About us

MDEpiNet is working to build a national medical device evaluation (and surveillance) system through improving and integrating infrastructure for real-world data, developing methodologies, and conducting studies.  MDEpiNet is a Public-Private Partnership bringing together leadership, expertise, and resources to build and operate in a national system that supports the development, regulation, and use of innovative medical devices.

MDEpiNet envisions a future in which studies of medical devices will be  more efficient (faster and cheaper), and patient, clinician, and public trust in medical devices increase.

Use the tabs below to find out more about the MDEpiNet Public Private Partnership. To view a list of core members and their specialties, please visit our Who we are pages.

Vision

MDEpiNet, a Public Private Partnership, provides global leadership in innovative data source development and analytic methodologies to enhance regulatory science applied to medical device research and surveillance.

What we do

The Medical Device Epidemiology Network Initiative (MDEpiNet) Public-Private Partnership is part of the Epidemiology Research Program (ERP) at the FDA’s Center for Devices and Radiological Health (CDRH).

MDEpiNet is bringing together leadership, expertise, and resources to build and operate a national device ecosystem supporting the development, regulation, and use of innovative medical devices.

MDEpiNet collaboratively provides tools including:

  • Study design for distributed network based research collaboration;
  • Advanced analytical overall methods such as multilevel analyses (hospital, surgeon, patient);
  • Advanced analytical methods for confounding adjustment – propensity scores, instrumental variables;
  • Cross design syntheses and Bayesian methods; and
  • Tools to help in strengthening relationships and stakeholder development.

Partnership expectations

MDEpiNet partners are expected to actively participate on committees, shape the overall scientific direction of the partnership, and work on specific projects. It is every partner’s responsibility to help assure the wise use of resources toward public health goals

Mission

The mission of the MDEpiNet PPP is to advance national and international infrastructure for patient-centered regulatory science, surveillance and quantitative methods. By doing so, MDEpiNet will be able to optimize evidence generation, appraisal, and synthesis for medical device Total Product Lifecycle (TPLC) evaluation.

Objectives

  • Improve how medical device information is utilized throughout the life cycle of a device.
  • Synthesize evidence from pre-market clinical trials, post-approval observational studies, domestic and international registries, medical claims data, and published literature on how medical devices are used throughout their life cycle.
  • Develop a conceptual framework for comparative effectiveness that examines relationships between and among medical treatments, patient outcomes, medical devices, resulting in development of novel study designs and analytical strategies, and application of these scientific advancements to CDRH regulatory decision making.
  • Advance the development and testing of new approaches to medical device studies that address the device’s life cycle.
  • Collaborate as co-authors/peer reviewers to communicate MDEpiNet work results.

Strategy

  • Systematically evaluate and integrate evidence of risks and benefits associated with medical devices into regulatory science.
  • Collaborate with external parties with relevant expertise to determine evidence gaps, study questions, datasets and best practices.
  • Incorporate appropriate study designs, analytical strategies, and regulatory decision making to develop a framework for patient-centered outcomes in medical device study and regulation.
  • Develop, test and disseminate innovative methodological approaches and study results in medical device research.
  • Leverage partner resources and expertise to create a sustainable infrastructure that stakeholders can use to obtain knowledge about medical devices.
  • Fully integrate the MDEpiNet infrastructure into CDRH decision making and the systematic evaluation of medical devices.

 

Governance

Below are the defined governance committees and current chairs for each. The committee names link to the members only section of the private SharePoint site were members can share documents, information and content relevant to each committee’s mission.

Executive Operations Committee

  • Mitchell Krucoff, MD (DCRI)
  • Sharon-Lise Normand, PhD (Harvard Medical School)
  • Art Sedrakyan, MD, PhD (Weill Cornell Medical College)
  • Danica Marinac-Dabic, MD, PhD (FDA)

Stakeholder Council (member login)

  • Co-Chair – Elise Berliner (AHRQ)
  • Co-Chair – David Feigal (Amgen)

Learn more about the Stakeholder Council


Scientific Oversight Committee (member login)

  • Co-Chair – Jesse Berlin (Johnson and Johnson)
  • Co-Chair – Gregg Pappas (FDA, CDRH)

Learn more about the Scientific Oversight Committee


International Committee (member login)

  • Co-Chair – Kazuhiro Sase (Juntendo University)
  • Co-Chair – Rob Nelissen (Leiden University Medical Center)

Learn more about the International Committee


 Committee of Public Programs and Meetings (member login)

  • Co-Chair – Gregory Daniel (Engelberg Center for Health Care Reform at Brookings)
  • Co-Chair – Thomas Maeder (Medical Device Summit)

Learn more about the Public Programs and Meetings Committee


 Publications Committee (member login)

  • Co-Chair – Bill Summerskill (The Lancet)
  • Co-Chair – Jack L. Cronenwett (Dartmouth-Hitchcock Medical Center)

Learn more about the Publications Committee


 Stakeholder Engagement and Sustainability Committee (member login)

  • Co-Chair – Elisabeth George (Philips)
  • Co-Chair – Pam Plouhar (DePuy Synthes)

Learn more about the Stakeholder Engagement and Sustainability Committee