Hardware Podcasts

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

Let's Combinate · 7 May 2025 · 16m

What this episode covers

Subhi Saadeh, host of Let's Combinate and Quality Professional, explains the distinct regulatory frameworks of Quality by Design (QbD) and Design Controls for drug-device combination products. She contrasts QbD's focus on manufacturing process control (ICH Q8, CQAs, Design Space) with Design Controls' focus on validating the final product against user needs (21 CFR 820.30, DHF, V&V). Saadeh argues that because drugs achieve therapeutic effects chemically while devices solve physical problems through engineering, these frameworks are not interchangeable but both are essential for safe combination products.

Most relevant to

early-stage companies

Topics

Mentioned

Also
Let's Combinate, ICH Q8, 21 CFR 820.30, ISO 14971, ICH Q9, ICH Q12, Marta New

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