# 202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-08-20
- Length: 32m
- Page: 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
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/202---Becoming-an-Expert-in-the-Work-Nobody-Wants-to-DoDesign--Risk--and-the-Messy-Middle-of-Combination-Products-wJoey-Frechin-e372hc6

## Summary

Joey Frechin, a Senior Technical Program Manager in med tech consulting, explains the complexities of aligning risk assessments for combination products, noting that while drug and device teams are starting to integrate their processes, significant methodological gaps remain. He details the P1/P2 probability scoring methodology used in ISO 14971 to distinguish between device failure and patient harm, and shares his career strategy of becoming an expert in 'unwanted' but high-value tasks like DFMEA and PFMEA to bridge engineering and quality teams. Frechin also discusses current industry trends, where companies often pivot from complex bespoke designs to simplified or off-the-shelf subsystems to meet clinical trial timelines, highlighting the critical importance of early sterilization and accelerated aging testing to avoid late-stage failures.

## Chapters

- [0:06](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#t=6) Introduction: Joey Frechin and the State of Risk Assessments
- [4:30](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#t=270) Challenges in Aligning Risk Processes Across Organizations
- [9:44](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#t=584) Understanding P1 and P2 Probability Scoring in ISO 14971
- [12:09](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#t=729) Joey's Career Journey: Bridging Design and Risk Management
- [24:03](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#t=1443) Trends in Combination Product Design: Bespoke vs. Off-the-Shelf

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- ISO 14971 (other)
- DFMEA (other)
- PFMEA (other)
- CMO (company)
- MiniTab (tool)
- SolidWorks (tool)
- Auto Injector (product)
- Plunger Barrel Lure (product)

## Related episodes from other shows

- [#422: ISO 14971 and the Road to Risk Management with Edwin Bills](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills) (Global Medical Device Podcast)
- [#325 The Role of dFMEAs in Risk Management for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices) (Global Medical Device Podcast)
- [Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-10-inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-26-384-insights-from-an-ex-fda-investigator-compliance-quality-systems-and-medtech) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to 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. 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 Let's Combinate.