
Preliminary Agenda
(As of 10/20/2010)
Wednesday, November 10, 2010
7:30 am - 2:00 pm
Myrna L Daniels Auditorium
7:30 am
Registration and Continental Breakfast
7:55 am
Welcome/ Introductory Remarks
I. Keynote Lectures
7:58 am
Introduction
8:00 am
The Role of FDA in Facilitating Medical Innovation in the United States
8:20 am
The Innovation Process: Key Ingredients and Case Examples of Breakthrough Technologies
8:40 am
Status Update of Medical Innovation in the United States: Is there cause for concern?
9:00 am
Roundtable Discussion
II. Defining the Issues: Stakeholder Problem Statements
9:30 am
FDA Perspectives
Strategic Medical Device Industry
Start-up Community
Physician Inventor/Innovator
Venture Capital
Financial Sector
The Payors
Representing the Patient
10:00 am
Roundtable Discussion
10:30 am
Break
III. Propositions For Change
10:45 am
Discussion
Breakout Sessions
11:00 am
Regulatory, CMS and Clinical Scientists
Financial Community
Industry (Strategics and Start-ups)
Innovators and Out-of-the Box Thinkers
12:00 pm
Networking Lunch
IV. Establishing Consensus (Proactive Solutions and Future Programs)
1:00 pm
Reports from Breakout Sessions
Consensus-Building Discussion
Next Steps and Future Initiatives
2:00 pm
Adjourn
Wednesday, November 10, 2010
7:30 am-2:00 pm
Myrna L Daniels Auditorium
Vivian and Seymour Milstein Family Heart Center
NewYork-Presbyterian Hospital/
Columbia University Medical Center
173 Fort Washington Avenue, 1st Floor
New York, NY 10032
Organizing Committee
John Abele
Elazer R. Edelman, MD, PhD
Peter J. Fitzgerald, MD, PhD
Thomas J. Fogarty, MD
Barry T. Katzen, MD
Martin B. Leon, MD
Julio Palmaz, MD
John B. Simpson, PhD, MD
Gregg W. Stone, MD
Paul G. Yock, MD



