Hardware Podcasts

217 - 5 Fixable Problems Holding Back Drug–Device Programs

Let's Combinate · 10 Dec 2025 · 17m

What this episode covers

Subhi Saadeh, founder of Let’s Combinate BioWorks, outlines five critical quality issues in drug-device combination products, drawing on his experience at Pfizer, Gilead, and Baxter. He addresses documentation misalignment in design transfer, late manufacturing input, arbitrary sampling plans, unclear method transfer ownership, and supplier qualification gaps. Saadeh proposes solutions such as integrating pharma change controls with device design plans, embedding DFM/DFA reviews, and adopting PPAP frameworks for component qualification. The episode emphasizes harmonizing drug and device development processes to ensure scalable, compliant, and patient-ready solutions.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Let's Combinate BioWorks, Pfizer, Gilead, Baxter, FDA
Also
ICH Q8, ISO 13485, PPAP, DFM, DFA, Boothroyd Dewhurst, ISO 2859, Z1, AQL, CPV

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