On 26th January, the FDA released a guidance document for industry, detailing how best to involve patients in medical device clinical trials. The guidance, which follows several years of FDA discussions, recommends that patients should be involved in an advisory capacity, not just as research participants. The upshot would be more patient-centric trials, and ultimately more user-friendly devices.
“Efforts like this are long overdue given that healthcare lags far behind other industries when it comes to incorporating consumer feedback into the product design process,” comments Dr Soheila Borhani, physician and cancer researcher at the University of Illinois.
