Episode
243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work
- Published
- Jun 24, 2026
- Duration seconds
- 878
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Summary
Chat with Subhi: https://calendly.com/letscombinate/let-s-combinate-intro-session Finished medical devices can create a lot of surprises when they are added to combination product kits. A needle, vial adapter, filter, or transfer device may already be sterile, cleared, qualified, and sold at massive scale. But already on the market does not automatically mean ready for your combination product. In this episode, I talk through the challenges of selecting finished medical devices for combination product kits and the three lifecycle moments that usually determine whether qualification goes smoothly or turns into a late-stage problem. We cover: * Why “already approved” does not mean combination-product ready * Why you inherit the supplier’s design, QMS, packaging, validation, change control, and outsourcing decisions * What to think about before supplier selection * How to set expectations during supplier selection * Why structured qualification matters * How PPAP concepts like process flow, PFMEA, control plans, inspections, sampling, and validation evidence can help The main point: A commercially available device may be qualified for someone else’s intended use. Your job is to determine whether it is qualified for yours. Chapters: 00:00 Device Selection Stakes 02:05 Common Supplier Myths 03:54 Inheriting the Device QMS 04:53 Three Crucial Moments 05:51 Before Selection: Intended Use 07:21 Packaging, Markets, and Risk Flags 08:55 During Selection: Set Expectations 10:33 Qualification: Use a Structured PPAP Approach 14:12 Wrap Up and Next Steps Subhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, supplier quality, and regulatory expectations across d…