Hardware Podcasts

064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling

Let's Combinate · 21 Dec 2022 · 54m

What this episode covers

Skip Creveling, President of PDSS Inc., explains how Design for Six Sigma (DFSS) and Critical Parameter Management integrate into the product development lifecycle of pharma and medical device companies like Merck and Pfizer. He details the CDOV model (Concept, Design, Optimize, Verify), emphasizing the distinction between Necessary, Unique, and Difficult (NUD) parameters and Existing, Common, and Old (ECO) elements to manage risk and complexity. Creveling argues that focusing on NUDs early through robust design and stress testing prevents costly failures, while leveraging ECOS accelerates development. The discussion covers specific tools like the 'Big Seven' checks, robustness optimization, and the cultural shift from rushing to rigorous, data-backed decision-making in regulated industries.

Most relevant to

large enterprises

Topics

Mentioned

Companies
PDSS Inc., Merck, Pfizer, Eastman Kodak, Becton-Dickinson, 3M, Samsung SDI
Products
Gene Sequencer, Pre-filled Syringe

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