217 - 5 Fixable Problems Holding Back Drug–Device Programs

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh addresses five significant quality issues in the combination product space.

This episode provides practical insights and strategies for overcoming these common hurdles to enhance quality and efficiency in developing combination products.

00:00 Introduction and Host Background

00:43 Overview of Development Processes

01:51 Issue 1: Documentation Approach in Design Transfer

04:45 Issue 2: Early Input from Manufacturing and Assembly SMEs

07:26 Issue 3: Control Strategies and Sampling Plans

10:23 Issue 4: Method Transfer and Control Planning

12:02 Issue 5: Qualification of Supplied Components

14:47 Issue 6: Monitoring Expectations in Combination Products

16:55 Conclusion and Summary

Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks and host of the Let’s Combinate: Drugs + Devices podcast/Youtube Channel. With experience across Quality, Manufacturing Commercialization, Sustaining and R&D, Subhi has helped industrialize and launch drug delivery systems for biologics, vaccines, and generics at leading organizations such as Pfizer, Gilead, and Baxter. Subhi focuses on bridging the disconnect between drug and device development and specializes in harmonizing internal systems, aligning internal and external partners, and helping combination product teams move from siloed execution to scalable, compliant, and patient-ready solutions. He currently chairs the Rx-360 Combination Product Working Group and was the International WG Chair at the Combination Product Coalition. He has contributed to global harmonization efforts through BIO, ASTM, and AAMI. He is a certified ISO13485 Lead Auditor, CQA and CQE.

For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.