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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-04-16
- Length: 30m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-16-184-program-management-in-pharma-devices-phase-gates-risk-planning-and-project-f
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/184---Program-Management-in-Pharma--Devices-Phase-Gates--Risk-Planning--and-Project-FMEAs-Explained-e31f8m2

## Summary

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.

## Chapters

- [0:07](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-16-184-program-management-in-pharma-devices-phase-gates-risk-planning-and-project-f#t=7) Introduction and Guest Background
- [1:15](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-16-184-program-management-in-pharma-devices-phase-gates-risk-planning-and-project-f#t=75) Transition from Kodak to Medical Devices
- [6:03](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-16-184-program-management-in-pharma-devices-phase-gates-risk-planning-and-project-f#t=363) The Case for Phase Gates and Discipline
- [13:17](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-16-184-program-management-in-pharma-devices-phase-gates-risk-planning-and-project-f#t=797) Scaling Project Management to Project Size
- [19:51](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-16-184-program-management-in-pharma-devices-phase-gates-risk-planning-and-project-f#t=1191) Scheduling, Monte Carlo, and Designed Experiments
- [25:54](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-16-184-program-management-in-pharma-devices-phase-gates-risk-planning-and-project-f#t=1554) Project and Portfolio FMEAs

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

large enterprises

## Mentioned

- Eastman Kodak (company)
- Beckton Dickinson (company)
- Alumina (company)
- 3M (company)
- Six Sigma (other)
- DFSS (other)

## Related episodes from other shows

- [Project Management for Product Development of Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-27-project-management-for-product-development-of-medical-devices) (Global Medical Device Podcast)
- [#359: Project Management in MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-04-359-project-management-in-medtech) (Global Medical Device Podcast)
- [#434: ICYMI (In Case You Missed It!) Project Management In Medtech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-11-24-434-icymi-in-case-you-missed-it-project-management-in-medtech) (Global Medical Device Podcast)
- [269: Ultra-Precise Death Ray (Repeat)](https://hardwarepodcasts.com/podcast/embedded-fm/2021-07-02-269-ultra-precise-death-ray-repeat) (Embedded.fm)
- [Waterfall vs. Agile: Battle of the Product Development Methodologies](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies) (Global Medical Device Podcast)

## Citing this page

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