# How AI Can Help You Manage Risk

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-05-26
- Length: 33m
- Episode: 319
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-26-how-ai-can-help-you-manage-risk
- Listen: https://podcast.greenlight.guru/episode/how-ai-can-help-you-manage-risk

## Summary

Tyler Foxworthy, Chief Scientist at Greenlight Guru, explains how his company applies Bayesian statistics and machine learning to transform medical device risk management from qualitative guesswork into rigorous, probabilistic assessment. He details how the platform mines FDA data and clinical literature to update risk probabilities, addressing the industry's struggle with false precision and the limitations of human intuition regarding rare events. Foxworthy argues that adopting these models, pioneered in nuclear and aerospace sectors, allows companies to right-size clinical sample sizes, reduce uncertainty, and accelerate time to market by providing statistically defensible confidence intervals.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-26-how-ai-can-help-you-manage-risk#t=0) Introduction: Greenlight Guru Academy and Tyler Foxworthy's Background
- [5:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-26-how-ai-can-help-you-manage-risk#t=328) Mining Unstructured FDA Data and Adverse Event Narratives
- [6:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-26-how-ai-can-help-you-manage-risk#t=413) The Problem with Qualitative Risk Assessment and False Precision
- [9:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-26-how-ai-can-help-you-manage-risk#t=594) Bayesian Analysis and Degrees of Belief in Risk
- [12:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-26-how-ai-can-help-you-manage-risk#t=756) Future of Risk Assessment: AI Copilots and Post-Market Surveillance
- [14:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-26-how-ai-can-help-you-manage-risk#t=864) Human Intuition Limits and Compounding Uncertainty in P1/P2
- [18:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-26-how-ai-can-help-you-manage-risk#t=1110) Economic Benefits: Right-Sizing Sample Sizes and Post-Market Testing
- [20:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-26-how-ai-can-help-you-manage-risk#t=1237) Bayesian vs. Frequentist Statistics: The Baseball Analogy
- [25:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-26-how-ai-can-help-you-manage-risk#t=1512) Change in Trajectory: Quantifying Uncertainty and Industry Adoption

## 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)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Resultant (company)
- Demand Jump (company)
- Vertex (company)
- ISO 14971 (other)
- FDA (other)
- NASA (other)
- Greenlight Guru Academy (product)

## Related episodes from other shows

- [098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-16-098-medtech-vs-aerospace-risk-management-afap-vs-alarp-alara-quantifying-benefit) (Let's Combinate)
- [202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin](https://hardwarepodcasts.com/podcast/lets-combinate/2025-08-20-202-becoming-an-expert-in-the-work-nobody-wants-to-do-design-risk-and-the-messy) (Let's Combinate)
- [014A - "The First P: Product" with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager) (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)
- [025 - “The Frying Pan to the Fire” with Edwin Bills](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills) (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/2023-05-26-how-ai-can-help-you-manage-risk. 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.