# How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-05-13
- Length: 45m
- Episode: 146
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-13-how-to-use-artificial-intelligence-machine-learning-to-produce-better-smarter-sa
- Listen: https://podcast.greenlight.guru/episode/how-to-use-artificial-intelligence-machine-learning-to-produce-better-smarter-safer-devices

## Summary

Host John Spear of Greenlight Guru interviews Devon Campbell, founder of Prodct LLC, and Anthony Habayeb, co-founder and CEO of Monitaur.ai, about the challenges and frameworks for integrating artificial intelligence (AI) and machine learning (ML) into medical devices. The discussion centers on 'Machine Learning Assurance,' a process for auditing and monitoring ML models to ensure safety and effectiveness in regulated environments, contrasting it with traditional Quality Management Systems (QMS). The guests share insights from FDA workshops and guidance, emphasizing the need for a 'culture of quality control' and Algorithmic Change Protocols (ACP) to manage the risks of evolving algorithms in Software as a Medical Device (SaMD).

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-13-how-to-use-artificial-intelligence-machine-learning-to-produce-better-smarter-sa#t=0) Introduction and Guest Backgrounds
- [4:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-13-how-to-use-artificial-intelligence-machine-learning-to-produce-better-smarter-sa#t=240) Defining AI vs. Machine Learning
- [9:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-13-how-to-use-artificial-intelligence-machine-learning-to-produce-better-smarter-sa#t=567) The Concept of Machine Learning Assurance
- [12:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-13-how-to-use-artificial-intelligence-machine-learning-to-produce-better-smarter-sa#t=756) ML Assurance vs. Traditional QMS
- [19:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-13-how-to-use-artificial-intelligence-machine-learning-to-produce-better-smarter-sa#t=1157) Using ML in Development and Manufacturing
- [28:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-13-how-to-use-artificial-intelligence-machine-learning-to-produce-better-smarter-sa#t=1689) FDA Guidance and Regulatory Engagement
- [36:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-13-how-to-use-artificial-intelligence-machine-learning-to-produce-better-smarter-sa#t=2181) Strategic Advice for Medical Device Companies

## Topics

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

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- Prodct LLC (company)
- Monitaur.ai (company)
- FDA (company)
- Butterfly Network (company)

## Related episodes from other shows

- [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)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [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)
- [67: Software for Things That Can Kill People](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people) (Embedded.fm)
- [188 – Certified Quality Auditor(CQA) and Audits in the Future](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-14-188-certified-quality-auditor-cqa-and-audits-in-the-future) (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/2020-05-13-how-to-use-artificial-intelligence-machine-learning-to-produce-better-smarter-sa. 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.