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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-12-29
- Length: 42m
- Episode: 439
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-29-439-medtech-ai-trends-2025-scaling-regulatory-intelligence-with-michelle-wu
- Listen: https://podcast.greenlight.guru/episode/439-medtech-ai-trends-2025-scaling-regulatory-intelligence-with-michelle-wu

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-29-439-medtech-ai-trends-2025-scaling-regulatory-intelligence-with-michelle-wu#t=0) Introduction and Michelle Wu’s Background
- [2:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-29-439-medtech-ai-trends-2025-scaling-regulatory-intelligence-with-michelle-wu#t=148) Personal Surgery Experience and Industry Pride
- [4:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-29-439-medtech-ai-trends-2025-scaling-regulatory-intelligence-with-michelle-wu#t=277) The 2025 Inflection Point: FDA ELSA and EU AI Act
- [9:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-29-439-medtech-ai-trends-2025-scaling-regulatory-intelligence-with-michelle-wu#t=574) The Great Rewiring of MedTech and Consulting Models
- [15:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-29-439-medtech-ai-trends-2025-scaling-regulatory-intelligence-with-michelle-wu#t=909) Greenlight Guru’s AI Adoption and Future Predictions
- [20:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-29-439-medtech-ai-trends-2025-scaling-regulatory-intelligence-with-michelle-wu#t=1231) The Holy Trinity Framework: Data, Workflow, and Agents
- [27:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-29-439-medtech-ai-trends-2025-scaling-regulatory-intelligence-with-michelle-wu#t=1636) Career Impact: Salary Premiums and Junior Professional Challenges
- [38:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-29-439-medtech-ai-trends-2025-scaling-regulatory-intelligence-with-michelle-wu#t=2332) Advice for Young RAQA Professionals and Closing

## Topics

- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

companies scaling up

## Mentioned

- Nyquist AI (company)
- Greenlight Guru (company)
- FDA (other)
- ELSA (other)
- EU AI Act (other)
- Novartis (company)
- BCG (company)
- Philips (company)
- Baxter (company)
- ChatGPT (product)
- Claude (product)
- Gemini (product)
- Google Flow (product)
- RAPS (company)
- MIT Press (company)
- Forbes (company)
- Stanford (company)
- Abet (company)
- JP Morgan (company)

## Related episodes from other shows

- [107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-25-107-distilling-decades-of-medtech-data-generative-ai-and-doing-without-tribal-kn) (Let's Combinate)
- [S5E44 Geoff Gaw | Nitinol, R&D, and How to Learn About New Technologies](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-11-01-s5e44-geoff-gaw-nitinol-r-d-and-how-to-learn-about-new-technologies) (Being an Engineer)
- [188 – Certified Quality Auditor(CQA) and Audits in the Future](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-14-188-certified-quality-auditor-cqa-and-audits-in-the-future) (Let's Combinate)
- [029 - "Purpose" with Marla Phillips](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-20-029-purpose-with-marla-phillips) (Let's Combinate)
- [216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-29-439-medtech-ai-trends-2025-scaling-regulatory-intelligence-with-michelle-wu. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.