MEDICAL DEVICES
from the very early planning phases of a trial. Sponsors might want to seek their input on barriers to recruitment, data collection techniques, and meaningful trial endpoints, among other talking points.
The advisers in question might themselves live with that particular disease. Perhaps they didn’t meet the criteria to be involved as research subjects, but are still interested in participating. Or, as per more generic devices like cancer screening tools, they might be healthy volunteers belonging to the at-risk demographic. The FDA also notes that patient advisers should be drawn from racially and ethnically diverse populations, which in turn might spur trial recruitment from these populations. “As a general rule, the sooner patient advisers can be involved, the better, because errors or on in the process,” says Borhani. “For instance, engaging with patients only at the 11th hour on a project involving a large team of doctors, engineers, and designers is not likely to produce any meaningful improvements.”
Putting it into practice How all this works in practice will really depend on the sponsor. FAST BioMedical, which is developing an innovative technology for kidney function, got deeply involved in patient advocacy groups and medical societies and sought nurses’ input prior to conducting its four clinical trials. “We decided early on we needed the voice of the patient at the centre of what we did. This is hard to do,” says Muldoon. “You have to get them involved often and early, along with their caregivers. I’ve also been fortunate to serve two terms on the Kidney Health Initiative Board, which gave me a front row seat to best practices in working with patient advisory councils. I met many patients through my role, and they were a source of both keen insights for our product development and motivation for our entire team.” He remarks that while patients may be too
busy to participate, patient advocacy groups are “There are wonderful patient ambassadors out there who are more than willing to share their story, give you input, and connect you with other you are working on,” he says. “Companies that
they have received from doing it.” that creates consumer and medical device innovations, believes lessons taken from the former can apply to the latter. “During the initial discovery and design phases, Nottingham Spirk leverages recruitment vendor partners specialising in healthcare to identify our relevant patient targets,” says Amanda Beacher, a former director of consumer insights for Nottingham Spirk. “This is similar to how we locate pertinent research audiences during consumer product development. Virtual insights methodologies allow a broader geographic net to be cast during recruitment, so if a medical condition is rare we have a greater chance of locating affected individuals.”
The push towards patient-centricity Beacher believes that infusing the patient voice into medical device development will eventually shift from a voluntary to mandatory practice. “Data linking increased patient acceptance and improved outcomes will catalyse this transition. Nottingham Spirk has been consumer- centric for the past 50 years, so the recent FDA guidance regarding patient-centricity feels familiar and prudent to us,” she says.
systems will play a critical role in this transition by enabling sponsors to sift through massive data sets to match trials up with patients. “A recent study of more than 60,000 patients with lung cancer showed that the driven approaches, which drastically improves the odds for completion of the trial,” she says. “Another study reported a near 60% increase in enrolment in a lung cancer trial as a result of employing AI-based clinical trial matching.” While there is clearly work to be done
here, many medical device companies are making an increased push towards patient- centricity. Recruiting patient advisers in clinical trials will no doubt gain traction. “I think most technologies are sincerely being developed with the patient in mind,” says Muldoon. “But I also think most could relationship with the patient’s journey, from the patient and their caregiver’s perspective.”
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