Stakeholder Council

Return to Committee list

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.

Membership

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

Responsibilities

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.

Deliverables

The Stakeholder Council will have no direct standing deliverables.

Members

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