Hardware Podcasts

166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success

Let's Combinate · 11 Dec 2024 · 20m

What this episode covers

Subhi Saadeh, who chairs the international working group of the Combination Products Coalition (CPC) and works in the CXO space, presents on three levels of harmonization for combination products: regulatory, sponsor-CXO, and internal drug-device alignment. He argues that while regulatory harmonization is critical, it is slow to implement, so companies should focus on operational harmony through standardized quality agreements and cross-functional collaboration. Saadeh highlights specific pain points such as misaligned definitions of combination products, inconsistent change notification processes between sponsors and contract manufacturers, and cultural silos between drug and device teams. He advocates for leveraging forums like RX360 and the CPC to drive standardization and trust.

Most relevant to

established companies

Topics

Mentioned

Companies
Combination Products Coalition
Also
MDSAP

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