Hardware Podcasts

184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained

Let's Combinate · 16 Apr 2025 · 30m

What this episode covers

Skip Creveling, a global expert in program management and Six Sigma methodologies, discusses structured development processes for highly regulated industries like medical devices and pharma. He advocates for phase-gate systems and tailored project management templates to balance speed with rigor, contrasting disciplined planning with the inefficiencies of 'build-test-fix' approaches. Creveling explains the use of project and portfolio FMEAs to manage risk and the importance of Monte Carlo simulations for realistic scheduling in complex product development.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Eastman Kodak, Beckton Dickinson, Alumina, 3M
Also
Six Sigma, DFSS

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