FDA Encourages Patient Engagement in Medical Device Development


Posted October 1, 2019

How can the patient's perspective improve the design of the medical devices that they use?

The Food and Drug Administration (FDA), though a new draft guidance, is providing recommendations for medical device manufacturers to more effectively engage patients in the design, clinical investigation process, and postmarket monitoring of their products, as well as collect and use patient engagement data in FDA submissions. 

“I believe when we engage patients, their families, and caregivers throughout the medical device clinical investigation process, we will have more patient-centric clinical investigations and ultimately timely access to innovative, safe and effective medical devices,” said Norman E. “Ned” Sharpless, acting commissioner of the FDA. “When we work with patients early on, we can advance the development and evaluation of innovative medical devices.

The draft guidance, Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations follows the first Patient Engagement Advisory Committee (PEAC) meeting in 2017. Following the meeting, PEAC members (consisting of patients, caregivers, and those who represent their needs) encouraged the FDA to collaborate with manufacturers to create a plan for engaging patient advisors (who have experience living with a disease or condition) in the clinical investigation process. This draft guidance does just that—outlining ways industry can engage patient advisors throughout the regulatory process.

The inclusion of patient input in the development and evaluation of medical devices “may ultimately lead to greater uptake of results by patients and providers when making treatment decisions and, ultimately, to earlier U.S. patient access to innovative, safe, and effective medical devices,” said Sharpless.

The FDA is seeking feedback from patients and manufacturers on this draft guidance at www.regulations.gov until Nov. 22 (docket number FDA-2019-D-3846).