ARTICLE SUMMARY:
Artificial intelligence is reshaping how everybody works, and medtech regulatory affairs is no exception. There is big promise in automating the massive amounts of documentation and managing the continuous change that regulatory experts face daily. But there are also concerns about overreliance and jobs. Market Pathways spoke to experts contending with and facilitating the rise of AI in RA.
Michael Nilo, a regulatory consultant and former FDA device reviewer, was recently test-driving a cloud-based automated AI platform that promises a “one-click” device submission. After he entered the relevant details and data, he reports, “it can spit out a C-minus 510(k). It's not going to get you there, but it's going to get you far enough along that you wouldn't be laughed out of the room.”
That doesn’t sound like a ringing endorsement, but, for Nilo, who runs Nilo Medical Consulting Group, it’s nothing to sneeze at. For one, he acknowledges that he is still learning how to best leverage the technology. It is also clear, he says, that its power is improving at a rapid pace. "The tools are getting there,” he states. “The people who know how to use them are just significantly better at it than the people who [don’t], but that gap is closing pretty quickly.”
Nilo is not alone in his efforts to experiment with using AI to support medtech regulatory affairs and in coming to the realization that the technology has reached a level of performance where he needs at least to contend with it. RA professionals operating everywhere from small medtech start-ups to multinational companies are increasingly looking to incorporate some type of AI into their work. And who can blame them?
"The tools are getting there. The people who know how to use them are just significantly better at it than the people who [don’t], but that gap is closing pretty quickly.”
Consider the enormous amount of information required to demonstrate safety, performance, and compliance of devices; the consistent need to iterate and update products; and the rapidly changing regulatory environment that medtech developers must adapt to in regions around the world. Meeting these challenges, and at a speed that aligns with commercial timelines, is a tall task, and rapidly advancing AI tools offer the potential to significantly cut down on the burdens.
“If you talk to regulatory people, a lot of them are stressed out, particularly when a new standard or new regulations come out,” says medtech regulatory expert Bassil Akra. Solutions to automate some RA work can “make their life much easier,” he notes.
