# Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-01-07
- Length: 44m
- Episode: 174
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-07-measuring-the-impact-of-ai-ml-technologies-on-the-current-medical-device-landsca
- Listen: https://podcast.greenlight.guru/episode/measuring-the-impact-of-ai-ml-technologies-on-the-current-medical-device-landscape

## Summary

Mike Drues, president of Vascular Sciences, argues that the FDA's current focus on 'locked algorithms' stifles true AI in medical devices, citing only 29 cleared products as evidence of regulatory hesitation. He proposes three pragmatic solutions to enable adaptive AI: pre-validating a range of dynamic changes, allowing software to recommend changes for manufacturer approval, and enabling devices to learn collectively from a 'herd' of similar units. Drues contends that these engineering challenges have significant precedent in traditional device development, such as catheter sizing, and urges the industry to lead the conversation on good machine learning practices rather than waiting for FDA guidance.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-07-measuring-the-impact-of-ai-ml-technologies-on-the-current-medical-device-landsca#t=0) Introduction: Mike Drues and Vascular Sciences
- [2:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-07-measuring-the-impact-of-ai-ml-technologies-on-the-current-medical-device-landsca#t=123) Defining True AI vs. Locked Algorithms
- [6:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-07-measuring-the-impact-of-ai-ml-technologies-on-the-current-medical-device-landsca#t=416) The Problem with Design Freeze and Locked Algorithms
- [14:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-07-measuring-the-impact-of-ai-ml-technologies-on-the-current-medical-device-landsca#t=870) Catheter Metaphor and Pre-validated Ranges
- [20:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-07-measuring-the-impact-of-ai-ml-technologies-on-the-current-medical-device-landsca#t=1251) Regulatory Precedent and FDA Critique
- [30:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-07-measuring-the-impact-of-ai-ml-technologies-on-the-current-medical-device-landsca#t=1823) Feedback Loops and Manufacturer-Driven Updates
- [38:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-07-measuring-the-impact-of-ai-ml-technologies-on-the-current-medical-device-landsca#t=2294) Summary of Solutions and Industry Leadership

## Topics

- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Green Light Guru (company)
- FDA (other)
- SAM D (other)
- 510 K (other)
- PMA (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)
- [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)
- [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)
- [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)

## 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/2021-01-07-measuring-the-impact-of-ai-ml-technologies-on-the-current-medical-device-landsca. 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.