Hardware Podcasts

157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura

Let's Combinate · 9 Oct 2024 · 21m

What this episode covers

Chuck Ventura, founder of Ventura Solutions and CEO of HemoTek, explains why poor design inputs are a primary cause of delayed product development and verification failures in medical device and combination product projects. He advocates for spending 30% of project time on design inputs using concurrent engineering, where systems engineers collaborate with verification teams early to define clear acceptance criteria. Ventura also clarifies the structural relationship between user needs, risk controls, and design inputs, arguing that risk controls should serve as parent requirements to design inputs to ensure traceability and effective risk management.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Ventura Solutions, HemoTek
Also
UL, ISO 14971

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