Hardware Podcasts

152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh

Let's Combinate · 4 Sept 2024 · 40m

What this episode covers

Subhi Saadeh, host of the Combinate Podcast and International Committee Chair for the Combination Products Coalition, joins Etienne Nichols to discuss the complexities of combination products. They define single-entity, co-packaged, and cross-labeled products, and explain the regulatory frameworks involving the FDA's CDRH, CDER, and CBER. Saadeh emphasizes that the primary mode of action determines the lead review office and highlights the importance of understanding QMSR updates and sterilization methods like VHP. The conversation also covers Saadeh's approach to podcast production, his use of coaching for career and fitness, and his recommendation of books like 'Quality is Free' and 'Bottle of Lies'.

Most relevant to

early-stage companies

Topics

Mentioned

Also
Combinate Podcast, Global Medical Device Podcast, Combination Products Coalition, ASTM Committee E55, AAMI, FDA, CDRH, CDER, CBER, EMA, QMSR, VHP, ETO, Gamma, E-Beam, Quality is Free, Man's Search for Meaning, Bottle of Lies

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