11:10

Structure of the Medical Device Industry Innovation Ecosystem

Josh Makower, Consulting Associate Professor of Medicine, Stanford University Biodesign Program, and Founder and CEO, ExploraMed Development, LLC

12:00 PM

Lunch

1:30

Impact of the Regulatory Framework on Medical Device Development and Innovation

David W. Feigal, Jr., Vice President, Global Regulatory, Amgen, and Associate Faculty, Arizona State University School of Law

2:10

Balancing Patient Safety and Innovation Panel Discussion

Moderated by William Vodra, Committee Member Panelists:

  • Workshop speakers: David W. Feigal, Jr., Peter Barton Hutt, Josh Makower, Philip Phillips, and Tim Ulatowski

  • Amy Allina, Program and Policy Director, National Women’s Health Network

  • D. Bruce Burlington, Independent Consultant

  • William Vaughan, Consultant, Consumer’s Union

3:00

Break

3:15

Public Comment—Registered Speakers

5:30

Recess

Tuesday, June 15, 2010

8:30 AM

Welcome

David Challoner, Chair, IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process

8:40

Comparative Overview of Medical Device Regulatory Systems

David Jefferys, Senior Vice President, Global Regulatory, Healthcare Policy Department, Eisai Europe Ltd.



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