The AI Reckoning in Medtech Regulatory Affairs
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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?
