Who we are

The MDEpiNet Public Private Partnership is composed of the FDA and world-leading academic organizations, healthcare organizations, medical device industry partners, patient groups, and the regulatory industry.

 


Centers

Visit the Center pages to learn more about how each center supports MDEpiNet.

Center-Methodology-Harvard-sm

Center-Infrastructure-Weill-Cornell-sm

Center-Coordinating-Duke-sm

Task Force

Read the Medical Device Registry Task Force Report released August 24, 2015

Comment on the Task Force Report in the Federal Register until October 26, 2015, or send an email with comments to mdepinet@dm.duke.edu.

Background

On June 24, 2014 in Washington, DC, the National Medical Device Registry Task Force (NMDRTF) was convened to consider both the objectives and the logistics of leveraging existing and evolving electronic registries and related tools toward the production of a national medical device evaluative system.

Read more about the Registry Task Force

Committees

Committees are composed of members from world-leading academic organizations, healthcare organizations, medical device industry partners, patient groups, and the regulatory industry. Visit the respective Committee page to learn more about each committee and view a list of current members.

Executive Operations Committee (EOC): coordinates operational leadership across the three MDEpiNet Centers and core committees.

Public Programs and Meetings Committee: coordinates facilities, agendas, and related aspects such as CME accreditation as appropriate for think tank and other public meetings.

Publications Committee: recommends topic selection priorities to the EOC, and subsequently coordinates topic meetings and related programs, and co-authorships and related matters for white papers or other cross-cutting publications that stem from the joint efforts of the collaboration.

Scientific Oversight Committee: oversees, facilitates, and coordinates the proposals, progress, and deliverables of the Disease-based Working Groups, and recommends prioritization of resources to the EOC.

Stakeholder Engagement and Sustainability Committee: solicits feedback from the medical device community to ensure broad stakeholder participation and input into development of a value-based plan for long term MDEpiNet sustainability and growth.

Stakeholder Council: provides strategic oversight, including high-level input from a wide range of stakeholders.

International Committee: Provides international expertise and input into methods and infrastructure development.

FDA

Center-FDA-sm

MDEpiNet is part of the Epidemiology Research Program (ERP) at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). The FDA supports the development of the program with the expectation that it will ultimately becomes a self-sustaining, independent Public-Private Partnership between the FDA and participating partners. Since its inception in 2010, FDA has invested in fellowships, contracts, and grants to support scientific efforts and partnership development. The enthusiasm generated by this endeavor has spurred excellent scientific output and has attracted world-renowned thought leaders in the field to actively participate in what is seen as shaping the future of epidemiology and surveillance of medical devices.

Food and Drug Administration Members

MDEpiNet Core

Marinac-DabicDanica Marinac-Dabic, MD, PhD, MMSc
Director, Division of Epidemiology, MDEpiNet Principal
Ben_EloffBen Eloff, PhD
Senior Scientific Program Manager, Division of Epidemiology, MDEpiNet Program Manager
person-placeholderMarta Steliac, MSc
Health Science Administrator. Division of Epidemiology, MDEpiNet Project Manager

MDEpiNet Committee Members

G. PappasGregory Pappas, MD, Ph.D
Associate Director for National Devices SurveillanceCo-Chair, MDEpiNet Scientific Oversight Committee

Murray_SheldonMurray Sheldon, MD
Associate Director for Technology and Innovation
Member, MDEpiNet Scientific Oversight Committee

Nilsa-Loyo-BerriosNilsa Loyo-Berrios, PhD, MSc
Associate Director, Division of Epidemiology, Office of Surveillance and Biometrics
Member, MDEpiNet Research and Publication Committee

Terri-Reed-200Terrie L. Reed
Senior Advisor for UDI Adoption

person-placeholderMartin Ho, PhD
Team Leader, Neurologic and Dental Biostatistics
Member, MDEpiNet Research and Publication Committee
person-placeholderJohn C. Laschinger, MD
Medical Officer, Division of Cardiovascular Devices

 

person-placeholderAndrew Farb, MD
Medical Officer, Division of Cardiovascular Devices

 

Daniel_CanosDaniel Caños, PhD
Associate Director, Division of Epidemiology

person-placeholderMitchell J. Shein, MS
Deputy Director (acting) Division of Cardiovascular Devices
FDA/CDRH
person-placeholderJose Pablo Morales, MD
Medical Officer, Division of Cardiovascular Devices
person-placeholderVahan Simonyan, PhD
Lead Scientist, Director of Bioinformatics, Center for Biologics Evaluation and Research
Yelizaveta-TorosyanYelizaveta Torosyan, MD, PhD
Health Scientist, Division of Epidemiology

Partners

Accomplishing MDEpiNet’s mission requires resources, skills, and expertise from a variety of partners, including other government agencies, academia, health care industry organizations, and patient and consumer groups. The Public-Private Partnership supports an open, transparent space for addressing issues that apply equally to a range of regulated medical devices. Development of new analysis models and fuller understanding of devices in this collaborative environment will promote innovation of medical devices while maintaining competitive interests.

If you are interested in becoming a partner, please email mdepinet@dm.duke.edu

Partners

Principals

Sedrakyan-200Art Sedrakyan, MD, PhD
Science and Infrastructure Center
Weill Cornell Medical College

Mitchell-Krucoff-200Mitchell Krucoff, MD
Coordinating Center
Duke Clinical Research Institute

Sharon-Lise-Normand-200Sharon-Lise Normand, PhD
Methodology Center
Harvard Medical School—Health Care Policy

Marinac-Dabic-200Danica Marinac-Dabic, MD, PhD
Office of Surveillance and Biometrics
CDRH/FDA