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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-12-21
- Length: 54m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/064---Pharma-and-Medical-Device-Development-Processes--DFSS-and-Design-Reviews-with-Skip-Creveling-e1sfus6

## Summary

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.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with#t=1) Introduction: Skip Creveling and PDSS Inc.
- [1:52](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with#t=112) Medical Device History and Phase-Gate Processes
- [4:38](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with#t=278) Comparing Kodak to Pharma/MedTech Disciplines
- [9:44](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with#t=584) Integrating DFSS into Modernized Risk-Based Processes
- [13:34](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with#t=814) Front-End Voice of the Customer and NUDs vs. ECOS
- [20:34](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with#t=1234) The Big Seven: Measurability, Robustness, and Capability
- [24:59](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with#t=1499) The CDOV Model: Concept, Design, Optimize, Verify
- [38:36](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with#t=2316) Stress Testing, Robustness, and Production Scale-Up
- [50:17](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with#t=3017) Three Levels of Reviews: Peer, Design, and Gate

## Topics

- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

large enterprises

## Mentioned

- PDSS Inc. (company)
- Merck (company)
- Pfizer (company)
- Eastman Kodak (company)
- Becton-Dickinson (company)
- 3M (company)
- Samsung SDI (company)
- Gene Sequencer (product)
- Pre-filled Syringe (product)

## Related episodes from other shows

- [#382: Design of Experiments - How and When to Use DOE](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-12-382-design-of-experiments-how-and-when-to-use-doe) (Global Medical Device Podcast)
- [#461: Why Manufacturing is Part of Product Development with Mike Dolphin](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-22-461-why-manufacturing-is-part-of-product-development-with-mike-dolphin) (Global Medical Device Podcast)
- [S2E34 How Process Engineering Will Make You An Invaluable Engineer | Zach O’Ferrell](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-08-06-s2e34-how-process-engineering-will-make-you-an-invaluable-engineer-zach-oferrell) (Being an Engineer)
- [S2 E6: Complex System Development with Kristine Barnes](https://hardwarepodcasts.com/podcast/the-builder-circle/2024-02-06-s2-e6-complex-system-development-with-kristine-barnes) (The Builder Circle)
- [S7E19 Ryan Schoonmaker | How to Take A Structured Approach to Solving Engineering Problems](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-05-01-s7e19-ryan-schoonmaker-how-to-take-a-structured-approach-to-solving-engineering) (Being an Engineer)

## Citing this page

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