If this year’s Consumer Electronics Show (CES) is any indication of things to come, we can expect the role of medical devices in digital health to move onward and upward. The popular annual trade show attracted over 500 exhibitors of digital health products, including hundreds of medical devices.
The show’s wide array of devices ranged from a mobile app that translates everyday language to pictures for people with autism to a virtual-reality system that provides surgeons with a guided map of a patient’s anatomy (1).
The buzz generated by digital-health related devices at CES is not a surprise. Medical device experts interviewed for a white paper anticipated such a trend this year after the ballyhooed introduction last year of two medical apps for Apple Watch Series 4. Both apps received a marketing authorization from the U.S. Food and Drug Administration (FDA).
The growth of the role of devices in digital health is No. 5 on a list of developments likely to affect the device industry this year, according to a new white paper, “Top 5 Medical Device Industry Trends in 2019.”
The FDA’s “Digital Health Innovation Action Plan” encourages innovation in digitally enabled devices through a pre-certification program, which allows pre-certified developers to market their lower-risk devices faster.
The agency heralded the two Apple Watch medical apps as a significant step forward for the agency’s overall approach to the development of digital health. The first app is an electrocardiogram monitor, which can detect heartbeats that are too low, while the second app can detect irregular heartbeat. Both apps can send alerts to the wearer.
The devices were De Novo applications. The FDA granted them marketing authorizations as opposed to a clearance or a premarket approval.
“I expect an increase in the number of De Novo applications and small human clinical studies to support efficacy,” said Rob Packard, president of Medical Device Academy (2).
Michelle Lott, principal and founder of Lean RAQA, said that a number of new policies open up new pathways to facilitate innovation and faster clearance or approval of medical devices. “Medtech companies need to embrace regulatory change and use it to their advantage to get their products to market and make money faster,” she added.
A new document from the FDA reinforces the increasing importance of digital health products. The FDA’s “Software Precertification Program: 2019 Test Plan,” released in January, explains how the agency will regulate those innovative products. The plan features a streamlined process for regulating “software as a medical device” or SaMD products.
This year the test plan will apply to a limited number of SaMD De Novo requests and selected SaMD 510(k) submissions. The former will be used to test the concept of special controls or postmarket data-collection requirements if necessary. The latter will be tested as if they were follow-on 510(k) submissions for devices classified through a Precert De Novo request.
The agency envisions the program as a voluntary pathway for assessing the safety and effectiveness of software technologies without inhibiting patient access to those technologies.
(1) “CES 2019: Medical Technologies You Need to Know” by Danielle Kirsh, Medical Design & Outsourcing, Jan. 7, 2019.
(2) Rob Packard is the president of Medical Device Academy, Inc. He has 25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He has served in senior management positions at several medical device companies, including as president and CEO of a laparoscopic imaging company. His quality management system expertise covers all aspects of developing, training, implementing and maintaining ISO 13485 and ISO 14971 certification.(3) Michelle Lott is the principal and founder of Lean RAQA, a regulatory and quality system solutions company. She has nearly 20 years of health care product experience, including holding executive roles for international regulatory and quality operations. She’s currently serving on the FDA’s Device Good Manufacturing Practices Advisory Committee as an industry representative.
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