# #350: The Evolving Landscape of AI in MedTech

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-01-04
- Length: 49m
- Episode: 350
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech
- Listen: https://podcast.greenlight.guru/episode/350-the-state-of-ai-in-medtech

## Summary

Eric Henry, a regulatory expert at King & Spalding and strategic committee member for the AI Global Health Initiative, discusses the evolving regulatory landscape for AI in medical devices with host Etienne Nichols. They explore the distinction between 'locked' algorithms, which are currently supported by the FDA, and 'adaptive' algorithms that modify themselves in the field, noting that the FDA's Predetermined Change Control Plan (PCCP) still requires human intervention for changes. Henry emphasizes the critical role of the Federal Trade Commission (FTC) and its 'algorithmic disgorgement' power, while advising companies to focus on robust design controls and engage with public-private partnerships like the Coalition for Health AI to navigate harmonization challenges.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech#t=0) Introduction and FTC Warning
- [3:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech#t=236) Locked vs. Adaptive Algorithms
- [8:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech#t=505) FDA PCCP Guidance Analysis
- [14:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech#t=899) Radiology and Epilepsy Use Cases
- [17:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech#t=1075) RAPS Summit and Regulatory Harmonization
- [22:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech#t=1338) Design Controls and Quality Systems
- [33:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech#t=1990) AI in Manufacturing and QMS
- [42:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech#t=2571) Standards Harmonization and Future Outlook

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

large enterprises

## Mentioned

- Greenlight Guru (company)
- King & Spalding (company)
- FDA (company)
- FTC (company)
- AI Global Health Initiative (company)
- Coalition for Health AI (company)
- PCCP (other)
- ISO 13485 (other)
- QMSR (other)

## Related episodes from other shows

- [094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products) (Let's Combinate)
- [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)
- [172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg) (Let's Combinate)
- [210 - How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-15-210-how-ai-is-rewriting-gmp-smarter-capa-pat-doe-and-continuous-yield) (Let's Combinate)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)

## 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/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech. 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.