Artificial intelligence and medical devices: Why you need to care

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:

 

locked algorithm

Engineering Better Devices at DeviceTalks Minnesota DeviceTalks Minnesota's engineering track is designed to provide attendees with with actionable lessons in a peer-to-peer format on topics such as: Human factors engineering Patient-centric device development R&D trends Manufacturing and scalability Navigating the product development process from start to finish "How We Built This" panels with top medical device groups Join industry leaders and medical device professionals at the most awaited medtech conference of the year, DeviceTalks Minnesota. Use code DT15 to save 15%! REGISTER NOW