MEDevice to Feature Keynote Addresses on Changing Regulatory Environment

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.

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