The once-straightforward definition of a medical device has begun to stretch. And so, for that matter, has the definition of a medical device company.
Software, far more malleable than your average hip implant or stent, can qualify. At-home DNA tests, not just the machines that sequence genomes in a lab. And as the universe expanded, consumer-focused tech firms started making their first moves into healthcare.
As our list of 2018’s top FDA approvals and clearances makes clear, though, the devices most likely to change a patient's life were designed to change their routines the least.
Whether it's consumer-focused tech that could help a user skip a trip to the doctor's office—or more traditional medical devices designed to better fit the human form in all its varieties—many of our 11 picks on this list fold well into the ever-present movement to personalize care. And that's not just about matching treatments with patients but with lifestyles, too.
Speaker manufacturer Bose’s inaugural turn at developing a hearing aid delivered the first product owners can program and adjust for themselves. HumanOptics’ artificial iris implant is designed to seamlessly match a person’s natural eye color. And Senseonics’ three-month continuous glucose monitoring system—as well as the Annovera 12-month birth control ring—both allow users more flexibility and control over their healthcare.
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Still other devices aim to help people get the care they need, wherever they happen to be. Consider the new Apple Watch’s onboard electrocardiogram and fall detection software, or Empatica’s seizure-detecting wearable that can alert family members and caregivers. And for patients already on the operating table, Biotronik’s covered rescue stent is designed to intervene if a heart artery tears during a minimally invasive procedure—without resorting to open surgery.
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Helping oversee these advancements has been, as ever, the FDA, which at the top of 2018 recommitted to making the U.S. a regulatory destination and priority market for medical device developers. By the end of 2020, the agency hopes to persuade more than half of manufacturers to consider bringing their novel technologies to the U.S. first—or at least in parallel with other major markets such as Europe. The agency will zero in on three priorities: improving employee engagement, streamlining processes and forming new collaborative communities.
Whether the FDA hits that target remains to be seen—in part because many device makers have committed to global R&D strategies years in advance—but 2018 did set a new agency record for novel approvals, with 106 new devices making it through premarket approvals, de novo and breakthrough 510(k) clearances, and humanitarian device exemptions.
That record could be topped in the near future as the broadening definition of medtech brings more companies and opportunities into the fold. And when coupled with the demand for products that personalize not only an individual’s healthcare but how they experience that care, the sky’s the limit. — Conor Hale, FierceMedTech editor