Hardware Podcasts

136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura

Let's Combinate · 15 May 2024 · 39m

What this episode covers

Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek, discusses systems engineering challenges for combination products, emphasizing the importance of robust traceability between user needs, design inputs, and risk management files. He advises on managing legacy Design History Files (DHF) by using a configuration management approach to remediate only affected subsystems rather than entire documents, and highlights the specific regulatory complexities when applying off-the-shelf drug delivery systems to new biologic or small molecule products. Ventura also evaluates traceability tools like DOORS and Polarion, arguing that manual methods using Excel and Word can be efficient for simple devices if trace links are centralized to avoid duplication errors.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Ventura Solutions, HemoTek, Baxter Healthcare
Tools
DOORS, Polarion, Excel, Word

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