Hardware Podcasts

190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong

Let's Combinate · 28 May 2025 · 15m

What this episode covers

Subhi Saadeh, Quality Professional and host of Let's Combinate, explains that drug-device combination products fail due to a lack of harmony across three levels: global regulatory alignment, sponsor-CXO collaboration, and internal cross-functional teamwork. He argues that while the market for products like autoinjectors and inhalers is projected to reach $181 billion by 2030, fragmented regulations and siloed teams delay patient access. Saadeh advocates for shifting from a 'license to operate' compliance mindset to a 'license to collaborate' culture, emphasizing that drug and device teams must align on shared blueprints and incentives rather than trying to make the distinct entities identical.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Amgen
Also
CPHI, FDA, EMA, Combination Products Coalition, ASTM Committee E55, AAMI, IMDRF, ICH, ISO 13485, ICHQ10, 21 CFR part 4, ICHQ 12, ICHQ6, QBD

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