About FDA

Entrepreneurs in Residence Program

The Entrepreneurs-in-Residence (EIR) program at CDRH is a time-limited recruitment of world-class entrepreneurs and innovators to join highly-qualified internal government employees in the development of solutions in areas that impact innovation. The EIR goal is to deliver transformational change by combining the best internal and external talent applying the principles of lean engineering in rapidly testing, validating and scaling new approaches. EIR Programs at CDRH currently last six months.

The White House Office of Science and Technology Policy supports the EIR program as a component of the administration's Strategy for American Innovation.

CDRH looks forward to continuing the program in order to cultivate new ideas and fresh perspectives that will advance our vision to provide patients in the U.S. with access to high-quality, safe, and effective medical devices of public health importance first in the world.



Entrepreneurs-in-Residence Program Two
October 2012 to April 2013

This year’s EIR team is confronting three challenging areas that have the potential to better support a more robust environment for medical device innovation:

  1. Streamlining clinical trials;
  2. Streamlining FDA approval to reimbursement; and
  3. Striking the right balance between pre- and post-market requirements.

The teams are assessing the current landscape, identifying problems and their underlying drivers and developing potential solutions.

CDRH plans to share results from the EIR team work in spring 2013.

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Strategic Team

  • Ross Jaffe – Managing Director, Versant Ventures
  • Ashley Wallin – Vice President, Emerging Growth Company Council, AdvaMed
  • Mark Leahey – President & CEO, Medical Device Manufacturers Association
  • Diane Dorman – Vice President, National Organization of Rare Disorders
  • David Holmes – Professor of Medicine, College of Medicine, Mayo Clinic, and former President, American College of Cardiology
  • Pam Bunes, Founder and CEO, EpiEP
  • Rick Hillstead – Partner, Georgia Venture Partners, and former Chief Science Officer, The Innovation Factory

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Tactical Team

  • Joseph Ladapo – Assistant Professor of Medicine, New York University’s School of Medicine
  • Robert (Chip) Hance – former President, Abbott Vascular, and Senior VP, Abbott Laboratories
  • Dawn Abens Lissy – President & CEO, Empirical Testing Corp.
  • Grant Campany – Managing Partner, B LOGiQ, and Prize Consultant, X PRIZE Foundation
  • Vizma Carver – VP Health Solutions, Long View International Technology Solutions
  • Louis Jacques – Director, Coverage & Analysis Group, Office of Clinical Standards and Quality, CMS

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FDA Team

  • Dorothy Abel, BS
  • Laura Adam, MS
  • Charles Anamelechi, PhD
  • Jodi Anderson, PhD
  • John Burke, BA
  • Andrew Farb, MD
  • Owen Faris, PhD
  • Charles Haggart, PhD
  • Anjali Kataria, MPP
  • Allison Kumar, BS
  • Danica Marinac-Dabic,PhD
  • Francisco Martinez-Murillo, PhD
  • Siromi Gardina, PhD, MPH
  • David McGurl, BS
  • Tina Morrison, PhD
  • Ahn Nguyen, MD, MBA
  • Kathryn O’Callaghan, BS
  • Daya Ranamukhaarachchi, PhD
  • Peter Rumm, MD, MPH
  • Ken Skodacek, BS
  • Kwame Ulmer, MS
  • David Windt, MPH

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Entrepreneurs-in-Residence Program One
October 2011 to April 2012

The first Entrepreneurs-in-Residence program brought in 20 outside FDA representatives--from industry, academia, venture capital and research—to work with CDRH staff and management to rapidly develop and test the Innovation Pathway 2.0, a streamlined regulatory pathway intended for innovative medical devices with significant public health impact.

Fifteen EIR members participated on the strategic team, serving as a sounding board as other EIR members worked to build Innovation Pathway 2.0. The strategic team provided vision and focus during the development phase of the Innovation Pathway, including the review of policies, business processes and tools helpful in bringing innovative and safe new products to the U.S. market.

Five members served on the tactical team, in either a full- or part-time capacity on FDA’s campus, alongside with FDA staff and management. This team worked with staff to build and implement the Innovation Pathway.

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Strategic Team

  • 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

  • Frank Baitman — U.S. Dept. Of Health and Human Services
  • Peter Haaland, MD — U.S. Dept. of Defense, DARPA
  • David Chan, MD/MSc — MIT
  • Paul Sobotka, MD — (formally) Medtronic
  • Maj. Gen. Tom Wilkerson, USMC (Ret.) —CMOH Foundation

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FDA Team

  • Dorothy Abel, BS
  • Patrick Axtell, PhD
  • Kristen Bowsher, PhD
  • Siromi Gardina, PhD
  • Charles Haggart, PhD
  • Telba Irony, PhD
  • Martin Ho, MS
  • Megan Moynahan, MS
  • Rahul Ram, BS
  • Daya Ranamukhaarachchi, PhD
  • Elizabeth Stafford, PhD
  • Kwame Ulmer, MS
  • David Windt, MPH

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Page Last Updated: 06/12/2014
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