# #443: Generative AI in MedTech: Quality, Risks, and the Autonomy Scale with Ashkon Rasooli

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-01-26
- Length: 44m
- Episode: 443
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-26-443-generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-ra
- Listen: https://podcast.greenlight.guru/episode/generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-rasooli

## Summary

Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD), discusses the unique quality assurance challenges of generative AI in the medical device industry. He explains that unlike traditional machine learning, generative AI creates new data, introducing failure modes like 'hallucinations' where outputs appear plausible but are factually incorrect. Rasooli argues that because GenAI behavior is statistical rather than deterministic, traditional pre-market validation is insufficient, necessitating a shift toward continuous post-market surveillance and real-time independent monitoring to ensure safety.

## Chapters

- [0:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-26-443-generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-ra#t=31) Introduction and Session Preview
- [3:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-26-443-generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-ra#t=227) Defining Generative AI vs. Traditional ML
- [5:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-26-443-generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-ra#t=338) Hallucinations and Risk Levels
- [5:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-26-443-generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-ra#t=338) The Autonomy Scale and ISO 14971
- [11:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-26-443-generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-ra#t=683) Regulatory Gaps and FDA Clearance
- [15:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-26-443-generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-ra#t=934) Top 5 Considerations for MedTech Professionals
- [22:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-26-443-generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-ra#t=1360) Safety by Design and Independent Verification
- [26:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-26-443-generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-ra#t=1599) Shift to Post-Market Validation and LDT Analogy
- [33:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-26-443-generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-ra#t=2016) Tribal Knowledge Loss and Coding Risks

## Topics

- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- Ingenious Solutions (company)
- MD&M West (other)
- FDA (other)
- ISO 14971 (other)
- ISO 13485 (other)
- ChatGPT (product)
- OpenAI (company)
- Google Maps (product)

## 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)
- [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)
- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (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)
- [134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities) (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/2026-01-26-443-generative-ai-in-medtech-quality-risks-and-the-autonomy-scale-with-ashkon-ra. 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.