Top FDA official to discuss medical device innovation with industry leaders at Stanford

How can the federal government help private industry bring lifesaving medical devices more quickly to patients while ensuring their safety and efficacy?

Jeffrey Shuren, MD, JD, the official charged with updating and streamlining how the U.S. Food and Drug Administration deals with these issues, will be speaking at Stanford University on Sept. 27 about new proposals and ideas for fostering innovation. After making his initial remarks, he will join a panel discussion with representatives from the key sectors that make Silicon Valley a major hub for the medical-device industry — entrepreneurs and inventors; venture capitalists and investors; the leaders of established medtech companies; anduniversity researchers.

Shuren, director of the FDA Center for Devices and Radiological Health, will make brief comments on the changing role of the CDRH as a catalyst for change in addition to its watchdog function. The main part of the event will be a conversation between him and the panelists: John Capek, PhD, executive vice president of medical devices at Abbott, a global health-care company; Ross Jaffe, MD, managing director of Versant Ventures; Josh Makower, founder and CEO of the firm Exploramed; and Stefanos Zenios, PhD, professor at Stanford’s Graduate School of Business. The discussion will be moderated by Dana Mead, partner in life sciences at Kleiner Perkins Caufield & Byers. Questions from the audience will be solicited via text messaging.

The event begins at 5 p.m. in McCaw Hall at the Arrillaga Alumni Center. Paul Yock, MD, director of Stanford’s Program in Biodesign, will give welcoming remarks, followed by an introduction by Philip Pizzo, MD, dean of the Stanford School of Medicine. Members of the media are welcome to attend, but are advised to RSVP to to reserve a seat. Although open to the public, registration has already reached the room’s maximum audience size of 500 attendees.

The event will be recorded for delayed web and audio broadcast.

Additionally, the university is hosting a daylong symposium Sept. 28 on medical devices, in conjunction with the FDA's Academic Centers of Excellence Program. The symposium is being sponsored by Spectrum, the organization that supports clinical and translational research at Stanford. The symposium is titled "A total product lifecycle approach to medical device research: Responsibilities and opportunities,"and will run from 7:55 a.m. to 5 p.m. in the new Li Ka Shing Center for Learning and Knowledge at the School of Medicine.

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