AdvaMed 2015: Patient Engagement in Medical Device Design

Can patients have a legitimate say in the quality of a medical device? For the first time, the U.S. Food and Drug Administration is saying, yes.

In September, the Center for Devices and Radiological Health rolled out a brand new initiative for patient engagement. The agency is establishing a Patient Engagement Advisory Committee, where for the first time there will be a voting member of the patient community on a committee. This committee’s goal is to help assure that “the needs and experiences of patients are included as part of the FDA’s deliberations on complex issues involving the regulation of medical devices and their use by patients.”

“I see a lot of furrowed brows,” panel moderator and Worldwide Vice President of Regulatory Affairs Medical Diagnostics and Devices for Johnson & Johnson Michelle McMurry-Heath, M.D., Ph.D., said during a panel on the subject at AdvaMed 2015. “This is a new, burgeoning field. The focus on patient preference aims to return agency to patients. They can say, ‘I’m an adult, I understand the risk, but these are benefits I really want.’”

Those furrowed brows were an indicator of how new and foreign this concept is to medical device industry players. AdvaMed attendees were struggling to follow this idea of materially considering—with a recorded committee vote—patient preferences in medical device design. After all, patients are not the experts. Right?

Bray Patrick-Lake begs to differ. Also a panelist at this discussion, the director of stakeholder engagement for the Clinical Trials Transformation Initiative provided insight from both sides of the patient-industry divide. Patrick-Lake founded the PFO Research Foundation in response to the lack of definitive scientific information regarding the condition of patent foramen ovale (PFO, or simply, a hole in the heart) after being a patient in an aborted clinical trial. Patrick-Lake has served as a patient representative at the FDA on a variety of advisory committees and panels.

“A lot of patients like me have strong preference for devices,” Patrick-Lake said, explaining how patients can provide input on treatment methods. “I was failing on medical therapy. The therapy was ruining quality of my life. Today there’s still no medical device approved for my condition, which is unfortunate.”

Panelist Kathryn O’Callaghan, acting associate center director for science and strategic partnerships for the CDRH, said that patient perspective can inform every single point of a medical device’s total product life cycle, from discovery and ideation, to clinical trial protocols, to marketing.

“Fifty percent of trials using patient input have been substantively changed from their original model,” O’Callaghan said.

During an AdvaMed panel on quality, Jeff Fecho, vice president of global quality for St. Paul, Minn.-based St. Jude Medical Inc., defined quality as the result of ensuring that features and characteristics of a product that define its ability to consistently satisfy customer needs are realized, and the products provide usability, achieve uniformity, satisfy customer requirements and expectations. Under that definition, it’s easy to see how patient perspective is a key contributor to achieving that quality.

“Patients are at the heart of what we do,” was the refrain of almost every panelist at AdvaMed 2015. If they are at the heart of device quality, the FDA is now saying that it’s high time they had a vote, too.