Frequently Asked Questions

MDEpiNet PPP = Medical Device Epidemiology Network Public-Private Partnership

Questions

Why do we need a new medical evaluation system?

There are knowledge gaps about medical device use and performance. Complete and accurate information will help the FDA, the medical device industry, medical professionals, and healthcare consumers make better, more informed healthcare decisions.


How is MDEpiNet Structured?

MDEpiNet is a multi-stakeholder public-private partnership, seeking active participation across the medical device ecosystem. The diagram below shows the proposed governance structure including leadership by FDA and three major Academic Centers — the Center for Infrastructure led by Weill Cornell Medical College (WCMC) of Cornell University, the Center for Methodology led by Harvard University and the Coordinating Center for Partners led by Duke University.

MDEpiNet membership is open to all who are interested in contributing to its mission and objectives.

The governance structure includes the following committees, each with a Chair and/or Co-Chair selected from the members:

  • Stakeholder Advisory Council
  • Scientific Oversight Committee
  • Executive Operations Committee
  • Stakeholder Engagement and Sustainability Committee
  • Public Programs and Meetings Committee
  • Publications Committee
  • Disease Based Working Groups (e.g., orthopedics, cardiovascular, etc.)
  • International
  • Informatics

Projects can be proposed to the Scientific Oversight Committee by any member of the PPP. Projects must include enough support and leadership to create a well-defined Working Group that will oversee the project and be responsible for defining and sharing deliverables.

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Who is paying for MDEpiNet?

Initial funding for MDEpiNet came from the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Future funding is expected to come from a variety of sources including member contributions, in-kind participation, and future grants from a variety of public and private sources.

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What is MDEpiNet’s role in the National Medical Device Evaluation System?

MDEpiNet brings together leadership, expertise, and resources from healthcare professionals, industry, patient groups, payers, academia, and government to build and operate a national medical device evaluation system. MDEpiNet is working to build this national system by improving and integrating real-world data infrastructure, developing appropriate methodologies, and conducting studies. The vision for this national system was set out in a report of a Planning Board made up of major stakeholders in the medical device ecosystem for improving development, regulation, and use of innovative medical devices and to improve patient centered outcome.

FDA’s vision for medical device postmarket surveillance is the creation of a national system that will support the need of all of its stakeholders. FDA has identified four primary functions for its needs:

  • Communicates timely, accurate, systematic, and prioritized assessments of the benefits and risks of medical devices throughout the product lifecycle using high quality, standardized, structured, electronic health-related data;
  • Identifies potential safety signals in near-real time from a variety of privacy-protected data sources;
  • Reduces the burdens and costs of medical device postmarket surveillance; and
  • Facilitates the clearance and approval of new devices, or new uses of existing devices.

 MDEpiNet aims to be the engine for this effort. It will use its structure as a public-private partnership and its objectives as an organization to enlist and engage stakeholders in furthering the vision and supporting the primary functions of the National Medical Device Evaluation System . A tangible example of MDEpiNet’s efforts to build this national systems is the establishment of a Medical Device Registry Task Force (see below) – one of four critical implementation areas identified in the National Postmarket Plan.

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What is the relationship of the National Planning Board to the Registry Task Force?

The establishment of a multi-stakeholder Medical Device Postmarket Surveillance System Planning Board (aka National Planning Board) is a second critical implementation component of the National Postmarket Plan. The goals of the National Planning Board include identifying the governance structure, practices, policies, procedures, methods and business model(s) necessary to facilitate the creation of a sustainable, integrated medical device postmarket surveillance system that leverages and complements existing and on-going efforts. One of those complementary efforts is the Registry Task Force, which will incorporate the principles outlined in the National Planning Board into Registry Task Force work products. Ongoing communication at both the leadership and membership levels of the two entities will ensure alignment of efforts, and that both will benefit from the work of the other.

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What are ICOR, ICTVR, and ICVR and how do they relate to other MDEpiNet activities?

ICOR stands for international Consortium of Orthopedic Registries www.icor-initiative.org and is the first pioneering effort of MDEpiNet Science and Infrastructure Center. It is based on a distributed network system of innovative methodological and analytic studies that improve understanding of the safety and effectiveness of orthopedic devices. ICOR was established in 2011 as a worldwide research consortium, and members of ICOR include data holders and researchers. There are records of more than 3,500,000 orthopedic surgeries covering all implantable devices on the market. There are over 30 publications from ICOR to date. Following on success of ICOR International Consortium of Trans-catheter Valve Replacement (ICTVR) and International consortium of Vascular Surgery (ICVR) initiatives provide a collaborative platform through which registries and other stakeholders around the world can start a dialog, discuss data/methodology issues, and use distributed/aggregate level innovative analytic methods for conducting worldwide studies. An additional goal is to work with stakeholders such as manufacturers and regulators to improve their understanding of safety and effectiveness of cardiac valves and vascular devices.

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What is the PASSION Cardiovascular Registries Program and how does it relate to other MDEpiNet activities?

PASSION stands for Predictable and Sustainable Implementation of National Registries. The PASSION Cardiovascular Program is the first Device-Specific Working Group created under the MDEpiNet PPP. PASSION’s aim is to support accomplishment of MDEpiNet’s objectives by providing a think tank incubator environment where stakeholders can share concerns and ideas and use the PASSION forum to spawn cardiovascular-specific working groups to work through and resolve the identified issues. Visit the PASSION page to learn more about the three ongoing projects.

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How is the MDEpiNet Public Private Partnership different from the Medical Device Innovation Consortium (MDIC)?

MDIC is a public-private partnership developed to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices. MDIC is an independent, nonprofit corporation that receives input from industry, government, and other nonprofit organizations to prioritize the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and pathway to market for these innovations.

While MDIC covers a breadth of topics related to improving the device design regulatory process, MDEpiNet’s focuse is on the innovative use of methodologies and supporting infrastructure to support the identification, integration and analysis of device performance information that can be used to address safety concerns as well as to provide benchmarks for new product development.

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How can I get involved in MDEpiNet?

We welcome and encourage active participation in MDEpiNet. If you are interested in improving data quality, integration, and use of medical device information in registries or other data sources to improve pre- and postmarket decision-making, then we would like to hear from you! We are also open to discussing other possibilities for collaboration and contributing to MDEpiNet sustainability. If you are interested in supporting MDEpiNet, please contact Britt Barham, Project Leader (britt.barham@duke.edu).

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