# #351: The State of AI & Clinical Investigations

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-01-11
- Length: 39m
- Episode: 351
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-11-351-the-state-of-ai-clinical-investigations
- Listen: https://podcast.greenlight.guru/episode/351-the-state-of-ai-clinical-investigations

## Summary

Dr. Maria Nyakern, founder of Acre Scientific Consulting (acquired by NAMSA), discusses the integration of AI in medical devices and the implications of the European AI Act. She explains how the regulation's focus on 'trustworthy' systems parallels existing medical device frameworks, emphasizing the need for robust data integrity and bias mitigation in clinical investigations. Nyakern highlights that AI can lower the cost of generating diverse patient datasets, potentially reducing the number of required clinical trials, while stressing the importance of maintaining human-centric oversight and addressing data privacy vulnerabilities.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-11-351-the-state-of-ai-clinical-investigations#t=0) Introduction: Dr. Maria Nyakern and the European AI Act
- [3:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-11-351-the-state-of-ai-clinical-investigations#t=229) Trustworthy AI and the Evolution of the AI Act
- [10:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-11-351-the-state-of-ai-clinical-investigations#t=619) US Predetermined Change Control Plans vs. EU Post-Market Oversight
- [15:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-11-351-the-state-of-ai-clinical-investigations#t=926) Transferable Skills from MedTech to AI Governance
- [19:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-11-351-the-state-of-ai-clinical-investigations#t=1178) Data Quality, Integrity, and Bias in Clinical Investigations
- [25:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-11-351-the-state-of-ai-clinical-investigations#t=1523) The Risk of AI-Generated Data Corruption and Bias
- [30:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-11-351-the-state-of-ai-clinical-investigations#t=1848) Human-Centric AI and the Role of Women in Leadership

## Topics

- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Acre Scientific Consulting (company)
- NAMSA (company)
- European AI Act (other)
- FDA (other)
- MDR (other)
- ChatGPT (product)
- Google Gemini (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)
- [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)
- [059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower) (Let's Combinate)
- [054 - "EUDAMED" with Richard Houlihan](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan) (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

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