The MDEpiNet Medical Counter Measures Study
The MDEpiNet Medical Counter Measures Study
09/2012 - 09/2018
MDEpiNet is a Public-Private Partnership that brings together leadership, expertise, and resources from health care professionals, industry, patient groups, payers, academia, and government to build and operate a national medical device evaluation system. As a voluntary organization, the success of MDEpiNet depends on the time and effort of its members. Visit the Who We Are and Centers pages on the MDEpiNet website to learn more.
MDEpiNet is working to build this national system by improving and integrating real-world data infrastructure, developing appropriate methodologies, and conducting studies. Three Centers support MDEpiNet operations under a cooperative agreement with the Center for Devices and Radiological Health (CDRH). The Projects of MDEpiNet have been funded by a variety of partners (listed with the project descriptions).
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 outcomes.
Read the Planning Board Report:
Strengthening Patient Care: Building an Effective National Medical Device Surveillance System
© The Brookings Institution, 2015
MDEpiNet is working to:
- create and manage data use agreements with partners and/or external organizations utilizing existing data infrastructure for evidence development activities,
- support the development and execution of priority pilot programs and,
- conduct assessments of evidence development activities to identify, adopt, and promote best practices in data capture, analytical methods, and technology changes.
The MDEpiNet Public Private Partnership uses core centers with expertise in each area.
The Methodology Center is responsible for:
- Developing and applying novel statistical and epidemiological methods to monitor the safety and effectiveness of medical devices.
- Advancing statistical and epidemiological methods to improve understanding of medical device vulnerabilities to chemical, biological, radiological, and nuclear events.
- Developing a comprehensive set of methodological approaches for continuous evaluation of pre-market and post-market device data.
The Methodology Center is located in the Department of Health Care Policy at Harvard Medical School and is charged with advancing statistical and epidemiological methods to improve the understanding of the safety and effectiveness of FDA-regulated medical devices.