'We can turn this ship around': FDA, Edwards on how devicemakers can better serve female patients

There’s no shortage of recent studies showing that women are significantly less likely than men to receive the healthcare they need—due in large part to a lack of research and education around sex-based differences in therapies from both the pharma and medtech industries.

Of individuals indicated to receive cardiac resynchronization therapy pacemakers, for example, women are far less likely to be implanted with the devices than their male counterparts, according to a recent analysis of the Swedish Heart Failure Registry that was cited by Suzanne Baron, M.D., during a panel at AdvaMed’s annual MedTech Conference in Boston.

“And it isn’t just under-recognition or under-treatment of women,” said Baron, an interventional cardiologist at Lahey Hospital and Medical Center.

She cited another pair of studies suggesting that women may respond differently than men to therapies like cardiac stents, coronary artery bypass surgery and surgical and transcatheter aortic valve replacement—though those differences still aren’t often taken into account when doctors select treatments.

Upping the rates of women who actually receive proper and effective treatments will start with practical changes at the clinical trial level, backed by an overhaul of traditional beliefs about who is represented in healthcare, according to Terri Cornelison, M.D., Ph.D., chief medical officer and director of the FDA’s Health of Women program.

“It’s a shift in science, a shift in thinking; and it takes us a while to do that, because we do want to follow the cardinal rule of medicine, which is ‘first, do no harm.’ And so there’s a lot of consideration that goes into who gets included on your clinical studies, and then the paths there forward,” she said during the panel session. “The great thing is now we have knowledge, so we can turn this ship around—but it’ll take all of us.”

For the FDA’s part, Cornelison said the agency recommends that all medtech companies perform tests and trials of their devices with equitable representation in mind. And companies developing technologies based in artificial intelligence and machine learning should be especially careful to ensure that equity extends to the data that are used to build their algorithms in the first place.

“You want your data to represent diverse populations, and so you want to be mindful of your sources of data and how they were collected, and keep going forward to making sure they are as representative as possible for the populations where you intend to intervene,” Cornelison said.

Tenley Koepnick, vice president of global clinical affairs for Edwards Lifesciences’ transcatheter heart valves division, echoed the need for medtechs to develop devices with equitable representation in mind not only to better serve all patients, but also because, in conducting more diverse research, “We may learn some things that really spur some innovation.”

Strategies to increase representation may include switching up a company’s go-to trial sites and principal investigators, involving female physicians and researchers in trial design and adjusting protocols to be more inclusive of differences in how different diseases present in women and men. Koepnick also suggested that tech developers look inward, ensuring women are included in conversations about the company’s projects at all levels.

Ultimately, she said, alongside those far-reaching changes within medical device companies, it’ll also take a proverbial village to actually change the face of medtech—not to mention clinical research and healthcare delivery in general.

“I don't know that it's industry that's going to solve it, that it is an investigator-initiated study, that it's the government—but it’ll be somebody saying we need to study this and taking that initiative to make that happen,” she said.