FDA Shells Out $500K for MDIC Patients' Perspective Study

What role should patients play in the development and approval of medical devices? FDA is handing the Medical Device Innovation Consortium (MDIC) half a million dollars to try to answer that question.

The MDIC, a public-private partnership formed in 2012 with the goal of advancing regulatory science, will use the money awarded by the agency to fund its Patient-Centered Benefit-Risk Project, an effort that will bring together patient's advocates, industry representatives, regulators, and academics to find ways to bring patients’ perspective into benefit-risk determinations for medical devices.

“FDA has emphasized that ‘patient tolerance of risk and perspective on benefits’ is an important consideration, and the tools studied in this project will help both industry and the FDA to assess patient preferences for benefit and risk in a meaningful way,” Bill Murray, president and CEO of the MDIC wrote in an e-mail.

The consortium plans to conduct a yearlong study to compile a catalog of methods for assessing patient preferences about medical devices, develop a framework for incorporating that data into medical device development and benefit-risk determinations, and set an agenda for further research. The MDIC will publish the findings of its research on its Web site and possibly in peer-reviewed publications, Murray said. The project is slated for completion in the first half of 2015.

“We anticipate that the catalog and framework developed as a part of this project will help regulators and industry integrate patient perspectives in a meaningful way,” Murray said.

But MDIC’s research could also have an impact in areas outside the medical device industry.

“While the project is the result of efforts to make the medical device regulatory approval process more patient-centered, this collection of methods reviewed in the report are the same methods for assessing patient preferences that can have value in pharmaceutical regulation, reimbursement coverage decisions by public and private payers, healthcare resource allocation decisions by providers as well as public entities, and the development of tools for shared medical decision making,” Murray said. “Although being developed to address the specific needs of CDRH and industry, MDIC hopes that this effort will become the first step in an ongoing effort to catalog methods available for assessing patient preferences, and will thereby become a core resource for a range of researchers, analysts, and decision makers in the healthcare field.”

—Jamie Hartford, managing editor, MD+DI
[email protected]

[image courtesy of DAVID CASTILLO DOMINICI/FREEDIGITALPHOTOS.NET]