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#439: MedTech AI Trends 2025: Scaling Regulatory Intelligence with Michelle Wu

·43 min·4 clips

Michelle Wu, named a top 100 women in AI, recounts seeing her clients' medical devices during her own surgery.

The episode begins with host Etienne Nichols introducing Michelle Wu, founder and CEO of Nyquist AI, who was named a top 100 women in AI in 2025. Michelle shares a personal story about her recent surgery, where she recognized medical devices from her clients in the operating room, feeling reassured by their quality. Etienne frames the discussion around AI's evolution in medtech, from initial skepticism post-ChatGPT to current adoption phases. Michelle identifies 2025 inflection points, including the IMDRF GMLP final version and EU AI Act timeline, making AI necessary for regulatory and quality professionals. She describes Nyquist AI's three-layer solution: data for regulatory intelligence, workflow automation for tasks like medical writing, and AI agents for employee-like capabilities. Michelle explains the industry's journey from AI-naive to overload, with tools overwhelming users, and now to adoption where some are running far ahead. Etienne compares this to a generational rewiring similar to social media's impact, noting his kids' AI-first approach. Michelle predicts that by 2026, every regulatory task will involve AI co-pilots, becoming normal rather than novel. She details how top users leverage Nyquist AI, with one VP building an internal tool that automated 17,000 quality jobs, aiming to free employees for higher-value work. Another user transformed from a regulatory consultant to teaching AI bootcamps and building AI agents. The conversation shifts to career implications, with Michelle citing data that AI literacy offers a 56.8% salary premium and 30% better resume screening odds. She warns that 700 occupations, including regulatory, face automation, urging professionals to outsmart AI by developing clarity of mind and courage. Michelle shares a success story of a senior manager who became the youngest VP by dedicating time to AI, building use cases, and leading her team. Etienne emphasizes starting small with specific AI applications. Michelle concludes with advice to spend 5-10 minutes daily on AI literacy for career advancement. The episode ends with contact details for Michelle and Nyquist AI resources.

As heard by us

A grounded forecast of specialized AI copilots becoming everyday tools in medtech quality and regulatory work.

Etienne Nichols and Nyquist AI founder and CEO Michelle Wu look at how AI copilots could change quality and regulatory work in medtech. Wu expects specialized copilots to emerge for particular roles and tasks, such as regulatory strategy, regulatory intelligence, quality…

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Why you'd press play

You'll hear how role-specific AI copilots could augment or automate work across regulatory and quality roles.

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