NESTcc Charter

NESTcc’s organizational structure consists of a multi-stakeholder Governing Committee, which is a Committee established by the MDIC Board of Directors, and an Executive Director supported by program staff.

Working Groups composed of experts representing diverse perspectives may be established by the Governing Committee on an ad hoc basis.

Governing Committee

The NESTcc Governing Committee is comprised of key stakeholders from across the medical device ecosystem committed to the success of NESTcc and charged with inaugurating a Coordinating Center that is inclusive, patient-focused, and anchored in accountability and transparency.

The Governing Committee approved the launch of the Data Quality Subcommittee and the Methods Subcommittee, which are charged with developing data quality standards and identifying appropriate statistical methods for the use of Real-World Data (RWD).

The Governing Committee also approved the establishment of a multi-stakeholder Active Surveillance Task Force, which is tasked with establishing a Roadmap for leveraging NESTcc’s work to advance active surveillance and subsequently launch NESTcc’s first active surveillance projects.

Naomi Aronson, Ph.D.

Naomi Aronson, Ph.D.

Executive Director, Clinical Evaluation, Innovation, and Policy, Blue Cross Blue Shield Association (BCBSA)
David Feygin, Ph.D., MBA

David Feygin, Ph.D., MBA

Chief Digital Health Officer, Boston Scientific
Andrew C. Fish

Andrew C. Fish

President and CEO of the Medical Device Innovation Consortium (MDIC)
Michael Gibson, MS, MA, M.D., FRCP, FAHA, FSCAI, FACC

Michael Gibson, MS, MA, M.D., FRCP, FAHA, FSCAI, FACC

Professor of Medicine, Harvard Medical School, and CEO of the non-profit Baim Institute of Clinical Research

Adrian Hernandez, M.D., MHS

Adrian Hernandez, M.D., MHS

Professor of Medicine at Duke School of Medicine, Vice Dean and Executive Director of the Duke Clinical Research Institute (DCRI)
Tamara Syrek Jensen, J.D.

Tamara Syrek Jensen, J.D.

Director, Coverage and Analysis Group, Center for Clinical Standards and Quality
Jennifer Kerr, MS, CCRA, RAC

Jennifer Kerr, MS, CCRA, RAC

President, Cook Research Incorporated, Medical Device Manufacturers Association (MDMA) nominee
David Maggs, M.D.

David Maggs, M.D.

Vice President, Medical Affairs, Becton Dickinson Technologies and Innovation
Michael Pfleger

Michael Pfleger

Head, External Affairs and Regulatory Policy, Alcon; AdvaMed nominee
David Rhew, M.D.

David Rhew, M.D.

Global Chief Medical Officer and Vice President of Healthcare, Microsoft
Mohamed Salama, M.D.

Mohamed Salama, M.D.

Chief Medical Officer, Sonic Healthcare USA, American Clinical Laboratory Association (ACLA) nominee
Jeffrey Shuren, M.D., J.D.

Jeffrey Shuren, M.D., J.D.

Director of FDA’s Center for Devices and Radiological Health (CDRH)
Diane Wurzburger, J.D.

Diane Wurzburger, J.D.

NESTcc Governing Committee Chair, Regulatory Affairs Executive at GE Healthcare, and Medical Imaging & Technology Alliance (MITA) nominee