# #441: ICYMI (In Case You Missed It!) How Artificial Intelligence is Impacting the MedTech Industry

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-01-12
- Length: 45m
- Episode: 441
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-12-441-icymi-in-case-you-missed-it-how-artificial-intelligence-is-impacting-the-med
- Listen: https://podcast.greenlight.guru/episode/441-icymi-episode-how-artificial-intelligence-is-impacting-the-medtech-industry

## Summary

Ashkon Rasooli, a biomedical engineer and quality management expert, discusses the integration of AI in the medical device industry, highlighting the fundamental difference between deterministic software and statistical AI models. He details current applications in radiology, cardiology, and neurology, as well as wellness wearables like January AI and Whoop, while addressing critical challenges such as data bias and regulatory validation. Rasooli advocates for a staged adoption approach to build confidence in AI outcomes and emphasizes the importance of managing risks through robust quality management systems and emerging frameworks like the EU AI Act.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-12-441-icymi-in-case-you-missed-it-how-artificial-intelligence-is-impacting-the-med#t=0) Introduction: Ashkon Rasooli and the Nature of AI
- [5:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-12-441-icymi-in-case-you-missed-it-how-artificial-intelligence-is-impacting-the-med#t=301) Quality Management Systems and Regulatory Frameworks
- [8:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-12-441-icymi-in-case-you-missed-it-how-artificial-intelligence-is-impacting-the-med#t=487) AI Bias, Correlation vs. Causation, and Healthcare Examples
- [18:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-12-441-icymi-in-case-you-missed-it-how-artificial-intelligence-is-impacting-the-med#t=1129) Wearable Health Monitors and Wellness Applications
- [27:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-12-441-icymi-in-case-you-missed-it-how-artificial-intelligence-is-impacting-the-med#t=1659) AI in Medical Device Operations and Manufacturing
- [34:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-12-441-icymi-in-case-you-missed-it-how-artificial-intelligence-is-impacting-the-med#t=2076) AI at the Point of Care and Clinical Documentation
- [41:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-12-441-icymi-in-case-you-missed-it-how-artificial-intelligence-is-impacting-the-med#t=2509) Regulatory Challenges and Staged Adoption Strategy

## Topics

- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- January AI (product)
- Whoop (product)
- 8 sleep (product)
- Unique (company)
- FDA (other)
- EU AI Act (other)
- AFDO/RAPS (other)

## Related episodes from other shows

- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (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)
- [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)
- [206 - Will AI Decide Your Next Drug/Device Approval?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval) (Let's Combinate)
- [244 - 5 Critical Quality Differences Between Drugs and Devices](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-01-244-5-critical-quality-differences-between-drugs-and-devices) (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/2026-01-12-441-icymi-in-case-you-missed-it-how-artificial-intelligence-is-impacting-the-med. 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.