3 ways the FDA furthers patient engagement in the med device process

The U.S. Food and Drug Administration is looking to include patients and caregivers every step of the way when it comes to development of new medical tools.

Consumers are becoming more involved in their health than ever before thanks to the increasing number of technologies available to them, and new approaches by the federal agency "will help to ensure that patient perspectives also have an effect on which medical products are developed and cleared or approved for the market," according to an article in the Journal of the American Medical Association.

FDA members Nina L. Hunter, Ph.D, Kathryn M. O'Callaghan and Robert Califf--the latter of whom has been nominated for FDA Commissioner--use the viewpoint to address efforts the agency is making in this area. Some highlights include:

  • Programs: FDA is part of the Medical Device Innovation Consortium, which put together a framework to guide researchers in ways to include patient views on devices, according to the article. In addition, the agency also has made a draft guidance with a structure for having patient preferences included in regulatory decision making, the authors write.
  • Patient partnerships: The FDA is getting the feedback from patient experts through its recently created Patient Engagement Advisory Committee. "The PEAC will help ensure that broad, diverse perspectives on the needs and experiences of patients inform the FDA's deliberations," the authors write.
  • Outcomes: A database of patient-reported outcomes is part of the National Institutes of Patient-Reported Outcomes Measurement Information System program. This incorporating that information into product evaluations allows device makers to use it "not as ancillary data, but as primary end points."

"The FDA is committed to integrating patient perspectives into its regulatory evaluations and decision making and also encourages medical product innovators and clinical researchers to collect information on patient perspectives to inform development programs," the authors say.

Earlier this month, the Bipartisan Policy Committee also called on acceptance of "real world evidence" drawn from claims, clinical and patient-generated data to improve the development and delivery of devices. The group also called for incorporating patient perspectives into benefit-risk assessments.

To learn more:
- here's the viewpoint