As the medical device industry begins to push the boundaries of artificial intelligence – exploring ways to use advanced AI systems to review, sort and process big data to find quality systems or product problems that would simply take too long for human eyes to see – FDA is also looking at ways to use AI for its own advantage. "AI will reduce investigational time and increase FDA's speed in taking action on a problematic firm," one agency official says. Meanwhile, a new Artificial Intelligence Initiative has been launched by Xavier University to better determine how AI can be used in the quality and regulatory space. Also: J&J subsidiary Janssen explains how it uses AI for quality and regulatory applications, and an expert from Shire tells how top management can be convinced that using artificial intelligence can save their firms money.

The Artificial Intelligence Initiative at Xavier University has formed teams to decide how to best scan for signals of device and drug troubles, and validate results generated from AI systems.

Quality metrics are being developed by the US FDA to not only determine which medical device facilities to inspect next, but to also raise firms' overall approach to quality above baseline. In-process metrics work by the Medical Device Innovation Consortium will be used as the agency comes up with its own robust set of measurements. Meanwhile, FDA is gearing up for a new pilot program targeting 10-20 device manufacturers that will submit quality data to the agency; MDIC explains how to calculate its three quality metrics; and quality officials from Baxter, J&J and Stryker weigh in.