Hardware Podcasts

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

Global Medical Device Podcast · 29 Dec 2025 · 42m · Episode 439

What this episode covers

Michelle Wu, Founder and CEO of Nyquist AI, discusses the transformative impact of AI on the MedTech regulatory and quality assurance (RAQA) industry. She outlines the shift from AI skepticism to necessity, driven by the FDA’s ELSA framework and the EU AI Act, and introduces her 'Holy Trinity' framework of Data, Workflow, and Agents. Wu highlights how AI literacy can command a 56.8% salary premium for professionals and shares case studies of companies automating thousands of tasks, emphasizing that future success depends on asking high-quality strategic questions rather than memorizing knowledge.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
Nyquist AI, Greenlight Guru, Novartis, BCG, Philips, Baxter, RAPS, MIT Press, Forbes, Stanford, Abet, JP Morgan
Products
ChatGPT, Claude, Gemini, Google Flow
Also
FDA, ELSA, EU AI Act

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