Closing the loop: using AI to turn post-market data into better designs

Date: June 18, 2026, 1:00 - 2:00 pm ET
Presenters: Etienne Nichols and Will Sanders, Greenlight Guru

Every post-market device team sits on a goldmine of field data: complaints, CAPAs, nonconformances, service records, returns. But in most organizations, that data lives in a closed compliance loop and never makes its way back to the people designing the next generation of the product. The same issues resurface and lessons learned stay buried.

This session reframes post-market data as one of the most underused strategic assets a device company has. We'll look at why the feedback loop breaks down between quality, regulatory, and R&D, and what high-performing teams do differently to keep design and risk files genuinely alive.

We'll also get practical about where AI fits. Once your structured data (feedback, complaints, CAPAs, nonconformances, risk matrices, design matrices, documents) is connected to an AI tool, you can start generating real insights from it. The point isn't to hand over the decisions. It's to cut the mental load of combing through mountains of data from scratch. AI can give you a head start and point you in a direction; you confirm the hunches and stay in control of the calls that matter. There's even room to use industry data in parallel by connecting live sources like the openFDA device event APIs to sharpen the picture further.

What you'll learn:

• Where AI points the way and where human judgment should stay in charge
• First steps to building a closed-loop culture across quality, regulatory, and R&D
• Why the post-market-to-design feedback loop breaks down in most organizations
• How leading teams turn complaint, CAPA, and field data into real design and risk inputs
• How connecting your structured data to an AI tool can take the grunt work out of analysis
• How teams are accessing live data, like the openFDA event database, to strengthen their analysis