The FDA has released new guidance on how to integrate patient engagement in medical device clinical studies. Abi Millar explores how patient advisors might add value to these trials.
On 6th 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. “The good news is that we do not have to reinvent the wheel. There is much that can be learned and adopted from the success of the user-centered design frameworks in other industries.”
Joe Muldoon, CEO of FAST Biomedical, adds that it is monumentally important for any medical technology to incorporate the voices and priorities of the patients.
“Their journeys are very heterogeneous and are often confusing, terrifying and exhausting,” he says. “They need to be heard, and they often are not. It is easier than most think to get very focused on the extremely challenging work of moving a medical technology forward, and in the fog of activity, lose sight of the human inside the patient.”
Read the rest of this article in the March 2022 edition of Medical Technology