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

Let's Combinate - Drugs + Devices

In this episode of Let's Combinate, host Subhi Saadeh welcomes back Skip Creveling, a global expert in program management and Six Sigma methodologies.

Skip shares his extensive experience helping Fortune 500 companies optimize design processes, reduce risks, and drive innovation—especially in highly regulated industries like medical devices, pharmaceuticals, and aerospace.

The discussion explores Skip’s career transition from Eastman Kodak to the medical device sector, the importance of structured program management, phase gate processes, and the balance between going fast and ensuring thorough planning.

Skip also delves into the differences between simple and complex projects and the necessity of having tailored project management templates for various project scales.

The episode concludes with insights into how to manage risks effectively through tools like project and portfolio FMEAs, and the importance of data-driven decision-making in project execution.

Timestamps:

00:00 – Introduction and Guest Welcome
00:19 – Skip's Background and Experience
01:10 – Transition to Medical Devices and Pharma
03:35 – Program and Project Management Insights
06:03 – Phases and Gates in Product Development
08:59 – Challenges and Strategies in Project Management
10:51 – Examples of Project Management in Action
13:28 – Importance of Planning and Risk Management
18:10 – Templates and Tools for Effective Project Management
29:49 – Final Thoughts and Contact Information

About the Host:
Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.

Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.

For questions, inquiries, or suggestions, please visit letscombinate.com or connect on the show's LinkedIn page.