187 - Why Drug And Device Development Use Different Playbooks (QbD Vs. Design Controls Explained) Let's Combinate

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187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)

1d ago 16:26

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What’s the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?

In this episode of Let’s Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical device design.

Learn how these two approaches tackle product realization, why they're not interchangeable, and how both are essential when building safe, effective, and compliant combination products.

Whether you work in drug development, medical devices, or the space in between, this episode will help you:

-Understand the regulatory foundations of QbD (ICH Q8) and design controls (FDA 21 CFR 820.30)

-Learn the core tools and deliverables (like CQAs, QTPP, design verification & validation, and risk assessments)

-See how each system addresses user needs, therapeutic effects, and process control

-Apply both systems effectively in combination product developmentTimestamps:

00:00 – Intro: Why Compare QbD and Design Controls?

01:31 – Philosophical Differences: Process vs. Product Control

03:10 – Practical Examples: Drugs vs. Devices

05:13 – Origins and Frameworks: ICH Q8 and Design Controls Regulation

06:46 – Deep Dive: What Are Design Controls? (Inputs, Outputs, DHF, V&V, Transfer)

11:51 – What Is Quality by Design (QbD)? (QTPP, CQAs, Design Space, DOE)

15:39 – Final Takeaways: How to Use Both in Combination Products

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.

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ICH Q8, Q9, Q10, and Q12ISO 14971 Risk ManagementDifferences between usability engineering and clinical trialsThe role of control strategies and process monitoring in pharmaRelevant for:Regulatory affairs professionalsQuality engineers in pharma and medtechDrug/device development teamsAnyone preparing for combination product submissions or audits

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