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.

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