Artificial intelligence and medical devices: Why you need to care

Friday, June 14, 2019

Source: MassDevice

Artificial intelligence presents a whole host of regulatory challenges when it comes to medical devices.

Regulatory consultant Mike Drues says he has had clients forced to dumb down their AI technology, with U.S. FDA requiring they lock the algorithm. Drues sees locking the machine learning algorithm is a Band-Aid solution — not a longterm fix.

The FDA in April released a discussion paper on AI and medical devices. But much more needs to be done to determine how to regulate the area — and the medical device industry runs the risk of others eventually deciding how to solve the problems.

The irony is that Drues thinks there are ways to allow AI to meet its potential in medtech without running afoul of regulations. “If you really understand the regulatory logic, there’s nothing new here,” said Drues, who is president of Vascular Sciences in Southern California.

Drues offered some ideas about how to better regulate AI in medical devices during Medical Design & Outsourcing‘s latest podcast.


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