LTR 161: AI Governance by Design
About this episode
Ankita Mishra discusses the importance of integrating AI governance into the product lifecycle to foster responsible innovation.
Summary “Let’s treat AI governance by design as the connective tissue of a product lifecycle ecosystem.” AI governance is often introduced as another layer of oversight—more procedures, approvals, documentation, and checklists. Ankita Mishra offers a different way to think about it: governance should be designed into the digital health product lifecycle from the beginning. In this episode of the Let’s Talk Risk! conversation , host Naveen Agarwal and Ankita Mishra explore how systems thinking and risk-based decision-making can help organizations innovate responsibly without applying the same level of rigor to every product or use case. They discuss flexible quality systems, the importance of defensible rationale, third-party AI solutions, supplier dependencies, privacy and security, model performance, and the need to monitor AI after deployment. The conversation also addresses what AI means for quality, regulatory, and risk professionals. Rather than making human expertise less relevant, Ankita argues that AI increases the need for critical thinking, judgment, collaboration, and continuous learning. Listen to the full 25-minute podcast or jump to a section of interest listed…
More episodes of Let's Talk Risk! with Dr. Naveen Agarwal
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- LTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety
- LTR 159: The Evolving Regulatory Landscape for AI in MedTech
- Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions
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