If you’ve ever wondered what a combination product is—or how to explain it—this video breaks it down clearly and simply. This is a non-technical, high-level explanation of what a combination product is. It’s meant for anyone who works in or around pharma, medtech, or biotech and wants a clear, shareable reference—without getting into detailed regulatory definitions or region-specific nuances.I’m Subhi Saadeh, and I’ve spent my career in drug-device combination products. In this short reference video, I walk through:- What defines a combination product- Two key factors: primary mode of action and how components are combined- The difference between drug-led and device-led products- Examples of single-entity, co-packaged, and cross-labeled products
Timestamps
- 00:00 Introduction to Drug Device Combination Products
- 00:31 Defining Combination Products
- 00:54 Philosophical Factors of Combination Products
- 01:10 Drug-Led Combination Products
- 01:51 Device-Led Combination Products
- 02:32 Combination Configurations
- 03:50 Summary and Conclusion
Additional Resources: – 21 CFR Part 4 FDA regulation on Current Good Manufacturing Practice (CGMP) requirements for combination products ecfr.gov FDA Guidance: Current Good Manufacturing Practice Requirements for Combination Productsfda.gov FDA Combination Products Overview Page fda.gov 21 CFR Part 3 Regulations on combination product classification and primary mode of action (PMOA) ecfr.gov EU MDR Article 117 Requirements for drug-device combinations under the European Medical Device Regulation (Regulation (EU) 2017/745) health.ec.europa.eu
Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
