FDA course explains role of patient advisors in medical device studies

Susan, a representative of a patient advocacy organization, opened an FDA-produced online training and summarized how people with lived experience can serve as patient advisors to medical device clinical studies.

The course, which the presenter said was accurate as of June 1, 2026, emphasized that the U.S. Food and Drug Administration (FDA) reviews data companies submit to show devices are safe and effective but does not itself run clinical studies. The presenter also stated that FDA oversees more than 240,000 medical devices, from simple tools to implantable technologies.

Why it matters: patient advisors bring firsthand knowledge of living with a condition to study teams, the course said, helping make study plans, consent materials and communications clearer and reducing burdens that can drive people to drop out.

The training described three broad stages of device development—Discovery/Development, Clinical Study/Regulatory, and Product Launch/Post-Market—and said patient advisors can contribute at each stage. During design, advisors can help refine inclusion criteria and reduce barriers to participation; during conduct, they can recommend flexible follow-up options and clearer participant communications; during analysis and dissemination, they can help select outcomes that matter to patients and advise on how to present results to patient communities.

The course included first-person vignettes. "I want to help device companies understand the patient perspective," said Chris, who described joining as a patient advisor to turn personal experience into improvements for future patients. Kay, who identified herself as living with Parkinson’s disease, described reviewing consent forms and highlighting outcomes likely to matter to patients. John, who said he has obstructive sleep apnea, recounted advising a study of an AI-enabled CPAP device and recommending extended clinic hours to reduce dropouts. Carlos, who described living with type 2 diabetes, said he helped identify patient groups and social channels that improved recruitment and result-sharing.

The presenter also covered practical next steps for people interested in advising: seek training (including FDA materials), contact patient organizations and organizations running studies, and be prepared for application processes, contracts and nondisclosure agreements. Viewers were directed to downloadable knowledge checks and resource links beneath the course video.

The session closed with a brief review of how patient advisors can strengthen study design, improve participant experience and make study findings more useful to patient communities. The presenter encouraged viewers to save training certificates and follow links for further resources and knowledge checks.