# 068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-01-18
- Length: 47m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/068---BenefitRisk-Ratios--PRRC--and-Mythical-Medical-with-David-Rutledge-e1th8uk

## Summary

David Rutledge, CEO of Global Strategic Solutions and author of 'Mythical Medical', discusses the critical importance of demonstrating product benefit in medical device development, arguing that the industry has historically focused too heavily on risk. He details the role of the Person Responsible for Regulatory Compliance (PRRC) under EU MDR, emphasizing the need for cross-functional teams to define and validate benefits through diverse data sources. Rutledge also shares insights from his book, using narrative characters to illustrate common regulatory pitfalls, audit preparation strategies, and the emotional weight of ensuring patient safety in combination products.

## Chapters

- [0:03](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=3) Introduction: David Rutledge and Global Strategic Solutions
- [2:34](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=154) Rutledge's Background and FDA Advisory Service
- [3:33](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=213) Mythical Medical Book and the 'Unsolvable Equation' of Benefit
- [7:24](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=444) Defining Benefit Buckets and Data Inputs
- [12:16](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=736) Integrating Benefit into Risk Management Early
- [14:13](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=853) Cross-Functional Data Sources for Benefit Analysis
- [17:07](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=1027) Global Harmonization of Benefit Expectations
- [19:59](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=1199) Significant Change and MDR Compliance
- [25:05](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=1505) Patient-Centric Design and Human Factors
- [26:37](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=1597) Post-Market Surveillance and Audit Preparation
- [29:29](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=1769) Regulatory Body Differences and CDRH Experience
- [35:48](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=2148) The PRRC Role under EU MDR
- [41:16](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge#t=2476) Influential Books and Future Projects

## 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)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

established companies

## Mentioned

- Mythical Medical (product)
- Global Strategic Solutions (company)
- FDA (company)
- EU MDR (other)
- CDRH (company)
- BSI (company)
- DEKRA (company)
- TÜV SÜD (company)

## Related episodes from other shows

- [How Jon Speer Met His Most Frequent Guest: Mike Drues](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues) (Global Medical Device Podcast)
- [The Best of Jon & Mike Through the Years](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years) (Global Medical Device Podcast)
- [Risk Management from a Regulatory & Product Development Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-risk-management-from-a-regulatory-product-development-point-of-view) (Global Medical Device Podcast)
- [#365: Medical Device Reporting: The Do's and Don'ts](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-07-365-medical-device-reporting-the-dos-and-donts) (Global Medical Device Podcast)
- [#362: Managing Risk in Clinical Investigations](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations) (Global Medical Device Podcast)

## Citing this page

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