We’re a month removed from 2018, and it’s clear that medical devices were a consistent newsmaker last year. Moreover, the mixed headlines about devices, from exciting innovations to public safety concerns, exposed the competing priorities of our regulatory bodies. As we’ve observed, the FDA performed a careful balancing act last year, as they aimed to speed up time to market while responding to public pressure regarding transparency and due diligence. Some contradictions arose, like proposals to reduce barriers for 510(k) submissions while overhauling the use of predicates, likely necessitating higher usage of the de novo path.
Overall, though, it was an exciting year for the industry, teeing up a promising 2019 that is now underway. And this year, amid all this recent change, Medrio will be working harder than ever to help device researchers navigate the complexities of their industry. It’ll be more important than ever for us to let the world know that not all eClinical platforms are built exclusively for large Phase III pharma studies – even though it can often seem that way.
Exciting Medical Device Market Arrivals in 2018
While the commotion around 510(k) pulled at our attention last year, the medical device clinical research industry in 2018 was about more than just regulation – innovation also had a big year. With a record 106 novel device approvals, surpassing 2017’s 98 approvals, 2018 brought incredible technologies to market. A continued trend from 2017 is the increasing connectivity of devices, exemplified by the approvals of multiple smartphone-syncing glucose monitors. As the prevalence of diabetes in the US ticks upward, this category continues to innovate steadily.
Other new products include a mobile app for managing substance abuse and the first artificial iris available in the US. Apps as diagnostics and devices is an exploding category as health technology increasingly integrates into our lives. The FDA also provided updates on its Breakthrough Device program. Since its inauguration in 2015, the FDA has granted 112 breakthrough designations, and nine of those products have been subsequently cleared or approved. Finally, the Center for Devices and Radiological Health (CDRH) announced an “overwhelming” number of applicants to its Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder. Ideally, many of these applicants will list among clearances and approvals in the future.
Will safety and innovation be at odds in 2019? The FDA certainly hopes not. With potential 510(k) reforms narrowing the scope of allowable predicates, the FDA could be ushering in a new era of invention. We’ve seen this happen before: In the 1980’s and 1990’s, the pharmaceutical industry was caught in a competition of “me-too” drugs and focused on major indications. In response, the Center for Drug Evaluation and Research (CDER) launched its expedited designations and other pilot programs encouraging black sheep development. Now, drugs targeting rare diseases are a leading category of approvals. Now, as the FDA considers 510(k) reforms, medical device makers may need to differentiate their products to tackle new problems, rather than iterating on the past.
Whether the latest regulatory proposals impact time to market is unclear – fortunately the FDA is enacting counter measures to keep the process timely. For example, the push toward slimmed down and single electronic submissions could bring huge time savings to both sponsors and administration. And perhaps the kind of progress we’ve seen at CDER, such as the recently-announced “innovation office,” which aims for faster evaluations, will begin to emerge at CDRH as well.
Whatever 2019 brings to the medical device clinical research industry and the rest of clinical research, one thing is certain: We’ll be keeping close watch, with an eye toward further optimizing our customers’ processes, as it plays out.