Entrepreneurs in Residence Program

The Entrepreneurs-in-Residence (EIR) program is supported by the White House Office of Science and Technology Policy as a component of the Administration's Strategy for American Innovation. The EIR model is a time-limited recruitment of world-class entrepreneurs and innovators to join highly-qualified internal government employees in the development of new operational procedures in areas that impact innovation. The EIR goal is to deliver transformational change by combining the best internal and external talent in testing, validating and scaling what works.

The FDA has built Innovation Pathway 2.0 over the last six months with support from the White House's EIR program. The EIR program allowed CDRH to bring in vision leaders in business process innovation, decision science, medical device innovation, venture partners, and information technology to work alongside agency staff and leadership, to develop Innovation Pathway 2.0.

Fifteen EIR members comprising the Strategic Team served as a sounding board as the program was being built. They provides vision and focus during the development of the Innovation Pathway, including the review of policies, business processes and tools that may be helpful in bringing innovative and safe new products to the U.S. market.

Five members served in either a full- or part-time capacity on site, embedded with FDA staff and management, as a boots-on-the-ground Tactical Team to build and implement the Innovation Pathway, including the development of new policies, processes, and tools.

Originally created for a six-month duration, the EIR program has been successful and the Center intends to continue the program in order to keep bringing new ideas and fresh perspectives to the Innovation Pathway.

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Strategic Team Members Participating in IP 2.0 Development

• Jeff Allen, PhD — Friends of Cancer Research
• Francis Beland — X Prize Foundation
• Riley W. Crane, PhD — Media Lab, MIT
• John P. Driscoll — MEDCO
• Elazer R. Edelman, MD/PhD — MIT/Harvard Medical
• Thomas Fogarty, MD — Fogarty Institute for Innovation
• William Hawkins — CEO of Medtronic (ret.)
• Mark Jeffrey, PhD — Kellogg School
• Mark Johnson — Innosight
• Dean Kamen — DEKA Research
• Anjali Kataria — Smith School, UMD
• Thane Kreiner, PhD — Santa Clara University
• W. Lasersohn — The Vertical Group
• Roger Lewis, MD/PhD — UCLA Medical Center
• Ken Miller — Change and Innovation Agency

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Tactical Team Members Participating in IP 2.0 Development

• Dorothy Abel — FDA
• Patrick Axtell, PhD — FDA
• Frank Baitman — EIR Fellow
• Kristen Bowsher, PhD — FDA
• Peter Haaland, MD — DARPA
• David Chan, MD/MSc — MIT - EIR Fellow
• Siromi Gardina, PhD — FDA
• Charles Haggart, PhD — FDA
• Telba Irony, PhD — FDA
• Martin Ho, MS — FDA
• Megan Moynahan, MS — FDA
• Rahul Ram — FDA
• Daya Ranamukhaarachchi, PhD — FDA
• Paul Sobotka, MD — EIR Fellow
• Elizabeth Stafford, PhD — FDA
• Kwame Ulmer, MS — FDA
• Maj. Gen. Tom Wilkerson, USMC (Ret.) — EIR Fellow
• David Windt, MPH — FDA