Stakeholder Council

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The Stakeholder Council is a high-level convening organization of the executive leadership of organizations with a stake in the system of medical device evaluation. This Council will be convened directly by the MDEpiNet Coordinating Center, and like the existing Interim Stakeholder Council will be charged with providing strategic guidance and aid for development of the medical device evaluation system. The Council meets remotely ad hoc as needed, but face to face at least once per year.


The Stakeholder Council engages leadership from a broad range of organizations, including (but, not limited to):

  1. S. FDA CDRH Pre-Market Group
  2. S. FDA CDRH Post-Market Group
  3. Academia
  4. Medical Device Industry
  5. Interested Foundations and Trusts
  6. Data Partners
  7. Hospital Systems, Private, University and Federal
  8. MDEpiNet Science and Infrastructure, Methodology, and Coordinating Centers
  9. Patient Advocates
  10. Medical claims payers
  11. Professional medical societies


The Council considers specific requests from the EOC regarding strategic prioritization, in-kind aid, and system support.  They give guidance and assistance to the EOC as their means allow.


The Stakeholder Council will have no direct standing deliverables.


person-placeholderElise Berliner, PhD (Co-chair)


DavidFeigal_HeadShotDavid Feigal, MD (Co-chair)


person-placeholderKathleen Blake


person-placeholderBruce Campbell


Jack-CronenwettJack L. Cronenwett, MD


person-placeholderGregory Curfman


GregoryDaniel_HeadShotGregory Daniel, PhD


Ben_EloffBenjamin Eloff, PhD


person-placeholderShamiram Feinglass


person-placeholderRichard Gilfillan


person-placeholderThomas Gross


Mitchell-Krucoff-200Mitchell Krucoff, MD


person-placeholderRichard Kuntz


person-placeholderMichael Lauer


Michael-MackMichael Mack, MD, FACC


Marinac-Dabic-200Danica Marinac-Dabic, MD, PhD, MMSc


person-placeholderMark McClellen


person-placeholderAnna McCollister-Slipp


person-placeholderKristi Mitchell


person-placeholderDavid Naftel


person-placeholderMarilyn Neder Flack


Sharon-Lise-Normand-200Sharon-Lise Normand, PhD


person-placeholderJohn Parkinson


Fred-Resnic-200Frederic Resnic, MD, MSc


person-placeholderJosh Rising


person-placeholderJohn Rumsfeld


person-placeholderJeffrey Secunda


Sedrakyan-200Art Sedrakyan, MD, PhD


person-placeholderJoe Selby


person-placeholderScott Smith


person-placeholderDiana Zuckerman