technology to replicate the cellular structure of cancellous bone. This process makes it possible to create any three dimensional complex structure or geometry with a desired modulus of elasticity that cannot be created by traditional orthopedic manufacturing processes.

Following the manufacturing process, the material undergoes a series of proprietary treatments to produce a micro and nanosurface topography which stimulates mesenchymal stem cells to differentiate into bone forming osteoblast cells that produce bone growth onto and throughout the 3-D printed material.

According to Dr. Robert L. Wertz, Director of New Product Development, “A glimpse inside of the NanoMatrixx material reveals its uniform 3-dimensional cellular architecture with 70% porosity. The cubical shaped scaffold provides an optimal biomechanical and biological environment for uninterrupted blood flow. Every surface of the NanoMatrixx material exhibits a micro and nanotextured topography that’s designed to elicit a superior osteogenic response. This allows bone to attach to the internal struts and grow entirely through the material while simultaneously providing optimal mechanical support without the stress shielding effects experienced with traditional titanium implants.

“Conventional textured or coated implant surfaces only achieve bone to implant contact or on-growth; however, NanoMatrixx’s consistent open and interconnected network of pores within a specific size range have been found to be osteoconductive and osteoinductive, promoting bone on-growth and bone in-growth for total osseous integration. Bone has the potential to not only grow into the pores and around the struts, but also attach to the nanotextured strut surfaces.”

For more information, visit: www.nexxtspine.com

Published in Nexxt Spine

Stratasys Ltd. announced that its color, multi-material technology is being successfully deployed to aid cancer surgeons in treating patients. Physicians use the models during pre-surgery planning of complicated kidney tumor removal, helping to perform precise and successful kidney-sparing surgery and improving patient outcomes. The 3D printed models are also used to improve surgeon training, as well as enhancing the explanatory process towards patients.

The advanced surgical process, which utilizes transparent and color 3D printed models produced on Stratasys' color, multi-material 3D Printer, the Objet500 Connex3 , is being pioneered by the Department of Urology and Kidney Transplantation at the University Hospital (CHU) de Bordeaux, in France. According to CHU surgeon Dr Jean-Christophe Bernhard, this is currently the only hospital in France - and one of the first in the world - to deploy Stratasys' multi-color, multi-material 3D printing technology for complex kidney tumor removal cases.

"Having a 3D printed model comprising the patient's kidney tumor, main arteries and vessels - each in a different color - provides an accurate picture of what we will see during operations," says Dr Bernhard.

"Importantly, the ability to visualize the specific location of a tumor in relation to these other elements, all in three dimensions, greatly facilitates our task and is not something that is easily achievable from a 2D scan," he adds.

According to Dr Bernhard, the clearer view offered by the 3D printed model may increase the ability to perform precise and successful kidney-sparing surgery. The pre-surgery planning aids in identifying and avoiding damage to the delicate nearby arteries and vessels which can result in complete kidney removal. Sparing the patient's kidney is important because it reduces the chance of subsequently suffering from chronic kidney disease.

"3D printing technology has effectively heralded a new dawn," continues Dr Bernhard. "A scan gives us good information, but it's in 2D. This relies on the surgeon to mentally reconstruct the tumor volume in 3D and estimate its location inside of the total volume of the kidney. The same process has to be done to clearly understand the relations between the tumor, the vessels (arteries and veins) and the collecting system. As you can imagine, this is difficult and time-consuming for the surgeon.

"Conversely, having a 3D printed kidney model in your hands that corresponds specifically to that of the patient you're going to operate on quite literally offers me a view from a new perspective. The only thing more accurate than that is the patient himself," he adds.

The CHU de Bordeaux uses three Stratasys PolyJet materials: transparent VeroClear to show the volume mass of the kidney itself, red for the arteries and yellow for the excretory tract. The red and yellow is then mixed on-the-fly - unique to Stratasys multi-material capabilities - to produce the all-important orange color of the tumor.

"The Stratasys transparent material is of fundamental importance as it allows us to see inside and estimate the depth at which the tumor resides," explains Dr Bernhard. "It enables us to see the arteries and the cavities that collect urine, so we can see if any of the arteries are touching the tumor. We need to remove the tumor, but not at the expense of the other vital elements that together enable the kidney to do its job. Finding that balance is much easier to achieve thanks to 3D printing."

Dr Bernhard also believes that use of 3D printed models will not be restricted to kidney surgery, and sees them being equally useful for any organ sparing surgeries.

Stratasys 3D printing solutions also significantly strengthens the CHU's capabilities from an instructional standpoint. For Dr Bernhard, this is a fundamental benefit of 3D printing and one that he sees making a big impact within the medical sector long-term.

"I think this technology will be a big driver in terms of shaping the future of teaching and surgical training," he says. "Having access to a 3D printed model that is completely accurate to the one that you're going to operate, not only enables you to train yourself on the operation, but it also greatly improves our ability to more accurately convey surgical procedures to students - who of course are the surgeons of tomorrow."

Another major benefit for the CHU of Bordeaux and Dr Bernhard is the ability to use the 3D printed models to more easily explain procedures to patients prior to surgery, thereby offering increased reassurance.

"Describing kidney tumor removal with 2D scan or a diagram will invariably leave most patients somewhat bewildered," he explains. "Presenting them with a 3D printed model that clearly shows the tumor puts them at ease and enables the patient to grasp exactly what we're going to do. Indeed, research from patient questionnaires shows that having 3D printed models increases their understanding of the surgery by more than 50%, so it's a considerable benefit in terms of overall patient care."

Commenting on the use of 3D printing technology at the hospital, Scott Rader, General Manager of Medical Solutions at Stratasys, says, "By putting exactly what the surgeon needs to see right in his hands, the pioneering use of Stratasys color multi-material 3D printing technology at the CHU de Bordeaux demonstrates its capability to improve medical operations by decreasing complexities to make the surgeon's role easier. Moreover, by enhancing procedures in this way, the prospect of organ-conserving surgery is increased, resulting in a far more favorable outcome for patients."

Published in Stratasys

4WEB Medical announced at the North American Spine Society annual meeting in Chicago that the company has launched its Posterior Spine Truss System in the U.S. market. The Posterior Spine Truss System is a comprehensive line of interbody fusion devices with applications across a wide array of posterior spine approaches including PLIF, TLIF, and Oblique procedures.

"The Posterior Spine Truss System represents a significant advancement in treatment options for my lumbar spine patients", said S. Babak Kalantar, M.D., Chief of Orthopedic Spine Surgery at Georgetown University Hospital. "The expansion of 4WEB's novel truss implant technology into posterior spine procedures will allow me to utilize an implant with proven clinical benefits across the majority of spine surgeries that I perform."

Encompassing 150 implants, the Posterior Spine Truss System affords surgeons a wide range of options that provide an optimal match for each patient's unique anatomy. The implants provide innovative functionality such as a biconvex web structure that distributes the load over a larger surface area at the endplate interface to minimize subsidence.

4WEB also has FDA cleared implants for cervical and anterior lumbar procedures. The company was the first medical device manufacturer to commercialize a 3D printed spine implant in the U.S. Since 2013, close to 6000 of 4WEB's 3D printed truss implants having been used in surgery worldwide.

"While many orthopedic companies are beginning to utilize 3D printing as a manufacturing process, they continue to produce antiquated annular designs that have been on the market for years," said Joseph O'Brien, M.D., Medical Director of Minimally Invasive Spine Surgery at The George Washington University Hospital.  "4WEB is unique in that they are the only company in the spine implant market to maximize the opportunity that 3D printing affords by producing truss designs with distinct structural mechanics that have considerable potential to accelerate healing for my patients. These patented structures were not even possible to manufacture at this scale until only a few years ago. "

4WEB Medical is an implant device company founded in 2008 by Jessee Hunt in Frisco, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. Mr. Hunt leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical's proprietary truss implant platform. The 4WEB Medical product portfolio currently provides implant solutions for Neuro and Orthopedic surgeons. The platform includes the Cervical Spine Truss System, the ALIF Spine Truss System, the Posterior Spine Truss System and the Osteotomy Truss System.  4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific procedures.

For more information, visit: www.4WEBMedical.com

Published in 4WEB Medical

Australian Minister for Industry and Science Ian Macfarlane congratulated CSIRO on its role in an international collaboration that has led to a world-first in surgery, using a 3D printed titanium sternum and rib implant for a cancer patient. The titanium sternum and rib implant was designed and developed in Australia, in a collaboration between a Melbourne-based medical device company, Anatomics, and CSIRO’s 3D printing facility, Lab 22, at Clayton.

After being diagnosed with a chest wall sarcoma, the 54-year-old man’s surgical team made the decision to remove his sternum and a portion of his rib cage and replace it with an implant. The implant was designed and manufactured by medical device company, Anatomics, who utilised the CSIRO’s 3D printing facility, Lab 22.

The surgical team, Dr José Aranda, Dr Marcelo Jimene and Dr Gonzalo Varela from Salamanca University Hospital, knew the surgery would be difficult due to the complicated geometries involved in the chest cavity.

“We thought, maybe we could create a new type of implant that we could fully customise to replicate the intricate structures of the sternum and ribs,” Dr Aranda said.

“We wanted to provide a safer option for our patient, and improve their recovery post-surgery.”

That’s when the surgeons turned to Anatomics. After assessing the complexity of the requirements, Anatomics CEO Andrew Batty said the solution was metal 3D printing.

“We wanted to 3D print the implant from titanium because of its complex geometry and design,” Mr Batty said.

“While titanium implants have previously been used in chest surgery, designs have not considered the issues surrounding long term fixation.

“Flat and plate implants rely on screws for rigid fixation that may come loose over time. This can increase the risk of complications and the possibility of reoperation.”

Through high resolution CT data, the Anatomics team was able to create a 3D reconstruction of the chest wall and tumour, allowing the surgeons to plan and accurately define resection margins.

“From this, we were able to design an implant with a rigid sternal core and semi-flexible titanium rods to act as prosthetic ribs attached to the sternum,” Mr Batty said.

Working with experts at CSIRO’s 3D printing facility Lab 22, the team then manufactured the implant out of surgical grade titanium alloy.

“We built the implant using our $1.3 million Arcam printer,” Alex Kingsbury from CSIRO’s manufacturing team said.

“The printer works by directing an electron beam at a bed of titanium powder in order to melt it. This process is then repeated, building the product up layer-by-layer until you have a complete implant.

“3D printing has significant advantages over traditional manufacturing methods, particularly for biomedical applications.

“As well as being customisable, it also allows for rapid prototyping – which can make a big difference if a patient is waiting for surgery.”

Once the prosthesis was complete it was couriered to Spain and implanted into the patient.

“The operation was very successful,” Dr Aranda said.

“Thanks to 3D printing technology and a unique resection template, we were able to create a body part that was fully customised and fitted like a glove.”

Minister Macfarlane said this type of collaboration can transform the way industries operate and compete in international markets.

“Collaboration is the key to boosting Australia’s innovation performance. Initiatives like our Industry Growth Centres will foster these links and relationships which are critical to future successes like this,” Mr Macfarlane said.

For more information, visit: www.csiro.au/en/News/News-releases/2015/Cancer-patient-receives-3D-printed-ribs-in-world-first-surgery

Published in CSIRO

A cancer diagnosis always comes as a shock. In the case of a boy from Croatia this was particularly true as an aggressive form of bone cancer had destroyed the teenager's hip. The only option for the doctors treating him was a complete reconstruction of the hip bone. The 3D printing experts at Alphaform, a company with extensive experience in the medical sector, successfully produced the implant relying on industrial metal 3D printing from EOS.

The surgeon's challenge: the 15-year-old patient from Croatia had a primary bone tumor, as such not formed by metastasis and lying directly on the bone. The malignancies generally grow destructively, meaning that the original tissue must be removed. A complete arthroplasty of the hip was the fundamental prerequisite for ensuring the cancer cells did not continue to spread in the boy's body. An intervention of this type limits the mobility of the joint, and thus the mobility of the patient. With a precision implant, a patient's motor skills can largely remain unaffected in the future. In the hip area, the precise shaping of the replacement bone is particularly important.

In addition to the pure destructive force of the cancer, time was crucial because the illness was spreading with speed. The new implant also had to meet the doctors' weight specifications. The Croatian surgical team ordered an implant from Alphaform that had to be delivered fast and needed to be lightweight, yet precise. Christoph Erhardt, Director of Additive Manufacturing at Alphaform AG adds: "The design process was a real challenge. We received the complete 3D data including the cavities from Instrumentaria. Based on this we were able to start with the precise manufacture of the implant."

The implant was produced within one week on the EOSINT M 280 using a stable yet light titanium alloy. The process, from the initial computer sketches to the final implant, took only six weeks. This period included the sophisticated finishing of the artificial bone.

The subsequent operation in May 2014 was a great success. First the team of doctors completely removed all of the parts affected by the cancer and then the new artificial hip was inserted, complete with the integrated joint. A part of the young patient's thigh was replaced so that both joint parts fit within one another perfectly. As such, all medical requirements for the implant were fulfilled and laid the foundation for the patient's successful recovery.

For more information, visit: www.eos.info/press/case_study/additive_manufactured_hip_implant

Published in EOS

Materialise NV announced the signing of an agreement with Lima Corporate for the use of surgical guides for partial knee implants.

Lima and Materialise entered into an agreement that allows Lima to offer the Materialise surgical knee guide system in the EEA region and Switzerland. Jeroen Dille, Director of Materialise’s Clinical Unit, states, “Materialise first pioneered medical image based guide technology, including solutions for the knee, as part of our company-wide mission to realize a better and healthier world through meaningful applications of 3D printing. Through this collaboration with Lima, orthopedic surgeons will be able to benefit from the advantages that 3D printing can offer in the planning and execution of partial knee arthroplasty.”

Luigi Ferrari, CEO of Lima Corporate said: “Lima is committed to supporting healthcare professionals in their daily efforts to improve the lives of their patients and to enabling better outcomes for patients and healthcare systems. The aim of our collaboration with Materialise is to allow the surgeons we work with to continue to pre-operatively plan and use patient-specific guides in pursuit of more predictable surgical outcomes.”

Materialise has 25 years of experience in 3D planning and printing for medical applications, which includes the development of dedicated 3D visualization and planning software, engineering and design services and the production of 3D printed patient-specific guides and implants..

Materialise offers a solution consisting of easy-to-use 3D surgical planning software and patient-specific surgical guides for knee surgery, allowing surgeons to efficiently and accurately plan knee surgeries based on the patient’s unique anatomy and structural damage. Based on that pre-operative plan, patient-specific guides are designed and 3D printed for use during surgery. Lima Corporate will now offer this solution to its surgeons with respect to the unicondylar knee system that it recently acquired from Zimmer.

Published in Materialise

Oxford Performance Materials announced that it has received 510(k) clearance from the FDA for its first-in-kind SpineFab® VBR implant system.

OPM's SpineFab system is the first and only FDA cleared 3D printed load-bearing polymer device for long-term implantation and represents OPM's third successful OsteoFab® regulatory clearance. OPM's first FDA clearance was for its OsteoFab Patient-Specific Cranial Device in February 2013, followed by its OsteoFab Patient-Specific Facial Device in July 2014.

"Receiving FDA clearance for our SpineFab system is a significant accomplishment for our team and a key milestone for OPM," said Scott DeFelice, Chief Executive Officer and Chairman of Oxford Performance Materials. "This clearance serves as further confirmation of our ability to repeatedly build fully functional 3D-printed parts and mission critical robust structures. The introduction of our SpineFab system represents exciting news for the Company's entry into the attractive spinal market, and this lays the foundation for future generations of load-bearing OsteoFab implants in the orthopedic industry."

OPM's SpineFab device is a vertebral body replacement (VBR) intended for use in the thoracolumbar regions of the spine to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To gain this FDA clearance, OPM's VBR implant system underwent extensive static and dynamic mechanical testing to assure it meets load and fatigue requirements as well as regulatory guidelines for its intended use. 

"We have built a strategy with the patient in mind by working together with clinicians to bring innovative device solutions that anticipate improved surgical outcomes," said Severine Zygmont, President of OPM Biomedical. "Today we have achieved our goal to build the first 3D printed polymer implant that has been cleared for a load bearing indication. Our OsteoFab process, which combines 3D printing with a unique material chemistry, is causing the industry to rethink how implants are designed and manufactured. We can now envision devices that will promote bone tissue formation while being imaging friendly and anatomically desirable."

OPM's SpineFab VBR System implants will be 3D printed in 48 sizes by OPM Biomedical, an original equipment manufacturer (OEM) of medical devices. Using only biocompatible polymer and laser light, the OsteoFab laser sintering additive manufacturing process is an extremely clean implant production method. All SpineFab implants will be manufactured by OPM utilizing the Company's OsteoFab® process, which combines OPM's exclusive 3D printing technology with the Company's proprietary OXPEKK® powder formulation to print orthopedic and neurological implants. The result is a unique and beneficial set of attributes, including radiolucency, bone-like mechanical properties, and bone ongrowth characteristics.

OPM is currently in discussions with a number of distributors regarding sales channels for its SpineFab VBR system as well as partnership options for orthopedic devices in development. OPM's OsteoFab Patient-Specific Cranial and Facial devices are distributed exclusively by Zimmer Biomet.

For more information, visit: www.oxfordpm.com

The German company joimax®, developer of technologies and training methods for minimally invasive endoscopic spinal surgery, announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endoscopic Lumbar Interbody Fusion, or EndoLIF® On-Cage implant.

The EndoLIF On-Cage consists of titanium alloy, produced with Electron Beam Melt (EBM) technology. The cage displays a porous surface with diamond cell structure, providing an optimal base for cell proliferation and bone growth. Two large openings, which may be filled with autogenous bone, support the creation of a straight column for fusion.

The EndoLIF implant allows surgeons to utilize an inter-muscular approach, similar to a mini transforaminal lumbar interbody fusion (TLIF), into the intervertebral disc, enabling endoscopic-assisted fusion. Dr. Ralf Wagner, LIGAMENTA Spine Center, Frankfurt and Dr. Bernd Illerhaus, ONZ, Datteln/Recklinghausen, two German spine specialists, have already performed more than 200 out of 600 EndoLIF procedures in Europe. “The access is dura and nerve-gentle, preserves the dorsal bony structures and we can avoid scar tissue because of the stepwise tissue dilation,” said Dr. Illerhaus.

The EndoLIF On-Cage is designed to be used with supplemental posterior fixation, such as the joimax Percusys® percutaneous pedicle screw-rod system. Cage implantation can be performed with a posterior or postero-lateral approach, either using an open or endoscopic-assisted method.

“With the EndoLIF program, joimax offers a complete endoscopic-assisted solution for spinal stabilization and fusion. In the future, we will be able to treat patients with even more gentle techniques,” comments Wolfgang Ries, CEO and founder of joimax. “Our next development will be an EndoLIF Cage on the basis of our iLESSYS Delta system for posterior lumbar inter-body fusion (PLIF).”

Founded in Karlsruhe, Germany, in 2001, joimax is one of the leading medical device companies in minimally invasive spinal surgery (“joined minimal access”). The company’s U.S. subsidiary was established in Irvine, California, in 2005. The company is primarily focused on the development, production and marketing of technologies and methods for minimally invasive endoscopic spinal surgery. joimax is active in 40 countries around the globe and its methods have been successfully employed in approximately 150,000 surgeries. With a special focus on education, the company provides surgeons with specialized technique training through the three-step joimax CM3 education program. This program includes visitations, cadaver workshops and live-surgery support.

For more information, visit: www.joimax.com

Published in Joimax

Precision Engineered Products (PEP), a manufacturer of medical devices and components, announced the acquisition of Trigon International, specialized in design, engineering, manufacturing and assembly services for orthopedic products. End applications range from trauma, knee, hip, extremities and other instruments.

The purchase of Trigon International, based in Aurora, Illinois, further increases Precision Engineered Product’s share in the orthopedic market. “The combination of Trigon International with our capabilities in orthopedic surgical device design, prototyping, package design, and validation services will provide customers with a full suite of services for orthopedic products,” said John Manzi President and CEO of PEP. “Trigon International enhances PEP’s ability to meet the stringent regulatory requirements for the orthopedic market and its position in the marketplace will drive continued customer growth with orthopedic and medical OEM’s.”

“We, at Trigon, are truly excited about this new partnership with PEP which will enable us to offer more capabilities to our existing customer base including sterile barrier packaging, precision stamping and plastic molding,” said Joe Fenoglio President & CEO of Trigon. “In this ever changing industry, it is critical that we be able to quickly respond to the customer with a full range of precision engineered solutions. With this new partnership, our ability to respond to that need will be second to none.”  Trigon International, which will be renamed PEP Trigon, is now a wholly-owned subsidiary of Precision Engineered Products. PEP Trigon will continue to operate under its current management out of its Aurora, Illinois and Warsaw, Indiana facilities.

Trigon International is an FDA-registered and ISO-13485:2003 certified orthopedic product manufacturer.  Trigon International offers development services, design services and an array of contract manufacturing capabilities from advanced machining and precision assembly to additive manufacturing.

For more information, visit: www.pep-corp.com

3D Systems (NYSE:DDD) announced that it has partnered with e-NABLE Community Foundation (ECF) to support e-NABLE, the global network of makers, inventors and designers using 3D printing to make functional, prosthetic hands that are donated to people in need. Building upon 3DS’ mission of Making Good, this partnership leverages the company’s 3D digital fabrication products, services and expertise to expand access to, improve the capabilities of, and educate the public about these life-changing assistive devices.

“Our technology unlocks everyone’s potential to transform great ideas into real outcomes,” said Avi Reichental, President and CEO, 3DS. “By teaming up with the e-NABLE community, we are giving more people the means and the skills to improve lives.”

3DS and ECF announced four key areas of collaboration as part of their partnership. Specifically,

• 3DS will collaborate with ECF to design an all-new hand. This design will be free, publicly-shared, customizable for sizing and optimized for printing on the Cube®, CubePro® and EKOCYCLE™ Cube®. To encourage and support greater community participation, 3DS and ECF will publish a video tutorial on how to print and assemble the free hand file.

• 3DS will provide technical advisory, aiding ECF with key industry and technical expertise on 3D technology, prosthetics design and more.

• 3DS and ECF will identify four or more university-based labs to qualify them as e-NABLE partners. These will be equipped with 3DS’ digital fabrication tools, including CubePro 3D printers, premium material cartridges, Sense™ 3D scanners, design software and the Touch™ 3D stylus.

• 3DS and ECF will collaborate to develop learning materials for formal and informal educators, introducing and facilitating 3D design and printing relating to ECF’s mission of sharing 3D-printed assistive technologies.

“We are excited to welcome 3D Systems into partnership with ECF and look forward to leveraging their solutions and expertise to further our reach and impact,” said Jon Schull, Enable Community Foundation President. “It's notable that 3DS has the vision to open-source their K1 hand so that all sorts of people can use it and learn from it."

The 3DS and ECF partnership will be celebrated at the upcoming Capitol Hill Maker Faire on June 11 and the National Maker Faire on June 12 and 13 at the University of the District of Columbia, where ECF will host workshops using 3DS’ Cube 3D printers.

At both Maker Faire events, 3DS will showcase its new prosthetic hand design, which was optimized for printing on the Cube and CubePro 3D printers. The stunning prosthetic was designed by 3DS’ industrial designer Evan Kuester. Kuester also designed the “Iron Man” prosthetic for the University of Central Florida that was presented to a young boy by Robert Downey, Jr. Kuester and other 3DS experts will be on hand to support the e-NABLE workshops and provide technical advice at both events.

For more information, visit: www.enablingthefuture.org

Published in 3D Systems

Biomerics LLC, a contract manufacturer and innovative polymer solutions provider for the medical device industry, announced the launch of its proprietary Rapid-Adapt™ injection molding tool system.

“We are very proud of the Rapid-Adapt™ system—we’ve been working on it for the last two years and we’re excited to see it launch,” stated Dan Brittingham, VP of Engineering at Biomerics. “The Rapid-Adapt™ system enables us to provide fast, low-cost tooling solutions for vertically overmolded ISO 594 luers, ‘Y/T’ connectors, and junctions, as well as horizontally molded custom components and inserts. Ultimately, the Rapid-Adapt™ system allows us to better support our customers and help them get their products to market more efficiently.”

The Rapid-Adapt™ system is a proprietary injection molding tooling solution that utilizes a custom base and cavity design to enable tool standardization of catheters and medical components. The tooling system is available in 1, 2, 4, 8, and 16 cavity drops, and can be applied to prototype manufacturing, bridge tooling, and/or full scale production. The system allows for fast cavity exchange without the removal of the base from the molding press. By stocking standard inserts, Biomerics can turn around new designs for its customers in as little as 2-3 weeks.

“As an FDA registered facility and an ISO-13485 certified manufacturer, we produce devices that must adhere to the requirements laid out under current good manufacturing practices (cGMP),” remarked Mike Anderson, Director of Sales and Marketing at Biomerics. “In order to ensure our compliance as a contract manufacturer, we have to document and manufacture products with precision and accuracy. The Rapid-Adapt™ system was developed with respect to cGMP and was designed to cut lead times and capital costs associated with traditional tooling, while preserving product realization/design transfer requirements.”

Travis Sessions, CEO of Biomerics, concluded, “We are excited about the Rapid-Adapt™ system and the flexibility and value it provides for customers. Combined with our expertise in material technologies, device development, and product manufacturing, the Rapid-Adapt™ system helps us deliver solutions to our customers faster than ever before. We are thrilled to expand our manufacturing capabilities and we are proud of the engineers who worked hard to develop this unique system.”

Biomerics LLC specializes in the design, development, and production of finished medical devices used in diagnostic and interventional procedures. Biomerics provides complete development and manufacturing solutions for customers in the cardiovascular, structural heart, cardiac rhythm management, electrophysiology, neurovascular, vascular access, and pain management markets. Headquartered in Salt Lake City, Biomerics has operations across four ISO-13845 compliant facilities.

For more information, visit: www.biomerics.com

Published in Biomerics

As part of its $20 million Google Impact Challenge focused on disabilities, Google.org has awarded a $600,000 grant to the Enable Community Foundation to further advance the e-NABLE community's innovative work on 3D-printed open-source prosthetics.

"We created the Enable Community Foundation to support the fast-growing community of volunteers now known around the world as "e-NABLE", said Foundation president Jon Schull. "Google.org's support will allow us to improve-- and to prove--our products and our processes."

As the world’s largest and most active open source prosthetics community, e-NABLE has produced hundreds of 3D printed prosthetic hands and continues to innovate low cost 3D printed prostheses.

Until recently, children with upper limb differences had few affordable prosthetic options because the conventional fabrication approaches are often too expensive and time-consuming for children who quickly outgrow them. The e-NABLE community leverages open source research and design, crowd-sourced fabrication, and mass-customization to produce affordable and effective prosthetics for children and adults.

"We think the e-NABLE community's products and practices are a potential model for other ventures that can inspire digital humanitarians to use emerging technologies to develop innovative solutions for underserved populations," said Schull, who is a Research Scientist at Rochester Institute of Technology. "Google.org has challenged us to test that idea, and given us the resources to do it, even as we continue to serve volunteers and recipients."

The Enable Community Foundation will use the funding to accelerate research and development through strategic partnerships, global design challenges, and to develop free and open source self-service software such as Handomatic which empowers individuals and groups to use, and to further develop, e-NABLE's inexpensive prosthetic solutions.

Ivan Owen, one of the Enable Community Foundation's directors observed, "We live in a time with an unprecedented level of access to knowledge, technology… and to each other. This opens the door to more flexible models for developing ideas and discovering unique solutions to unique problems, including the ability for people to work together even when they are an incredible distance apart. Our community has thrived as a result of powerful communications tools like Google Hangouts. It is a truly wonderful thing to now have Google’s direct support. As has always been the case with the e-NABLE community, by working together we can do more than we could ever dream of doing on our own."

The e-NABLE community is an open community founded by Jon Schull in 2013 to crowd-source the design, fabrication, and dissemination of 3D-printed prosthetics for children and others missing fingers or hands  The volunteer community has grown continuously since then, and has already delivered hundreds of devices to  recipients in at least 37 countries. The Enable Community Foundation was founded in October 2014 to support the mission and operations of the e-NABLE community.

For more information, visit: www.enablingthefuture.org

Published in Enabling The Future

Celebrating its 25th anniversary, global 3D Printing pioneer Materialise (NASDAQ:MTLS) announces the launch of the latest Mimics Innovation Suite, including the Mimics® 18.0 and 3-matic® 10.0 software solutions. The new and improved tools increase user-friendliness, reduce segmentation time and make design and modeling even more realistic. It’s also possible to 3D print the results in full color. In addition, the visualization capabilities have been expanded with a fluoroscopy view and virtual X-ray simulation.

The Mimics Innovation Suite offers a complete set of tools developed for biomedical professionals. With the addition of the ‘Fluoroscopy View’, healthcare professionals can simulate the angiographic view they would have during surgery and identify optimal c-arm angles for fluoroscopy for their region of interest. “This impressive new tool will be useful for our case planning as well as during conversations with physicians”, says Srinivasan Varahoor, Principal R&D Engineer at Medtronic. A second new visualization option is the ‘Virtual X-ray’* tool, which allows engineers to create virtual X-rays of projects to find the optimal angle for 2D/3D registration. This allows for an evaluation of the 3D position of bones and implants without a post-operative CT or MRI scan.

Another exciting and time-saving tool is the automated ‘Heart Segmentation’. This flexible, user-friendly solution allows for an effortless segmentation of the cardiovascular anatomy for advanced research and analyses. On a good quality dataset, segmentation now requires only a few mouse clicks rather than several hours of tedious work. In addition, the ‘Loft’ and ‘Sweep Loft’ tools make it easy to design benchtop models.

With the advanced export options, it is now possible to add a logo to the design in only a few seconds and export it in *zpr format for 3D Printing in multiple colors. Holding such a model in one’s hand can greatly improve the understanding of the different anatomical structures.

Apart from software improvements, a new way to characterize the mitral valve has been added to the Mimics Innovation Suite. This new patent pending workflow allows for a detailed analysis of this complex anatomy, reduces the number of design iterations needed and permits more confident entry into clinical trials.

*Available in the Research Edition of the Mimics Innovation Suite only

For more information, visit: biomedical.materialise.com/MIS/new-release

Published in Materialise

The Wyss Institute's human organs-on-chips, represented by the human lung, gut and liver chips, have won the 2015 Designs of the Year Awards prize in the best Product design category. The annual awards and museum exhibition by the Design Museum in London recognizes the most innovative, high–impact, and forward–thinking designs from across the world.

"This year's judges were united in their responsibility to award projects that emphasize design's impact on our lives now and in the future. Solving diverse problems with innovation, intelligence and wit, each of these six designs is a worthy winner," said Gemma Curtin, Curator of Designs of the Year, speaking about the six prize winners representing Product, Architecture, Fashion, Transport, Digital and Graphics design.

Currently in its eighth year, the 2015 Designs of the Year Awards & Exhibition features 76 total nominees across six categories, chosen by the world's top design experts, practitioners, curators and academics. This year's awards will climax next month, in June, when an overall Design of the Year prize will be bestowed upon one of the six selected finalists.

To clinch the Product prize, the Wyss' human organs–on–chips competed against 22 other product designs, including: QardioArm, a discreet personal heart monitor; Project Daniel, a lab that braves hostile war conditions to 3D–print prosthetic arms for children in Sudan; Dragonfly, an asymmetric chair inspired by insects; a DIY gamer kit, which can be a technology learning aid for children; CurrentTable, a table that photosynthesizes electricity; and an air–purifying billboard that turns pollution into clean air.

"As a scientist whose work has been influenced and inspired by art and design from the very beginning of my career, I am greatly honored that organs–on–chips have won this year's Product prize for design," said Wyss Institute Founding Director Donald E. Ingber, M.D., Ph.D., who invented human organs–on–chips alongside Dan Dongeun Huh, Ph.D., who was a Wyss Technology Development Fellow at the time of its invention. "We are thrilled to know that an international forum of experts who are passionate about the power of design appreciate both the elegance and potential impact of our living organs–on–chips microdevices."

The initial human organ-on-a-chip, designed at the Wyss Institute in 2010 by Ingber and Huh, has since been leveraged for the design of several additional human organs-on-chips. These microdevices have the potential ability to deliver transformative change to human health and pharmaceutical care due to the accuracy with which they emulate human organ-level functions. They stand to significantly reduce the need for animal testing by providing a faster, less expensive, less controversial and much more accurate means to predict whether new drug compounds will be successful in human clinical trials. In 2014, the startup company Emulate, Inc., sprang out of the Wyss Institute in order to commercialize human organs-on-chips.

"With drug development costs running into billions of pounds, this entry really caught the imagination of all the judges. It's an intriguing and exciting prospect that has the potential to reduce animal testing, and at the same time speed up development of new drugs," said member of the award jury Richard Woolley, who is Studio Director at Land Rover Design Research & Special Vehicle Operations.

Human organs-on-chips are built using an innovative microfabrication process adapted from the computer chip industry, in which multi-layer photolithography is used to manufacture memory-stick-sized blocks of crystal-clear, flexible rubber that contain hollow microchannels. These microchannels are then lined with living organ cells and blood capillary cells under fluid flow and manipulated mechanically using vacuum-powered movements to replicate organ movements.

The human organs-on-chips and 75 other overall nominees are currently on display in the Designs of the Year Awards Exhibition at the Design Museum in London, which will remain open until August 2015.

Published in Harvard

A patient in Argentina required a particularly large cranial implant after stroke-related surgery, placing stringent requirements on the manufacture of the prosthetic. Naturally it needed to fit precisely, but in this case it also had to be permeable to allow brain fluid to pass through. Minimal heat conduction to the cerebral tissue was important, especially in a sunny climate. Additionally, biocompatibility was needed to allow the bone to grow into the edges of the implant.

A titanium alloy lattice structure secured by screws directly into the skull was deemed to be ideal. It was additively manufactured layer by layer from metal powder in a machine produced by German firm, EOS, whose UK subsidiary is on the Warwick Technology Park.

The one-and-a-half-hour surgical procedure was carried out successfully in May last year (2014). The patient left hospital after two days and the wound healed within three weeks. Since that time there have been no complications and the patient has been able to lead a normal life.

Several stringent mechanical requirements had to be met to ensure a successful result and technological advances in additive manufacturing allowed them to be achieved. The pores in the implant are approximately 1 mm across, while the links are about 0.2 mm thick, resulting in 95 percent porosity. To achieve such a fine mesh in a rigid structure to tight dimensional and profile tolerances would be impracticable using conventional, subtractive production techniques.

Time was of the essence in producing the implant. The process was started by Novax DMA in Buenos Aires, which specialises in developing and supplying medical implants for traumatology, orthopaedics and craniofacial surgery. For the 3D design of the implant, software was employed from UK company, Within, which allowed the basic form and porous structure to be defined quickly.

As soon as the CAD work was completed, Alphaform AG, near Munich, manufactured the implant in a matter of hours in an EOSINT M 280 metal additive manufacturing machine from EOS. The implant was in the operating theatre less than three weeks later, with transportation consuming one-third of that time.

Christoph Erhardt, Director of Additive Manufacturing at Alphaform, commented, “We had already successfully completed many additively manufactured products in the EOS system.

“However, we are particularly proud of this implant, not only because of the precise realisation of the form, but also because we were able to optimise the porous structure and the difficult process of cleaning the small interior spaces.

“We developed a multi-step process of abrasive and mechanical cleaning, rinsing and ultrasonics to arrive at the required level of medical purity, which is vital as particles can dislodge with the slightest movement, leading to the possibility of infections or rejection.”

The level of cleanliness was verified by extensive tests, including particle and cytotoxicity testing. Gas-chromatography analysis was also performed. Other tests confirmed that the implant fulfilled the necessary requirements to stabilise and protect the patient's skull.

Daniel Fiz, CEO of Novax DMA, added, “We have been supplying medical implants since 1995. Additive manufacturing represents a new milestone for patients. It offers optimal biomedical characteristics together with the highest levels of compatibility, thereby having a lasting effect on improved quality of life.

“For these reasons, we have applied the technology with success to other areas of the body. Alphaform has also manufactured jaw implants for us, as well as a hip joint and a spinal implant. For the latter, we are currently considering series production using additive manufacturing.”

Christoph Erhardt concluded, “For us, additive manufacturing and EOS are synonymous. We have already produced an enormous number of parts for many companies. Both we and our customers are continually amazed by the application possibilities and the high-quality production that can be achieved.

“That was once again the case here. We were able to help a person to live a normal life, on an ongoing basis, despite their having suffered a very serious injury.”

Published in EOS

3D Systems (NYSE:DDD) announced that more than 10,000 disabled dogs are now able to run faster, jump higher and play harder thanks to 3D printed metal orthopedic knee implants that the Company manufactured for Rita Leibinger Medical. Digitally designed and 3D fabricated titanium implants empower veterinarians to compress the treatment-to-recovery cycle of a common, but difficult-to-solve problem in dogs' legs, underscoring the power of 3D printing to improve the quality of life for all.

The patent pending TTA RAPID™ (Tibial Tuberosity Advancement) implant effectively repairs damage to cruciate ligaments in dogs' hind legs caused by trauma, degeneration or genetics. This revolutionary treatment begins with a 3D printed implant that is inserted into the dog's lower leg, reorganizing the mechanical forces of the bones and creating dynamic knee stability without the need to repair the damaged ligament. In success, dogs – from Jack Russells to Great Danes – are able to walk and run freely six weeks after surgery.

"It is heartbreaking to see your dog in so much pain that he or she can barely walk," said Rita Leibinger, owner and founder of Rita Leibinger Medical. "With this implant we experienced faster, more successful surgery and a faster recovery period. It is gratifying to see progress like this improve the lives of these animals and their families."

The key to this ground breaking implant's success is its complex, open structure that promotes rapid bone ingrowth, with less risk of infection. Rita Leibinger Medical teamed up with 3DS to manufacture these proprietary titanium implants in its state-of-the-art healthcare manufacturing facility in Leuven, Belgium, while the surgical technique was perfected in collaboration with Dr. Yves Samoy from Ghent University in Belgium.

"With 3D printing complexity is free, which is critical to unlocking performance and efficacy in the medical field," said Kevin McAlea, Chief Operating Officer, Healthcare Products, 3DS. "Unlike traditional manufacturing, there is no penalty for complexity or scale, so we are able to produce a wide range of implant sizes quickly and economically. 3D printing is the clear choice for better functional and scalable solutions, in healthcare and beyond."

A year after an initial European release and subsequent distribution in the U.S., the Rita Leibinger Medical TTA Rapid implant is poised for worldwide release and the team is working on scaled down implants for smaller dogs and cats.

RITA LEIBINGER GmbH & Co. KG is a family owned and family run company. The headquarter is located in South-West Germany near the Black Forrest. The Leibinger Family has a long history and experience in the medical business starting with Rita's father Oswald Leibinger who was a highly recognized entrepreneur in human medicine. The RITA LEIBINGER business is focused on innovative veterinary medical products. Now the company is the worlds leading supplier for 3D printed Knee and Spinal Implants for companion animals.

For more information, visit: www.leibinger-medical.com

Published in 3D Systems

3D Systems (NYSE:DDD) announced that it has successfully outfitted Derby the dog with 3D printed prosthetics, allowing him to run down the street for the first time ever. Derby was born with a congenital deformity characterized by small forearms and no front paws. While always cheerful, Derby was, until now, only able to get around on soft surfaces. Hard surfaces, like sidewalks, cause severe abrasions on his front extremities.

Having fostered Derby through the dog rescue group Peace and Paws in Hillsborough, N.H., Tara Anderson decided to help. Tara, as a 3D Systems employee, knew that 3D printing afforded an unmatched level of design freedom, functionality and speed. Using 3D technology, she knew it would be possible to rapidly design and manufacture prosthetics customized to Derby's morphology.

Marshaling help from Derrick Campana, a certified Orthotist at Animal Ortho Care in Chantilly, VA, and 3DS designers, Kevin Atkins and Dave DiPinto, data of Derby's forearms and 3D scan data of a cup design, created by Campana, were used to create the 3D design. The team utilized Geomagic Freeform, 3DS' digital sculpting platform, which allowed them to create perfect organic shapes and smooth curves for Derby's shape.

The ProJet 5500X delivers multi-material 3D printing in a single build, so Tara and the designers could build complete prosthetics with comfortable cups in rubber and rigid spokes and base. Ready in a few hours, the prosthetics were shipped to Derby for testing.

"The beauty of 3D printing is that if the design needs to be adjusted, we don't have to wait for time-consuming and expensive traditional manufacturing processes, we can simply print out a new set," said Buddy Byrum, Vice President of Product and Channel Management, 3DS. "The dovetailing of 3D scanning and design with the ProJet 5500X multi-material 3D printing allowed for the creation of complete prosthetics printed in a single build, custom-fit to Derby."

Through the power of 3D, Derby is now able to run alongside, and sometimes past, his newly adoptive owners, Sherri and Dom Portanova.

""He runs with Sherri and I every day, at least two to three miles," said Dom Portanova. "When I saw him sprinting like that on his new legs it was just amazing."

For more information, visit: www.3dsystems.com

Published in 3D Systems

Oxford Performance Materials Inc. (OPM) announced that it has received a three-year, $150,000 grant from the National Institutes of Health (NIH) to explore new approaches to improve the treatment of infections related to artificial hips, knees and other implanted devices through advanced applications of 3D printed poly-ether-ketone-ketone (PEKK).

The NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) provided the funding to Dr. Adam Hacking, PhD, Chief Scientific Officer, at OPM. The long-term goal of this research is to develop improved methods to treat infections associated with implanted devices. The NIH grant will support research developing new approaches for the delivery of antibiotics through OPM's 3D printed PEKK implants.

"We are extremely grateful for the NIH support, as well as the peer reviewed process that recognized the magnitude of the clinical problem and the potential for advancement that our approach offers," said Dr. Hacking. "Device related infections are a burdensome clinical issue that results in prolonged patient suffering, increased mortality, and are expected to cost $12 billion per year by 2015. With this support from the NIH, we have the potential to rapidly advance treatment for bone and joint infections, reduce healthcare costs, reduce patient suffering and improve patient care."

Dr. Hacking continued, "3D printing has enabled the combination of a load-bearing implantable material, PEKK, with the simplicity, flexibility and availability of perfusable drug delivery systems. Perfusion is a desirable approach since nearly all therapeutics are deliverable in solution. Perfusion also enables the initiation, change, cessation or restoration of therapeutic delivery at any point in time."

This multidisciplinary research program involves established and productive experts in infectious disease, orthopedic surgery, chemical engineering, fluid dynamics and biomedical engineering from the Dept. of Orthopedics at the Massachusetts General Hospital (MGH), Harvard Medical School and the School of Engineering and Applied Sciences at Harvard University.

Oxford Performance Materials (OPM) is a recognized leader in 3D printing and high performance additive manufacturing (HPAM™). OPM has developed a range of advanced materials technology focused on the high performance polymer, poly-ether-ketone-ketone (PEKK). OPM is the first company to successfully apply additive manufacturing solutions to PEKK by utilizing the company's proprietary OXPEKK® formulation and delivers enterprise level, functional end-use products to the biomedical, aerospace and industrial markets. A pioneer in personalized medicine, OPM became the only company to receive FDA clearance to manufacture 3D printed patient-specific polymeric implants for its cranial prostheses line in February 2013, and its Biomedical division received a second 510(k) for its patient-specific facial implants in July 2014.

For more information, visit: www.oxfordpm.com

CSIRO, St Vincent's Hospital and Victorian biotech company Anatomics have joined together to carry out world-first surgery to implant a titanium-printed heel bone into a Melbourne man.

Printed using CSIRO's state-of-the-art Arcam 3D printer, the heel bone was implanted into 71-year-old Len Chandler, a builder from Rutherglen Victoria, who was facing amputation of the leg below the knee following a diagnosis of cancer of the calcaneus, or heel bone.

St Vincent's Hospital surgeon Professor Peter Choong was aware of CSIRO's work in titanium 3D after reading about our work producing an orthotic horseshoe in 2013, and contacted CSIRO's John Barnes in early June about his vision for a metallic implant which would support the body's weight.

At the time, CSIRO happened to be working with the Victorian-based biotech company Anatomics on metallic implant technology and CSIRO brought Anatomics into the discussion with Professor Choong to draw on their experience as a certified custom medical device manufacturer.

Working from Anatomics' schematics for the calcaneus heel bone, teams at Anatomics and CSIRO developed the design requirements with Professor Choong's surgical team.

Included in the design were smooth surfaces where the bone contacts other bone, holes for suture locations and rough surfaces to allow tissue adhesion. Anatomics and CSIRO produced three implant prototypes in the days before the surgery.

In the space of two weeks, from first phone call to surgery, CSIRO and Anatomics were able to custom-design and present an implant part to the St Vincent's surgical team, in time for the surgery on the second week of July.

Mr Chandler returned to St Vincent's Hospital this week for a check-up and said he was recovering well, and able to place some weight on his implant.

"The customisation of 3D printing is good in emergency situations such as these," a member of CSIRO's titanium printing team Dr Robert Wilson said.

"Custom designed implants mean job opportunities in this area as these types of surgeries become more commonplace."

CSIRO is working with a number of major companies and SMEs across Australia to build capacity in biotech and manufacturing.

"3D printing is a local manufacturing process, meaning Australian companies produce implants for our own patients for our own doctors to use," CSIRO's Director of High Performance Metal Industries John Barnes said.

"We would no longer have to rely on imported parts that slow the process down and is less personal for the patient.

"At some point in the future we expect that local for-profit businesses will have the capacity to work on projects like this, and meanwhile the CSIRO is here to help local industry grow and build momentum."

For more information, visit: www.csiro.au/Organisation-Structure/Flagships/Future-Manufacturing-Flagship/Ti-Technologies.aspx

Published in CSIRO

Materialise NV (Nasdaq:MTLS), a leading provider of additive manufacturing software and of sophisticated 3D printing solutions in the medical and industrial markets, has listed its 3D-printed cardiovascular HeartPrint® models as a medical device in the USA and EU markets. After years of 3D printing anatomical models for educational and research purposes, the company addressed the need for models that can assist with diagnosing, planning and practicing complex cardiovascular procedures. This move strengthens the company's unique position in the market and is a natural extension of its Mimics® Innovation Suite of software for medical image processing which has an existing 510(k) clearance and CE mark.

By listing HeartPrint as a Class 1 medical device, the company is able to add HeartPrint models to their offering for pre-operative planning. The 3D-printed, patient-specific cardiovascular models are created from medical image data to provide cardiologists and surgeons with supplemental information to determine the best treatment for each unique patient.

"Where I think clinically 3D printing will take us, is to the next generation of imaging. As we've seen in the history of medicine, the better and better our imaging, the more precise we are to pre-operatively be able to say what operation we're going to do," said David Morales, MD, Chief of Cardiovascular Surgery for the Heart Institute at Cincinnati Children's Hospital Medical Center.

Nearly every week, the added-value of 3D printed solutions in the medical arena makes headlines. A recent story covered a 1-week-old baby who was born with a complex form of congenital heart disease in which both the aorta and pulmonary arteries arise from the right ventricle as well as a large hole in the heart called a ventricular septal defect (VSD). Only one day after he was born, an extremely low dose chest CT scan was acquired and data was sent to Todd Pietila, Cardiovascular Business Development Manager at Materialise, who created a digital 3D model of the baby's heart using Mimics® and then 3D-printed a replica where even the smallest details were visible. With the walnut-size model in hand, the team of clinicians at the NewYork-Presbyterian/Morgan Stanley Children's Hospital were able to find a solution for repairing all of the baby's defects in one procedure rather than the typical series of palliative operations which can be life threatening.

"After the success of this surgery, it's hard to imagine entering an operating room for another complex case without the aid of a 3D printed model. It's definitely going to be standard of care in the future and we're happy to be leading the way," said Dr. Emile Bacha, a congenital heart surgeon and Director of Congenital and Pediatric Cardiac Surgery at NewYork-Presbyterian/ Morgan Stanley Children's Hospital.

Regulatory entities have raised concerns about 3D printing in a clinical environment as a validated quality system is critical for ensuring accuracy and safety. Materialise is the only company who is actively addressing these issues with their Mimics Innovation Suite for segmenting the medical image data and Streamics, which is dedicated to automating, controlling and tracking the 3D printing process to ensure traceability and clinical-level quality standards.

"We're proud that the Mimics Innovation Suite is one of the few engineering packages with the appropriate validation to be considered a medical device. This makes it easier for Materialise and our customers to bring patient-specific, 3D-printed treatments to the market. It's important for us to stay ahead of the regulatory requirements," Koen Engelborghs, Director of Biomedical Engineering at Materialise, states. "We saw the advantages for patients when HeartPrint models were used in a clinical environment and are looking forward to continuing our collaborations with hospitals to address their 3D printing needs."

For more information, visit: www.biomedical.materialise.com/heartprint

Published in Materialise

Materialise, a pioneer in the medical applications of 3D Printing, has worked together with hand specialist Dr. Verstreken to give children with complex, improperly-healed forearm fractures a fresh chance for a carefree and active childhood. One of these children is 7-year-old Joos. Although he once avoided the use of his badly-healed arm, Joos can no longer tell which arm he had surgery on without looking for the scar.

The beginning of Joos’s story is a familiar one for many parents of active young children as it starts when he broke both bones in his left forearm in a playground accident in 2013. Where this story differs is that when the healing process was complete and the cast was removed, it was revealed that Joos had a crooked, improperly-healed arm for which the simplest movements had become impossible. This also left him without feeling in his fingers.

Against the advice of their doctor and physiotherapist who told them that there was nothing to be done, Joos’s parents started looking for a way to fix their son’s arm and found hand specialist Frederik Verstreken MD (Monica Hospital, Antwerp, Belgium). Dr. Verstreken used Materialise’s technology, including 3D surgical planning solutions and 3D printed, patient-specific surgical guides, and Mobelife’s 3D-printed, custom-made titanium implants to perform an osteotomy and restore full-functionality to the boy’s arm.

The result of the surgery exceeded the parents’ expectations. Soon after the surgery, Joos regained the feeling in his fingers, a sensation he had not felt for the previous 6 months, and could once more enjoy life as an active young child. “I had a child with a handicap, now he’s a normally functioning boy,” Kathleen, Joos’s mom, testifies.

In the meantime, Dr. Verstreken has performed four other similar surgeries on children who lacked full mobility in their forearm after double fractures improperly healed. “These cases were so difficult and complex that it would not have been possible to obtain a successful reconstruction using conventional techniques.”

For more information, visit: ortho.materialise.com

Published in Materialise

A team of researchers at Louisiana Tech University has developed an innovative method for using affordable, consumer-grade 3D printers and materials to fabricate custom medical implants that can contain antibacterial and chemotherapeutic compounds for targeted drug delivery.

The team comprised of doctoral students and research faculty from Louisiana Tech's biomedical engineering and nanosystems engineering programs collaborated to create filament extruders that can make medical-quality 3D printing filaments. Creating these filaments, which have specialized properties for drug delivery, is a new concept that can result in smart drug delivering medical implants or catheters.

"After identifying the usefulness of the 3D printers, we realized there was an opportunity for rapid prototyping using this fabrication method," said Jeffery Weisman, a doctoral student in Louisiana Tech's biomedical engineering program. "Through the addition of nanoparticles and/or other additives, this technology becomes much more viable using a common 3D printing material that is already biocompatible. The material can be loaded with antibiotics or other medicinal compounds, and the implant can be naturally broken down by the body over time."

According to Weisman, personalized medicine and patient specific medication regiments is a current trend in healthcare. He says this new method of creating medically compatible 3D printing filaments will offer hospital pharmacists and physicians a novel way to deliver drugs and treat illness.

"One of the greatest benefits of this technology is that it can be done using any consumer printer and can be used anywhere in the world," Weisman said.

Weisman, who works out of a lab directed by Dr. David K. Mills, professor of biological sciences and biomedical engineering, partnered with Connor Nicholson, a doctoral candidate in nanosystems engineering and member of a lab operated by Dr. Chester Wilson, associate professor of electrical and nanosystems engineering, to develop the technology in collaboration with Mills. The group also worked with Extrusionbot, LLC of Phoenix, Arizona, who provided important materials support throughout the development and testing process.

"We had been working on several applications of 3D printing," said Mills. "Several students in my lab including Jeff and Connor, who was a guest researcher from Dr. Wilson's lab, had been working with colleagues for some time. I sent an email to them and asked them the question, 'Do you think it would be possible to print antibiotic beads using some kind of PMMA or other absorbable material?'"

From that point, the technology evolved and has become a highly innovative approach to overcoming many of the limitations encountered in current drug delivery systems. Most of today's antibiotic implants, or "beads," are made out of bone cements which have to be hand-mixed by a surgeon during a surgical procedure and contain toxic carcinogenic substances. These beads, which are actually a type of Plexiglas, do not break down in the body and require additional surgery for removal. Weisman and his team's custom 3D print filaments can be made of bioplastics which can be resorbed by the body to avoid the need for additional surgery.

The nature of the 3D printing process developed at Louisiana Tech allows for the creation of partially hollow beads that provide for a greater surface area and increased drug delivery and control. Localized treatment with the 3D printed antibiotic beads also avoids large systemic drug dosages that are toxic and can cause damage to a patient's liver and kidneys.

"Currently, embedding of additives in plastic requires industrial-scale facilities to ensure proper dispersion throughout the extruded plastic," explains Mills. "Our method enables dispersion on a tabletop scale, allowing researchers to easily customize additives to the desired levels. There are not even any industrial processes for antibiotics or special drug delivery as injection molding currently focuses more on colorants and cosmetic properties."

"It is truly novel and a worldwide first to be 3D printing custom devices with antibiotics and chemotherapeutics."

The team said the environment at Louisiana Tech played a large role in this project making the progress it has, in a relatively short period of time. "The project has been able to advance to this point because of the support of and easy access to interdisciplinary facilities and outstanding faculty such as Drs. Mills, Wilson and [Dr. Mark] DeCoster," said Weisman. "They and their labs have been crucial in taking cell culture and chemotherapeutic related aspects of this project to the next level"

"It is important to continue support of this research and to help bring Louisiana Tech to the forefront of rapid prototyping designs that will have impacts on a national scale."

For more information, visit: www.latech.edu

Oxford Performance Materials, Inc. (OPM), a leading advanced materials and additive manufacturing (3D printing) company, announced that it has received 510(k) clearance from the FDA for its 3D printed OsteoFab® Patient-Specific Facial Device (OPSFD).

OPM's facial device is the first and only FDA cleared 3D printed polymeric implant for facial indications, and follows FDA clearance of the first and only 3D printed polymeric implant, OPM's OsteoFab Patient-Specific Cranial Device, which was granted in February 2013.

"There has been a substantial unmet need in personalized medicine for truly individualized - yet economical - solutions for facial reconstruction, and the FDA's clearance of OPM's latest orthopedic implant marks a new era in the standard of care for facial reconstruction," said Scott DeFelice, Chief Executive Officer and Chairman of Oxford Performance Materials. "Until now, a technology did not exist that could treat the highly complex anatomy of these demanding cases. With the clearance of our 3D printed facial device, we now have the ability to treat these extremely complex cases in a highly effective and economical way, printing patient-specific maxillofacial implants from individualized MRI or CT digital image files from the surgeon. This is a classic example of a paradigm shift in which technology advances to meet both the patient's needs and the cost realities of the overall healthcare system."

The OPSFD will be 3D printed by OPM Biomedical, an original equipment manufacturer (OEM) of medical devices utilizing the company's OsteoFab® process, which combines laser sintering additive manufacturing technology and OPM's proprietary OXPEKK® powder formulation to print orthopedic and neurological implants. These implants are biocompatible, mechanically similar to bone, radiolucent, and support bone attachment (i.e. osteoconductive).

OPM technology is also designed to reduce the overall "cost of ownership" to the customer by decreasing operating room time, hospital length of stay and procedure complications. In addition, OsteoFab customers do not pay a premium for the individualized 3D printed implant.

"An exciting aspect of our technology is that additional complexity does not increase manufacturing cost, and having both cranial and facial devices cleared now enables us to answer ever more complex cases where upper facial structures can be incorporated with cranial implants as a single device," added Severine Zygmont, President of OPM Biomedical. "As a result, additive manufacturing has the potential to not only improve patient outcomes, but fundamentally improve the economics of orthopedics on a global scale – for developed and developing countries. These are disruptive changes that will allow the industry to provide the finest levels of healthcare to more people at a lower cost."

Biomet, Inc., a leading distributor of advanced technologies for the treatment of arthritis, joint and spine related injuries and facial reconstruction, will be the exclusive global distributor of OPM's OPSFD. Biomet is also the exclusive global distributor of OPM's OsteoFab Patient-Specific Cranial Device.

Oxford Performance Materials (OPM) is a recognized leader in 3D printing and high performance additive manufacturing (HPAM™). OPM has developed a range of advanced materials technology focused on a high performance polymer, poly-ether-ketone-ketone (PEKK), and delivers enterprise level, functional end-use products to the biomedical, aerospace and industrial markets as the first company to successfully apply additive manufacturing solutions to PEKK. A pioneer in personalized medicine, OPM became the only company to receive FDA clearance to manufacture 3D printed patient-specific polymeric implants for its cranial prostheses line in February 2013, and its Biomedical division received a second 510(k) for its patient-specific facial implants in July 2014.

For more information, visit: www.oxfordpm.com

3D Systems (NYSE:DDD) announced that it entered into a definitive agreement to acquire Simbionix for $120 million in cash, subject to customary closing adjustments. Simbionix is the global leader in 3D virtual reality surgical simulation and training with 60+ interventional procedures across 8 specialties through 16 simulation platforms — a complementary building block that expands 3DS’s breadth and reach within the open-ended 3D healthcare field.

“Simbionix is a perfect match for our healthcare business and its powerful technology, products, channels and domain expertise expands our 3D healthcare capabilities from the training room to the operating room, and extends our first mover advantage in this fast growing vertical,” said Avi Reichental, President and Chief Executive Officer, 3DS.

Headquartered in Cleveland, Ohio with a research and development center in Israel, Simbionix pioneered patient-specific simulation with FDA-cleared solutions that are changing the way preparation for individual surgeries are carried out. Its proprietary simulation and training products are revolutionizing the way physicians practice and master surgical procedures with improved learning that can favorably impact patient outcomes.

“3D Systems is the recognized 3D healthcare leader and they have an exceptional track record of commercially deploying innovative virtual surgery and medical device products and services,” said Gary Zamler, Simbionix Corporation CEO. “We couldn't be more excited to join this fine organization and look forward to accelerate our growth by enhancing the entire 3D digital thread for the benefit of our customers worldwide.”

The recent acquisition of industry leader Medical Modeling brought to 3DS world-class clinical capabilities in Virtual Surgical Planning (VSP®), guiding and instrumenting of complex personalized surgical procedures, production at scale of 3D printed implants, and delivery of a wide variety of 3D printed patient-specific medical devices.

In addition to synergistic technology and products, Simbionix brings to 3DS global sales channels and deep clinical relationships to accelerate the adoption of best medical practices, to advance clinical performance, and to optimize procedural outcomes. The company’s products can be found in simulation centers, hospitals, colleges and other educational facilities in over 60 countries.

The company plans to operate Simbionix under the continued leadership of Gary Zamler, CEO of Simbionix, who will become Vice President and General Manager, Simbionix Products for 3DS and immediately pursue synergistic integration opportunities leveraging the combined resources and expertise to advance 3DS’ healthcare portfolio further and faster.

For more information, visit: www.simbionix.com

Published in 3D Systems

Materialise is proud to announce the launch of the latest Mimics Innovation Suite, including the Mimics 17.0 and 3-matic 9.0 software solutions. As the industry standard for processing and editing anatomical data from medical images, the software is now further strengthened with numerous time-saving new tools, the ability to import 3D Ultrasound data* and two new modules: X-ray* and Pulmonary.

For nearly 25 years, Materialise has been leading the way in solutions for evidence-based R&D starting with medical image data. Now, with the addition of the X-ray Module*, it’s  possible to analyze the 3D position of bones and implants at each critical moment of a patient’s treatment, without the expense of multiple MRI scans and unnecessary exposure to high doses of radiation with additional CT scans. By combining 3D imaging modalities with X-ray images engineers can work in the 3D environment they prefer, while collaborating with clinicians in the modality they’re most accustomed to using. This powerful combination opens up numerous possibilities such as comparing 3D pre-operative plans with post-operative results to analyze and improve surgical procedures.

The new Pulmonary Module enables clinicians to derive more anatomical information from your lung CT scans. This flexible, fast and user-friendly solution facilitaties the accurate segmentation of the lower respiratory system for advanced research and analyses. Though segmenting the pulmonary system has always been possible in Mimics, the new module offers improved outcome parameters that enable the early detection of diseases and the innovation of options for localized therapies.

By adding new import modalities to the Mimics Innovation Suite like 3D Ultrasound*, Engineering on AnatomyTM acquires a much broader scope, allowing for fully dynamic cardiovascular analyses. As Ultrasound is readily available, safe for patients, administered in comfortable positions, less expensive compared to MRI or CT and now able to be imported into the Mimics Innovation Suite; its utility for R&D is higher than ever.

*Available in the Research Edition of the Mimics Innovation Suite only

For more information, visit: biomedical.materialise.com/mimics-innovation-suite-new-release-out-now

Published in Materialise

Motorcyclist Stephen Power was severely injured in an accident near Cardiff, UK. He broke both arms and his right leg was damaged so badly it required a bone graft. Stephen also suffered major injuries to his head and face. He regained consciousness after several months in the hospital.

Consultant maxillofacial surgeon Adrian Sugar explains that a specialist team at the Morriston Hospital in Swansea, UK, successfully dealt with all facial injuries, with the exception of his left cheek and eye socket. The patient’s cheekbone was too far out and his eye was sunk in and dropped. Due to the close proximity of critical and sensitive anatomical structures, the team applied a more accurate expertise approach. This strategy ensured no further damage to his eye in order to maintain his eyesight. The expertise approach entailed the latest 3D computer-aided practices applied by PDR and innovative 3D printing of the titanium implant and fixation plate by LayerWise.

LayerWise manufactured the implant and fixation plate in medical-grade titanium (Ti6Al4V ELI) in accordance with the ISO 13485 standard. “The 3D printing technology mastered by LayerWise is perfectly suited for producing this kind of ultra strong, precise and lightweight titanium implants,” says Peter Mercelis, Managing Director of LayerWise.

“The reconstructive orbital floor plate plays an essential role in the repositioning of the eye in light of the targeted facial symmetry and eye alignment,” explained Romy Ballieux from LayerWise’s Medical Business Unit. “LayerWise produced the floor plate, and polished its upper surface to minimize friction with soft tissues. The floor plate was fixated to the zygomatic bone through the plate’s dedicated slip with attachment holes. The digital 3D printing technology successfully maintained the accuracy of the precise medical imaging data, pre-operative planning and implant design. The 0.1 millimeter (4 mils) geometric accuracy of the floor plate’s freeform surfaces could not be achieved using traditional manufacturing methods.”

Accuracy is even more critical with regard to the fixation plate. This fairly long, slim, curved 3D printed plate requires precise positioning to be able to tie together many fractured bone pieces of the cheek region. A custom-fitting guide was used to fit securely around the anatomy, with slots located to guide the surgeon’s movement when positioning the plate. The fixation plate restored the correct anatomical connection between the frontal, zygomatic and temporal bone. This connection contributed to the successful reconstruction of the patient’s anatomy, providing the best possible facial symmetry.

Ballieux noted: “Dedicated medical engineering specialized in the production aspects of metal 3D printing were key in achieving the impressive facial reconstruction in such a short timespan. The digital process resulted in the 3D printed implant and fixation plate produced in a single manufacturing step in only a couple of hours.”

After his recovery, Stephan Power experiences the results of the surgery as ‘totally life changing’. Instead of using a hat and glasses to mask his injuries, he is now able to do day-to-day things, go and see people, walk in the street, and even go to any public areas. The improved facial symmetry and alignment of his eyes, achieved with the LayerWise implant and fixation plate, clearly made a big difference to the patient. “We are confident that our metal 3D printing technology is capable of improving the quality of life of many more patients,” Ballieux concluded. “The fast-turnaround digital process, from medical imaging up to the finalized 3D printed implants, delivers the required implant geometry and precision to obtain such great facial reconstructions.”

These implants were the result of a close collaboration beween LayerWise specialists and PDR design experts Sean Peel and Dr. Dominic Eggbeer. PDR has a formal collaboration with the Maxillofacial Unit at Morriston Hospital: cartis (Centre for Applied Reconstructive Technologies in Surgery).

LayerWise’s Medical Business Unit aims at providing maximum patient comfort through serial and patient-specific implant manufacturing. The metal Additive Manufacturing (AM) process mastered by LayerWise yields fully anatomic implant shapes offering increased functionality and esthetics as well as improved osseo-integration. LayerWise offers cost-effective manufacturing of orthopedic, cranio-maxillofacial, spinal and dental implants and instruments.

LayerWise also built the world’s first patient-specific lower jaw using metal 3D printing.

For more information, visit: www.layerwise.com/medical

Published in LayerWise

According to a new research report from Albany, NY based Transparency Market Research, the global market for 3-D printing in medical application was valued $354.5 million in 2012 and is expected to grow at a compound annual growth rate (CAGR) of 15.4 percent from 2013 to 2019 to reach $965.5 million by 2019.

Additive manufacturing has allowed the successful printing of prosthetics, dental work and hearing aids, which can all be made from plastic or pliable materials and often need to be tailored to a specific patient. New technology will soon be able to print blood vessels, skin, even embryonic stem cells and more.

IQPC's Additive Manufacturing: Medical and Healthcare Conference, taking place on May 19, 2014 in Boston, MA will bring together top university researchers and AM services providers to discuss the latest insights on the future of AM technology specifically within the medical and healthcare field. Gain access to over 15 presentations and network with OEMs and hospitals looking for AM services in the medical community.

What topics will be covered?

  • Quality standards (set by FDA)
  • New materials for medical AM
  • Developments for prosthetics and dental filling
  • Innovations in bio-printing (human tissue)

Hear from High Profile Speakers Including:

  • Dr. Steven Pollack, Director, Office of Science and Engineering Laboratories, Food and Drug Administration
  • Harry Kleijnen, Manager, Development and Engineering Grids, Philips GTC Netherlands
  • Dr. Tariq Rahman, Head of Pediatric Research and Engineering, Nemours Hospital
  • Chris Korkuch, Senior Development Engineer, Teleflex
  • Herb Caloud, Development Engineer, GE Healthcare
  • And more

For more information or to register, visit: www.AdditiveManufacturingHealthcare.com

Published in IDGA

Infocast, the leading producer of business intelligence and networking events, is pleased to announce the inaugural BIO-PRINTING Summit. The event is scheduled to take place on November 13-14, 2013 in Atlanta, Georgia. Attendees will be able to join leading international researchers, start-ups and early adopters.

Leading international researchers from the tissue engineering, bioengineering and bio-medical communities, start-up companies, early adopters and investors will convene for Infocast's inaugural BIO-PRINTING Summit to survey the latest innovations in biological laser/inkjet printing, cell and tissue patterning, blood vessels and vascularized networks fabrication, scaffolds and bio-materials.

The Summit will also provide an opportunity to not just hear from distinguished experts, but to build relationships with VCs, end-users and bio-medical device companies for licensing and commercialization opportunities.

Though still in its infancy, bio-printing is poised to revolutionize healthcare and tox testing. In accordance with Henry Fountain’s article – "At the Printer, Living Tissue" – published on August 18, 2013, in the New York Times, “Someday, perhaps, printers will revolutionize the world of medicine, churning out hearts, livers and other organs to ease transplantation shortages.” However, many biological, technical and regulatory challenges must be overcome before these profound biomedical innovations can be put to widespread practical use in improving human health.

This first-ever event will be chaired by Professors Lawrence J. Bonassar, Ph.D., and Jonathan T. Butcher, Ph.D., from the Department of Biomedical Engineering, Sibley School of Mechanical and Aerospace Engineering, CORNELL UNIVERSITY. As Dr. Bonassar recently stated, “Bio-printing promises to change the way we manufacture medical implants, perform toxicology studies, and conduct pharmaceutical screening. This meeting brings together world experts in additive manufacturing and tissue engineering from academics and industry to discuss the history, state-of-the art, and future directions in this exciting new field.”

For more information or to register, visit: www.infocastinc.com/bioprint13

Published in Infocast

Researchers working to design new materials that are durable, lightweight and environmentally sustainable are increasingly looking to natural composites, such as bone, for inspiration: Bone is strong and tough because its two constituent materials, soft collagen protein and stiff hydroxyapatite mineral, are arranged in complex hierarchical patterns that change at every scale of the composite, from the micro up to the macro.

While researchers have come up with hierarchical structures in the design of new materials, going from a computer model to the production of physical artifacts has been a persistent challenge. This is because the hierarchical structures that give natural composites their strength are self-assembled through electrochemical reactions, a process not easily replicated in the lab.

Now researchers at MIT have developed an approach that allows them to turn their designs into reality. In just a few hours, they can move directly from a multiscale computer model of a synthetic material to the creation of physical samples.

In a paper published online June 17 in Advanced Functional Materials, associate professor Markus Buehler of the Department of Civil and Environmental Engineering and co-authors describe their approach. Using computer-optimized designs of soft and stiff polymers placed in geometric patterns that replicate nature’s own patterns, and a 3-D printer that prints with two polymers at once, the team produced samples of synthetic materials that have fracture behavior similar to bone. One of the synthetics is 22 times more fracture-resistant than its strongest constituent material, a feat achieved by altering its hierarchical design.

Two are stronger than one

The collagen in bone is too soft and stretchy to serve as a structural material, and the mineral hydroxyapatite is brittle and prone to fracturing. Yet when the two combine, they form a remarkable composite capable of providing skeletal support for the human body. The hierarchical patterns help bone withstand fracturing by dissipating energy and distributing damage over a larger area, rather than letting the material fail at a single point.

“The geometric patterns we used in the synthetic materials are based on those seen in natural materials like bone or nacre, but also include new designs that do not exist in nature,” says Buehler, who has done extensive research on the molecular structure and fracture behavior of biomaterials. His co-authors are graduate students Leon Dimas and Graham Bratzel, and Ido Eylon of the 3-D printer manufacturer Stratasys. “As engineers we are no longer limited to the natural patterns. We can design our own, which may perform even better than the ones that already exist.”

The researchers created three synthetic composite materials, each of which is one-eighth inch thick and about 5-by-7 inches in size. The first sample simulates the mechanical properties of bone and nacre (also known as mother of pearl). This synthetic has a microscopic pattern that looks like a staggered brick-and-mortar wall: A soft black polymer works as the mortar, and a stiff blue polymer forms the bricks. Another composite simulates the mineral calcite, with an inverted brick-and-mortar pattern featuring soft bricks enclosed in stiff polymer cells. The third composite has a diamond pattern resembling snakeskin. This one was tailored specifically to improve upon one aspect of bone’s ability to shift and spread damage.

A step toward ‘metamaterials’

The team confirmed the accuracy of this approach by putting the samples through a series of tests to see if the new materials fracture in the same way as their computer-simulated counterparts. The samples passed the tests, validating the entire process and proving the efficacy and accuracy of the computer-optimized design. As predicted, the bonelike material proved to be the toughest overall.

“Most importantly, the experiments confirmed the computational prediction of the bonelike specimen exhibiting the largest fracture resistance,” says Dimas, who is the first author of the paper. “And we managed to manufacture a composite with a fracture resistance more than 20 times larger than its strongest constituent.”

According to Buehler, the process could be scaled up to provide a cost-effective means of manufacturing materials that consist of two or more constituents, arranged in patterns of any variation imaginable and tailored for specific functions in different parts of a structure. He hopes that eventually entire buildings might be printed with optimized materials that incorporate electrical circuits, plumbing and energy harvesting. “The possibilities seem endless, as we are just beginning to push the limits of the kind of geometric features and material combinations we can print,” Buehler says.

The work was funded by the U.S. Army Research Office.

Written by: Denise Brehm, Civil and Environmental Engineering

Three-dimensional printing technology is now being used in a University of Colorado Denver | Anschutz Medical Campus laboratory, thanks to a $600,000 capital equipment grant from the Veterans Administration. The CU Denver | Anschutz Medical Campus / VA Biomechatronics Development Laboratory is home to a cutting-edge 3D printer: a metal laser sintering machine.

Richard Weir, Ph.D., a leading researcher in robotic technology for arm amputees, said the fabricator will allow his research team to develop better components -- created faster and less costly -- for prosthetic fingers, hands and arms. Weir, an associate research professor in the Department of Bioengineering, College of Engineering and Applied Science, also envisions creating a prototyping center as a resource for other university and VA researchers.

"It's a whole new way of thinking about how to make things," Weir said. "... The revolutionary aspect is to be able to do stuff that you can't using conventional technology. There is the possibility to fabricate impossible-to-machine components and to explore whether that confers advantage to the designs we're working on."

While 3D plastic printers have been available for many years, metal printing is still "a very nascent technology," Weir said. He estimates that only a couple dozen of the devices -- called direct metal laser-sintering machines and built by German-based EOS e-Manufacturing Solutions -- are being used in the United States, mostly for biomedical and aeronautical applications.

Weir first saw a 3D metal rapid prototype machine being used to create cranial implants -- custom titanium plates in the shape of the human skull -- at a laboratory at North Carolina State University. "When I saw that I said, 'I want one of those.'"

He got his wish in 2011 when the VA, well aware of Weir's pioneering research that could benefit veteran amputees, funded, through a Capital Equipment Grant, the purchase of one of these machines. His lab had already been using a 3D plastic printer, but a metal prototyping machine dramatically expands the horizons for their prosthetic designs.

"That's what we have a need for when we're building our small hands," said Weir, whose Implantable MyoElectric Sensors work will be tested in clinical trials this spring. "We have all of these tiny parts that need to be very strong, and a lot of times steel turns out to be the best material to work in. If we want, we can change the machine's set-up, for a fee of course, that will allow us to print in a different metal. We can print in titanium, nickel, magnesium, cobalt."

Weir and his team, which includes graduate students from the CU Denver | Anschutz Medical Campus College of Engineering and Applied Science (Matthew Davidson and Nili Krausz, bioengineering and mechanical engineering departments) and University of Colorado-Boulder (Jacob Segil, mechanical engineering), saw the EOSINT M270 arrive from Germany in late 2011. Weir received a $250,000 discount on the reconditioned machine because it had been used in an EOS facility.

But they had to wait a year to pull it out of storage while space was prepared for it in the Research Institute where Weir's lab is located, in the basement of Children's Hospital Colorado.

The machine uses a three-dimensional digital image to methodically laser-sinter beads of metal powder into solid metal. Most components will be built overnight in the machine, which has a door -- much like a microwave oven -- that allows manufacturers, or in this case researchers, to view the progress of each iterative design.

Segil said the machine creates a "whole new modality" to turn ideas into reality, especially in the tricky area of anthropomorphic design. "For things that don't have hard edges, like our bodies, it makes a world of difference," he said. "To (create) something like our finger, which has curvature and intricacies, out of metal is a horribly difficult and expensive thing to do using conventional machining processes. Now we have a machine to do it."

Weir said he'd like to make the metal prototype machine accessible to other researchers, as has been done with the plastic 3D printer. "We have a lot of rapid-prototyping capability within three or four rooms here. Our hope is to start a sort of prototyping center."

Meanwhile, the president hailed 3D printing technology in his recent State of the Union speech, saying it "has the potential to revolutionize the way we make almost everything." Obama said an innovative manufacturing institute has already launched in Youngstown, Ohio, and he's pushing for as many as 18 such facilities around the nation.

Weir said it will be a process to learn all of the new machine's capabilities. "We will print a part, but it won't necessarily be a finished part," he said. "There's a post-finish process we have to do to clean up a part before it's usable. How much of that we need to do we need to discover."

He pointed out that the university's newly formed Bioengineering Department will begin an undergraduate program this fall. The program will include a design track that will train students to be able to take advantage of such cutting-edge rapid-prototyping equipment.

For more information, visit: www.ucdenver.edu/academics/colleges/Engineering/Programs/bioengineering/Pages/Bioengineering.aspx

Published in University of Colorado

Small is really big in manufacturing these days. From developing micro structures that become heart stents, to adding micro features to enhance the functionality of existing products, the world of micromanufacturing is opening new opportunities for product developers and manufacturing professionals.

To meet the growing interest in this smallest of technologies, the Society of Manufacturing Engineers will bring together industry professionals to discuss the latest developments and to improve processes at its annual MicroManufacturing Conference and Exposition in Minneapolis, April 16-17, 2013.

“While the electronics and medical device fields have led the way in micromanufacturing, we’re now seeing its use in aerospace and defense, automotive and energy,” said Lauralyn McDaniel, event manager. “Micromanufacturing is solving problems such as improving part quality and lowering production costs in all these industries.”

Three keynote presentations will explore global issues facing manufacturing. Keith Guggenberger, senior vice-president of operations at Starkey Hearing Technologies will share best practices in adopting new technologies and innovation for growth. William Strauss, senior economist and economic advisor for the Federal Reserve Bank of Chicago, will focus on the economic outlook and what that means for manufacturing and technology. Dale Wahlstrom, president and CEO of the LifeScience Alley and the BioBusiness Alliance of Minnesota, will discuss the impact of American Healthcare Act and changing regulations on medical device manufacturers’ ability to innovate.

Conference sessions will cover a wide range of topics, including: combining micromanufacturing technologies for new processes, laser and mechanical micro machining, micro additive manufacturing, forming, metrology and surface micro machining.

Premiering at this event is SME’s Medical Manufacturing Innovations (MMI) series which looks to help facilitate technology exchange and improve the product development cycle. The conference will include an MMI track with live, interactive panel discussions and new technology displays and demonstrations.

Additionally, there are several pre-conference options. Workshops include: MicroManufacturing Fundamentals, Introduction to Lithographic Micromachining, and Metrology: Quality Control for Medical or Micro Components.

Throughout the event, industry experts will share real examples that not only illustrate how to use the technologies, but also what not to do. The conference offers many opportunities for attendees to network with experts and peers, have specific problems solved and find vendors for nearly every micromanufacturing challenge.

For more information, visit: micro.sme.org/2013/public/enter.aspx

Published in SME

Materialise is proud to announce the launch of the latest Mimics Innovation Suite of Software and Services including Mimics16 and 3-matic8. The Suite is an industry standard for processing and editing anatomical data from CT and MRI scans. Engineering on Anatomy™ has never been easier! This release focused heavily on adding new features and functionalities that increase efficiency and overall capabilities.

For over twenty years, Materialise has been leading the way in evidenced-based R&D with Mimics. We strive to remain on the cutting-edge through market-driven improvements with each release. Now 3D PDF files can be generated directly from the Mimics Innovation Suite allowing you to publish your 3D medical models in a universal file format for viewing, navigating and interacting. We also improved the traceability of the segmentation process by incorporating a log that’s saved in your project file or as a separate document for training or recommending a workflow for similar cases.

In addition, new measurement tools have been added including the ability to quantify elliptical shapes to export for advanced analyses, multi planar re-slice for comparing common clinical measurements from specific anatomical planes, curve planar re-slice to easily quantify a narrowing in a tubular structure, as well as exciting enhancements to the centerline tools.

For cardiovascular professionals, whether you are designing stents, valves, CRM devices or benchtop models; beginning with image data is helpful and the Mimics Innovation Suite’s new capabilities make it easier than ever before. With this release, you can save time and increase consistency with semi-automated coronary segmentation tools and the mask morphing technology for 4D segmentation. In addition you can improve visualization with a link between 3D view and fluoroscopy angles and perform TAVI/TAVR valve sizing and planning.

For orthopaedic and cranio-maxillofacial professionals, we are committed to driving the future of evidence based solutions by continuously improving our segmentation capabilities and developing design tools for your anatomy based workflow. With the new Smart Expand tool, segmenting bones and muscles from MRI data is even more efficient. You can also now design a patient-specific cage, generate ‘production ready’ custom plates, or create base plates for patient specific instruments.

For more information, visit: biomedical.materialise.com/mimics-innovation-suite-latest-release

Published in Materialise

Physicians at Weill Cornell Medical College and biomedical engineers at Cornell University have succeeded in building a facsimile of a living human ear that looks and acts like a natural ear. Researchers believe their bioengineering method will finally succeed in the long quest by scientists and physicians to provide normal looking "new" ears to thousands of children born with a congenital ear deformity.

In their PLOS ONE study, the researchers demonstrate how 3D printing and new injectable gels made of living cells can be used to fashion ears that are identical to a human ear. Over a three-month period — the length of the study — these flexible ears steadily grew cartilage to replace the collagen that was used to help mold them.

"I believe this will be the novel solution reconstructive surgeons have long wished for to help children born with absence or severe deformity of the ear," says the study’s co-lead author, Dr. Jason Spector, director of the Laboratory for Bioregenerative Medicine and Surgery (LBMS) and associate professor of surgery of plastic surgery in the Department of Surgery at Weill Cornell Medical College and an adjunct associate professor in the Department of Biomedical Engineering at Cornell University. "A bioengineered ear replacement like this would also help individuals who have lost part or all of their external ear in an accident or from cancer."

Currently, replacement ears are constructed using materials that have a Styrofoam-like consistency or, sometimes, surgeons will build ears from rib that is harvested from a young patient. "This surgical option is very challenging and painful for children, and the ears rarely look totally natural or perform well," says Dr. Spector, who is also a plastic and reconstructive surgeon at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. "All other attempts to 'grow’ ears in the lab — including one 1997 study widely publicized by photos of ears implanted on the backs of mice — have failed in the long term."

This Cornell bioengineered ear is the best to date in appearing and acting like a natural ear, the researchers report. Also, the process of making the ears is fast — it takes a week at most.

"This is such a win-win for both medicine and basic science, demonstrating what we can achieve when we work together," says the study’s other lead author, Dr. Lawrence J. Bonassar, associate professor and associate chair of the Department of Biomedical Engineering at Cornell University.
Scanning, Printing and Molding a Human Ear in a Week

The deformity that both Dr. Spector and Dr. Bonassar seek to remedy is microtia, a congenital deformity in which the external ear is not fully developed. Although the causes for this disorder are not entirely understood, research has found that microtia can occur in children whose mothers took an acne medication during pregnancy. Typically, only a single ear is affected.

The incidence of microtia varies from almost one to more than four per 10,000 births each year. Many children born with microtia have an intact inner ear, but experience hearing loss due to the missing external ear structure, which acts to capture and conduct sound.

Dr. Spector and Dr. Bonassar have been collaborating on bioengineered human replacement parts since 2007, and Dr. Bonassar has also been working with other Weill Cornell physicians. For example, he and Weill Cornell’s neurological surgeon Dr. Roger Härtl are currently testing bioengineered disc replacements using some of the same techniques demonstrated in this current study.

The researchers specifically work to develop replacements for human structures that are primarily made of cartilage — joints, trachea, spine, nose — because cartilage does not need to be vascularized with a blood supply in order to survive.

To make the ears, Dr. Bonassar and his colleagues first took a combination laser scan and panoramic photo of an ear from twin girls, which provided a digitized 3D image of their ears on a computer screen. That took 30 seconds, and did not involve any ionizing radiation. The researchers then converted that image into a digitized "solid" ear and used a 3D printer to assemble a mold of the ear. The mold is like a box with a hole in the middle that is in the shape of the mirror image of the ear, say researchers.

They injected animal-derived collagen into that ear mold, and then added nearly 250 million cartilage cells. The collagen served as a scaffold upon which cartilage could grow. Collagen is the main structural protein in the body of every mammal. Animal-based collagen is frequently used for cosmetic and plastic surgery. This high-density collagen gel, which Cornell researchers developed, resembles the consistency of flexible Jell-O when the mold is removed.

"The process is fast," Dr. Bonassar says. "It takes half a day to design the mold, a day or so to print it, 30 minutes to inject the gel and we can remove the ear 15 minutes later. We trim the ear and then let it culture for several days in a nourishing cell culture medium before it is implanted."

During the three-month observation period, the cartilage in the ears grew to replace the collagen scaffold. "Eventually the bioengineered ear contains only auricular cartilage, just like a real ear," says Dr. Spector. Previous bioengineered ears have not been able to maintain their shape or dimensions over time, and the cells within them did not survive.

The researchers are now looking at ways to expand populations of human ear cartilage cells in the laboratory so that these cells can be used in the mold.

Dr. Spector says the best time to implant a bioengineered ear on a child would be when they are about 5- or 6-years-old, because at that age, ears are 80 percent of their adult size. "We don’t know yet if the bioengineered ears would continue to grow to their full size, but I suspect they will," says Dr. Spector. "Surgery to attach the new ear would be straightforward — the malformed ear would be removed and the bioengineered ear would be inserted under a flap of skin at the site."

Dr. Spector says that if all future safety and efficacy tests work out, it might be possible to try the first human implant of a Cornell bioengineered ear in as little as three years.

"The innovation in this study is two-fold," says Dr. Bonassar. "The use of imaging technology to rapid and accurately make the shape of the ear implant is new, as is the high-density collagen gel for the mold."

"These bioengineered ears are highly promising because they precisely mirror the native architecture of the human ear," Dr. Spector says. "They should restore hearing and a normal appearance to children and others in need. This advance represents a very exciting collaboration between physicians and basic scientists. It is a demonstration of what we hope to do together to improve the lives of these patients with ear deformity, missing ears and beyond."

Other co-authors of the study are Dr. Alyssa J. Reiffel, Dr. Karina A. Hernandez, and Justin L. Perez from the Laboratory for Bioregenerative Medicine and Surgery at Weill Cornell Medical College; and Concepcion Kafka, Samantha Popa, Sherry Zhou, Satadru Pramanik, Dr. Bryan N. Brown and Won Seuk Ryu, from the Department of Biomedical Engineering at Cornell University.

For more information, visit: www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0056506

Organovo Holdings, Inc. (OTCQX: ONVO) ("Organovo"), a creator and manufacturer of functional, three-dimensional human tissues for medical research and therapeutic applications, is working together with researchers at Autodesk, Inc., the leader in cloud-based design and engineering software, to create the first 3D design software for bioprinting.

The software, which will be used to control Organovo's NovoGen MMX bioprinter, will represent a major step forward in usability and functionality for designing three-dimensional human tissues, and has the potential to open up bioprinting to a broader group of users.

"Autodesk is an excellent partner for Organovo in developing new software for 3D bioprinters," said Keith Murphy, Chairman and Chief Executive Officer at Organovo. "This relationship will lead to advances in bioprinting, including both greater flexibility and throughput internally, and the potential long-term ability for customers to design their own 3D tissues for production by Organovo."

"Bioprinting has the potential to change the world," said Jeff Kowalski, Senior Vice President and Chief Technology Officer at Autodesk. "It's a blend of engineering, biology and 3D printing, which makes it a natural for Autodesk. I think working with Organovo to explore and evolve this emerging field will yield some fascinating and radical advances in medical research."

Organovo's 3D bioprinting technology is used to create living human tissues that are three-dimensional, architecturally correct, and made entirely of living human cells. The resulting structures can function like native human tissues, and represent an opportunity for advancement in medical research, drug discovery and development, and in the future, surgical therapies and transplantation.

The Autodesk Research group is dedicated to innovation and discovery ranging from methods to help users learn powerful digital prototyping tools to visualization and simulation techniques that enable designers to achieve new levels of performance. Advancing the state of the art in human-computer interaction, computer graphics and digital design technology, Autodesk Research collaborates openly with researchers at leading universities around the world. The bio/nano/programmable matter group within Autodesk Research is extending this expertise by developing software for the design and simulation of molecular systems and living systems.

Organovo designs and creates functional, three-dimensional human tissues for medical research and therapeutic applications. The company is working in collaboration with pharmaceutical and academic partners to develop human biological disease models in three dimensions that enable therapeutic drug discovery and development. Organovo's technology can also be applied to create surgical tissues for direct therapy. Their three-dimensional bioprinting technology was selected as one of the "Best Inventions of 2010" by TIME Magazine. Organovo leads the way in solving complex medical research problems and building the future of medicine.

For more information, visit: www.organovo.com/products/novogen-mmx-bioprinter

Published in Organovo

3D Systems (NYSE:DDD) announced the immediate availability of Dreve FotoTec hearing aid material for use in the ProJet® 6000 professional 3D printer.  
 
As a leader in additive manufacturing for healthcare, 3D Systems’ printers transformed the production of hearing aids almost a decade ago from labor-intensive, hand-crafted devices to fully automated, 3D printed, personalized in-ear hearing aids. The ProJet 6000 combines the ease of use of an office printer with the performance of genuine SLA® parts to deliver a nearly 2X improvement in throughput for hearing-aid production with a printed surface so smooth that it results in 50% less finishing time.
 
“We are pleased to expand our 3D Systems partnership with the addition of the ProJet 6000 to our own fleet of 3D Systems production printers,” stated Dr. Volker Dreve, CEO Dreve GmbH. “Our customers, like Comfoor B.V., will benefit by upgrading to the new ProJet 6000 using our new Fototec Otoplastik SL.E material based on its proven performance.”
 
“We are thrilled to offer our hearing aid customers a proven, integrated solution that combines the latest products from two leading providers into a powerful and affordable manufacturing tool,” said Lee Dockstader, Vice President of Business Development for 3D Systems.
 
For more information, visit: www.printin3d.com/projet-6000

Published in 3D Systems

The U.S. Department of Commerce’s United States Patent and Trademark Office (USPTO) will host a Medical Device Technology Partnership Meeting on Tuesday, January 29, 2013 designed to bring the medical device and biotechnology stakeholders together to share ideas, experiences and insights on best practices and provide a forum for discussion on how the USPTO can improve and expand its relationship with medical device technology stakeholders. The meeting, sponsored by Technology Centers 3700 and 1600, will include discussions on the Leahy-Smith America Invents Act (AIA), the Cooperative Patent Classification (CPC) system, and 101 subject matter eligibility.

Combined Medical Device & Biotechnology Partnership Meeting
January 29, 2013 at 8:30 a.m. – 3:45 p.m. EDT

USPTO Campus, Madison North Auditorium
600 Dulany Street
Alexandria, VA  22314

Space is limited and registration will be done on a first-come first-served basis.

For more information, visit: www.uspto.gov/about/contacts/phone_directory/pat_tech/TC_3700_MEDICAL_PARTNERSHIP.jsp

Published in USPTO

NineSigma, Inc., of Cleveland, the leading innovation partner to organizations worldwide, announced today they will work with Cincinnati, OH-based AtriCure, Inc. under the new Ohio Third Frontier Open Innovation Incentive (OII) Program. In August, NineSigma was selected by the State of Ohio to help catalyze the growth of middle market companies, with revenues between $10 million and $1 billion, by accelerating their adoption of open innovation. The Ohio Third Frontier OII is aimed at fostering collaborative innovation that will lead to job creation within Ohio and build competitive advantage on the national and global level.

AtriCure, Inc. is a growing medical device company with a strong presence in atrial fibrillation (AF). They are a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems. These systems are designed to create precise lesions, or scars, in heart tissue for the treatment of atrial fibrillation. AF is the most common irregular heartbeat and is characterized by palpitations, dizziness and shortness of breath.
 
“Atrial fibrillation affects more than 5.5 million people worldwide and carries with it a five-fold increased risk of stroke. We look forward to beginning our work with the team at AtriCure to help them find best-in-class partners and technologies globally that will advance their cardiac surgical solutions and ability to treat this pervasive condition,” said Andy Zynga, CEO of NineSigma.

Open innovation involves “looking to the outside” for technologies, solutions, and ideas to accelerate the development of new products and increase speed to market. Through the Open Innovation Incentive, NineSigma will work closely with solution seekers to create custom networks of innovation providers to find viable solutions, filtering responses for their quality and fit. The State will assist solution seekers by funding a portion of the transactional costs of engaging an open innovation company.

NineSigma connects organizations with external innovation resources to accelerate innovation in private, public and social sectors. The company provides open innovation services to organizations worldwide, including Kraft, Philips, Siemens, and Unilever, to solve immediate challenges, integrate new knowledge, fill product pipelines, and stay ahead of the competition. Named to the 2012 Inc. 5000 list of fastest-growing private U.S. companies, NineSigma’s proprietary process has produced billions of dollars in value for its clients. NineSigma has the largest open global network of solution providers and an extensive database of existing solutions spanning numerous industries and technical disciplines. NineSigma’s online innovation community, NineSights™, is the world’s first open innovation social media destination, connecting innovators of all sizes with resources and relationships to drive growth.

For more information, visit: www.ninesigma.com or www.ninesights.com

Published in NineSigma

Cadence, Inc., a leading provider of medical device outsourcing solutions, announced today that it will open a finished medical device facility in Cranberry Township, PA in the first quarter of 2013.

The 21,000 square foot facility will include up to 10,000 square feet of clean room space and 5,000 square feet of office space.  The company expects to employ as many as 60 people in the new facility located just outside of Pittsburgh.

For Cadence, which has achieved 74% revenue growth in the past three years, entrance into the finished device business is another step in its long-term strategic plan.

“Cadence started as a provider of highly-engineered specialty blades and has evolved into a provider of complex components and sub-assemblies critical to the performance of a variety of medical devices,” said Alan Connor, President of Cadence, Inc.  “Medical device customers are looking to consolidate their supply chains around their most critical and trusted suppliers.  The addition of finished device and sterilization management capabilities allows us to better serve our customers’ needs.”

Pittsburgh was chosen for Cadence’s newest facility because of the availability of employees with specialized medical device knowledge and experience.  Pittsburgh was also chosen for its proximity to existing Cadence facilities.

Marc Mabie, Vice President & General Manager of the Cadence Pittsburgh facility, said, “The Pittsburgh location has enabled us to put together an experienced and proven team from the medical device industry to expand Cadence’s business. We look forward to continued team growth in 2013.”

Cadence, Inc. is a premier contract manufacturing company improving patient outcomes by creating new medical technologies for minimally invasive devices.  Headquartered in the Green Hills Technology Center in Staunton, Virginia, Cadence has over 200 shareholders.  Cadence creates new-to-the-world manufacturing technologies to make devices the world has never seen. This is Outcome-based Manufacturing™.

For more information, visit: www.cadenceinc.com

Published in Cadence, Inc

A quality system rigorous enough to support the medical device industry is a necessary component of any welding company doing business in that sector. But just exactly what does that include? A little bit of everything, it turns out. From IQ/OQ/PC (installation qualification/ operational qualification/ performance qualification) documentation, to adherence to ISO 13485 quality management standards, to compliance with FDA good manufacturing practices; quality procedures and documentation pervade the entire organization.

Ensuring that welding processes meet necessary quality standards is relatively simple. Work with an established welding firm having robust engineering resources that are involved from prototype to production and FDA submission. Firms with these capabilities can offer help in selecting materials and designing weld joints to improve functionality while ensuring a stable manufacturing process.

IQ/OQ/PQ documents the process and equipment

IQ/OQ/PQ (installation qualification/operational qualification/production qualification) is a complete verification of equipment and process protocol often required by medical device companies, and performed by each supplier. One particularly rigorous method of documenting the production process is known as “alphabet soup”. With this method everything that happens to that component gets documented – for example, which machine it is run on, what inspections will be conducted and at what frequency, etc. To ensure the process is sound, the documentation may also include a capability study and gauge repeatability and reproducibility to prove out any variances in setup and operator factors.
 
Each IQ/OQ/PQ is conducted to suit the requirements of the customer, and the process is massaged as needed to match hardware functionality. For example, a validation procedure may demonstrate that the development meets engineering requirements and acceptance criteria for nominal settings on a sample set of components. A statistical analysis must be carried out for each process step.

After the detailed work is completed, to ensure regulatory compliance it is essential that the supplier prepare and maintain the applicable machinery and equipment qualification reports for auditing purposes. No structural changes may be made to the equipment without first notifying the customer and evaluating whether a requalification is necessary.

ISO 13485 certification

An important aspect of the medical device quality support story is the ISO 13485 Medical Device Standard, which outlines a comprehensive quality management system for the design and manufacture of medical devices. Subcontract manufacturers who achieve this certification can demonstrate that they are processing parts to the same rigorous standards as major medical device manufacturers.

ISO 13485 involves the development of controls to ensure product safety with a focus on risk management and design control activities during product development. For implantable devices, there are specific inspection and traceability requirements; sterile medical devices require verification that corrective and preventive actions will actually be effective.

To gain the certification, the welding service provider generally conducts an internal quality audit to ensure it meets the standards, and then contracts with a third party for the actual registration audit. The company then trains its own internal quality auditors who work to maintain the standards.

Joining Technologies decided to pursue ISO 13485 certification as a way of showing that it processes parts to the same standards as its medical customers. The company was already certified to quality management standards under NADCAP (National Aerospace and Defense Contractors Accreditation Program) and AS9100, so the move to ISO 13485 was a natural step.

Food and Drug Administration requirements

According to the FDA’s Quality System (QS) Regulation/Medical Device Good Manufacturing Practices, “Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.” Quality systems for FDA-regulated medical devices are known as current good manufacturing practices (CGMPs). Over the years, CGMPs for medical devices have been revised to include design controls, becoming more closely aligned with the international standards found in ISO 9001 and ISO 13485.

In 1997, the FDA revised the CGMP requirements for medical devices and incorporated them into a quality system (QS) regulation called Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation, found in 21 CFR Parts 808, 812, and 820. While not regulating exactly how a manufacturer should produce specific devices, the QS regulation sets out a framework to be followed, requiring  manufacturers to use “good judgment” when developing their quality system and applying the QS sections that are specific to their products and operations.

Welding engineering capabilities – from prototyping through FDA submission

Medical device welding qualification is a team effort. Having a dedicated project manager along with an experienced engineering team can give great peace of mind to the customer who will assemble and sell the complete medical device. An important factor in developing and implementing a quality welding process is to ensure that the engineering team gets involved in the earliest stages. Being involved from prototype to production and FDA submission allows the development engineers to provide input on functionality and the redesign of joints, if necessary, to meet quality objectives.

The best approach is to work with a welding firm that gives its customer access to its processes. Medical device developers can then see how their part gets welded and be involved throughout the qualification and production stages. Of course, this kind of open access policy must be coupled with a strong intellectual property (IP) program so that the customer’s IP is always protected.

Maintaining a flexible approach in the joining process, including the ability to access a variety of fusion techniques, helps provide optimal solutions based on part design and geometry. Companies offering electron beam, laser and traditional welding techniques within the same facility have a clear advantage over those that are limited to, for example, just laser welding.

Quality systems for the welding of medical devices rely on a variety of set standards. A project is most likely to succeed when a medical device manufacturer works with an engineering firm that can perform feasibility studies, process development, validation and certification, systems engineering and integration, and full scale production.

For more information, visit: www.joiningtech.com

Published in Joining Technologies

MD+DI (Medical Device and Diagnostic Industry), UBM Canon’s leading brand providing the medical device industry with the latest news, information, and in-depth analysis, announced the winners of the 2012 Manufacturers of the Year awards in its November print issue published this week.

UBM Canon has selected three companies that are creating products to drive effortless patient data collection, help empower patients and healthcare workers, and do so immediately and wirelessly. These winning companies will change the game when it comes to reducing costs and improving hospital and home care.

“We are very proud to honor these three companies for making a difference in the MedTech industry,” stated Heather Thompson, Editor-in-Chief, MD+DI. “We are declaring 2012 the year that wireless broke into healthcare. We feel that these three winners stand out as companies the industry will still be talking about in five years.”

2012 Manufacturers of the Year

AirStrip Technologies is a software development company located in San Antonio, Texas. The company develops mobile applications that enable medical practitioners to view patient data in near-real time and displayed on a smart phone or tablet. This frees doctors from being tied down to a local network, as the data is transmitted over the Internet (either via the cellular network or Wi-Fi). Their first product was AirStrip OB, which provides obstetricians and nurse midwives with the ability to view fetal-monitoring waveforms, such as contractions and fetal heart rate. Later, the company introduced AirStrip CARDIOLOGY for cardiac units and AirStrip PATIENT MONITORING for critical care.

Sotera Wireless  has developed the first continuous non-invasive blood pressure monitoring device, which also captures all vital signs. Its product, the VisiMobile System has received 510(k) clearance from FDA and the company is commencing sales to hospitals nationwide. The ViSi Mobile System, as approved, uses WiFi (802.11) wireless technology for transmission of patients’ vital signs, keeping hospital clinicians connected to their patients, whether patients are in bed or up and moving around.

Proteus Digital Health  has created an integrating wearable and ingestible sensor technology to detect patient’s medication intake and physiologic data. Its digital health feedback system stores information in a secure database accessible from a variety of devices. The company received 510(k) clearance for its patient-powered system in July.

For more information, visit: www.mddionline.com/article/2012-medical-device-manufacturers-year

Published in UBM Canon

The MedTech Industry’s Premier Design Competition is now accepting entries. Proudly presented by UBM Canon and MD+DI, the Medical Design Excellence Awards program has provided market visibility to over 500 innovative MedTech products that are changing the face of healthcare today. The MDEA also celebrates the achievements of medical product manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for these groundbreaking innovations.

Entries are evaluated by a multidisciplinary panel of jurors with expertise in industrial design, engineering, human factors, manufacturing, medicine, and other design and healthcare-related fields. Selected products must not only pass design and engineering excellence, manufacturing effectiveness and innovation, but also the overall benefit to the medical and healthcare industry.

Eligibility Requirements and Categories:
    
The MDEA competition accepts entries in ten medical product categories from companies and individuals worldwide involved in the design, engineering, manufacture, or distribution of finished medical devices or medical packaging products. To be eligible for entry in the 2013 MDEA competition, products must be commercially available—able to be ordered or purchased—by December 31, 2012.

Deadlines and Entry Fees:

Standard: December 7, 2012 -$600 (Reduced Entry Fee)
Late: January 11, 2013 – $700

Winners, Finalists, and their Suppliers benefit from:

  • Extensive publicity in connection with MDEA announcements, which are carried on PR Newswire and delivered to hundreds of wide-reaching media outlets.
  • Coverage in UBM Canon MedTech Group’s industry-leading Events, Conferences, and Media products, including publications like MD+DI, MPMN, IVD Technology, PMPN, and EMDT.
  • Recognition of excellence at the live MDEA ceremony, attended by over 400 MedTech industry leaders, held at the Philadelphia Marriott Downtown on June 19, 2013, in conjunction with UBM Canon’s MD&M East event.
  • Exclusive right to use and display the special MDEA logos on their product packaging, promotional materials, advertisements, and company websites.

The MDEA will also be honoring an individual with the prestigious Lifetime Achievement Award for contributions over a long career that have a demonstrable impact on technological, business, and cultural advancements in medical devices. This award was given to Dr. Thomas Fogarty at the 2012 MDEA ceremony and was presented to him by industry luminary Dean Kamen.

The MDEA program is endorsed by AdvaMed; the American Institute for Medical and Biological Engineering; the Healthcare Technology Foundation; the Human Factors and Ergonomics Society; the Medical Device Manufacturers Association; and the National Collegiate Inventors and Innovators Alliance. The Medical Design Excellence Awards are underwritten and produced by theUBM Canon MedTech Group.

For more information, visit: www.MDEAwards.com

Published in UBM Canon

Morgan Technical Ceramics (MTC) announces that it has been awarded a contract to participate in a Defense Advanced Research Projects Agency (DARPA) project with the Biomimetic Microelectronics Systems Centers at the University of Southern California (BMES-USC). The project will develop biocompatible hermetic coatings, high density ceramic feed-throughs, and hermeticity test chips for biomedical microsystems applications. The aim of the research is to develop technology that will enable implanted electronics used in medical devices and other neural stimulation-based prostheses to operate in the body for decades. MTC’s New Bedford, MA site will develop the feed-through, while the Allentown, PA site will apply the special diamond-like coating (DLC) to hermetically seal prosthetic devices for protection from body fluids.

The project will provide a robust hermetic barrier to protect medical implantable electronics, enable high-density, high lead count hermetic feed-throughs to connect to advanced neural interfaces, and provide novel devices and circuits for integrity monitoring.
 
Current biomedical implants only need a few signal contacts with tissue, while advanced neural prostheses under development may need as many as a thousand, requiring a fundamentally different approach for feed-throughs and encapsulation. The work will include using diamond-like carbon technology from MTC’s Allentown site to provide impermeable and biocompatible insulating coatings, and technology for high density, and high lead count feed-throughs from MTC New Bedford to enable parallel connection to the nervous system. A novel hermetic coating test chip is being developed by BMES-USC, and will include both passive and active sensors to investigate contamination, moisture, and corrosion.

“MTC is proud to be part of this high level, innovative research to help truly miniaturize implantable devices” said Chris Vaillancourt, Medical Products Business Unit Manager. “By dramatically reducing feed-through size while increasing the number of leads, and improving coating longevity and reliability, the innovative research will extend neuromodulation’s promise.”

The project will also directly benefit several Department of Defense-funded DARPA projects, including Reliable Neural-Interface Technology (RE-NET), which is investigating stimulation-based neural prostheses; Restorative Encoding Memory Integration Neural Device (REMIND), which seeks to restore memory through devices programmed to bypass injured regions of the brain; and Revolutionizing Prosthetics (RP3), which has developed advanced prosthetic arms that can be controlled via electronic brain implants.

For more information, visit: bmes-erc.usc.edu or www.morgantechnicalceramics.com

Geomagic® is showcasing innovative, digitally designed facial prostheses, implants and surgical guides at this week’s International Congress on Maxillofacial Rehabilitation in Baltimore, Md. Made by Geomagic customers, these medical designs are used to rebuild and restore the facial features of cancer, tumor and trauma patients. At this annual meeting, Geomagic’s exhibit will feature real 3D models from a variety of patient cases. Additionally, a workshop will illustrate digital design workflows for custom implants and prostheses that restore disease- or injury-impacted areas of the anatomy.

Geomagic Freeform® and Geomagic Studio ® deliver precision design and 3D processing capabilities, allowing researchers and doctors to easily convert scan data into usable 3D models. Geomagic’s toolset also includes intuitive, flexible sculpture tools to quickly design perfect custom-fit prostheses and implants for better patient treatment and repair.

A workshop titled “Craniofacial Reconstruction: Scan, Plan and Manufacture,” being held at the event on October 29, 2012, will offer hands-on experience with the Geomagic® Freeform® Plus modeling system, a Geomagic product widely used in prosthetic and implant design and manufacture.

“The advances made possible by using the right software in the digital workflow are astonishing, and they eliminate patient discomfort while enabling better fit and aesthetic results,” said Dr. Dominic Eggbeer, Research Officer at Cardiff Metropolitan University and member of the Centre for Applied Reconstructive Technologies in Surgery (CARTIS) in Wales. “Geomagic Freeform has become the centerpiece of our process because it lets us sculpt our designs into the perfect fit and appearance, and it lets us work faster without needing the patient to be present,” added Eggbeer, whose patient work will be showcased at the event.

“Geomagic Studio has the easiest and most accurate tools for registering models,” said Nancy Hairston, president of MedCAD, a biomedical device manufacturer in Dallas Tx.  Registration is pivotal when users merge multiple scan files of patient data. “In seemingly difficult registrations, it finds the right topology between different pieces to register perfectly.”  

One particularly complex piece, a silicone partial facial prosthesis covering 30% of the patient’s face, was designed and produced by CARTIS and will be profiled in Geomagic’s booth, #3. In this particular case cancer treatment required the removal of the patient’s eye, orbital bone, and nose; at the same time, radiotherapy compromised the shape and depth of the remaining bone. Compounding this already-difficult challenge, the prosthesis also needed to match the patient’s wrinkles, skin texture and dimples, a task that typically defies the capabilities of conventional CAD software.

Using Geomagic Freeform, CARTIS eliminated two clinic visits and cut in half the time required from initial visit to final fitting.  Instead of requiring the patient to endure three clinic visits including painful and messy fittings with silicone impression material, CARTIS was able to work from a 3D surface scan and CT scan data. CARTIS technicians then used Geomagic Freeform to view and analyze the anatomy in 3D space from multiple angles, obtaining a wound’s-eye view of bony protrusions or concave areas, and noting damage that otherwise was hidden. The CARTIS team built up facial structures on the prosthesis to match the patient’s face and designed an area where a glass eye could be inserted.

Geomagic Freeform software also allowed subtle detailing of skin folds and textures along with ultra-thin 40-micron edges required to achieve a pressure fit. Once the design was finalized, CARTIS digitally designed the molds in Freeform. The finished silicon prosthesis was then color and texture matched for a natural look.

“Through the Maxillofacial Unit at Morriston Hospital, we’re routinely delivering prosthetic ears, noses, orbital areas and implants for jaw or cranial replacement sections using scans and digital modeling in Geomagic Freeform so that the patient looks natural even down to the wrinkles,” Dr. Eggbeer said.

“The examples showcased by our customers at this event provide a reminder that 3D software truly has the power to change lives,” said Joan Lockhart, VP of Marketing, Geomagic. “We applaud the work of organizations such as CARTIS, MedCAD and others for showing that 3D scanning and design solutions, and new additive fabrication technologies, can be used in transformative ways for the betterment of humanity. I’m proud our solutions played a part in these remarkable examples.”

For more information, visit: www.geomagic.com/en/products/freeform/overview

Published in Geomagic

Thogus, a 62-year old custom injection molder expands services to include rapidly developing medical device market. JALEX Medical, LLC will focus exclusively on biomedical engineering, product development and regulatory/quality assistance. JALEX joins Thogus and Rapid Prototyping and Manufacturing (rp+m) under the same roof, fostering accelerated product design through complete production. “Our clients demand flexibility, speed and quality as they compete in the tough, highly-regulated medical device market,” states Matt Hlavin, president and owner of all three companies. “The investment in equipment and personnel is our commitment to fulfilling our client obligation.”
 
Mr. Hlavin estimates investing $1.6 million in equipment, jobs and facilities in the coming year, expanding on their current 35-acre site. JALEX Medical has worked on medical devices such as a biopsy needle, cervical plates, cranial screws and a PEEK interbody fusion device. JALEX is quickly becoming known for their expertise in compliance consulting along with prototype design and engineering.
 
Thogus is a full-service injection molding company located in Avon Lake, Ohio, USA. Founders Jack Thompson and Walter Gus established Master Mold & Die in 1950. The tool and die shop led the founders into a whole new world of plastics. In 1958, they changed the name to Thogus Products Company, a combination of the last names Thompson and Gus, and molded their first nylon and polyethylene plastic tube and hose fittings. Now, under the leadership of Jack Thompson’s grandson, Matthew K. Hlavin, the family-owned business is thriving in an industry, location and time when most are not. Thogus turned to rapid prototyping in 2009 when it purchased two machines for fused deposition modeling. The concept was strengthened further when it formed Rapid Prototype and Manufacturing LLC (rp+m) as its own company in 2011.

For more information, visit: www.jalexmedical.com

Published in Thogus

EOS is joining forces with Innovative Medical Device Solutions (IMDS), the strategic source for full-service medical device development and manufacturing. Together they offer customers, including industry-leading orthopedic and spine surgeons and implant companies, extensive product development resources for creating novel metal additive manufacturing (AM) designs.

This partnership will allow IMDS to manufacture products with patient-benefiting features that are made possible with the use of AM technology.

“Until now, using AM for medical devices was considered a high-technology novelty done on a few implants, but mainly used to make quick metal prototypes,” says Dan Justin, Chief Technology Officer for IMDS. “However, recent advances—such as increased materials choices, enhanced manufacturing precision, and faster build speeds—have made medical product developers worldwide more willing to co-invest in developing implants made by laser-sintering systems. This partnership marks the most comprehensive resource alignment between contract medical device development and metal additive manufacturing expertise available to our industry.”

EOS offers decades of experience designing and manufacturing laser-sintering systems that can create high-quality prototypes and end-use parts. IMDS specializes in partnering with medical device customers to develop and produce new implant and instrument systems. The company has recently added the latest-generation EOSINT M 280 direct metal laser-sintering (DMLS™) systems to its already industry-leading product development and manufacturing capabilities across the U.S.

In response to requests by major medical product developers, EOS and IMDS have begun investigating partnerships with leading companies to bring out products that could only have been imagined previously.

“Our laser-sintering technology has opened up a door for developers who have formerly focused on subtractive processes,” says Andrew Snow, Regional Sales Director, EOS of North America, Inc. “Instead of being constrained by traditional technology, engineers and medical professionals are now free to explore a world of new designs—perhaps with varied porosity built in, or features nested inside.”

For example, most titanium implants are currently manufactured by subtractive machining, followed by adding a porous coating.  Now, some implants under development are being built one 20-micron layer at a time on high-precision DMLS machines. Each finished product is a functionally gradient single piece that transitions from a precisely shaped porous structure to a less porous, more solid load-bearing structure—a design with significant performance benefits that is not practical to undertake with traditional processes.  Other designs in development include patient-specific surgical guides for placement of pins, saws, and drills.

In the long term, the partnership will also provide orthopedic companies with a more cost-effective design-to-manufacturing pathway for customized implants—for instance, ultra-thin, bone-conserving hip, knee, and shoulder joint bearing implants—digitally designed from patient CT scans. DMLS can build medical products from regulatory approved implant materials such as stainless steel, cobalt-chrome, or titanium alloys.

The two companies will exhibit at the North American Spine Society (NASS) 2012 Annual Meeting (Dallas, Texas, Oct. 24-27), where IMDS will showcase the EOSINT M 280 and laser-sintered display pieces in IMDS booth # 2821. Also on display are parts created with software from WITHIN, an EOS partner and IMDS collaborator, which provides significant design-driven manufacturing capabilities to the overall e-Manufacturing solution.  WITHIN Medical software optimizes the design of innovative lattice structures. www.withinlab.com

For more information, visit: www.imds.net or www.eos.info

Published in EOS

What are today’s latest trends in thermoplastics and liquid silicone medical molding technologies? What innovative injection molding solutions will help you to maintain your competitive advantage in the future?  These questions and more will be answered at ENGEL’s upcoming medical symposium being held October 2nd through 4th at ENGEL’s Technical Center in Corona, California.

ENGEL North America, member of the ENGEL group, a world leader in the design and manufacture of injection molding machines and parts-handling automation, is hosting a three day symposium focused specifically on new developments in both thermoplastic and liquid silicone molding for the medical industry.  The event will be held at ENGEL’s Technical Center in Corona, California.

ENGEL’s symposium has been designed as three separate programs:  day one focuses on thermoplastic medical molding processes, day two centers on liquid silicone rubber medical molding processes, and day three is an in-depth, hands-on training in liquid silicone rubber.  Attendees are welcome to attend one day, or all three, based on their interests.

The programs for days one and two will include a diverse mix of interesting and informative presentations by professionals, for professionals, relating to all aspects of the medical molding industry. Some of the technical sessions include:

  • Preplan and Verify - Injection Molding Machine Concepts for the Medical Industry
  • Injection Mold Strategies for Profitability
  • Two Component Injection Molding – Soft to Hard
  • New Processing Potential Unleashed
  • Maximize Your Molding Efficiency and Improve Part Quality at the Same Time
  • Healthcare Materials Designed With Your Needs In Mind
  • LSR Applications in the Medical Industry & LSR Specific Machine Requirements
  • LSR Dosing System Requirements and Solutions
  • Understanding Silicone Viscosity Variation
  • Silicone Molding in the Medical Industry

The third day of the event provides in-depth, hands-on training in liquid silicone rubber.  This training includes:

  • Dosing system maintenance and assembly:  Cleaning, assembly and installation of various dosing system elements, as well as dosing system operation and trouble shooting.
  • Injection unit maintenance and assembly:  Cleaning, assembly and installation of LSR plasticizing unit, including the screw, barrel, non- return valve and pneumatic shut off nozzle.
  • Process start up:  Systematic approach to developing a stable LSR process, including start-up procedures, trouble shooting and setting up process monitoring systems.


Throughout the symposium, demonstrating ENGEL’s competency in both thermoplastic and liquid silicone rubber areas of the medical technology field, three injection molding systems will be running, providing visitors with a first-hand look at some of today’s latest molding processes and technologies.

An ENGEL hybrid tie-bar-less injection molding machine – the ENGEL e-victory 200/55 US -- running a 4-cavity LSR mold, producing a nasal prong.  Automatic part removal will be handled by the ENGEL viper 6 linear servo robot.  The system also features the new ENGEL flomo -- an extremely compact temperature controlling water distribution system with electronic monitoring.  For added efficiencies, ENGEL’s ecodrive has been installed – reducing energy consumption by up to 70 percent compared with standard hydraulics, providing savings similar to comparable fully electric machines.

An all-electric ENGEL e-motion 310/110 T US machine will run a 16 cavity thermoplastic syringe mold.  The syringes, with extremely long and thin mold cores, require exceptional process control of high speed injection to meet the demanding levels of product quality.  The ENGEL e-motion press not only delivers the level of process control required, but does so with a cycle time of 5.5 seconds.  The mold, provided by Tech Mold, provides a side-gated / close-pitch solution for customers that need to optimize their production footprint.

Another fully electric injection molding machine – an ENGEL e-motion 200/60 US equipped with an ENGEL viper 6 robot – will utilize the ENGEL x-melt process to mold a thin-walled device cover.  The extremely thin-walled design of this part (0.3 mm) makes this a perfect application for demonstrating the ENGEL x-melt process.  The ENGEL x-melt process provides a cost-effective method of producing thin-walled and micro parts – accumulator free – without the need to invest in special purpose capital equipment.  As well as the ability to produce extremely thin-wall parts, the x-melt process also provides unsurpassed repeatability. Several studies have shown that x-melt can improve part weight consistency by up to a factor of 10 when compared to conventional molding.

For more information, visit: www.engelglobal.com/engel_web/ena/en/2723_4168.htm

Published in ENGEL

Innovative tailor-made seats will be used for the first time by Paralympics GB for the wheelchair basketball events this summer. Using cutting-edge research the seats are individually moulded for each player to provide the best possible support. They will help the athletes to improve their speed, acceleration and manoeuvrability around the court. The seats have been developed with UK Sport funding at Loughborough University’s Sports Technology Institute, which is supported by the Engineering and Physical Sciences Research Council (EPSRC). The new seats are revolutionary because they take the individual’s size, shape and particular disability into account. For example, a player with a spinal cord injury will have a seat that provides additional support around their lower back.

Harnessing a range of cutting-edge design and manufacturing techniques and developed in close consultation with the British men’s and women’s wheelchair basketball teams, these customised seats consist of a foam interior and a plastic shell. They are simply clamped onto the current wheelchair design in which the frames are already made to measure for the players. Team members initially underwent 3D scans to capture their bodies’ biomechanical movements and their positions in their existing wheelchairs. A moulding bag containing small polystyrene balls (similar to a bean bag style seat), was used to capture the shape of the player when seated. The seat was then made up by hand.

Computer-aided design (CAD) capabilities were then used to refine the shape of the outer layer of the seat to suit each individual player and help position the seat onto the frame. Using this prototype the next stage involved quickly producing copies of each individual seat so that they could be further tested and amended if necessary following feedback. For this speedy production an additive manufacturing technique called selective laser sintering (otherwise known as 3D printing) was used to build up each seat layer by layer. This resulted in a final product that exactly replicated what was on the computer screen. This is the first time anywhere in the world that these existing techniques have been harnessed together to produce a sports wheelchair seat.

For more information, visit: www.epsrc.ac.uk

Published in EPSRC

ENGEL has equipped a growing custom-molding and moldmaking operation with an advanced vertical press for manufacturing a life-saving surgical component housing -- an insert molded needle nearly five inches long.

ENGEL North America, member of the ENGEL group, a world leader in the design and manufacture of injection molding machines and parts-handling automation, recently delivered a new molding system built-up around a 45-ton ENGEL insert 80V/45 vertical injection molding machine to Matrix Tooling, Inc./ Matrix Plastic Products of Wood Dale, IL.

Equipped with ENGEL's sturdy C-frame clamping unit, key features of the new Matrix press include dual core-pulls, a two-station rotary table, and a highly accurate and repeatable servomotor-controlled injection unit that incorporates a high-temperature barrel package. Matrix uses its new ENGEL vertical press to insert mold TPE surgical catheter tubes with stainless-steel needles that are nearly five inches long.

“It's a pretty complicated job,” says Andy Ziegenhorn, Molding Accounts Manager at Matrix. “One of the reasons we chose the ENGEL was the flexibility of the controller. It allowed us to handle the mechanics of the tool and also allows for future improvements to the process, such as cutting the catheter tube to length within the mold."

“Although we're still in the initial stages with this project, and we are hand-loading the inserts at the present time, we have realized there are many automation possibilities.  We plan to automate this process with a side-entry robot as the production volumes ramp up.”

A Flawless Start-Up

According to Patrick Collins, the Molding Operations Manager at Matrix, “The start up on this complicated mold—a mold with removable core mandrels—was flawless. The mold has two ejector halves that rotate on the turntable. As the one side is being injected with plastic, the other is being ejected and loaded.

“At this time, we have three sets of core/insert mandrels that we are hand loading.  The core/insert mandrels have been designed to hold the stainless-steel needles with a detent that can be actuated by a lever on the mandrel. This allows the inserts to be held in place as they are being molded.”

 “We have a great team here at Matrix,“ Collins continues.  “Tom Ziegenhorn, one of our Design Engineers, and I met this new customer while working a trade show.  Tom was able to visualize that the customer needed to replace a costly manual process with a more cost-effective insert molding process.

“The mold he designed was built by our team of skilled tool builders led by Mike Martin and Gary Eckman, and our inspection team led by Gary Johansson qualified everything to exceed our customer’s expectations.”

Deciding Factors

“When choosing the machine vendor for this project – especially as we were bringing a new technology into our facility -- we wanted to limit our risk/exposure as much as possible,” says Ziegenhorn. “ENGEL's reliability and service have always been top notch in our experience, so even though the machine was a little more expensive upfront than some of their competitors, we felt that quality of the end product and service justified the investment.”

“Personally, I think you can tell the difference just by looking at the machines. Our ENGELs appear to be more solid / well built. But more to the point, we end up requiring fewer service calls on these machines than some of the others on our floor.”

A One-Stop Shop

At its 30,000-sq. ft. facility in Wood Dale, IL, Matrix employs about 50, working three shifts. The company designs and builds its own molds, and has done so for more than three decades. It operates a combination of 14 electric and hydraulic molding machines ranging from 5-to-300 tons, including two presses in a Class 100,000 cleanroom. Matrix specializes in running engineering resins, such as PEEK, PEI, LCP, PC, and nylons to produce some 20-million parts per year for its medical/surgical, electronics, military and consumer products customers.

And, since it also processes expensive resorbable materials—like PLA, PLG, and PLC—Matrix understandably makes a consistent effort to minimize shot sizes, and reduce material waste.

Matrix also adds value to the full range of services it provides its customers with such in-house secondary processes as assembly, sonic welding, laser marking, and project-specific labeling. Although pad printing and other secondary operations may be outsourced to approved suppliers of such services, Matrix oversees and manages all projects. Its state-of-the-art quality assurance lab facilitates customized inspection reporting and full qualification services. Matrix is both ISO 9001- and ISO-13485-certified.

For more information, visit: www.matrixtooling.com

Published in ENGEL

The Thiel Foundation announced today three new grants awarded through Breakout Labs, its revolutionary revolving fund to promote innovation in science and technology. The newest awards focus on solutions at the intersection of biology and advanced technologies.

Breakout Labs recipient Modern Meadow is developing a fundamentally new approach to meat and leather production that is based on the latest advances in tissue engineering and causes no harm to animals. Co-founders Gabor and Andras Forgacs respectively invented and helped commercialize bioprinting, a technology that builds tissues and organ structures based on the computer-controlled delivery of cells in three dimensions. They previously co-founded Organovo, a San Diego-based regenerative medicine company which applies bioprinting to a range of medical applications, including drug discovery, drug testing and ultimately transplant tissues. With Breakout Labs funding, they plan to apply the latest advances in tissue engineering beyond medicine to produce novel consumer biomaterials, including an edible cultured meat prototype that can provide a humane and sustainable source of animal protein to consumers around the world.

“Breakout Labs is a much-needed source of funding and support for emerging technologies like ours,” said Andras Forgacs. “Investors across the board have become more risk-averse and yet early funding is critical to enable truly innovative ideas. We are proud to be a part of the Breakout Labs program.”

“Modern Meadow is combining regenerative medicine with 3D printing to imagine an economic and compassionate solution to a global problem,” said Lindy Fishburne, Breakout Labs’ executive director. “We hope our support will help propel them through the early stage of their development, so they can turn their inspired vision into reality.”

Additional Breakout Labs grants were awarded to Bell Biosystems and Entopsis. Bell Biosystems is developing a technology that can be introduced into therapeutic cells to track them using magnetic resonance imaging (MRI) instruments. Entopsis is developing a low-cost, versatile, nano-engineered platform for diagnosing multiple diseases from a single sample.

Launched in November 2011, Breakout Labs provides teams of researchers in early-stage companies with the means to pursue their most radical goals in science and technology. To date Breakout Labs has awarded a total of nine grants, of up to $350,000 each. Breakout Labs accepts and funds proposals on a rolling basis.

Previous grants, announced in April 2012, have been awarded to companies working on brain reconstruction, reversible cryopreservation, human cell re-engineering, universal airborne contaminant detection, artificial protein therapeutics, and antimatter based fuel.

“People used to dream about how innovation would make the future a radically better, more advanced place,” said Jonathan Cain, president of the Thiel Foundation. “By funding unusual approaches to known challenges, such as conflict over food prices or the diagnosing and curing of diseases, we hope that Breakout Labs helps bring about the sort of technologically prosperous world that people once imagined possible.”

For more information, visit: www.BreakoutLabs.org or www.gust.com/c/modern_meadow

Published in Breakout Labs

The moment Megan Lavelle saw the device, she knew it would change her daughter’s life. Lavelle is an energetic, unstoppable mom whose youngest daughter, Emma, was born with arthrogryposis multiplex congenita (AMC). At a Philadelphia conference for AMC families, Lavelle learned about the Wilmington Robotic Exoskeleton (WREX), an assistive device made of hinged metal bars and resistance bands. It enables kids with underdeveloped arms to play, feed themselves and hug.

AMC is a non-progressive condition that causes stiff joints and very underdeveloped muscles. Emma was born with her legs folded up by her ears, her shoulders turned in. “She could only move her thumb,” says Lavelle. Doctors immediately performed surgery and casted Emma’s legs. The baby girl went home with parents determined to provide the best care.

Medical experts warned that AMC would prevent Emma from ever experiencing any sort of normalcy. She developed more slowly than an average child and spent much of her first two years in casts or undergoing surgery. Unable to see Emma play and interact with her environment in ways her older daughter had, Lavelle privately wondered whether Emma’s cognitive ability would be hampered as well.

Determined to Grow

But Emma progressed, slow and steady. As she grew and became able to move about with the help of a walker, it became clear that her mind was sharp and her determination on par with her mom’s. At two years old, she still couldn’t lift her arms, and the smart little girl wanted more. “She would get really frustrated when she couldn’t play with things like blocks,” Lavelle says. And so the mom would be Emma’s arms for her; playing with blocks, eating, brushing teeth.

Then came the WREX, demonstrated at the conference by an 8-year-old AMC patient lifting his arms and moving them in all directions. Lavelle met with the presenters, Tariq Rahman, Ph.D, head of pediatric engineering and research, and Whitney Sample, research designer, both from Nemours/Alfred I. duPont Hospital for Children in Wilmington, Delaware. Rahman and Sample had worked for years to make the device progressively smaller, serving younger and younger patients. Attached to a wheelchair, the WREX worked for kids as young as six. But Emma was two, small for her age, and free to walk.

In Sample’s tool-and-toy filled workshop, the team strapped Emma’s little arms into a small but awkward trial WREX attached to a stationary support. “She just started throwing her hands around and playing,” Sample says. Megan brought Emma candy and toys and watched her lift her arms toward her mouth for the first time.

Tiny Rewards

For Emma to wear the WREX outside the workshop, Rahman and Sample needed to scale it down in size and weight. The parts would be too small and detailed for the workshop’s CNC system to fabricate. But humming along near Sample’s desk was a Stratasys 3D Printer, which can build complex objects automatically from computer designs — like an inkjet printer but in three dimensions. Sample often used it to work out ideas with physical models, so he 3D printed a prototype WREX in ABS plastic. The difference in weight allowed Sample to attach the Emma-sized WREX to a little plastic vest.

The 3D-printed WREX turned out to be durable enough for everyday use. Emma wears it at home, at preschool, and during occupational therapy. And the design flexibility of 3D printing lets Sample continually improve upon the assistive device, working out ideas in CAD and building them the same day.

Fifteen kids now use custom 3D-printed WREX devices. For these littlest patients, Rahman explains, the benefits may extend beyond the obvious. Prolonged disuse of the arms can sometimes condition children to limited development, affecting cognitive and emotional growth. Doctors and therapists are watching Emma closely for the benefits of earlier arm use.

Emma quickly grew to love the abilities WREX unlocked in her. “When she started to express herself, we would go upstairs [to Sample’s workshop] and we would say, ‘Emma, you know we’re going to put the WREX on.’ And she called them her magic arms,” Lavelle says.

The little girl’s approval is a fitting reward for her determined mom and dedicated researchers. Sample says: “To be a part of that little special moment for someone else, can’t help but tug at your heart strings.”

For more information, visit: www.stratasys.com or www.nemours.org

Published in Stratasys

Researchers are hopeful that new advances in tissue engineering and regenerative medicine could one day make a replacement liver from a patient’s own cells, or animal muscle tissue that could be cut into steaks without ever being inside a cow. Bioengineers can already make 2D structures out of many kinds of tissue, but one of the major roadblocks to making the jump to 3D is keeping the cells within large structures from suffocating; organs have complicated 3D blood vessel networks that are still impossible to recreate in the laboratory.

Now, University of Pennsylvania researchers have developed an innovative solution to this perfusion problem: they’ve shown that 3D printed templates of filament networks can be used to rapidly create vasculature and improve the function of engineered living tissues.

The research was conducted by a team led by postdoctoral fellow Jordan S. Miller and Christopher S. Chen, the Skirkanich Professor of Innovation in the Department of Bioengineering at Penn, along with Sangeeta N. Bhatia, Wilson Professor at the Massachusetts Institute of Technology, and postdoctoral fellow Kelly R. Stevens in Bhatia’s laboratory.

Without a vascular system — a highway for delivering nutrients and removing waste products — living cells on the inside of a 3D tissue structure quickly die. Thin tissues grown from a few layers of cells don’t have this problem, as all of the cells have direct access to nutrients and oxygen. Bioengineers have therefore explored 3D printing as a way to prototype tissues containing large volumes of living cells.

The most commonly explored techniques are layer-by-layer fabrication, or bioprinting, where single layers or droplets of cells and gel are created and then assembled together one drop at a time, somewhat like building a stack of LEGOs.

Such “additive manufacturing” methods can make complex shapes out of a variety of materials, but vasculature remains a major challenge when printing with cells. Hollow channels made in this way have structural seams running between the layers, and the pressure of fluid pumping through them can push the seams apart. More important, many potentially useful cell types, like liver cells, cannot readily survive the rigors of direct 3D bioprinting.

To get around this problem, Penn researchers turned the printing process inside out.

Rather than trying to print a large volume of tissue and leave hollow channels for vasculature in a layer-by-layer approach, Chen and colleagues focused on the vasculature first and designed free-standing 3D filament networks in the shape of a vascular system that sat inside a mold. As in lost-wax casting, a technique that has been used to make sculptures for thousands of years, the team’s approach allowed for the mold and vascular template to be removed once the cells were added and formed a solid tissue enveloping the filaments.

“Sometimes the simplest solutions come from going back to basics,” Miller said. “I got the first hint at this solution when I visited a Body Worlds exhibit, where you can see plastic casts of free-standing, whole organ vasculature.”

This rapid casting technique hinged on the researchers developing a material that is rigid enough to exist as a 3D network of cylindrical filaments but which can also easily dissolve in water without toxic effects on cells. They also needed to make the material compatible with a 3D printer so they could make reproducible vascular networks orders of magnitude faster, and at larger scale and higher complexity, than possible in a layer-by-layer bioprinting approach.

After much testing, the team found the perfect mix of material properties in a humble material: sugar. Sugars are mechanically strong and make up the majority of organic biomass on the planet in the form of cellulose, but their building blocks are also typically added and dissolved into nutrient media that help cells grow.

“We tested many different sugar formulations until we were able to optimize all of these characteristics together,” Miller said. “Since there’s no single type of gel that’s going to be optimal for every kind of engineered tissue, we also wanted to develop a sugar formula that would be broadly compatible with any cell type or water-based gel.”

The formula they settled on — a combination of sucrose and glucose along with dextran for structural reinforcement — is printed with a RepRap, an open-source 3D printer with a custom-designed extruder and controlling software. An important step in stabilizing the sugar after printing, templates are coated in a thin layer of a degradable polymer derived from corn. This coating allows the sugar template to be dissolved and to flow out of the gel through the channels they create without inhibiting the solidification of the gel or damaging the growing cells nearby. Once the sugar is removed, the researchers start flowing fluid through the vascular architecture and cells begin to receive nutrients and oxygen similar to the exchange that naturally happens in the body.

The whole process is quick and inexpensive, allowing the researchers to switch with ease between computer simulations and physical models of multiple vascular configurations.

“This new platform technology, from the cell’s perspective, makes tissue formation a gentle and quick journey,” Chen said, “because cells are only exposed to a few minutes of manual pipetting and a single step of being poured into the molds before getting nourished by our vascular network.”

The researchers showed that human blood vessel cells injected throughout the vascular networks spontaneously generated new capillary sprouts to increase the network’s reach, much in the way blood vessels in the body naturally grow. The team then created gels containing primary liver cells to test whether their technique could improve their function.

When the researchers pumped nutrient-rich media through the gel’s template-fashioned vascular system, the entrapped liver cells boosted their production of albumin and urea, natural components of blood and urine, respectively, which are important measures of liver-cell function and health. There was also clear evidence of increased cell survival around the perfused vascular channels.

And theoretical modeling of nutrient transport in these perfused gels showed a striking resemblance to observed cell-survival patterns, opening up the possibility of using live-cell data to refine computer models to better design vascular architectures.

Though these engineered tissues were not equivalent to a fully functioning liver, the researchers used cell densities that approached clinical relevance, suggesting that their printed vascular system could eventually be used to further research in lab-grown organs and organoids.

“The therapeutic window for human-liver therapy is estimated at one to 10 billion functional liver cells,” Bhatia said. “With this work, we’ve brought engineered liver tissues orders of magnitude closer to that goal, but at tens of millions of liver cells per gel we’ve still got a ways to go.

“More work will be needed to learn how to directly connect these types of vascular networks to natural blood vessels while at the same time investigating fundamental interactions between the liver cells and the patterned vasculature. It’s an exciting future ahead.”

With promising indications that their vascular networks will be compatible with all types of cells and gels, the team believes their 3D printing method will be a scalable solution for a wide variety of cell- and tissue-based applications because all organ vasculature follows similar architectural patterns.

“Cell biologists like the idea of 3D printing to make vascularized tissues in principle, but they would need to have an expert in house and highly specialized equipment to even attempt it,” Miller said. “That’s no longer the case; we’ve made these sugar-based vascular templates stable enough to ship to labs around the world.”

Beyond integrating well with the world of tissue engineering, the researchers’ work epitomizes the philosophy that drives much of the open source 3D printing community.

“We launched this project from innovations rooted in RepRap and MakerBot technology and their supporting worldwide communities,” Miller said. “A RepRap 3D printer is a tiny fraction of the cost of commercial 3D printers, and, more important, its open-source nature means you can freely modify it. Many of our additions to the project are already in the wild.”

Several of the custom parts of the RepRap printer the researchers used to make the vascular templates were printed in plastic on another RepRap. Miller will teach a class on building and using these types of printers at a workshop this summer and will continue tinkering with his own designs.

“We want to redesign the printer from scratch and focus it entirely on cell biology, tissue engineering and regenerative medicine applications,” Miller said.

In addition to Miller, Chen, Bhatia and Stevens, the research was conducted by Michael T. Yang, Brendon M. Baker, Duc-Huy T. Nguyen, Daniel M. Cohen, Esteban Toro, Peter A. Galie, Xiang Yu and Ritika Chaturvedi of Penn Bioengineering, along with Alice A. Chen of MIT. Bhatia is also a Howard Hughes Medical Institute investigator.

This research was supported by the National Institutes of Health, the Penn Center for Engineering Cells and Regeneration and the American Heart Association-Jon Holden DeHaan Foundation.

For more information, visit: www.upenn.edu

3D Systems Corporation (NYSE: DDD) announced today that several of its VisiJet® materials have met the rigorous requirements for USP Class VI certification, including biocompatibility for healthcare applications. Class VI plastics can be used to produce medical devices, surgical guides and other implements used in and around the human body. These VisiJet® materials are now approved for use in a broad set of applications that improve treatment outcomes and patience experience.  Through enhanced bio-mimicry, individualized fit and accelerated delivery, medical and dental treatment quality can be enhanced at higher provider productivity and lower costs.

The USP Class VI VisiJet® materials listed below are available for immediate delivery and are suitable for:

  • 3D printed dental and orthopedic surgical guides;
  • 3D printed one day custom crown preparation guides; and
  • 3D printed parts for use in other medical applications.

The following are USP Class VI certified VisiJet® materials with their companion, integrated ProJet™ 3D Printers:

VisiJet® Crystal Plastic Material
ProJet™ SD 3500, HD 3500 & HD3500plus

VisiJet® Stoneplast Plastic Material
ProJet™ MP 3500

VisiJet® Clear Plastic Material
ProJet™ 6000/7000

VisiJet® EX200 Plastic Material
ProJet™ SD 3000, HD 3000 & HD3000plus

VisiJet® MP200 Plastic Material
ProJet™ MP 3000

For more information, visit: www.printin3d.com/class-vi-certification-information-visijet-materials

Published in 3D Systems

UBM Canon’s online event and conference: Emerging Trends in Medical Device Outsourcing/Contract Manufacturing takes place this week on Thursday June 14, 2012, from 11am until 5pm Eastern time.

The combined online conference and event will kick-off with a keynote address by Venkat Rajan, Industry Manager of Medical Devices with Frost & Sullivan. The Keynote presentation, New Medical Device Landscape: Adapt or Fade Away, will examine the potential effects of new business models and other healthcare cost-containment pressures, as well as the impending medical device tax, that have forced medical device companies to rethink their long-term strategies and approach to development. Mr. Rajan will also explain what these changing dynamics could mean for long-term stakeholders across the medical device supply chain.

Multiple speaker and chat sessions will follow the keynote address. In the first session, Design Trends in Outsourcing Innovation, Jim Mellor, VP of Marketing & Sales at Lake Region Medical, and John Carey, Vice President of New Business Development for Foliage, will provide insights on best practices for working with contractors on how to yield innovative, next-generation medical devices.

In the second conference session, Medical Device Miniaturization: The Quest for the Incredible Shrinking Parts, micromanufacturing experts Brent Hahn, Senior Sales Engineer for Accumold, and John Whynott, Technical Director for Mikrotech LLC, will discuss such topics as micromolding and micromachining of medical device parts and features.

The final conference session will cover Sourcing Suppliers in China. Industry experts will participate in a roundtable discussion and Q&A on the changing face of China and what it means for medical device OEMs seeking supplier partnerships. Speakers include:  John Merritt, Founder of Merritt for Myers Inc.; Todd Dickson, Co-founder and President of Lumenous Device Technologies Inc.;  Ames Gross, President of Pacific Bridge Medical; Tez Kurwie, International Sales Director, based in Europe, for Rosti Group; and Karl Stillman, Asia Region Sales Director, based in China, for Rosti Group.

Chat sessions topics include:  Advances in Testing, sponsored by Nelson Laboratories Inc., and New Challenges in Medical Packaging.

Event sponsors include Lumenous, Executive Sponsor, and our Exhibiting Sponsors Microspec, Fluortek, and Minnetronix.

For more information or to register, visit: https://presentations.inxpo.com/shows/ubm/UBMCanon/Emerging_Trends/2012_06_14/Microsite/home.htm

Published in UBM Canon

Geomagic®, a global company providing 3D technology solutions for digital reality, today announced it will showcase best practices and output from its customers’ digital orthopedic product workflows at this week’s OMTEC 2012 event in Chicago beginning Wednesday, June 13th. As orthopedic implant manufacturers work to apply the latest technologies to their patient-specific implant processes, Geomagic’s customers demonstrate the results that are made possible when medicine meets 3D capture, touch-enabled design, 3D inspection and digital manufacturing technology.

Speakers and exhibits at OMTEC 2012 will depict the use of Geomagic’s products in the latest materials for the ultimate in personalized fit, form and function.  For example, Level 3 Inspection’s Bill Greene will outline the advantages of Computer Aided Inspection for orthopedic implants as a way to deliver better patient-specific forms, faster, with fewer iterations, less waste, and lower cost.  Bill will be presenting at the conference on Thursday June 14, at 10 am CT.  

Geomagic will be demonstrating its Freeform® Modeling System for organic design and preparing files for manufacturing.  Level 3 Inspection also will join Geomagic and demonstrate its scanning solution using Geomagic Qualify for inspection and analysis.

“Advanced software is allowing us to solve clinical problems we couldn’t even begin to touch before, and Geomagic’s solutions are at the heart of the innovation,” said Barry Fell, president of Thermoplastic Products Corp. in Hummelstown PA, who designs and prototypes custom orthopedic implants.

By using Geomagic’s suite of 3D solutions, including Geomagic Studio® to capture real world data, Freeform to develop designs, and Geomagic Qualify™ to inspect and check manufactured products, medical manufacturers are moving to successful mass custom manufacturing through 3D digital reality.  Innovative orthopedic products created using Freeform, Geomagic Studio and Geomagic Qualify on display at OMTEC include:

  • Implant designs by almost every leading orthopedic implant manufacturer
  • The Smart Inspection System (SiS) for robotic Computer-Aided Inspection (CAI) with automated measurement and reporting
  • Custom implants by university hospitals, medical service bureaus, small manufacturers, Walter Reed Military Medical Center, Wilford Hall Medical Center at Lackland Air Force Base, and other major names.
  • Custom prosthetics, implants and surgical guides from ProPrecision, Medical Modeling and MedCAD
  • Surgical planning models from Thermoplastic Products Corp. and Walter Reed Military Medical Center
  • Educational models from GPI Anatomicals, Protowerx, The Chamberlain Group, and others

“Digital reality, like the digital economy, is a fact of life today, allowing art and science, and in this case medicine, to achieve breakthrough results that are not possible without our technology,” said Ping Fu, CEO of Geomagic. “A good example is the use of additive manufacturing in exciting new ways.  What was previously utilitarian, and perhaps cast or vacuum formed with standard parts, now can be designed more elegantly, ergonomically and aesthetically – and printed in new bio-compatible materials.  It’s a new era for the practitioners and patients in the orthopedic industry.”

Geomagic is exhibiting in booths 831-833 at OMTEC, which takes place at the Donald E. Stephens Convention Center, 5555 North River Road in Chicago, on Wednesday June 13 from 9 am – 6 pm CT, and Thursday June 14 from 9 am – 12 noon CT.

For more information, visit: www.omtecexpo.com

Published in Geomagic

The ODT conference unites everyone in the orthopedic manufacturing community and this year the theme of the event is achieving both operational, and technical excellence in the field of orthopedics.

Professionals in the orthopedic manufacturing community will gather to discuss and share the advancements being made in the industry. Attendees can educate each other on the latest industry news while networking with peers and industry leaders. When asked, 92% of people who have attended this event in the past were “extremely satisfied” with their experience.

This marks the 4th year of the ODT Forum which is hosted by well known orthopedic publication, Orthopedic Design & Technology. The publication has been published for 6 years and is considered the leading publication in the industry. The objective of the event is to join all the players in the orthopedic manufacturing industry to work together with the collective goal of improving the overall industry.

The more professionals and companies in the orthopedic industry that attend the event the more valuable it will become. Able Electropolishing Vice President of Sales, Tom Glass encourages peers and affiliates to join Able Electropolishing at this important event. “Coming up next month is the ODT Forum in Memphis, Tenn., on May 2-3rd. Able Electropolishing will be participating at this important orthopedic industry event, and we encourage you to register today and come see the solutions we have to offer your company. Thanks and hope to see you at the ODT Forum!”

This year the conference is made up of several presentations, a panel discussion as well as built in opportunities for networking throughout the day. Presenters include Lee Berger, MD of Ortho-Tag, Dr. David M. Anderson of Build-to-Order Consulting, Steven Mounts of Musculoskeletal Clinical Regulatory Advisers, Scott Hay of 3D Engineering and Tim Ruffner of GPI Prototype & Manufacturing Services, Inc.

The panel discussion will feature Barbara Blum Ph.D. of Wright Medical Technology, Inc and Chris Patterson of Medtronic.

Some of the ideas and topics that will be covered in these presentations include:

  • The move towards wireless and implantable technology in the medical field.
  • Ideas and tips on where to cut the cost of medical devices and where not to.
  • Ensuring proper validation.
  • Advances in technology and new techniques.

For attendees able to arrive on May 2nd, the event will kick off a day early with factory tours of Orchid Orthopedic Solutions and the Fed Ex Hub. Space is limited for these tours and registration is required.

Able Electropolishing will be attending the ODT Forum in Memphis Tennessee on May 3rd as a sponsor. Since 1954 Able Electropolishing has been providing metal finishing services from a state of the art Chicago facility. The services include passivation, electropolishing as well as other various metal finishing techniques. The company provides metal finishing services within the United States as well as overseas.

The success of the ODT Forum depends on the attendance of all players in the orthopedic manufacturing industry.

For more information, visit: www.odtforum.com or www.ableelectropolishing.com

Published in Able Electropolishing

A new 3D printing process developed at the University of Glasgow could revolutionise the way scientists, doctors and even the general public create chemical products.

Professor Lee Cronin, Gardiner Chair of Chemistry at the University, believes his research could lead to the development of home chemical fabricators which consumers could use to design and create medicine at home.

A new research paper, published in the journal Nature Chemistry, outlines how the process has been proven to work. Using a commercially-available 3D printer operated by open-source computer-aided design software, Professor Cronin and his team have built what they call ‘reactionware’, special vessels for chemical reactions which are made from a polymer gel which sets at room temperature.

By adding other chemicals to the gel deposited by the printer, the team have been able to make the vessel itself part of the reaction process. While this is common in large-scale chemical engineering, the development of reactionware makes it possible for the first time for custom vessels to be fabricated on a laboratory scale.

Professor Cronin said: “It’s long been possible to have lab materials custom-made to include windows or electrodes, for example, but it’s been expensive and time-consuming. We can fabricate these reactionware vessels using a 3D printer in a relatively short time. Even the most complicated vessels we’ve built have only taken a few hours.

“By making the vessel itself part of the reaction process, the distinction between the reactor and the reaction becomes very hazy. It’s a new way for chemists to think, and it gives us very specific control over reactions because we can continually refine the design of our vessels as required.

“For example, our initial reactionware designs allowed us to synthesize three previously unreported compounds and dictate the outcome of a fourth reaction solely by altering the chemical composition of the reactor.”

Although the technology they are developing is still at an early stage, the team, comprised of researchers from the University’s School of Chemistry and School of Physics and Astronomy, is also considering the long-term implications of developments in 3D printing technology.

Professor Cronin added: “3D printers are becoming increasingly common and affordable. It’s entirely possible that, in the future, we could see chemical engineering technology which is prohibitively expensive today filter down to laboratories and small commercial enterprises.

“Even more importantly, we could use 3D printers to revolutionise access to healthcare in the developing world, allowing diagnosis and treatment to happen in a much more efficient and economical way than is possible now.

“We could even see 3D printers reach into homes and become fabricators of domestic items, including medications. Perhaps with the introduction of carefully-controlled software ‘apps’, similar to the ones available from Apple, we could see consumers have access to a personal drug designer they could use at home to create the medication they need.”

Professor Cronin’s paper, titled ‘Integrated 3D-printed reactionware for chemical synthesis and analysis’, is published in Nature Chemistry. The research was supported by funding from the Engineering and Physical Sciences Research Council.

For more information, visit: www.gla.ac.uk

Published in University of Glasgow

UBM Canon’s Medical Design Excellence Awards (MDEA), the industry’s premier awards ceremony for medical device design and innovation, has announced Dr. Thomas Fogarty as the recipient of the 2012 MDEA Lifetime Achievement Award. This award honors an individual whose contributions during a long career have had a demonstrable impact on technological, business, and cultural advancements in medical devices. Last year’s recipient was Alfred E. Mann. Fogarty was selected by the entire UBM Canon Medical Content Team and the Medical Device and Diagnostic Industry (MD+DI) Editorial Advisory Board.

Dr. Fogarty’s vast accomplishments in the medical device industry include having founded or co-founded more than 33 medical companies. Fogarty holds 135 patents on surgical instruments, among them is the Fogarty balloon embolectomy catheter which revolutionized vascular surgery, became the first minimally invasive surgical device, and is still commonly used. Before Fogarty invented the arterial embolectomy catheter, up to 50% of patients were dying or losing limbs during surgery to remove blood clots. Fogarty’s inventions have saved the lives of millions of people.

“I am very proud to announce Dr. Fogarty as this year’s Lifetime Achievement Award recipient,” stated Rich Nass, Director of Content, UBM Canon. “His work has greatly influenced the medical device industry and the advancement of medical device technologies. The Lifetime Achievement Award was created to acknowledge the great commitment and ground-breaking contributions that individuals like Dr. Fogarty have accomplished.”

Fogarty has published approximately 180 scientific articles and textbook chapters related to general and cardiovascular surgery. He founded the Fogarty Institute for Innovation, was inducted into the National Inventors Hall of Fame, along-side Thomas Edison and the Wright Brothers, and has won countless other awards including the Lemelson-MIT Prize for Invention and Innovation.

Fogarty will be present at the 2012 MDEA awards ceremony during the MD&M East conference and tradeshow in Philadelphia on May 23, 2012 to accept his award.

Sponsored by MD+DI and organized by UBM Canon, MDEA is the premier awards program for the medical technology community. It recognizes the achievements of medical device manufacturers, their suppliers, and the many people behind the scenes-engineers, scientists, designers, and clinicians-who are responsible for the groundbreaking innovations that are changing the face of healthcare. MDEA-winning entries excel in the areas of product innovation, design and engineering achievement, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery.

For more information, visit: www.canontradeshows.com/expo/awards/home

Published in UBM Canon

Imagine opening a gift on Christmas morning and finding a body part in the box.  This happened to CJ Howard in 2010...well, sort of.

CJ was a normal, active teenager in 2002. He liked to snowboard, run, hike, cycle, and swim. And then one day he was diagnosed with osteogenic sarcoma, a form of cancer that led to part of his leg being amputated just below the knee.  He was 18 years old.

In 2008 he met Mandy Ott, a mechanical engineer working for a large aerospace company and an avid climbing enthusiast. He wasn't going to be deterred from joining her in her avocation.

Everything worked just fine, except for one thing: the prosthetic was quickly ruining the expensive climbing shoe on that foot. CJ would have the shoes resoled, but eventually would have to purchase new pairs.

Around this time, Mandy was working with Morris Technologies.  She was aware that the folks at MTI are experts in direct metal laser sintering (DMLS). A custom foot was an ideal "fit" for additive metal manufacturing. So a titanium foot was created.

CJ had taken part in the design of the foot, but by Christmas 2010, he had forgotten about it.

"I was completely shocked," says CJ. "When she handed me the box with the foot I was totally expecting to pull out a [climbing] rope, not a shiny, new climbing foot.  Definitely a one-of-a-kind gift!"

The new foot has advantages for CJ. Mandy reports that "the stiffness keeps him from slipping (unlike what he was using before), and the size helps him with crack climbing (and keeps him from getting stuck so easily)."

Other good news: CJ is nine years cancer-free April 2012.

Based in Cincinnati, Ohio, Morris Technologies, Inc. (MTI) has been on the cutting edge of additive manufacturing technologies since 1994.   MTI invests heavily in R&D and specializes in end-to-end product development, from engineering to prototyping to low-volume manufacturing.

For more information, visit: www.morristech.com

Published in Morris Technologies

Biomerics LLC, a leading supplier of polymer solutions to the medical device and healthcare industries, recently completed a 10,000-square-foot expansion at its Salt Lake City, Utah, plant. The expansion included an ISO Class 8 clean room for injection molding and device assembly, a medical device packaging cell, and a fulfillment warehouse.

“We are excited about the new capabilities this expansion provides for customers,” said Travis Sessions, President and CEO of Biomerics. “The additional clean room enables us to have dedicated production areas for material polymerization and compounding, as well as injection molding and medical device assembly. The new packaging and warehouse space expands our capability to manage sterile medical device fulfillment for our customers.”

The facility expansion was managed by Entelen, LLC, a Salt Lake City based design and construction company that specializes in clean manufacturing facilities. “We are focused on this growing market and partnering with innovative biomedical companies like Biomerics,” stated Steve Burt, CEO of Entelen. “We designed the clean room to exceed Federal Standard 209e and ISO Class 8 requirements for cleanliness and to the highest safety standards.”

In addition to the facility expansion, Biomerics has invested $1.5 million in new plastics manufacturing equipment. “The operations team has been focused on expanding and developing our manufacturing capabilities to support the growth,” said Jeff Clark, VP of Operations for Biomerics. “In the past six months, the team has brought online new medical and Pharma compounding lines, an automated material handling system, and expanded our capabilities in injection molding, vibration welding, and device assembly.”

The expansion of this ISO 13485 registered facility has resulted in the hiring of 15 employees and is expected to support the creation of an additional 20 positions over the next 12 months.

Biomerics LLC, headquartered in Salt Lake City, Utah, is a leading and innovative medical polymer solution provider to the medical device market. Biomerics specializes in biomedical materials, compounding, injection molding, extrusion, and medical device fabrication. Biomerics partners with its customers to increase their profitability via material technology, operational excellence, and customer service.

For more information, visit: www.biomerics.com

Published in Biomerics

SLM Solutions, pioneer and leader in Rapid Manufacturing Technology, and Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG, leading international specialist in prosthodontics, concluded a patent agreement for medical and dental branches.

Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG, is one of the leading international companies in prosthodontics and implantology. The Company from Bremen has been invested in R&D and the development of future technologies massively since a couple of years. Comparably in the future market of digital CAD/CAM solutions, BEGO is a pioneer in Selective Laser Melting Technology (SLM) for the dental branch and holds important patents concerning this manufacturing process.

SLM Solutions and BEGO concluded a licensing agreement. Signing the contract allows the german manufacturer of systems for generative manufacturing processes to be also successful in the medical and dental industry. “We feel very glad about the licensing agreement with SLM Solutions. I´m convinced that we created a win-win-situation, from which both companies will benefit enormously in the future. I also understand this as a verification of our business strategy to advance Research and Development”, said Christoph Weiss, managing partner of BEGO. Hans J. Ihde, President and CEO of SLM Solutions agreed with this statement: “Using the Bego- patents gives our customers legitimated security rights and strengthens our offer for using SLM Systems in the dental market. After having launched the SLM-Technology successfully into the industrial sector 10 years ago, we are definitely better positioned in the medical sector now!“

The SLM-Process generates precise and homogenous metal parts from 3 D CAD-data of computers in a layer building process without limits in design and in remarkable speed and accuracy. BEGO launched this technology into the dental industry in 2011. In contrast to the classical cutting technology it can be worked more efficiently concerning energy and material output.

After EOS GmbH Electro Optical Systems, SLM Solutions GmbH is the second manufacturer BEGO concluded a comparable licensing agreement about using the SLM-Patents. “In this way we not only document a strong position of our SLM-Technology, either we give a sign to the market: BEGO defends and merchandises its patents successfully.“, underlines Dr. Thomas Kosin, technical director of BEGO.

For more information, visit: www.slm-solutions.com or www.bego.com

Published in SLM Solutions

Objet Ltd., the innovation leader in 3D printing for rapid prototyping and additive manufacturing today announced that Oratio B.V. a leading dental industry company in the Netherlands, has developed a complete in-house digital workflow for fabrication of models for dental implants with the help of an Objet 3D Printer. The addition of 3D printing into Oratio’s workflow has turned Oratio into a fully digital dental provider, allowing it to significantly expand its implantology practice while offering higher accuracy and faster turnaround times.

Oratio identified the use of digital solutions for implantology as a potential growth opportunity. However, the company did not want to increase staff or costs, nor compromise its high standards. According to Siebe van der Zel, Chief Operating Officer of Oratio: “Digital dentistry could enable a new level of implant models and allow us full control of the complete process – from the dentist’s initial order, to designing the restoration, through final manufacturing."

Leveraging its strong experience in producing dental parts from CAD design imagery, Oratio chose to integrate the Objet Eden260V 3D Printer into its workflow. Since Installing the Objet 3D Printer Oratio has digitized the entire design and manufacturing process for dental implants. This has significantly improved the productivity of dental technicians by allowing them to focus on higher-level tasks. Implant models printed by the Objet 3D Printer are delivered with exceptionally fine details and an outstanding surface finish – to the full satisfaction of Oratio’s dentist customers. Dentist clients are also benefitting from improved turnaround times, enabled by the in-house rapid manufacturing process.

Avi Cohen, Head of Medical Solutions at Objet, commented: “Practices that specialize in dental implantology inherently require support systems that are flexible and versatile. For this reason Objet’s 3D printing systems represent the perfect fit. They enable labs such as Oratio to continue delivering specialist products to market while, at the same time, even broadening their range of services with new, value-added offerings.”

Summing up the benefits, van der Zel said: “Business growth followed immediately after we installed the Objet 3D Printer. We increased our productivity and as a result we can provide new and better solutions for implantology.”

The Objet Eden260V 3D Printer was recently recognized as a 2011 “Readers’ Choice” by subscribers to Dental Lab Products magazine. It was the only Rapid Prototyping platform honored in the magazine’s annual “Best of the Best Products” list.

For more information, visit: www.ObjetDental.com

Published in Objet

LayerWise applied Additive Manufacturing (AM) to produce an award-winning Titanium total lower jaw implant reconstruction, developed in collaboration with project partners from medical industries and academia. To treat a senior patient’s progressive osteomyelitis of almost the entire lower jawbone, medical specialists and surgeons opted for such a complete patient-specific implant the first time ever. AM technology specialists at LayerWise printed the complex implant design incorporating articulated joints and dedicated features. The reconstruction – post-processed with dental suprastructure provisions, polished joint surfaces and a bioceramic coating – has been implanted successfully. It restored the patient’s facial esthetics and allowed her to regain her speech within hours.

Complex AM implant produced as a single part

LayerWise in Leuven, Belgium, produced the metal implant structure layer by layer using its dedicated metal AM technology. A high-precision laser selectively heats metal powder particles, in order to quickly and fully melt to properly attach to the previous layer without glue or binder liquid. As layers are built successively, AM hardly faces any restrictions to produce the complex lower jaw implant structure. AM is used to print functional implant shapes that otherwise require multiple metalworking steps or even cannot be produced any other way.

The revolutionary patient-specific implant has been developed and produced under supervision of Prof. Dr. Jules Poukens, in collaboration with specialized industrial and academic parties in Belgium and The Netherlands.. Just recently, the innovative implant was granted the “2012 AM-Award” by the Additive Manufacturing Network in Belgium. The jury members of Sirris and VITO praised the fact that AM played a decisive role in the realization of this revolutionary mandible implant.

A giant leap forward in mandibular treatment

Dr. ir. Peter Mercelis, Managing Director of LayerWise: “Besides a successful track record in industrial sectors, metal AM is gaining importance in medical implantology. AM’s freedom of shape allows the most complex freeform geometries to be produced as a single part prior to surgery. As illustrated by the lower jaw reconstruction, patient-specific implants can potentially be applied on a much wider scale than transplantation of human bone structures and soft tissues. The use of such implants yield excellent form and function, speeds up surgery and patient recovery, and reduces the risk for medical complications.”

Prof. Dr. Jules Poukens of the University Hasselt: “The new treatment method is a world premiere because it concerns the first patient-specific implant in replacement of the entire lower jaw. The implant integrates multiple functions, including dimples increasing the surface area, cavities promoting muscle attachment, and sleeves to lead mandible nerves. Furthermore, the mandible implant is equipped to directly insert dental bar and/or bridge implant suprastructures at a later stage. I led the team of surgeons who implanted the AM-produced structure during a surgery of less than four hours at the Orbis Medisch Centrum in Sittard-Geleen. Shortly after waking up from the anesthetics the patient spoke a few words, and the day after the patient was able to speak and swallow normally again.”

LayerWise is one of the top players in metal Additive Manufacturing technology. As an AM technology innovator, LayerWise stretches the limits of metal part performance and manufacturing economics. After gaining recognition across industrial sectors, AM is increasingly being adopted in different medical fields such as dentistry, orthopaedics, maxillofacial and spinal surgery. LayerWise intensively collaborates with academic partners, and heavily invests in research and development to push the boundaries of AM technology.

For more information, visit: www.layerwise.com



Published in LayerWise

The Medical Design Excellence Awards (MDEA) program, the medical device industry’s premier design awards competition, announced today that is has extended the deadline for the call for entries to February 8, 2012.

The MDEA is presented by UBM Canon, the global advanced manufacturing and MedTech authority, and by Medical Device and Diagnostic Industry (MD+DI), the industry’s central source for late breaking news, information, and business intelligence.

Entries are accepted from companies and individuals worldwide involved in the design, engineering, manufacture, or distribution of finished medical devices or medical packaging products.

“We are very proud to be a part of a long tradition of innovation in medical device products,” stated Heather Thompson, Editor-in-Chief, MD+DI. “Through the MDEA, we have honored nearly 450 groundbreaking products, including the AcceleDent Orthodontic System; Avedro Vedera KXS Vision Correction Device, and many more deserving products.”

The program recognizes both the design achievements and healthcare contributions of medical product manufacturers and the many people behind the scenes-engineers, scientists, designers, and clinicians-who are responsible for the groundbreaking innovations that are changing the face of healthcare.

The MDEA will also be honoring an individual with the prestigious Lifetime Achievement Award for contributions over a long career that have a demonstrable impact on technological, business, and cultural advancements in medical devices.

Accepted in ten medical product categories, entries are evaluated by a multidisciplinary panel of jurors with expertise in engineering, medicine, human factors, industrial design, manufacturing, and other design and healthcare-related fields.

Finalists will be publicly announced in the April issue of MD+DI magazine. The winners will then be announced in May at a special presentation ceremony held in conjunction with the Medical Design & Manufacturing (MD&M) East Conference and Exposition, May 22-24, 2012, at the Pennsylvania Convention Center in Philadelphia. MDEA-winning products will be honored with Bronze, Silver, or Gold-level awards in each category. Also, one Gold-winning product will be awarded “Best-in-Show”.

Parties interested in entering in the 2012 MDEA competition are encouraged to visit www.mdeawards.com for complete program details, including eligibility requirements, a downloadable entry form, rules, instructions, and an entry materials checklist.

Published in UBM Canon

SurgiCase Connect is a free, interactive tool that enables surgeons to upload medical image data and communicate about 3D surgical plans and the design of 3D printed surgical guides. In order to make SurgiCase Connect easier to use than ever, Materialise is proud to announce that there is now a SurgiCase Connect iPad App available for download in European App Stores.

Thanks to this mobile platform surgeons will be able to fit SurgiCase Connect seamlessly into their fast-paced lives. In addition, the fact that they can use their fingers to manipulate 3D models and review surgical plans brings an extra “personal touch” to the planning of patient-specific surgical procedures. Perfection has never been so easy to achieve.

SurgiCase Connect is an interactive tool that allows you to:

* Upload CT images and other case data. Our clinical engineers convert the scanner data into virtual 3D models; you can use the 3D models to examine your patient’s pathology from various angles
* Work as a team to brainstorm the best possible surgical plan
* Receive unique surgical guides along with a physical 3D model of the pathology, designed by your engineer at Materialise.
* Step confidently in the operating room, fully prepared

For more information, visit: www.materialise.com/ortho/connect

Published in Materialise

A remarkable team of plastic surgeons, led by Prof. Blondeel at the University Hospital of Ghent, have successfully executed Belgium’s first full face transplant. Although it was the world’s nineteenth face transplant, this was the first time that the complex procedure was fully planned using digital planning and 3D printing. During the 20 hour long procedure the patient, who suffered from a large facial defect, received bone, muscles, veins, nerves, and of course skin from a donor who had just died.

Pre-operative planning for both the donor and the recipient was completed in collaboration with Materialise CMF (cranio-maxillo facial) clinical engineers using ProPlan CMF. Using CT data, a digital representation of the patient’s anatomy was created and used in the formation of a detailed plan for this complex procedure. In order to put the surgical plan into action, anatomical models and patient specific surgical guides were 3D printed for use before and during the operation. The anatomical models allowed the surgeons to see below the skin of both the patient and the donor and carry out advanced preparation. The 3D printed guides were used during the procedure itself to aid the surgeons and allow them to realize the surgical plan they had created.

The entire CMF team at Materialise is proud of the contribution they have made to this incredible milestone in Belgian medical history.

Materialise would like to congratulate the team of 65 surgeons and medical staff at the University Hospital of Ghent for successfully completing this remarkable procedure. This is an incredible achievement, even more so given that the patient is already making a recovery that surpasses expectations; regaining the ability to speak only 6 days into recovery.

For those that understand Dutch, a video interview is available outlining the procedure at: www.deredactie.be/permalink/1.1191529

Published in Materialise

MD+DI (Medical Device and Diagnostic Industry), UBM Canon’s leading brand providing the medical device industry with the latest news, information, and in-depth analysis, announced a series of articles and discussion covering perspectives on the human element of medical device design.

“We’re taking a close look at what the human element means to the medical device industry,” stated Brian Buntz, Editor for MD+DI. “To some, the focus of that is on the patient’s experience living with a medical device. For others, the emphasis is on producing devices that are safer and easier for physicians to use in their procedures. In an industry focused on saving and enhancing people’s lives, sometimes the human element gets lost in the shuffle of regulatory issues, recalls, pricing squeezes, and rising costs-yet it is an integral part of the entire industry.”

For the first two parts of the series, Buntz spoke with Professor Mary Beth Privitera, a designer of medical devices and biomedical-engineering professor at the University of Cincinnati who oversaw the Medical Design Excellence Awards judging process in 2011 to get her view on the human element of innovation.

In the first part, “Designing the Devices Surgeons Want,” Privitera states, “The human element is the one common thread that is throughout the entire process and throughout the entire innovation cycle where you get the idea, the inspiration for the idea, and then there is a whole push from a regulatory perspective of making products that are more advanced with regard to ergonomics and human factors.”

Privitera also discusses the importance of clinical observation and how crucial it is for the problem solver (design engineer) and problem owner (surgeon) to work together to find the best solution. She discusses clinical observation including stress testing. Read more and join the discussion here.

In part two, “Pushing Boundaries of Innovation,” Privitera takes a deeper dive into the idea behind stress monitoring of physicians to identify challenging components of procedures to then address in specific medical device design and delivery methods. She also discusses the use of personas to “help break out large market segments based on use behavior” as well as visual mapping of clinical procedures.

Published in UBM Canon

It looks like bone, it feels like bone, for the most part it acts like bone, and it came off an inkjet printer.

Washington State University researchers have used a 3D printer to create a bone-like material and structure that can be used in orthopedic procedures, dental work and to deliver medicine for treating osteoporosis. Paired with actual bone, it acts as a scaffold for new bone to grow on and ultimately dissolves with no apparent ill effects.

The authors report on successful in vitro tests in the journal Dental Materials and say they’re already seeing promising results with in vivo tests on rats and rabbits. It’s possible that doctors will be able to custom order replacement bone tissue in a few years, said Susmita Bose, co-author and professor in WSU’s School of Mechanical and Materials Engineering.

"If a doctor has a CT scan of a defect, we can convert it to a CAD file and make the scaffold according to the defect,” Bose said.

The material grows out of a four-year interdisciplinary effort involving chemistry, materials science, biology and manufacturing. A main finding of the paper is that the addition of silicon and zinc more than doubled the strength of the main material, calcium phosphate.

The researchers – who include mechanical and materials engineering Professor Amit Bandyopadhyay, doctoral student Gary Fielding and research assistant Solaiman Tarafder - also spent a year optimizing a commercially available ProMetal 3D printer designed to make metal objects.

The printer works by having an inkjet spray a plastic binder over a bed of powder in layers of 20 microns, about half the width of a human hair. Following a computer’s directions, it creates a channeled cylinder the size of a pencil eraser.

After just a week in a medium with immature human bone cells, the scaffold was supporting a network of new bone cells.

The research was funded with a $1.5 million grant from the National Institutes of Health.

For more information, visit: wsutoday.wsu.edu

Photo Credit: Shelly Hanks of WSU Photo Services

Active wheelchair users will be excited to learn that Proto Labs has chosen Whirlwind Wheelchair International as the latest recipient of its Cool Idea! Award. Proto Labs – the leading online and technology-enabled manufacturer of quick-turn prototype and short-run parts – will help the company launch its innovative RoughRider wheelchair to the U.S. market.

The RoughRider was originally designed for those with disabilities in developing countries as a low-cost, highly durable wheelchair that can handle rough terrain with ease. The RoughRider combines a revolutionary long wheelbase with a unique, high-impact/high-flotation wheel to allow users to safely descend curbs and short flights of stairs and to easily traverse obstacles in their path.

Proto Labs identified the RoughRider, now in use in more than 40 countries, as a good candidate for the Cool Idea! Award amid growing U.S. demand for the product. U.S. riders seeking a more active lifestyle value the chair’s performance and rugged durability, and began asking when it would be available. In preparation for the release to a mainstream U.S. audience, the RoughRider underwent a redesign with the addition of lightweight side panels to make it better looking and customizable, something U.S. customers will love. As a Cool Idea! Award recipient, Proto Labs provided Whirlwind Wheelchair International with the key side panels needed for an initial U.S. launch.

“We wanted to recognize Whirlwind Wheelchair International’s response to the demand for their product outside of the developing countries they had been serving. They were able to improve upon the existing model to accommodate wheelchair riders in the U.S. who are accustomed to the luxury of high-end chairs, while still keeping the design that allows for off-road experiences intact,” said Proto Labs Founder and CTO Larry Lukis. “The RoughRider is a great example of trickle-up innovation and something that perfectly fits the innovative spirit of the Cool Idea! Award.”

"Scores of wheelchair riders in the U.S. have inquired about purchasing the RoughRider specifically for off-pavement adventures that are difficult with U.S. style wheelchairs," said Whirlwind Wheelchair Founder Ralf Hotchkiss. "Entering the U.S. market at this time will provide Whirlwind with a wealth of critical feedback from well-informed consumers, and may raise enough funds to do much-needed development of the innovations coming in from riders in developing countries. Besides, some U.S. riders who have ridden the Rough Rider had so much fun that they would love to get one for themselves. We will do whatever is necessary to make this happen."

The RoughRider wheelchair has received critical support, both from within the wheelchair riding community, and from former President Bill Clinton at a Walkabout Foundation Benefit.

The Cool Idea! Award is a new program offered by Proto Labs that gives product designers the opportunity to bring innovative products to life. Whirlwind Wheelchair International is the third recipient, with additional award winners to be named. During 2011, Proto Labs will provide an aggregate of up to $100,000 worth of prototyping and short-run production services to award recipients.

For more information, visit: www.protolabs.com/coolidea

Published in Proto Labs

The University of California Berkeley is using Z Corporation 3D printing technology to accelerate the evolution of a new medical device that promises to deliver safe, non-invasive angiography.

Called X-space Magnetic Particle Imaging (MPI), the technology will let doctors look inside the heart and brain without the dangers of radiation, iodine, guide wires or catheters, according to Patrick Goodwill, University of California Berkeley research associate and developer of both the theory and first x-space MPI scanner. The MPI scanner detects nanoparticles spotlighted by benign iron oxide tracers injected into the bloodstream.

Goodwill and a team of graduate engineering students in the Conolly Laboratory use the ZPrinter® 150 3D printer to create parts for MPI scanner prototypes that can image small animals. These devices are precursors to human-scale scanners.

"Since we're building the world's first MPI scanners, we can't just buy parts off the shelf," said Goodwill. "We're using the ZPrinter to manufacture parts such as transmit coils, receive coils, heated animal beds and even custom components for delivering animal anesthesia. Every scanner we've built has incorporated at least two or three ZPrinted parts."

Goodwill purchased the ZPrinter after trying Dimension 3D printers, which were expensive -- costing up to $1,500 per part in materials -- and time consuming, taking as much as 20 hours to make a single part. The ZPrinter creates parts in half the time, at a fraction of the price, and even produces multiple parts in each build cycle. "We can build 30 parts for the price of one," Goodwill said.

"ZPrinting is the fastest way we can create the parts we need to rapidly iterate our design so we can bring MPI to the general public sooner," Goodwill said. "We train all our students on SolidWorks® CAD software and have them manufacture their own parts. Now, whenever we have an inspiration, we try it out with a real part. We never have to leave the lab."

3D printing creates physical models you can hold in your hand from 3D digital data, much as a document printer creates a business letter from a word-processing file. ZPrinters are the fastest, most affordable 3D printers and the only ones capable of simultaneously printing in multiple colors.

For more information, visit: www.qb3.org/blog/2011/09/magnetic-particle-imaging-0

Published in Z Corporation

Kemeera, Inc., a California-headquarters product development services company and Objet Geometries reseller, today announced availability of a new high temperature 3D printing material (RGD525™). The high temperature material is capable of simulating the thermal performance of engineering plastics and provides outstanding dimensional stability for static 3D models and prototypes.

"We are very excited to offer our customers a wide spectrum of materials for simulating engineering plastics," said Kemeera co-principal Michelle Mihevc. "High temperature material will allow industrial designers and manufacturing engineers to perform genuine thermal functional testing of 3D printed parts and prototypes. The models created in this material are more resilient in diverse environmental conditions."

RGD525 has a heat deflection temperature (HDT) of 0.45MPa at 149°F out of the printer and 176°F after a short oven-based, post-thermal treatment. The High Temperature material produces 3D models and prototypes combining high thermal functionality with outstanding dimensional stability. The material's temperature resistance makes it highly beneficial for thermal testing of static parts such as hot air-flow or hot water-flow in taps and faucets. When jetted off the Objet Connex multi-material 3D printer, the High Temperature Material can be simultaneously printed with Objet's Tango family of rubber-like materials to simulate over-molded parts such as air-flow vents used in automotive, defense and household appliances.

With these new additions, the number of Objet 3D printing materials is brought to a total of 68, including 51 composite materials (Digital Materials), enabling a wide range of rapid prototyping usages, from realistic product visualization to advanced functional testing.

California-based Kemeera, Inc. is a full-service product development company offering laser scanning, reverse engineering, rapid prototyping and manufacturing solutions. Kemeera represents Objet Geometries in Northern California, Northern Nevada, Oregon, Washington, Hawaii and Alaska to deliver Objet Connex500, Connex350, Objet260 Connex, Eden500V, Eden 350/350V, Eden 260V, Eden250, Objet24 Personal 3D Printer and the Objet30 Desktop 3D Printer to the region. Connect with Kemeera on Facebook, Google+, Twitter, Linkedin and YouTube.

For more information, visit: www.kemeera.com

Published in Kemeera

Sensable announced that custom facial prosthetics, custom dental and maxillofacial implants, as well as custom surgical guides, created with its Freeform® 3D modeling and design system will be spotlighted at the 2011 American Association of Maxillofacial Prosthetics annual conference starting this Saturday, October 29th in Scottsdale, Arizona. Freeform’s touch-enabled 3D modeling system allows maxillofacial surgeons and prosthetic designers to start with existing CT or MRI scans, then create and manufacture complex and exceptional-fitting restorations in a fraction of the time previously required by producing them by hand – speeding patient access to improved comfort, aesthetics and function.

Also at the conference, speakers from US military medical institutions will cite custom implants and prostheses created using Sensable Freeform, during a session on advances in the use of digital techniques for treating wounded soldiers.

Maxillofacial medicine treats anomalies of the face, skull and jaws, both congenital and acquired, through surgery and custom-made implants and appliances. Prosthetists – specialists in designing and fitting restorations – are going digital, and rely on Freeform as their go-to tool for the prosthetics-making process.

“FreeForm allows us to help surgeons rebuild faces -- and lives," said Nancy Hairston, president of MedCAD, a Dallas based custom medical device manufacturer whose custom surgical splints for a complex mandible/maxilla realignment were made on a 3D printer in biocompatible material and are on display at the show. "In the past, custom implants and guides cost a lot more than off the shelf parts. Today, with digital solutions like Freeform, we can create customized parts for the same cost, save time, and with even greater accuracy.”

“With FreeForm, our team can create our ClearShield craniofacial implants at least 50 percent faster , moving from an STL file created from a patient-specific CT scan, through to completed design a 3D model in as little as a week,” said Cynthia Brogan, CEO of Osteosymbionics, whose naturally shaped implants correct cranial defects.

In addition to the above cases, other custom prosthetics and surgical guides designed in Freeform and showcased at the AAMP conference include:

* Custom dental guides for complex implant surgeries from ProPrecision Guides of Gainesville FL.
* 3D study model of an aneurism to help a surgeon better locate and analyze a treatment plan than by using 2D radiology images alone, from service bureau Protowerx of Langley, British Columbia.
* An obturator from City University of New York (CUNY), and other complex dental appliances provided to treat congenital deformities or for cancer patients when large sections of their palates must be removed, restoring basic human functions such as speaking, breathing and eating.

As a design solution optimized for organically-shaped products, Freeform saves hours, even days, when designing human forms. Its design-for-manufacturability features allow service bureaus to streamline the process of delivering a completed implant or appliance, as well as custom tools and guides which can aid in surgery, using the latest additive manufacturing techniques and biocompatible materials.

“Precise dental implant placement is paramount to stability, comfort and life expectancies. With Freeform, I can design a typical surgical guide in 15 minutes, instead of 45 minutes. The resulting surgical guide is a perfect fit, and with direct manufacturing, we also avoid the heat, fumes, dust and debris involved when manually forming acrylic guides and grinding them to fit, as well as numerous intermediary steps,” said John Pellerito, principal of ProPrecision Guides.

“Freeform is the one solution I can’t live without in my toolbox,” said Shawn Cherewick, owner of Protowerx. “The product has made it possible for us to take notoriously ‘noisy’ CT scan files, and manipulate their organic shapes so that even jagged and protruding edges of the aneurism – shapes that traditional CAD would choke on - could be produced as models effectively and efficiently like never before.”

Freeform Enables Maxillofacial Implant Designers to:

* Easily mirror intact anatomy from one side of the body to the other damaged side, to create perfect symmetry
* Split anatomical files at precisely the right location – both standard and non-standard
* Intuitively control the position of anatomy and implants
* Match jagged or irregular edges – for example, a skull patch for a wounded soldier – at least 5 times faster than traditional CAD
* Prep models for rapid manufacturing and tooling quickly and accurately
* Readily drive new biocompatible materials and additive manufacturing processes, including

* Trabecular metal that supports bone in-growth;
* 3D printing in a host of new biocompatible resins including polymethyl methacrylate (PMMA)
* Milling and traditional casting, in titanium or PEEK

* Streamline digital workflows
* Scan, then design complex solid models such as in medical applications.
* Easily and quickly explore designs and produce study models
* Readily create manufacturable files, for example testing insertion directions and draft

“We’re witnessing a revolution in patient-specific manufacturing today, where implants are being designed and produced faster, more accurately and in new materials that provide enormous benefits to patients,” said Joan Lockhart, vice president of marketing, at Sensable. “We’re proud to showcase the innovation of our Freeform customers and demonstrate how they are using our systems to produce transformational implants and prosthetics for patients.”

Founded in 1993, Sensable remains the leading developer of touch-enabled solutions and technology that allow users to not only see and hear an on-screen computer application, but to actually “feel” it. With 44 patents granted and over 10,000 systems installed worldwide, Sensable helps people innovate with human touch solutions. The company markets and sells the Intellifit™ Digital Restoration System for dental labs; a suite of 3D organic design solutions that includes its flagship product, Freeform; and the Phantom® and Omni™ lines of haptic devices, used in surgical simulation and planning, stroke rehabilitation, medical training, and a range of research and robotic applications. With an unparalleled commitment to partnering with customers, Sensable brings a human touch to innovating and implementing customer-centric solutions. Sensable products are available through direct and reseller channels worldwide.

For more information, visit: www.sensable.com

Published in SensAble Technologies

The Medical Design Excellence Awards (MDEA) program is accepting entries for its 2012 competition from companies and individuals worldwide involved in the design, engineering, manufacture, or distribution of finished medical devices or medical packaging products. The MDEA is presented by UBM Canon, the leading producer of face-to-face, digital, print, and online business acceleration products for the worldwide medical device industry and sponsored by MD+DI (Medical Device and Diagnostic Industry) magazine.

Now in its 15th year, the MDEA competition is a prestigious, publicity-charged program that provides companies with year-round opportunities to increase the distinction of their MDEA-finalist and winning products. The program recognizes both the design achievements and healthcare contributions of medical product manufacturers and the many people behind the scenes-engineers, scientists, designers, and clinicians-who are responsible for the groundbreaking innovations that are changing the face of healthcare.

Parties interested in entering in the 2012 MDEA competition are encouraged to visit www.MDEAwards.com for complete program details, including eligibility requirements, a downloadable entry form, rules, instructions, and an entry materials checklist. Industry professionals are encouraged to review the information provided on the website and become involved in building recognition for medical product excellence, both in their own companies and industry wide. Although entries are most often submitted by manufacturers, firms that provide materials, components, or design and consulting services may submit an entry on behalf of a product manufacturer with that manufacturer’s written consent.

The early-bird submission deadline for the 2012 MDEA competition is November 14, 2011 and its standard deadline is December 9, 2011.

Accepted in ten medical product categories, entries are evaluated by a multidisciplinary panel of jurors with expertise in engineering, medicine, human factors, industrial design, manufacturing, and other design and healthcare-related fields.

Finalists will be publicly announced in the April issue of MD+DI magazine. The winners will then be announced in May at a special presentation ceremony held in conjunction with the Medical Design & Manufacturing (MD&M) East Conference and Exposition, May 22-24, 2012, at the Pennsylvania Convention Center in Philadelphia. MDEA-winning products will be honored with Bronze-, Silver-, or Gold-level awards in each category. Also, one Gold-winning product will be awarded “Best-in-Show”.

MDEA awards have been given to nearly 450 groundbreaking products, including the AcceleDent Orthodontic System; Avedro Vedera KXS Vision Correction Device; cobas b 123 point-of-care blood gas analyzer system; Compass interchangeable modular system; Cranial Loop nonmetallic cranial fixation device for postcraniotomy bone flap fixation; DISTALOCK Intramedullary (IM) Nail and Drill System; Encircle Compression Therapy device; Inogen One G2 portable oxygen concentrator; Integrated Cycler real-time polymerase chain reaction (PCR) thermocycler; iO-Flex surgical system; JuggerKnot Soft Suture Anchor; Leica BOND-III immunohistochemistry and in-situ hybridization staining system; Lifeline View automated external defibrillator; LipiView Ocular Surface Interferometer; MAGPIX versatile multiplexing bioassay platform; MalleoLoc ankle orthosis; Mindray V Series Patient Monitoring System; Orascoptic Freedom cordless LED headlamp for dentists and hygienists; PleuraFlow active tube clearance system; Pronto-7 handheld noninvasive hemoglobin spot-check testing device; Propoint obturation point for use in root canal therapy; Radiant Heat Warmer (RHW) 3000 series; Selenia Dimensions tomosynthesis (3D) system; SpeediCath Compact Male intermittent catheter; Triangular Prostatic Stent; UroLift System minimally invasive device; VeinViewer Vision vascular imaging device; and the Venner A.P. Advance Video Laryngoscope.

The MDEA program is endorsed by AdvaMed; the American Institute for Medical and Biological Engineering; the Healthcare Technology Foundation; the Human Factors and Ergonomics Society; the Medical Device Manufacturers Association; and the National Collegiate Inventors and Innovators Alliance.

Published in UBM Canon

Objet Ltd., the innovation leader in 3D printing for rapid prototyping and additive manufacturing today announced that Guide3D Lab will start offering its dentist customers surgical guides made of the new Objet Bio-Compatible 3D printing material (MED610™). According to Guide3D, the material combines bio-compatibility with high transparency, which makes it an ideal material for the production of highly accurate, customized implant surgical guides.

According to David Kenyan, General Manager of Guide3D Lab, "Using the Objet Bio-Compatible material enables dentists to easily use customized 3D printed surgical guides in the mouth and better monitor the soft tissue underneath to ensure a safer and more successful dental procedure."

Avi Cohen, Head of Medical Solutions at Objet adds: "Objet Bio-Compatible transparent material is manufactured under the ISO 13485:2003 certification, which guarantees fulfilment of comprehensive quality management procedures for the manufacture of medical devices."

"The new Objet Bio-Compatible material is ideal for prolonged skin contact of over 30 days and mucosal-membrane contact of up to 24 hours. It has five medical approvals according to the harmonized standard ISO 10993-1: Cytotoxicity, Genotoxicity, Delayed Type Hypersensitivity, Irritation and USP Plastic Class VI.* MED610 is also manufactured under the ISO 13485:2003 certification, which specifies that each and every batch of the material undergoes bio-compatibility conformity testing, including GC-FID, before it is packaged. This ensures the highest bio-compatible standards for dental solutions requirements" Added Avi Cohen.

MED610 is the second material Objet has created specifically for dental and medical solutions. It joins the company's original Objet VeroDent material, currently used extensively in the digital dental process at dental labs worldwide.

Guide3D Lab is a dental institute that develops advanced technologies and procedures for the dental implants market. Guide3D's team has developed a smart design solution that features numerous technical dental implants and surgical guides using CyberMed Inc software specifically designed for making very precise surgical guides.

Founded in 2010, Guide3D is among the most promising companies nationwide for the manufacture of surgical guide appliances. Guide3d will also manufacture modules made of transparent material which can be used for the planning and precise execution of major intra oral and maxillofacial surgical procedures, such as block excision of aggressive tumors and closure of large maxillary clefts by bone grafting with block grafts. Gude3d Lab is also investigating and developing the use of 3D modeling in field of orthopedic surgery.

For more information, visit: www.objetdental.com or www.guide3d.net

Published in Objet

A Canadian-invented prosthetic arm that's controlled by brain signals is being recognized by the James Dyson Award.

AMO Arm and its two Canadian inventors – Michal Prywata and Thiago Caires – have officially moved on to the final Top 15 round of finalists in the prestigious, international engineering award.

On November 8, 2011, inventor and innovator James Dyson will select the top scoring design. The winner will receive receive £10,000 (for the student or the team) and £10,000 for the winner's university department.

Prywata and Caires' invention was selected from a competitive field of 550 inventions from 18 countries.

"AMO Arm is a prosthetic limb that is controlled using brain signals," explains the team. "AMO Arm replaces an invasive, costly and lengthy surgical procedure, dramatically improving the quality of life for amputees."

Prywata and Caires have already turned AMO Arm into a successful business venture which includes development of assistance devices for paraplegics, various types of amputations, and non-invasive blood glucose meters for diabetes patients. The Ryerson Biomedical Engineering students have built a company, Toronto-based Bionik Laboratories Inc., and are currently securing their first round of investor funding.

See below for the full list of the Top 15 inventors:

AMO Arm (Canada)
Problem: The loss of an arm can often demand invasive muscle re-innervation surgery for full arm prosthetics.
Solution: AMO Arm bypasses the medical procedure. It can be strapped on and is controlled using brain signals, avoiding major surgery and the long rehabilitation period after.
Dyson engineers said: "It is quite incredible that so many complex movements can be achieved by thought alone. Very slick, very hi tech and very impressive."

Air Massage (UK)
Problem: Arthritis sufferers experience stiff joints which can effectively "seize up" and are difficult and painful to get moving again.
Solution: The device uses PVC air bags which fill to create a wave of pressure across the hand. This provides a massage and compression, both of which are beneficial to the sufferer.
Dyson engineers said: "This is a good product idea which is demonstrated by great rigs."

Airdrop Irrigation (Australia)
Problem: Drought has devastating consequences, but there is an abundant source of water in the air around us.
Solution: Airdrop Irrigation feeds air though a network of subterranean piping, cooling the air and allowing condensation. It then pumps this water directly to the crops above.
Dyson engineers said: "We like how the designer engineered a very simple low cost product to help drought stricken areas. The clever idea here is how he's used cool subterranean ground to condense water out of the air."

AudioWeb (UK)
Problem: The internet is highly visual and can be difficult for the blind and partially sighted to navigate. Existing products simply read the page content and can be confusing.
Solution: AudioWeb uses multiple voices to reflect text formatting, and music provides the context of where you are on the screen - making web use faster and easier.
Dyson engineers said: "A satisfactory program that helps blind people to use the internet seems long overdue – this is an improvement on the existing technology available."

Blindspot (Singapore)
Problem: The white cane is an invaluable tool in guiding the visually impaired away from hazards, but it's not intelligent enough to guide them towards things, like a nearby friend.
Solution: Blindspot augments the existing white cane with technology to direct the user towards a chosen destination using an optical track button.
Dyson engineers said: "Designers should always consider how new technology can improve existing products."

dbGLOVE (Italy)
Problem: The deaf and blind can suffer from a lack of access, communication and mobility.
Solution: This interactive glove helps not only the deaf but also the deaf and blind by using a range of stimulations and buttons to allow computer mediated communication.
Dyson engineers said: "DbGLOVE allows the deaf and blind to communicate at the 'tips of their fingers.'"

Ecoclean (Spain)
Problem: Using a conventional mop and bucket means you're always returning dirty water to your clean floor. On top of which, most buckets require between 5 and 7 litres of water.
Solution: Ecoclean uses two receptacles in the bucket separate the clean water from the dirty water, so the two are never mixed. Instead of 7 litres of water, Ecoclean requires only 1 litre to work effectively. This cuts back on water consumption and contamination.
Dyson engineers said: "A simple, yet revolutionary re-invention of the traditional mop and bucket. This hygienic and eco-conscious design works with basic principles to solve two problems at once."

KwickScreen (UK)
Problem: Hospital wards do not afford patients privacy and can be a breeding ground for hospital acquired infections.
Solution: KwickScreen is a portable, retractable room divider. Using Rolatube technology it increases the privacy, dignity and protection afforded to patients. It allows healthcare professionals to make the best use of available space and can be wiped clean to improve hygiene.
Dyson engineers said: "KwickScreen exploits the benefits Rolatube technology and is an hygienic alternative to dusty curtains. A slick project, brilliantly done."

MediMover (Ireland)
Problem: Devices to manoeuvre patients in hospitals are often flimsy and impractical. This can contribute to back problems for porters.
Solution: MediMover is an aid to transfer patients from one hospital bed to another bed. The process uses minimal effort and eliminates the need to roll or lift the patient.
Dyson engineers said: "This is a good example of how good design can reduce the strain caused by an everyday task."

Open Socket (USA)
Problem: The current cost (approx. $5,000) and complexity of assembly of prosthetic arms is a huge barrier to helping amputees in developing countries.
Solution: The Open Socket prosthetic arm is mechanically controlled by simple body movements which allow the hook to be opened and closed and replace the function of a human hand. It can be fitted onto an amputee in under 10 minutes and costs only $100.
Dyson engineers said: "Open Socket is an ingenious answer to a longstanding need for a low cost, easy-fit prosthetics for use in developing countries."

R2B2: Mechanised Kitchen Utensils (Germany)
Problem: We use vast amounts of energy in food production; every stage from growing, harvesting, packaging, purchasing and cooking can place a strain on our resources.
Solution: R2B2 uses a fly wheel, driven by a pedal, to generate and store electricity. This eliminates the need for electricity in food preparation.
Dyson engineers said: "We loved this how this technology engages the user with the whole cooking process; from the creation and storing of energy, to the preparation of food."

Rabbit Ray (Singapore)
Problem: Children often associate hospital procedures with punishment, ultimately leading to an unhealthy mindset in later years.
Solution: Rabbit Ray is communication tool for hospital staff and children to explain blood taking and intravenous drips. Using a rabbit to demonstrate the child is shown how and why the simple procedures are taking place, allaying their fears.
Dyson engineers said: "Everyone remembers being terrified of injections as a child. Rabbit Ray is about prevention rather than cure – explaining something to a child through a medium they understand."

Suppostin (UK)
Problem: About 95% of people who suffer from a spinal cord injury require at least one intervention to initiate defecation. This is often aided by an insertion of a gloved finger into the anus which can be frustrating and embarrassing for patients.
Solution: The Suppostin suppository inserter removes the need for the insertion of fingers. In this way, it allows users to be more independent and dignified in their bowel care.
Dyson engineers said: "A challenging problem and a brilliant solution."

You'd Better Drink Tea (Germany)
Problem: Millions of cups of tea are brewed around the world and each one uses a myriad of materials which negatively affect our environment.
Solution: You'd Better Drink Tea cuts the materials down to just one - a biodegradable plastic pocket which protects, brews and then stirs your tea.
Dyson engineers said: "A teabag and teaspoon in one. You'd Better Drink Tea enables the drinker to make a cup of tea with just one material, eliminating a lot of the waste from your daily brew."

Mobile Furniture (Japan)
Problem: Finding adaptable furniture for a small narrow room is difficult.
Solution: Mobile Furniture uses link mechanics to create adaptable furniture – creating a dining table, cupboard, bed space, shelving unit and high table.
Dyson engineers said: "Amazing furniture design – fantastically prototyped. It is incredible that something so small can incorporate so much engineering and function".

For more information, visit: www.jamesdysonaward.org or www.bioniklabs.com

Published in James Dyson Foundation

SolidWorks® software reseller CADD Edge announced today that John Slamin, SVP of Engineering for ConforMIS, leading manufacturer of partial knee implants and orthopedic devices, will serve as their annual user event’s keynote speaker. The 2011 CADD Edge User Group & Training Event takes place Wednesday-Thursday, October 26-27, 2011, at the MGM Grand at Foxwoods in Mashantucket, CT and begins with Mr. Slamin’s address on how ConforMIS has utilized Solidworks to develop its innovative product line and bring products to market quickly.

The user group coincides with the launch of the SolidWorks 2012 product line, the newest release of the popular 3D CAD design, simulation, product data management, and documentation software. However, the conference is educational in nature, specifically geared toward the learning needs of new and experienced SolidWorks users alike - offering attendees over 35 technical training sessions from which to choose, each led by Certified SolidWorks Instructors and Technicians.

The theme of this year’s event is “Seeing Is Believing: Better, Faster Designs” and Mr. Slamin’s presentation promises to be an exemplary case-in-point. “CADD Edge has been instrumental in facilitating our rapid product development cycle,” said Slamin, adding: “We’ve been working with them since 2007 when we adopted SolidWorks as our primary CAD design software and, without their dedicated, knowledgeable training and support staff, it would have taken twice as long to get up to speed.”

CADD Edge Chief Operating Officer, Marcel Matte, commented “ConforMIS’ collection of industry awards speaks for itself and serves as testimony to the product excellence that is possible when visionary designers and engineers have the right tools to execute their ideas.” In June 2011, ConforMIS’ iTotal® Knee Replacement System was recognized as the winner of the American Technology Award in the Health & Medical technologies category. Other ConforMIS accolades include 2009 Winner of the Medical Design Excellence Award for its iUni and iDuo knee resurfacing devices.

Following the keynote address by Slamin at 9am on Wednesday, October 26th, attendees will have access to a vast array of live training breakouts covering all facets of 3D CAD design, FEA design validation, CAD/CAM, product data and product lifecycle management, 3D printing and rapid prototyping, design automation, and solids modeling – culminating in a detailed SolidWorks 2012 feature walk-through at the end of the second day. Aside from SolidWorks, other CADD Edge partners that are sponsoring and attending the conference include: Objet Geometries, HSMWorks, HP, Omnify, Tacton Systems, DriveWorks, Extensible CAD, E3.WireWorks, and SolidThinking

According to CADD Edge Technical Manager Leon Austin, “This user group offers an unmatched opportunity for SolidWorks users to receive detailed instruction from experienced, certified professionals on tackling such a wide range of engineering and design challenges. In fact,” Austin added, “I'm not aware of any other SolidWorks events in the Northeast that will offer the breadth or depth of topics we plan to cover.”

Online registration for the user conference as well as a complete agenda and schedule of training sessions are available at: www.regonline.com/builder/site/Default.aspx?EventID=1006979

Published in CADD Edge

Objet Ltd., the innovation leader in 3D printing for rapid prototyping and additive manufacturing, is demonstrating the benefits of adding 3D printing to the dental workflow, at International Expodental Rome, today. Exhibiting at Hall 9, Stand D12 from October 6-8 - Objet presents the new Bio-Compatible 3D printing material (MED610™) and its 3D printers that help dental labs to digitize their dentistry for more accurate and cost effective results. According to Objet, the material combines bio-compatibility with high dimensional stability and clear transparency. This makes it useful for PMMA simulation and a wide range of dental solutions - particularly the production of highly accurate, customized surgical guides.

Avi Cohen, Head of Medical Solutions at Objet adds, "Objet invests significantly in R&D in order to proactively meet the requirements of our customers. The advanced mechanical properties of the new Bio-Compatible material, including clear transparency, bring benefits to the entire medical and dental workflow - from surgical planning through to the procedure itself."

The new Objet Bio-Compatible material is ideal for prolonged skin contact of over 30 days and mucosal-membrane contact of up to 24 hours. It has five medical approvals according to the harmonized standard ISO 10993-1: Cytotoxicity, Genotoxicity, Delayed Type Hypersensitivity, Irritation and USP Plastic Class VI.* MED610 is also manufactured under the ISO 13485:2003 certification, which specifies that each and every batch of the material undergoes bio-compatibility conformity testing, including GC-FID before it is packaged. This ensures the highest bio-compatible standards for dental solutions requirements.

Objet is also showcasing a broad range of the dental models at the event, specifically designed for the dental market. The material features extreme toughness, dimensional stability and great detail visualization-producing modelsthat can be handled immediately after being built.

Avi Cohen concludes, "Choosing the right equipment to get the best return on investment is not trivial. Objet enables dental practitioners to reap the maximum benefits from the digital dentistry era, which is exactly what we'll be demonstrating at the International Expodental Rome."

Among dental laboratories already using Objet 3D printing technology are Glidewell Laboratories, Albensi Laboratories, iDent Imaging and Remedent to fabricate unique stone models, orthodontic appliances, delivery and positioning trays, veneer try-ins, full and partial denture try-ins, surgical guides, clear aligners and retainers.

To find out more about Objet's digital dentistry solutions please visit: www.ObjetDental.com

*Biological Testing: Parts printed by Objet according to Objet MED610 Use and Maintenance Terms (DOC-08242) were evaluated for biocompatibility in accordance with standard DIN EN ISO 10993-1: 2009, Biological evaluation of medical devices-Part 1: Evaluation and Testing within a risk management process. This addresses cytotoxicity, genotoxicity, delayed hypersensitivity, and USP plastic Class VI which includes the test for irritation, acute systemic toxicity and implantation.

DISCLAIMER: It is the responsibility of the Customer and its respective customers and end-users to determine the biocompatibility of all the component parts and materials used in its finished products for their respective purposes, including in relation to prolonged skin contact (of more than 30 days) and short-term mucosal-membrane contact (up to 24 hours). Results may vary if different conditions apply than those existing at Objet Ltd.'s ("Objet")  laboratories at testing time and those that applied for the purposes of the evaluation of biological testing specified in 2009, Biological evaluation of medical devices-Part 1: Evaluation and Testing within a risk management process. Customer acknowledges the contents of this document and that Objet parts, materials, and supplies are subject to its standard terms and conditions identified at www.objet.com/termsandconditions which are incorporated herein by reference.

Published in Objet

NVision, Inc., a leader in 3D non-contact optical scanning for over 21 years, recently provided an orthodontic company with the information it needed to recalibrate its CT scanner. The company, an orthodontic supplier, utilized NVision’s Engineering Service Division to scan a human skull as part of the verification/inspection process for its in-house CT machine. The scanning results provided by NVision contained all the measurement data necessary for the orthodontic company to recalibrate its CT machine to the highest possible level of accuracy.

The use of CT scans in orthodontics has increased in recent years, primarily because such scans can provide practitioners with an enhanced view of a patient's facial anatomy. Unlike traditional 2D X-rays, CT scans provide a three-dimensional image of the patient's skull, teeth, roots, and jaw that can be viewed from all angles, providing extra information that can't be obtained soley with X-rays. This information can aid orthodontists and oral surgeons in diagnosing problems and planning treatment.

The orthodontic company needed a high-precision 3D scan of the skull to compare to measurement results obtained from its own cone-beam CT scanner. They sent NVision the skull and engineers began scanning it with NVision’s HandHeld laser scanner.

The NVision Handheld scanner is a powerful portable scanning device that is capable of capturing 3D geometry from objects of almost any size or shape. The scanner is attached to a mechanical arm that moves about the object, freeing the user to capture data rapidly with a high degree of resolution and accuracy. An optional tripod provides complete portability in the field. Intuitive software allows full model editing, polygon reduction, and data output to all standard CAD packages.

“Our scan of the skull confirmed that the orthodontic company’s CT machine, although only 1/1000 of an inch off in its measurements, was in need of some recalibration,” says Colin Ellis, Engineering Manager at NVision. “The company subsequently used our skull measurements as its key tool in the recalibration process.”

For more information, visit: www.nvision3d.com

Published in NVision

Objet Ltd., the innovation leader in 3D printing for rapid prototyping and additive manufacturing, today launched a new Bio-Compatible 3D printing material (MED610™). According to Objet, the material combines bio-compatibility with high dimensional stability and clear transparency. This makes it useful for PMMA simulation and a wide range of medical and dental applications - particularly the production of highly accurate, customized surgical guides.

Dr. Stan Brodie, Specialist in Digital Implant Planning and Surgical Guides at iDent, and a user of Objet 3D printing technology, comments, "The accuracy and fine detail of Objet 3D-printed surgical guides guarantee surgeons a consistently high level of precision that's unmatched by manual processes. The new Bio-Compatible material now introduces further benefits to the process with improved transparency, making it easier to monitor underlying soft tissue during dental procedures."

Avi Cohen, Head of Medical Solutions at Objet adds, "Objet invests significantly in R&D in order to proactively meet the requirements of our customers. The advanced mechanical properties of the new Bio-Compatible material, including its clear transparency bring benefits to the entire medical and dental workflow - from surgical planning through to the procedure itself."

The new Objet Bio-Compatible material is ideal for prolonged skin contact of over 30 days and mucosal-membrane contact of up to 24 hours. It has five medical approvals according to the harmonized standard ISO 10993-1: Cytotoxicity, Genotoxicity, Delayed Type Hypersensitivity, Irritation and USP Plastic Class VI.* MED610 is also manufactured under the ISO 13485:2003 certification, which specifies that each and every batch of the material undergoes bio-compatibility conformity testing, including GC-FID before it is packaged. This ensures the highest bio-compatible standards for medical and dental application requirements.

MED610 is the second material the company has created specifically for dental and medical applications. It joins the company's original Objet VeroDent material, currently used extensively by dental labs worldwide in the digital dental process.

The Bio-Compatible material can be used on all Objet Connex and Eden 3D printers and is available for purchase immediately. Existing customers can use this material following a software upgrade.

*Biological Testing: Parts printed by Objet according to Objet MED610 Use and Maintenance Terms (DOC-08242) were evaluated for biocompatibility in accordance with standard DIN EN ISO 10993-1: 2009, Biological evaluation of medical devices-Part 1: Evaluation and Testing within a risk management process. This addresses cytotoxicity, genotoxicity, delayed hypersensitivity, and USP plastic Class VI which includes the test for irritation, acute systemic toxicity and implantation.

DISCLAIMER: It is the responsibility of the Customer and its respective customers and end-users to determine the biocompatibility of all the component parts and materials used in its finished products for their respective purposes, including in relation to prolonged skin contact (of more than 30 days) and short-term mucosal-membrane contact (up to 24 hours). Results may vary if different conditions apply than those existing at Objet Ltd.'s ("Objet")  laboratories at testing time and those that applied for the purposes of the evaluation of biological testing specified in 2009, Biological evaluation of medical devices-Part 1: Evaluation and Testing within a risk management process. Customer acknowledges the contents of this document and that Objet parts, materials, and supplies are subject to its standard terms and conditions identified at http://www.objet.com/termsandconditions/  which are incorporated herein by reference.

Objet does not guarantee the final release and availability of materials, products and/or features referred to herein. Materials will be released subject to Objet's sole discretion. Not all released materials are currently available for all platforms / systems. Objet will update its website further as releases become available and/or compatible with specific platforms/systems.

For more information, visit: www.objet.com/3D-Printing-Materials/Overview/Bio-Compatible

Published in Objet

Researchers have been working at growing tissue and organs in the laboratory for a long time. These days, tissue engineering enables us to build up artificial tissue, although science still hasn’t been successful with larger organs. Now, researchers at Fraunhofer are applying new techniques and materials to come up with artificial blood vessels in their BioRap project that will be able to supply artificial tissue and maybe even complex organs in future. They are exhibiting their findings at the Biotechnica Fair that will be taking place in Hannover, Germany on October 11-13.

There were more than 11,000 persons on the waiting list for organ transplantation in Germany alone at the beginning of this year, although on the average hardly half as many transplantations are performed. The aim of tissue engineering is to create organs in the laboratory for opening up new opportunities in this field. Unfortunately, researchers have still not been able to supply artificial tissue with nutrients because they do not have the necessary vascular system. Five Fraunhofer-institutes joined forces in 2009 to come up with biocompatible artificial blood vessels. It seemed impossible to build structures such as capillary vessels that are so small and complex and it was especially the branches and spaces that made life difficult for the researchers. But production engineering came to the rescue because rapid prototyping makes it possible to build workpieces specifically according to any complex 3-D model. Now, scientists at Fraunhofer are working on transferring this technology to the generation of tiny biomaterial structures by combining two different techniques: the 3-D printing technology established in rapid prototyping and multiphoton polymerization developed in polymer science.

Successful Combination
A 3-D inkjet printer can generate 3-dimensional solids from a wide variety of materials very quickly. It applies the material in layers of defined shape and these layers are chemically bonded by UV radiation. This already creates microstructures, but 3-D printing technology is still too imprecise for the fine structures of capillary vessels. This is why these researchers combine this technology with two-photon polymerization. Brief but intensive laser impulses impact the material and stimulate the molecules in a very small focus point so that crosslinking of the molecules occurs. The material becomes an elastic solid, due to the properties of the precursor molecules that have been adjusted by the chemists in the project team. In this way highly precise, elastic structures are built according to a 3-dimensional building plan. Dr. Günter Tovar is the project manager at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB based in Stuttgart. When we caught up with him, he described the latest work: The individual techniques are already functioning and they are presently working in the test phase; the prototype for the combined system is being built.

When ink becomes an artificial vessel system
You have to have the right material to manufacture 3-dimensional elastic solids. This is the reason why the researchers came up with special inks because printing technology itself calls for very specific properties. The later blood vessels have to be flexible and elastic and interact with the natural tissue. Therefore, the synthetic tubes are biofunctionalized so that living body cells can dock onto them. The scientists integrate modified biomolecules – such as heparin and anchor peptides – into the inside walls. They also develop inks made of hybrid materials that contain a mixture of synthetic polymers and biomolecules right from the beginning. The second step is where endothelial cells that form the innermost wall layer of each vessel in the body can attach themselves in the tube systems. Günter Tovar points out that »the lining is important to make sure that the components of the blood do not stick, but are transported onwards.« The vessel can only work in the same fashion as its natural model to direct nutrients to their destination if we can establish an entire layer of living cells.

Opportunities for Medicine
The virtual simulation of the finished workpieces is just as significant for project success as the new materials and production techniques. Researchers have to precisely calculate the design of these structures and the course of the vascular systems to ensure optimum flow speeds while preventing back-ups. The scientists at Fraunhofer are still at the dawn of this entirely new technology for designing elastic 3-dimensionally shaped biomaterials, although this technology offers a whole series of opportunities for further development. Günter Tovar acknowledges »we are establishing a basis for applying rapid prototyping to elastic and organic biomaterials. The vascular systems illustrate very dramatically what opportunities this technology has to offer, but that’s definitely not the only thing possible.« One example would be building up completely artificial organs based on a circulation system with blood vessels created in this fashion to supply them with nutrients. They are still not suited for transplantations, but the complex of organs can be used as a test system to replace animal experiments. It would also be conceivable to treat bypass patients with artificial vessels. In any event, it will take a long time until we will actually be able to implant organs from the laboratory with their own blood vessels.

This is a project that the Fraunhofer Institute for Applied Polymer Research IAP in Potsdam, Germany, the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in Stuttgart, Germany, the Fraunhofer Institute for Laser Technology ILT in Aachen, Germany, the Fraunhofer Institute for Manufacturing Engineering and Automation IPA in Stuttgart, Germany and the Fraunhofer Institute for Material Mechanics IWM in Freiburg, Germany are all participating in. They are exhibiting a large model of an artificial blood vessel printed with conventional with rapid prototyping technologies and samples of their current developments in Hall 9, Stand D10 at the Biotechnica Fair.

For more information, visit: www.igb.fraunhofer.de

Published in Fraunhofer

FineLine Prototyping is pleased to be exhibiting, sponsoring, and presenting at Medical Design’s first ever Medical Prototyping Conference (MPC).  The conference will be held in Minneapolis, home to many medical device companies, September 7-8, 2011.  Unlike other prototyping conferences, MPC will focus exclusively on the medical device industry.  FineLine Prototyping is a rapid prototyping and additive manufacturing service organization specializing in high-accuracy, high-resolution parts for the medical device industry.

Modeled after the successful two-day Medical Silicone Conference events, MPC will feature presentations by leading industry experts, including FineLine Co-Founder and President Rob Connelly, who will present on stereolithography as a means to reduce product development time.  “The many possible uses of stereolithography for medical applications have proven effective for reducing product development time, saving costs, and increasing quality,” said Connelly.  “Some applications just are not possible without the use of additive manufacturing.”

Other presentation topics scheduled for the conference include selective laser sintering, 3D printing, rapid injection molding, and other topics specific to medical device OEMs.  Keynote sessions will address the significance of prototyping in the medical device industry, particularly in light of market forces.

Founded in 2001, FineLine Prototyping, Inc. services the US's medical device product development community with precision stereolithography technology.  FineLine pioneered the use of high-resolution stereolithography, and helped develop it into a mainstream tool, used by product development professionals around the globe.

For more information, visit: www.finelineprototyping.com or http://medicaldesign.com/microsites/protoyping-conference

Published in FineLine Prototyping

UBM Canon has announced details of the keynote addresses at next month’s inaugural MEDevice Forum-the September 13-14 conferences and supplier showcase in San Diego which focus upon current and emerging innovations in materials for medical applications and implant device development.

The Forum’s conferences will begin with a September 13th keynote address by Dr. Chandramallika (Molly) Ghosh, senior scientific reviewer in the Office of Device Evaluation, Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA). The presentation is entitled, “Submissions and Approvals for Innovative Devices: An FDA Update”.  Dr. Ghosh will discuss the FDA’s review approach for pre-market evaluation of medical devices, and provide an overview of the Medical Device Innovation initiative launched by FDA’s Center for the CDRH in 2011.

The next day’s address, entitled “Post Market-Enforcement and Risk Management”, will be delivered by Vipul Sheth, Vice President of Quality, Coronary/Peripheral for Medtronic. The presentation will discuss the impact of healthcare reform, increased regulatory scrutiny, FDA modernization and implementation of initiatives under the new commissioner, pricing pressures faced by industry, and the strengthening of regulatory systems in developing countries. Mr. Sheth will also offer insights into how medical device companies can prepare themselves for the future.   

Multiple presentations will follow these keynote addresses. Presentations in the Implantable Device Design track include: Part I: Applying Standards and Regulation to Implantable Device Design, Part II: Beyond ISO: Material Testing That You Should Do but Probably Don’t, Part III: Examining the Process, and Part IV: Working with Suppliers.

The presentations covered under the Applying New Materials to Enable Innovative Devices conference track include Part I: Addressing Materials Challenges, Part II: Materials and Electronics, and Parts III and IV: Applications for Specialty Materials: Opportunities and Challenges Ahead

About  Chandramallika (Molly) Ghosh

Dr. Ghosh holds a Ph.D. in Pharmacology and Toxicology from University of Louisiana at Monroe and did postdoctoral research at Purdue University. She is a Diplomate of the American Board of Toxicology. She serves as a United States Expert on ISO TC 194, the International Organization for Standardization (ISO) Technical Committee (TC) responsible for developing standards for biological evaluation of medical devices. She is a founding member of Medical Device Specialty Section (MDSS) at Society of Toxicology. Prior to joining FDA, Dr. Ghosh was the Associate Director of Toxicology at NAMSA, Ohio. Dr. Ghosh has presented and published over 50 papers and was an Adjunct (prestige appointment) Associate Professor of Pharmacology and Toxicology in the College of Pharmacy at University of Toledo, Ohio.

About Vipul Sheath

Mr. Sheath’s current responsibilities include Design Assurance Engineering for R&D projects that include Drug Eluting Stent products such as Endeavor and Resolute. He is responsible for Design Assurance activities at multiple sites - Santa Rosa, Danvers, MA, Galway Ireland and our recently acquired business Invatec (based in Switzerland and Italy) and Ardian (based in Mountain view, CA). Mr. Sheath reports directly to the General Manager of the Coronary business unit, as well as the VP of QA for the Cardiac /Vascular sector, and is accountable for all aspects of Quality Assurance for the Coronary business (approximately $1.5B in revenue). In previous roles at Medtronic, Mr. Sheath has supported the Endovascular business as Director of QA and successfully launched several projects and led a cross-functional team to resolve significant compliance issues related to clinical trials. He has overseen business integration activities post business acquisitions and participated in due diligence activities. Mr. Sheath has overseen all areas of QA during his tenure at Medtronic including product development support, manufacturing support, manufacturing transfer, business acquisition and integration, supplier quality, audit and compliance functions, software quality, configuration management and other shared services. 

The inaugural MEDevice Forum will focus on modern biomaterials and developing next-generation implant technology. The conference will also discuss how to successfully take next-generation devices that incorporate innovative technologies to market. The event will take place on September 13-14, 2011, from 9:00-4:00 PDT. Registration is now available. Admission to the conference is complimentary for employees of qualifying implantable device manufacturers. Supporting Organizations include ASM International, the Society of Plastics Engineers, and the Surfaces in Biomaterials Foundation.

For more information, visit: www.medeviceforum.com

Published in UBM Canon

Tissue engineering pursues the aim of replacing natural tissue after injuries and illnesses with implants which enable the body to regenerate itself with the patient’s own cells. So that tissue can be produced to replicate the body’s natural tissue, knowledge of the interaction between cells in a three-dimensional framework and the growth conditions for complete regeneration is essential. Using a special laser technique, research scientists at the Fraunhofer Institute for Laser Technology ILT and other Fraunhofer Institutes have succeeded in producing hybrid biomimetic matrices. These serve as a basis for scaffold and implant structures on which the cells can grow effectively.

If tissue has been badly damaged by disease or due to an accident or if parts of the tissue have been completely removed, the body is often unable to regenerate this tissue itself. What’s more, in many cases no endogenous material is available for transplants. As a result, demand in the medical field is increasing for implants which enable complete regeneration to take place. But the current artificially produced implants are often not adequately adapted to the environment in the patient’s body and are therefore of limited use as a tissue replacement. The main reason for this lack is the missing knowledge on how cells react to a threedimensional environment. Scientists at Fraunhofer ILT in cooperation with other Fraunhofer Institutes, however, have developed a process for producing biomimetic scaffolds which closely emulates the endogenous tissue. This process allows the fabrication of specialized model systems for the study of three dimensional cell growth, for the future generation of optimal conditions for the cells to colonize and grow. For this purpose the Aachen-based research scientists have transferred the rapid prototyping technique to endogenous materials. They combine organic substances with polymers and produce three-dimensional structures which are suitable for building artificial tissue.

Laser light converts liquid into 3-D solids As the basis the research scientists use dissolved proteins and polymers which are irradiated with laser light and crosslinked by photolytic processes. For this they deploy specially developed laser systems which by means of ultra-short laser pulses trigger multiphoton processes that lead to polymerization in the volume. In contrast to conventional processes, innovative and low-cost microchip lasers with pulse durations in the picosecond range are used at Fraunhofer ILT which render the technique affordable for any laboratory. The key factors in the process are the extremely short pulse durations and the high laser-beam intensities. The short pulse duration leads to almost no damage by heat to the material. Ultra-fast pulses in the megawatt range drive a massive amount of protons into the laser focus in an extremely short time, triggering a non-linear effect. The molecules in the liquid absorb several photons simultaneously, causing free radicals to form which trigger a chemical reaction between the surrounding molecules. As a result of this process of multiphoton polymerization, solids form from the liquid. On the basis of CAD data the system controls the position of the laser beam through a microscope with a precision of a few hundred nanometers in such a way that micrometer-fine, stable volume elements of crosslinked material gradually form.

"This enables us to produce scaffolds for cell scaffolds with a resolution of approximately one micrometer directly from dissolved proteins and polymers to exactly match our construction plan," explains Sascha Engelhardt, project manager at the ILT. "These biomimetic scaffolds will enable us to answer many aspects of threedimensional cell growth." For this purpose the team of research scientists uses various endogenous proteins, such as albumin, collagen and fibronectin. As pure protein structures are not very shape-stable, however, the Aachen-based researchers combine them with biocompatible polymers. These polymers are used to generate a scaffold which in a subsequent step provides a framework for the protein structures that have been produced. This new process makes it possible to create structures offering much greater stability. The scaffold can be seeded with the patient’s own cells in a medical laboratory. The colonized scaffolds can then be expected to produce good implant growth in the patient’s body. The long-term aim is to use the process to produce not only individual cell colonies but also complete artificial tailor-made organs. That would represent a huge medical advance!

The Fraunhofer ILT research scientists are currently engaged in work to optimize the process. For example, they want to greatly increase the production speed by combining the fabrication process with other rapid prototyping methods, in order to reduce the time and cost involved in producing tailor-made supporting structures for synthetic tissue.

For more information, visit: www.ilt.fraunhofer.de

Published in Fraunhofer

MassDevelopment has provided a $1,445,000 loan from the Emerging Technology Fund to Burlington’s ConforMIS, Inc., a privately held medical device company that is pioneering new types of implants used in orthopedics. ConforMIS uses computed tomography scans and proprietary computer aided design technology to create customized knee implant solutions for each patient. This customized approach also allows for a highly efficient just-in-time delivery model that takes full advantage of manufacturing innovations such as 3D printing.

ConforMIS will use loan proceeds to purchase multiple pieces of fabrication equipment and instruments used in its Massachusetts-based manufacturing operations.

At the end of 2010, the company moved to a larger facility to accommodate its aggressive growth and manufacturing expansion. With the recent 510(k) clearance from the U.S. Food and Drug Administration for the iTotal® CR, the only patient-specific total knee implant cleared for sale in the US, the company expects to accelerate its rapid growth.

“With this new technology, ConforMIS will be able to provide knee replacements to those who are underserved by current designs,” said MassDevelopment President and CEO Marty Jones. “The Emerging Technology Fund helps companies that are starting or expanding manufacturing in Massachusetts, and this project is a triple play: boosting production, creating jobs, and serving the health needs of the Commonwealth.”

“The loan from MassDevelopment will further support the expansion of our supply chain and manufacturing presence, which is critical to our competitiveness within the orthopedics industry,” said Dr. Philipp Lang, MD, CEO of ConforMIS. “Ultimately, the loan will help ConforMIS push the orthopedics industry toward a more efficient and more personalized approach to osteoarthritis treatment, and ultimately to enhance patients’ quality of life."

For more information, visit: www.conformis.com or www.massdevelopment.com

Published in MassDevelopment

OPM is very pleased to announce it has secured funding for the purchase of an EOSINT P 800 SLS machine for the production of the firm’s OsteoFab™ medical implants. The funding was provided by the Connecticut Innovations, Inc.’s BioScience Facilities Fund. Financing is in the form of special debt instrument. The equipment is part of a multi-million dollar project to produce medical implants through additive fabrication with the firm’s proprietary OXPEKK® products which have properties comparable to human bone. The facility will be certified to ISO 13485, ISO 9001 and AS9100 and be equipped with clean rooms and world-class design and inspection capabilities. The project is expected to be completed by September 2011.

“We are very pleased that CI has provided the funding via their BioScience Facilities Fund for this extremely important project. We have had a long, successful relationship with CI that has resulted in positive financial return on their previous investment and the growth of jobs and world class technologies in the state,” said Scott DeFelice, President of OPM. “We are exceedingly confident that this particular undertaking will further position our firm and the state on the leading edge of biomedical and manufacturing technologies.”

OPM currently sells its biomedical polymeric OXPEKK® products on a global basis with regulatory approvals from the FDA, KFDA, ANVISA, COFEPRIS, and several CE Marks. It has traditionally sold these products as raw materials. With the addition of the EOSINT P 800, however, it will now be able to provide value-added manufacturing in-house. The P 800 allows for direct digital additive manufacturing through selective laser sintering (SLS), which means nearly anything that can be designed can be built with the firm’s implantable polymer. This enhanced capability positions the firm to lead innovation in biomedical technologies and the polymer market. The initial focus of the firm’s efforts will be the production of custom cranial and maxillofacial implants which are anatomically identical implants derived directly from a CT scan or MRI.

For more information, visit: www.oxfordpm.com

After months of researching, designing and testing prosthetic hand devices to help a three-year-old hold a pencil and draw for the first time, an all-girl FIRST LEGO League team of kid inventors, The Flying Monkeys, finally met in person this week with the toddler who is successfully using their invention. The meeting culminated in a celebration of patent-pending kid inventions designed to help kids with their health-related issues during the inaugural FIRST LEGO League Global Innovation Award ceremony, June 16, hosted at the United States Patent and Trademark Office (USPTO).

FIRST is a not-for-profit organization that inspires an appreciation of science and technology in young people. The Flying Monkeys are a FIRST LEGO League team comprised of girls, ages 11 to 13. The team created the BOB-1, a prosthetic hand device to enable users with limb abnormalities to hold, stabilize or secure items.

The Flying Monkeys' inspiration for the invention is a three-year-old girl who was born with missing fingers on her dominant hand. The team's coach discovered this child's needs through correspondence with a Yahoo Group for families affected by congenital limb differences. Using Danielle's hand measurements, the FIRST LEGO League teammates invented the device from moldable plastic, a pencil grip and Velcro.

"I see the BOB-1 helping many kids... all over the world," said one of the FIRST LEGO League team members from The Flying Monkeys.

"With FIRST LEGO League, we are reaching kids at a really young age who are making inventions, and they are unbounded in what they think is possible," said Dean Kamen, iconic inventor and founder of FIRST.

The FIRST LEGO League Global Innovation Award, presented by the X PRIZE Foundation in collaboration with the USPTO, offered teams an opportunity to further develop and submit ideas stemming from their 2010 FIRSTLEGO League research projects.

The Flying Monkeys earned first prize and were honored at the ceremony with $20,000 from the X PRIZE Foundation to apply toward patenting the BOB-1; they already hold a provisional patent for the device. The runner-up teams were also honored on June 16. The winners and their inventions are:

* First Place Winner: The Flying Monkeys of Ames, Iowa, invented a prosthetic hand device enabling users with limb abnormalities to hold, stabilize, or secure items
* Runner-Up: The 4thMotor of East Troy, Wis., invented a non-invasive glucose monitoring device for kids with diabetes; using RFID technology and microchips to eliminate finger pricking
* Runner-Up: Blue Gear Ticks of Lincoln, Mass., invented an unfurling bio-absorbable arterial stent that expands upon demand as children grow

"Today... help me salute my new heroes: The Flying Monkeys, The 4th Motor and The Blue Gear Ticks," said Robert K. Weiss, Vice Chairman and President, X PRIZE Foundation, during the ceremony. "The Global Innovation Award was a competition for these kids to create something really great, to be recognized... and to give real meaning to what these kids have accomplished."

The Global Innovation Award encouraged FIRST LEGO League kids to practice creative problem-solving, a crucial skill in addressing complex, real-world issues. The award ceremony celebrated the winning teams' creativity, compassion and innovation.

The award submissions were based on the 2010 FIRST LEGO League Challenge, BODY FORWARD, which tasked FIRST LEGO League teams in more than 56 countries to explore the cutting-edge world of bio-engineering and discover innovative ways to repair injuries, overcome genetic predispositions, and maximize the body's potential with the intended purpose of leading happier and healthier lives.

FIRST LEGO League teams from 15 countries entered 179 submissions. The entries were voted upon by the public and then judged by an expert panel to determine the most patentable ideas. Close to 400,000 public votes were cast by nearly one million people who visited the award website.

During the award ceremony, members from all three winning FIRST LEGO League teams revealed their paths to innovation during a kid inventor panel. The students also presented their inventions to patent experts, asked the experts for advice and visited the Inventor's Hall of Fame and Museum.

For more information, visit www.usfirst.org or www.newsinfusion.com/events/firstlegoleague

Published in FIRST

Kelyniam Global, Inc. (OTC: KLYG), an emerging medical device manufacturing company that recently was granted FDA 510(k) approval, announced today that it will acquire Cranston Holdings, LLC. Cranston Holdings, LLC has rapid prototyping operations in Connecticut, and its employees have tremendous knowledge and expertise in Stereolithography and multiple aspects of rapid prototyping for the medical industry. Kelyniam is a pioneer in the production of custom cranial implants utilizing computer aided design and computer aided manufacturing of advanced medical grade polymers. This addition significantly strengthens Kelyniam’s position in the medical device space and positions them as a company to watch.

“This acquisition will immediately add additional shareholder value by integrating Cranston’s employees and equipment into our infrastructure,” said James Ketner, president and CEO of Kelyniam. “Most importantly, Cranston owns an in-house developed proprietary software package that will assist us in our ISO 13485, 21 CFR 820 compliance, and that software package is now IP of Kelyniam.”

Chris Breault, former president of Cranston Holdings, LLC, stated, “We are pleased to join the Kelyniam team, and are excited about what we have seen with how dynamic Kelyniam can be implementing processes and controls. This is a great marriage of two companies that both have exceptional technology and capabilities.”

Mr. Breault will be joining Kelyniam’s Board of Directors, and will be in charge of Operations at Kelyniam’s new Engineering and Manufacturing facility in Canton Connecticut.

Cranston Holdings had revenues in 2010 of approximately $600,000 USD. The acquisition is for an equity swap for assets and revenues.

Kelyniam Global (OTC: KLYG), Inc. specializes in the use of CAD/CAM technology to provide patient specific custom implants to assist medical professionals by allowing them to operate more effectively, improve patient care, and reduce health care costs by providing the highest quality products available with today's technology. The company is continually researching and developing new products and processes to help patients live more active and productive lives.

For more information, visit: www.kelyniam.com

Published in Kelyniam Global

As demand for smaller, less intrusive medical devices continues to grow, designers and OEMs are increasingly seeking materials with properties that can make these new devices possible. Bayer MaterialScience LLC is launching a new grade of medical polycarbonate to address this need during the Medical Design & Manufacturing East conference, taking place at the Jacob K. Javits Convention Center in New York City, June 6-9.

"Bayer MaterialScience has been a trusted material supplier to the medical market for more than 50 years," said Bruce Fine, market segment leader, Medical and Consumer Products, Bayer MaterialScience LLC. "Introducing this new material is indicative of our commitment to meeting the evolving needs of the medical market."

Specifically engineered for molding devices with extremely thin walls (as low as 0.014 inches) and long flow lengths (150 millimeters), Makrolon® 2258 polycarbonate is a high-flow grade with an internal mold release additive that allows it to be more easily released from the mold. These properties translate into a number of benefits. Among them, it enables designers/OEMs to use less material, offers greater processing efficiency, and reduces the invasiveness of procedures for patients. This material is expected to be used for such applications as trocars, needle safety guards and other medical devices requiring thin walls and complex components.

This material allows for ethylene oxide and steam sterilization at 121°C and meets many ISO 10993-1 biocompatibility test requirements. It is currently available in the United States and Europe.

To learn more about this material and other medical-grade polycarbonates, visit the Bayer MaterialScience LLC booth, #832, at MD&M East.

Bayer MaterialScience LLC is one of the leading producers of polymers and high-performance plastics in North America and is part of the global Bayer MaterialScience business with approximately 14,700 employees at 30 production sites around the world and 2010 sales of 10.2 billion euros. The company manufactures high-tech polymer materials and develops innovative solutions for products used in many areas of daily life. The main segments served are the automotive, electrical and electronics, construction, medical, and sports and leisure industries. Sustainability is central to Bayer MaterialScience LLC's business and is based around the key areas of innovation, product stewardship, excellence in corporate management, social responsibility and respect for the environment.

For more information about Bayer MaterialScience's medical polycarbonate technology visit: www.bmsnafta.com

Published in Bayer MaterialScience

UK technology events organisers UMR have announced that they are to launch MEDELEC, a technology event focused specifically on the increasingly important role electronics components and embedded systems are playing in the design, development and manufacture of medical devices for the clinical and healthcare sectors. UMR will be building on the success that they have experienced with other events such as Advanced Automotive Electronics and Military and Aerospace Electronics.

The MEDELEC conference and exhibition will take place in Cambridge on 29th November 2011 and is expected to attract a broad range of engineers working in electronics, product design, biotechnology and software development. The event will be ideal for engineers seeking to keep abreast of new technology and those looking for an opportunity to discuss new projects, innovations, and design challenges with industry leading experts.

“We are very excited about this new launch which complements our portfolio of technical conferences for the embedded design market very well,” said David Williams, Director of UMR. "Most vendors we speak to confirm that they are either supplying the medical sector with embedded technologies, or are planning to in the near future as they see this as a fast-growing industry, and are pleased that they will now have a dedicated event where they can present their products and services. Exhibition stands have been selling fast with currently only ten available and we anticipate running out very soon"

Demand for such an event has been growing as UK technology companies have increasingly targeted the global medical device sector. The UK is now a leading player and a global centre of excellence in research and innovation in medical device technologies. The UK now has more specialist medical product design companies than in any other European country. The UK medical device market is also growing at 9% per year and is estimated to be worth more than £11 billion.

"There is definitely a swing back to shows and exhibitions,” said Williams. "Providing they are focused and offer engineers information and an experience that is of real value we are finding that our shows are growing in popularity with both vendors and engineers. There is simply no substitute to meeting face to face and having an in-depth discussion with an expert or maybe a hands-on demonstration of a new technology. We will be working hard to make sure this is such an event."

MEDELEC is the only technical event in the UK which focuses specifically on the increasingly important role that electronics components and embedded systems are playing in the design, development and manufacture of medical devices. The UK is a global centre of excellence in research and innovation, and this one-day conference and exhibition is being organised for electronics engineers and technical managers working in the clinical and healthcare sectors to learn about the very latest advances in medical electronics through the technical seminar programme and workshops, view demonstrations of innovative software and hardware technologies, and network with peers. This event will be held on 29th November 2011 in Cambridge.

For more information visit: www.medelec.co.uk

Published in MEDELEC

Delcam’s PartMaker Division will demonstrate the unique solutions offered by its PartMaker software for the manufacture of implantable medical devices at the Orthopaedic Manufacturing & Technology Exposition, OMTEC, to be held in Chicago on 15th and 16th June.

"Implantable orthopaedic devices are getting more complicated with each passing year,” commented PartMaker Division President, Hanan Fishman.  "PartMaker 2011 gives our users the tools to make more complex medical devices more productively on a wide platform of CNC equipment from Swiss-type lathes to bar-fed mills, and everything in between.”

"Since joining Delcam, the functionality, capability and power of the PartMaker CAM software suite has grown massively by taking advantage of Delcam’s extensive development resources.  Delcam’s worldwide team of over 225 developers is the largest in the CAM software industry.  Multi-axis milling functionality that has taken Delcam many, many man years to develop is being added to PartMaker at a rapid pace and reduced cost, which provides a major benefit to the product’s end users.”

"PartMaker Version 2011 also has an optional module for 3D design, providing PartMaker users with best-in-breed software for both CNC programming and addressing ‘design for manufacturability’ issues,” added Mr. Fishman.

Medical device manufacturers unable to attend OMTEC can find out more from the monthly webinar series on medical device manufacture being held by the PartMaker Division.  The next webinar will take place on 27th May and will focus on the relative merits of three different methods of manufacturing these plates, using a Swiss-type lathe, a table-table 5-axis mill or a bar-fed mill.  Each manufacturing method has its relative pros and cons depending on the application, and these will be explored during the webinar.

The PartMaker webinar series for manufacturing professionals focuses on the optimal manufacturing and CNC programming techniques for a variety of common families of medical device.  Each one hour webinar focuses on the manufacture of a particular device and covers such issues as part application, machine tool selection, tooling options and CNC programming considerations.  They are being conducted by PartMaker product specialists with extensive medical device manufacturing expertise.  The webinars are all free of cost and available to both existing PartMaker users and prospective users alike.

For more information visit: www.partmaker.com/medicaldevice

Published in Delcam

Developments in the manufacture of internal fixation plates for spinal support will be the topic for the third webinar in the monthly series on medical device manufacture being held by Delcam’s PartMaker Division.  The webinar will take place on 27th May and will focus on the relative merits of three different methods of manufacturing these plates, using a Swiss-type lathe, a table-table 5-axis mill or a bar-fed mill.  Each manufacturing method has its relative pros and cons depending on the application, and these will be explored during the webinar.

The PartMaker webinar series for manufacturing professionals focuses on the optimal manufacturing and CNC programming techniques for a variety of common families of medical device.  Each one hour webinar focuses on the manufacture of a particular implantable device and covers such issues as part application, machine tool selection, tooling options and CNC programming considerations.  They are being conducted by PartMaker product specialists with extensive medical device manufacturing expertise.  The webinars are all free of cost and available to both existing PartMaker users and prospective users alike.

The American Academy of Orthopaedic Surgeon (AAOS) explains that using plates, screws, and rods to help hold the spine still, a procedure called ‘internal fixation’, may increase the rate of successful healing.  With the added stability provided by internal fixation, most patients are able to move earlier after surgery.  Fixation strategies can differ depending on the part of the spine being operated on.  The type of spinal plate to be the subject of the webinar is commonly used in cervical spinal procedures.

"Manufacturing options available to companies making medical devices are changing rapidly,” commented PartMaker Division President, Hanan Fishman.  "The machine tool, cutting tool and CNC programming techniques available in the market today to make medical devices has changed immensely in the past 24 months.  The idea of this webinar series is explain what these changes are and how firms that are either making medical devices currently, or are considering doing so, need to apply the latest in advanced manufacturing to manufacture medical devices productively and profitably given the dynamics of their business.”

The final webinar will be on June 24th when the topic will be the manufacture of spinal hooks.  For more details, please go to www.partmaker.com/medicaldevice

Published in Delcam

PartMaker Inc., a division of Delcam Plc, in partnership with Mazak Corp. will demonstrate the benefits of using bar-fed milling technology for the manufacture of medical devices at Mazak’s Discover Mazak Northeast event at the company’s technology center located in Windsor Locks, Connecticut May 17 – 18, 2011.

The presentations will feature the manufacture of titanium spinal plate like the one shown above on the Mazak i-150. In addition to the machining presentations, PartMaker technical specialists will conduct seminars each day on the benefits of using bar-fed mills like the Mazak i-150 for the automated manufacture of medical devices as well CAD/CAM considerations for doing so.

"In many way, bar-fed mills like the Mazak i-150 represent the future of small, complex, low-volume CNC manufacturing, such as that often found in the medical arena,” says PartMaker Inc. division President Hanan Fishman.  "Together with Mazak we are very pleased to have the opportunity to demonstrate live the benefits of how CAM software can help manufacturers take advantage of this unique technology.  The Northeast has traditionally been a hub for leading-edge manufacturing techniques, so the fact that these presentations are being done in at Mazak’s Northeast Technology Center are highly appropriate.”

Unique Support for Bar-Fed Mills

PartMaker Version 2011 has been specifically designed to automate the programming of Bar-Fed Mills like the Mazak i-150.  Bar-fed mills are a new breed of machine tool technology that is growing more popular for the production of small, complex parts for such applications as medical device, aerospace, fluid power and any other industry that requires complex small parts.  In many ways, these machines represent the future of complex, low volume, small parts manufacturing.  With Version 2011, PartMaker aims to establish itself as the market leading system for automating the programming of Bar-Fed Mills by introducing a number of new features for handling the unique programming issues presented by these machines. PartMaker Version 2011 simulates the unique architectures and machine kinematics of Bar-Fed mills in its 3D simulation module and supports the Bar-Fed mill offerings with robust post processors and vivid simulation of such machines.

More on PartMaker

PartMaker is a Knowledge Based Machining system, allowing it to provide a substantial gain in programming efficiency by remembering the tools, material and process information necessary to machine individual part features.  It thus relieves the user from reentering the same features information for subsequent parts.  It also improves productivity by placing the emphasis on tool management functions.

PartMaker pioneered the field of CAM software for Turn-Mills and Swiss-type lathes with its patented Visual Programming Approach for programming multi-axis lathes with live tooling. It assures quicker learning and easier use. It makes an extensive use of pictures to help the user describe tools, part features and machining data.  Synchronization of tools working on multiple spindles is achieved by a few mouse clicks.

PartMaker Inc. is a subsidiary of Delcam Plc, the world’s leading developer and supplier of complete CAD/CAM software solutions.  Delcam Plc is publicly traded on the AIM exchange in London.  While PartMaker is sold direct in North America by PartMaker Inc. PartMaker is sold overseas through a network of sales partner offices operating in over 120 countries.

You can learn more about this event by visiting: www.mazakusa.com/dmnortheast

Published in Delcam

The question, “Hey, Grandpa, where’d your fingers go?” haunted the man featured in the YouTube video for months after he lost two digits to a table saw. But somehow, he’s on the screen wiggling four normal-length fingers. Two he was born with; the other two Dan Didrick gave him. The latter are surgical steel digits called X-Fingers, which move, flex, and grasp just like his originals.

“Now when the grandkids come over, they’re totally amazed. They call me Robo Man,” says the grandfather, his voice mellowing. “I can’t believe it myself. I actually have fingers that work.”

Didrick, of Naples, Fla., designed these, the world's first active-function artificial finger assemblies specifically for amputees, in SolidWorks® software. He accomplished this feat over a two-week period with no engineering experience – just a week of self-paced tutorials. In fact, he didn’t know what computer-aided design was before he started using it. He’d whittled his first concept prototype from pine.

Eight years and 80-plus designs later, X-Fingers and X-Thumbs mimic natural body parts without any electronics. The criss-crossing surgical steel levers, which put the “X” in X-Fingers, are actuated by the remaining finger or thumb and covered in thermoplastic for a lifelike look and feel. Patients can pick up coins, button shirts, tie shoes, type letters, carry buckets – even play the piano.

X-Fingers, notes Didrick, are a huge leap from the traditional flaccid latex appendages whose only function is masking the problem. As such, X-Fingers have earned his company, Didrick Medical, global recognition:

-Didrick Medical received the 2009 Perfect Pitch Award in November 2009, judged by several successful entrepreneurs, including Sir Richard Branson of Virgin.

-X-Finger has been showcased in the Isimbardi Palace in Milan, Italy, as well as several museums, including the United States Patent and Trademark Museum, the California Science Center in Los Angeles, the Museum of Science and Industry in Chicago, the Museum of Science in Boston, the Vanderbilt Hall in Grand Central Terminal in New York City, and the National Inventors Hall of Fame.

-X-Finger was a finalist in the 2009 INDEX: Awards in Copenhagen sponsored by the Crown Prince of Denmark and recognizing “designs for a better life.”

An estimated 94 percent of all non-fatal amputations involve fingers, according to the US Bureau of Labor Statistics. Approximately 30,000 people are rushed to US emergency rooms each year because they've amputated one or more, often in a door slam or via power tools, according to the National Center for Injury Prevention and Control.

Hundreds of adult X-Fingers are in use today. Just entering volume production, they come in 500 different configurations covering five different finger thicknesses, 16 different lengths, and myriad injury profiles. Didrick makes these to order using electric discharge machining (EDM) driven by SolidWorks files. “When a patient needs X-Fingers, I pick a drawing, save it as STL or IGES, send it to a manufacturer, and it comes back a beautiful part,” Didrick says. “SolidWorks is one of the most amazing tools I’ve ever used.”

Years of hard work invested

It’s been a long road for the former medical equipment salesman who has taught himself engineering, patent basics, regulatory relations, manufacturing, and marketing. FDA approval was challenging enough; European approval was excruciating. Applying for the patents alone took a year. “It’s been difficult, but this is my life’s work,” he says. “I do this 80 hours a week. I put everything into this.”

One thing that came remarkably easy, however, was becoming productive with SolidWorks software. “SolidWorks has been really important,” Didrick says. “I had the vision in my head and needed a way to make it reality. SolidWorks helped me do exactly that in three weeks. Because of the complexity of the product and of the dynamics of the injured hand, I’ve been unable to find engineers who can help me. So it’s me and SolidWorks. Without SolidWorks, this never could have happened.”

Didrick Medical relies on authorized SolidWorks reseller The SolidExperts for ongoing software training, implementation, and support.

For more information visit: www.didrickmedical.com/didrick or www.solidworks.com

Published in SolidWorks

What are today‘s latest trends in medical technology? What innovative injection molding solutions will help you to maintain your competitive advantage in the future? These questions and more will be answered at ENGEL’s upcoming medical symposium being held June 15th & 16th in York, PA.

ENGEL North America, member of the ENGEL group, is hosting a two day event focused specifically on new developments in medical molding. The event will be held in the Technical Center of ENGEL’s North American headquarters, York, PA.

The program will include a diverse mix of interesting and informative presentations by professionals, for professionals, relating to all aspects of the medical molding industry. Some of the technical sessions include:

• Preplan and Verify - Injection Molding Machine Concepts for the Medical Industry
• Fundamentals of Particle Counting
• Precision Automation Solutions for the Medical Molding Industry
• Advanced Processes and Technologies for Medical Device Manufacturing
• Authentication Features for Medical Devices and Packaging
• Functional & Economical Considerations for Plastics in Human Diagnostics
• Multivariate Closed-Loop Control for Parametric Release in Injection Molding

To demonstrate ENGEL’s competency in the medical technology field, three injection molding systems will be running during the event, providing visitors with a first-hand look at some of today’s latest molding processes and technologies.

* An ENGEL e-motion 1340/280 T will be demonstrating fully automatic, fully electric production of a polystyrene petri dish with a cycle time of 3.7 seconds, using an 8 + 8-stack mold. The system supports fully automated takeout, quality assurance sampling without interruption in production, assembly, and stacking and bagging of the parts. The 3.7 second cycle time is almost a full second faster than existing hydraulic machines and makes this the fastest, most energy efficient petri dish system in the world.

* A fully integrated system for the manufacturing of PP pipette tips will be shown on a 110 ton ENGEL e-max all-electric machine. In a cycle time of just 6 seconds, the parts are molded in a 32 cavity precision mold, extracted by a side entry robot, inspected by a vision system and deposited on racks sorted by cavity. The pipette tips, with extremely long and thin mold cores, require exceptional process control of high speed injection to meet the demanding levels of product quality.

* The hybrid ENGEL e-victory 80/30 US will run a 2-cavity LSR duck bill mold with automatic part inspection and removal. The extremely small shot size of this mold (0.062 grams / 0.0035 cubic inches) makes this an excellent application for demonstration of the ENGEL x-melt process. Use of the ENGEL x-melt process enables the accumulator-free, cost-effective production of parts with wallthicknesses significantly less than 0.5-mm, and provides molders with the ability to produce microparts with unprecedented repeatability, but without the need to investment in special-purpose capital equipment. The ENGEL e-victory machine series is characterized by a high-precision, servoelectrical injection unit and a tie bar-less, hydraulic clamping unit. With the addition of the new ecodrive, this machine has become as energy efficient as an all-electric machine.

Injection molders wanting more information, or to register for the June 15-16 symposium, can e-mail This e-mail address is being protected from spambots. You need JavaScript enabled to view it

For more information visit: www.engelglobal.com

Published in ENGEL

3D models, produced by combining a patient's CT scans and 3D printing technology are proving useful in neurosurgical planning.

3D printing technology is a fast and affordable way to build 3D models for neurosurgical planning. Radiologists are able to transform ultra high-resolution CT patient images into 3D solid models using a 3D color printer commonly used in architecture, engineering and construction.

An advantage of 3-D models is that they identify defects that 2-D images do not, which helps radiologists view a clearer impression of the image. With increasing frequency, surgeons and other physicians, and patients alike, request assistance from radiologists in order to identify complex morphologies demonstrated on imaging studies.

"We are applying a technique that has many uses in other industries to aid surgeons in planning procedures on complicated anatomy and pathology as well as help them communicate with patients and their families. Tripler doctors were sending data from Hawaii to the mainland US to have models made at great expense and considerable time. Other radiologists may find these resources in an architect's office or at a factory using 3D printing to make prototypes for just about anything you can fit in a shoebox," said Michelle Yoshida, MD, one of the authors of the exhibit.

The exhibit is being presented in conjunction with the 2011 American Roentgen Ray Society's annual meeting April 30 in Chicago. The exhibit was a collaborative effort between the Department of Radiology at Tripler Army Medical Center in Honolulu, HI, and the Joint POW/MIA Accounting Command/Central Identification Laboratory, at the Joint Base Pearl Harbor-Hickam, Hawaii. For a copy of the exhibit abstract or to request an interview with the lead author, please contact Keri Sperry via email at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or 703-296-3104.

For more information visit: www.arrs.org

Bespoke Innovations today announced the availability of a new line of FairingsTM, custom-tailored prosthetic leg covers that are personally designed and customized for each user to satisfy their specific preferred aesthetic. The new line of Fairings are offered in a variety of patterns, graphics and materials, serving as a new and unique form of expression for leg amputees.

Bespoke Fairings enable their wearers to individualize their prosthetics in ways that have never before been possible. The first step in the creation of a customized Fairing is a three-dimensional scan that captures the wearer’s unique shape, providing a natural leg contour and body form that current prosthetic limbs lack. Once the scan is complete, the customer can choose from any number of specific finishes and materials, including ballistic nylon, leather, chrome plating or mirror-polished metal. Tattoos can even be laser-etched into leather or embossed into the polymer surface.

Fairings have both front and back components, which can be quickly and easily swapped to suit lifestyle and activity. For instance, if the user is going out for the evening, he or she might choose to wear a metalized back and a black leather front. Alternatively, a lightweight polymer front Fairing might be combined with an easily cleaned ballistic nylon-wrapped back for a casual walk about town. Active users may choose a durable polymer Sport Fairing, which can be washed after use and worn for the rest of the day.

“Our products are shaped by human needs and enhanced by individuality. Because each Fairing is a custom-crafted work of art, its unique and striking impact is not limited by the inherent generic nature of mass production,” according to Bespoke Innovations Founder Scott Summit. “We developed Fairings to provide leg amputees with a unique way to recreate their body, and also, to showcase their individuality and style. They have a way of turning something ordinary and mechanical into something amazing.”

Fairings are made using 3D Printing technology, which creates the parts from high-quality, lightweight, and durable materials. And because removing Fairings only takes a minute, cleaning is easy. Sport Fairings are extra rugged, and like all polymer-only Fairings, are even dishwashersafe. The polished metal plating resists scratching and buffs quickly to a mirror shine.

“Instead of trying to blend in and be like everyone else, now I really go out of my way to show off my leg,” said Deborah, artist and Bespoke Fairing user. “I have become more confident with my style and creative with my outfits. I often try to match the leg to my outfit. With the chrome Fairing I can do a lot of cool 80’s things like matching it to leather jackets with grommets and leather boots with accents.”

Bespoke Innovations will be exhibiting their Fairings at the Amputee Coalition National Conference June 2-4 in Kansas City.

Fairings are custom-crafted through a proprietary process that combines today’s latest prototyping technologies with leading edge fashion design. Fairings cost between $4,000 and $6,000 depending on the complexity of design and finish materials chosen. They weigh between 8-16 ounces, depending largely on materials and size.

Bespoke Innovations, Inc. was founded in 2009 by an Industrial Designer and an Orthopedic Surgeon whose mission was to bring more humanity to people who have congenital or traumatic limb loss. The company is part of the movement towards individualized medicine and a leader in bringing a more personal approach to the way a broad spectrum of medical devices are developed and used.

For more information visit www.bespokeinnovations.com

Published in Bespoke Innovations
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