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.
- Kumar A, Matheny ME, Ho KK, Yeh RW, Piemonte TC, Waldman H, Shah PB, Cope R, Normand SLT, Donnelly S, Robbins S, Resnic FS. The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance. Circ Cardiovasc Qual Outcomes 2015 Jan;8(1):38-46.
- M. Gomes, L.A. Hatfield, S-L.T. Normand. Handling incomplete correlated continuous and binary outcomes in meta-analysis of individual participant data. Statistics in Medicine, 35(21):3676-89, 2016. PMID: 27090498 doi: 10.1002/sim.6969.
- L.A. Hatfield, D.B. Kramer, R. Voyla, M.R. Reynolds, S-LT Normand. Geographic and Temporal Variation in Cardiac Implanted Electric Devices to Treat Heart Failure. J Am Heart Assoc. 2016 Jul 28;5(8).
- L.A. Hatfield, C.M. Baugh, V. Azzone, S-L.T. Normand. Regulator loss functions and hierarchical modeling for safety decision making. Medical Decision Making. Med Decis Making. 2017 Jan 1:272989X16686767.
- R. Providência, D. Kramer, D. Pimenta, G. G. Babu, L.A. Hatfield, A. Ioannou, J. Novak, R. Hauser, and P. Lambiase. Transvenous ICD lead performance: A meta-analysis of observational studies. Journal of the American Heart Association, 4(11):e002418, 2016. PMID: 26518666 PMCID: 4845221
- Kramer D, Reynolds M, Normand S-L, Parzynski C, Spertus J, Mor V, Mitchell S. Hospice use following implantable cardioverter-defibrillator implantation in older patients: results from the National Cardiovascular Data Registry. Circulation, 2016, 133:2030-2037.
- Resnic FS, Majithia A, Marinac-Dabic D, Robbins S, Semaganda H, Hewitt K, Ponirakis A, Loyo-Berrios N, Moussa I, Drozda J, Normand S-L, Matheny ME. Registry-Based Prospective, Active Surveillance of Medical-Device Safety. N Engl J Med. 2017 Feb 9;376(6):526-535. doi: 10.1056/NEJMoa1516333. Epub 2017 Jan 25.
- Govindarajulu US, Stillo M, Goldfarb D, Matheny ME, Resnic FS. Learning Curve Estimation In Medical Devices and Procedures: Hierarchical Modeling. Stat Med. 2017 May 3. doi: 10.1002/sim.7309. [Epub ahead of print]
- Wimmer NJ, Robbins S, Ssemaganda H, Yang E, Normand SL, Matheny ME, Herz N, Rising J, Resnic FS. Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices. J Health Care Finance. 2016 Summer;2016(Spec Features). PMCID: PMC5340422
- Chughtai B, Barber MD, Mao J, Forde JC, Normand S-L T, Sedrakyan A. Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence. JAMA Surg. 2016 Nov 30. [Epub ahead of print]
- Kramer DB, Reynolds MR, Normand S-L T, Parzynski CS, Spertus JA, Mor V, Mitchell SL. Nursing Home Use After Implantable Cardioverter-Defibrillator Implantation in Older Adults: Results from the National Cardiovascular Data Registry. J Am Geriatr Soc. 2017 Feb;65(2):340-347.