
The episode discusses the responsible use of AI in medical device product development, emphasizing human oversight and accountability.
Summary “AI can be a powerful helper, but it should not be the decision-maker.” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with David Grilli about how MedTech teams can use AI responsibly in product development without losing control of risk, quality, or accountability. David brings experience across medical device risk management, system safety, reliability engineering, and regulated product development. He shares practical examples of where AI may help—such as requirements development, software troubleshooting, and early discovery—while emphasizing the need for clear boundaries, human judgment, validation, and leadership oversight. The conversation also explores how teams should define the intended use of AI applications, how to communicate AI proposals to leadership, and why AI should be treated as a cognitive partner rather than an accountable decision-maker. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 – Introduction 03:20 – Where AI is showing up in product development 05:00 – Using AI for requirements without giving up decision authority 08:45 – Treating AI as a helper, not an accountable…
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