Regulations aren’t needed for everything, but savvy digital medicine companies realize FDA approval is an important mark of approval, according to speakers on the regulatory panel discussion moderated by Wade Ackerman of Covington & Burling at Digital Medicine & Medtech Showcase January 9 in San Francisco.
Technology companies haven’t always understood the need for regulation, but that is changing, according to Nancy Bradish Myers, president and founder, Catalyst Healthcare Consulting, Inc. “Now, some companies want to be regulated because FDA standards prove quality and improve the chances of reimbursement. And, clients are accustomed to FDA-regulated products.”
In fact, FDA regulation can be a distinguishing characteristic and a competitive advantage. Savonix, for example, operates in the cognitive testing space and doesn’t have to file a 510(k) premarket notification. “We’re doing it anyway,” Mylea Charvat, CEO and founder, Savonix, says, as a way to assure customers of the rigor of its products in terms of traceability and secure practices for data, product development, and software upgrades.
Pear Therapeutics, the first company to receive FDA clearance for a digital therapeutic, sees regulation as a part of good product development. “We approach FDA regulations as good product hygiene,” says Beth Rogozinski, chief content officer, Pear Therapeutics. “When you embrace regulation as a part of agile development processes, it doesn’t hinder innovation.”
That said, the FDA must strike the right balance, ensuring it neither over- nor under-regulates while dealing with complex issues like interoperability, cybersecurity, and artificial intelligence. “The guidances (implementing the 21st Century Cures Act) got it right,” says Michelle Jump, principal regulatory affairs specialist, Stryker.
The FDA’s precertification initiative is another good step. This program audits digital device developers rather than individual products, to ensure that proper policies and procedures are in place, that rigorous attention is given to privacy and data protection, and that relevant details can be traced throughout the organization.
The FDA still maintains a conservative approach, and still is evaluating certain aspects of digital medicine (like how to combine multiple approved products), but it also is better-defining the space.
As pharmas redefine themselves as healthcare companies, presenting products as “FDA-regulated” has enduring value. As Rogozinski says, “People around the world understand what FDA approval means.”
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