Medical Device, Diagnostics & Drug Delivery
Sponsored by 
| Wednesday, October 27, 2010 |
| Session I: 9:00 a.m. - 10:15 a.m. |
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Is the 510(k) Review Really an Overhaul? The vast majority of medical devices find their way to the U.S. marketplace via the 510(k) clearance process. This process has historically involved the demonstration of “substantial equivalence” to existing medical devices, and in most cases involves 90-120 days of regulatory review. The FDA’s Center for Devices and Radiological Health (CDRH) has announced a new set of strategic priorities for 2010 and beyond, and the changes include an overhaul of the 510(k) clearance process.
CDRH created an internal 510(k) Working Group, which issued its initial recommendations in August 2010. The Agency has also commissioned an Institute of Medicine review of the 510(k) process that is set to publish in June 2011. Industry representatives have expressed concern that the impending changes will ultimately blunt innovation through unnecessary regulations that would increase the development cost and timeline for new devices.
The panel will review the 510(k) changes that are likely to be implemented and outline how companies will likely need to adapt.
Moderator:
Alon Gev
Partner, New York Metro Area Technology Industry Practice Leader
Grant Thornton LLP
Panelists:
Brendan Benner Jonathan Sackner-Bernstein, M.D.
Associate Center Director, Post Market Operations, CDRH U.S. Food & Drug Administration Judy Ways, Ph.D.
Vice President, Regulatory Affairs and Quality Assurance
Neuronetics, Inc.
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| Session II: 10:30 a.m. - 11:45 a.m. |
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Reimbursement with a Global Flair: What You Need to Trek the Medical Device Reimbursement Landscape Design control…Check. Freedom to operate…Check. Channel analysis…Check. Reimbursement strategy…What?
Medical device reimbursement is sometimes overlooked and frequently misunderstood. A poorly-defined or missing reimbursement strategy could eliminate you from the market before you make your first sales call. Unfortunately, because a mastery of the subject is not typically built into the organizational DNA, this is a lesson that many early-stage companies have learned the hard way.
In this session, the panel will walk the audience through a real-time “how to guide” focusing on the major components of reimbursement strategy for new medical device technologies.
Supported by actual case studies, the session will provide insight into:
Moderator: Bruce Shook Panelists: Michael Heggie Debra Parrish (Presentation)
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| Session III: 1:45 p.m. - 3:00 p.m. |
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Partnering Among Pharma, BioPharma, Diagnostics, and Medical Device Companies – the New Deal? An increasing trend is emerging in which pharmaceutical and biopharmaceutical companies are partnering with medical device and diagnostic companies to formulate combination products. These collaborations not only forge new partnerships and develop new ways of doing business, but can ultimately result in highly-innovative life-saving technologies.
This track will present technological advances and improved medical benefits derived from these types of partnerships. Through the use of real world illustrations, the panelists will share their perspectives on:
Moderator: Pascal Yvon, PharmD, MBA Panelists: Stephen Allan (Presentation) Salvatore Salamone, Ph.D. (Presentation) Daniel Skovronsky, M.D., Ph.D. |