Agenda Sessions
April 14, 2010
| 7:30 a.m. - 9:00 a.m. | Registration/Networking/Breakfast Buffet |
| 9:00 a.m. - 9:30 a.m. | Keynote Address: The new future of the medical technology industry Featuring: |
| 9:30 a.m. - 10:30 a.m. | Breakout Session 1: FDA's 510(k) Process: Reform or Ruin? A panel comprised of industry and legal experts will address the current status of ongoing efforts to evaluate, and possibly significantly change, the primary pathway by which medical devices are authorized for U.S. marketing. The panel will discuss the recent FDA public meeting on the 510(k) process and comments submitted to the related public docket, the Institute of Medicine's consideration of 510(k) issues, and possible regulatory or statutory changes that may result. The panel will also provide a forum for open discussion of industry concerns, suggestions, and comments related to the 510(k) pathway. Speakers: Elaine Tseng, Partner, FDA & Life Sciences Practice, King & Spalding Michael Minogue Chairman, President & Chief Executive Officer, ABIOMED, Inc. |
| 10:45 a.m. - 11:45 a.m. | Breakout Session 2: Implementing an Effective Corporate Compliance Program - Does it meet the Stress Test? Medical device companies continue to struggle with developing and implementing an effective corporate compliance program. What do I need to implement? How do I know whether my program is "effective"? Compliance cannot be achieved with a "one size fits all" approach, a concept that small medical device companies understand. This session will provide an overview of the key elements of a corporate compliance program and discuss what needs to be done today to get your program off the ground. Speakers: |
| 11:45 a.m. - 12:45 p.m. | Lunch: Networking Networking and plated banquet lunch |
| 12:45 p.m. - 1:45 p.m. | Breakout Session 3: Taking the Mystery out of the CPT Code Process During this hour hear from experts who will speak about the CPT code process and how the AMA CPT code panel and insurance carriers decide how much medical device companies are reimbursed for their devices. What are the stipulations and guidelines medical device companies can follow in order to get the most money for their devices? And lastly learn priceless "tips" on ways companies can more likely get a new CPT code approved. Confirmed Speakers: Grant Bagley, M.D., Chariman HillCo HEALTH Robert C. McDonald, MD, MBA President, Aledo Consulting, Inc. |
| 2:00 p.m. - 3:15 p.m. | Breakout Session 4: Should you Build it or Get Acquired? Do your Regulatory, IP, Reimbursement and Financing Strategies Need to Adjust? The Pulse of the Industry - Medical Technology Report by Ernst & Young Panel Discussion Moderator: Dan Buchler, Partner, Transaction Advisory Services, Ernst & Young Speakers: Steven R. Pacelli, Chief Administrative Officer, DexCom J.C. MacRae, Former Chief Financial Officer, CoreValve Jim Talevich, Former Chief Financial Officer, I-flow |
| 3:15 p.m. - 3:45 p.m. | Networking/Refreshment Break |
| 3:45 p.m. - 5:00 p.m. | Breakout Session 5: Whats Hot and What are They are Running From? During this session a panel of finance experts will explore the financing trends in both public and late stage private markets. Learn who's buying and what they are buying and the preferred deal structures. They will debate whether the IPO is in fact making a comeback while discussing the emerging opportunities that are arising in molecular diagnostics, spine and orthopaedics and the convergence of wireless and healthcare. Finally, you will hear their predictions for 2010 and what is to be expected. Moderator: Panelists: |
| 5:00 p.m. - 6:15 p.m. | Closing Reception |