Hardware Podcasts

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

Let's Combinate · 20 Aug 2025 · 32m

What this episode covers

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.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
CMO
Products
Auto Injector, Plunger Barrel Lure
Tools
MiniTab, SolidWorks
Also
ISO 14971, DFMEA, PFMEA

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