Device Design Advice Offered to CDRH by PEAC Committee

Device manufacturers should be more conscious of potential demographic bias in clinical trials, which could show up as differences in safety, effectiveness or ease of use, according to members of the FDA’s Patient Engagement Advisory Committee (PEAC).

Because devices can be very complex and require not only in-depth learning about the device, but also the supporting technological infrastructure, they are more prone to user error, frustration and confusion than medications, the committee told CDRH. Learning to operate a device requires basic skills in reading, comprehension and manual dexterity, which can vary according to demographic group, geography, education level and native language — not to mention the very disorder for which a device is designed. All of these factors should be considered during the design phase, the panel said, and incorporated into the clinical testing that will ultimately result in marketing approval.

The PEAC is the FDA’s only advisory committee comprised solely of patients, caregivers and patient advocates. It typically meets once a year to advise the agency on how medical devices can best meet the real-life needs of a patient. FDA staff asked for members’ input on several questions, including how manufacturers could design devices that function consistently and reliably in a variety of environments — home, school, work and leisure.

To read the full story, click here to subscribe.

Related Topics