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