MEDICAL DEVICES
Patient advisers: could they change the face of medtech trials?
The FDA has released new guidance on how to integrate patient engagement in medical device clinical studies. How might patient advisers add value to these trials? Abi Millar reports.
O
n 26 January 2022, the US Food and Drug Administration released guidance 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, chairman and CEO of FAST BioMedical, adds that it is important for any medical technology to incorporate the voices and priorities of the patients. “Their journeys 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.”
When sponsors don’t listen to patients There are various ways that failing to involve patients can pose problems. In cases focusing on some groups of patients at the expense of others can mean bias is encoded in the design. Borhani cites assistive devices designed for patients with spinal cord injuries. Because more than 80% of these patients are male, she says women may be forced to use devices with male-
70 | Outsourcing in Clinical Trials Handbook
oriented designs and features. A similar issue applies to pulse oximeters, which notoriously work less well in patients with darker skin tones. In other cases, it can mean the device just
isn’t user-friendly – and the effects here can be far more damaging than with, say, poorly designed consumer goods. Borhani notes that many women skip their routine mammograms due to concerns about discomfort. “Patient engagement during the device
development process can lead to manufacturing user-friendly mammogram machines that are accepted and used by more women,” she remarks. “For example, a new generation of self-controlled mammograms gives patients the ability to adjust the pressure applied to the breasts, which gives the patients more control over their experience. The same principle holds true with colonoscopies, cystoscopies, and other intrusive cancer-screening methods.”
Rare diseases have low patient engagement Devices for rare diseases are another category with reduced patient engagement. Because these affect only a small group of people, trial recruitment can be challenging – a quarter of rare disease trials were terminated between 2016 and 2020 because of low patient numbers, according to GlobalData. This means patients for their condition. In a 2016 FDA survey, 37% of clinicians said they had repurposed an existing medical device for patients with rare diseases. “Children are another example,” says Borhani.
“Many paediatric patients require devices and implants that should grow with them… [this is] a problem that is not shared by adult patients, and can thus be easily overlooked without active participation during the design process.” As per the FDA’s recommendations, sponsors should consider involving patient advisers
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