# #362: Managing Risk in Clinical Investigations

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-04-25
- Length: 39m
- Episode: 362
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations
- Listen: https://podcast.greenlight.guru/episode/362-the-state-of-ai-in-clinical-investigations

## Summary

Helene Quie, a medical device regulatory expert, explains the dual nature of risk management in clinical investigations, distinguishing between residual product safety risks and procedural risks inherent in study protocols. She emphasizes the need for measurable, data-driven benefit-risk assessments to satisfy ethics committees and competent authorities, particularly under the EU MDR. Quie highlights the operational challenges of enrolling vulnerable patient populations, such as children or acute patients, and the regulatory confusion surrounding the integration of AI in medical devices.

## Chapters

- [0:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations#t=32) Introduction: Helene Quie and Risk Management Overview
- [3:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations#t=214) Residual Product Risks and Benefit-Risk Assessments
- [7:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations#t=472) Procedural Risks and Protocol Design
- [15:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations#t=927) Practical Protocol Failures and Regulatory Clashes
- [26:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations#t=1601) EU MDR Impact on Small Patient Populations
- [32:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations#t=1959) Regulatory Uncertainty for AI in Medical Devices

## Topics

- [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)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)

## Most relevant to

early-stage companies

## Mentioned

- Helene Quie (other)
- Etienne Nichols (other)
- EU MDR (other)
- MDD (other)
- FDA (other)
- ISO 14155 (other)

## Related episodes from other shows

- [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)
- [161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products](https://hardwarepodcasts.com/podcast/lets-combinate/2024-11-06-161-iso-14971-and-ich-q9-explained-risk-management-frameworks-in-medical-devices) (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)
- [091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca) (Let's Combinate)
- [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)

## 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/2024-04-25-362-managing-risk-in-clinical-investigations. 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.