A.J. Bahou Quoted in Medical Device Network on AI Governance Across the Product Lifecycle

Bradley attorney A.J.Bahou was quoted in Medical Device Network, arguing that medical device companies should embed AI governance into products from the beginning and maintain it throughout the product’s lifecycle, regardless of evolving regulations.

Bahou advised companies to “build governance in” to AI products instead of waiting for regulatory certainty, as U.S. AI laws continue to evolve.

“The struggle for everyone in the industry comes down to uncertainty regarding federal versus state pre-emption,” he said.

Rather than focusing on conflicting regulations, Bahou encouraged companies to ask, “What can you do to have a safe and secure device?”

“If you build those factors in, that is the governance structure for the full lifecycle of the device, then you tend to relax the conversation and stop fighting over what Colorado has versus what California has versus federal pre-emption.”

Bahou also stated:

“Companies should be hyper-focused on the developmental factors for their AI devices, but they should also consider – once their device is FDA-approved and launched in the marketplace – what will happen in, say, six months when their device’s AI model gets updated, and to bear in mind what impact those changes could have on real patients.”

Bahou stressed that AI-enabled devices require continuous oversight after they reach the market and that “manufacturers need to continually test and monitor their devices throughout their lifecycle post-market.”

He contrasted this with traditional medical devices, noting that manufacturers previously viewed FDA approval as the endpoint. Once a device was approved and “its software locked down,” companies were “very resistant to changing anything about their device.”

The full article, “AI in Medical Imaging: The Key Tenets of an Effective Governance Strategy,” was published by Medical Device Network on July 31, 2026.