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The Innovation Policy Forum
Medical Devices Innovation: Opportunities, Threats, and Challenges 
National Academy of Sciences, Lecture Room
2100 C Street NW
Washington, DC
10 September 2014





8:30 AM           Continental Breakfast
9:00 AM           Welcome
Sujai Shivakumar, The National Academies
9:05 AM           Introductory Comments
Alan Wm. Wolff, Co-Chair, Innovation Policy Forum
9:15 AM           Keynote Address
Murray Sheldon, MD, FDA
9:45 AM           Panel I: Infrastructure Challenges for the Medical Device Industry
Moderator: Frank L. Douglas, Austen Bioinnovation Institute
Understanding our National Biomedical Device Network
Howard Schmidt, Ridge Schmidt Cyber LLC
Suzanne Schwartz, MD, FDA
 Matthew Quinn, FCC
10:45 AM             Coffee Break
11:00 AM             Panel II:  A Case Study of Patient-Driven Medical Device Ecosystem
Moderator: Dale Nordenberg, MD, MDISS

Role of Medical Devices in Today’s Healthcare System
Joseph M. Smith, MD, West Health Institute
The Technical and Engineering Framework for Medical Device Deployment
Ken Herold, Wind River
11:30 AM             Panel III: Opportunities: Health System Impact
Moderator: Joseph M.  Smith, MD, West Health Institute
Michael J. Mack, MD, Baylor Scott and White Health System 
Impact of a Connected Health Environment on Safety and Efficiency
Andrew Sargent, Philips Healthcare
Bradley M. Thompson, Epstein Becker & Green; mHealth Regulatory Coalition
12:30 PM             Lunch
1:30 PM               Panel IV: Challenges: The Digital Health Platform (System of Systems)
Moderator: Julian M. Goldman, MD, Harvard, MGH
Bakul Patel, FDA 
Medical Device Supply Chain Challenges
Ken Herold, Wind River
Steven Abrahamson, GE Healthcare
2:30 PM                Coffee Break
2:45 PM                Panel V: Threats: Cybersecurity, Privacy, and Safety
Moderator: Dale Nordenberg, MD, MDISS
Ron Mehring, Texas Health Resources 
Axel Wirth, Symantec
3:45 PM                Roundtable Comments
Moderator: Gail Cassell, Member, Innovation Policy Forum
Dale Nordenberg, MD, MDISS
Bakul Patel, FDA
Matthew Quinn, FCC
Suzanne Schwartz, FDA
Jodi G. Daniel, DHHS
4:30 PM               Adjourn