205 - Why Less Than 20% of Companies Have Started Quality 4.0
Nearly two-thirds of companies believe Quality 4.0 will transform their operations in the next five years yet fewer than 20% have started, and most haven’t even reached the planning stage. In this con...
11 Sep 202535min
204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle
In this episode of Let’s ComBinate: Drugs + Devices, we welcome back Susan Neadle, author of The Combination Products Handbook. Susan explores the persistent and evolving challenge of terminology in c...
3 Sep 202532min
203 - Drug Delivery, Platforms, IP Battles, Supply Chain Risks with Jim Collins
In this episode of Let’s Combinate, Subhi Saadeh sits down with Jim Collins, a leader in drug delivery with over 30 years of experience at Eli Lilly, Sanofi, and now as an advisor and board member. Ji...
27 Aug 202545min
202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin
In this episode of Let's Combinate, host Subhi Saadeh is joined by long-time friend and Senior Technical Program Manager Joey Frechin, who brings a wealth of experience in med tech consulting. They di...
20 Aug 202532min
201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0
In this episode of Let’s ComBinate, Subhi Saadeh sits down with Jeff Gensler, a quality and regulatory leader with 30+ years in MedTech, pharma, and combination products.Jeff takes us inside FDA warni...
13 Aug 202534min
200 - MedTech and Pharma After 200 Episodes…..
In this milestone episode, I reflect on what it’s taken to record, edit, and release 200 episodes focused on medical devices, pharma, and combination products.I share three hard-earned lessons not jus...
6 Aug 202517min
199 - How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall
In this episode of Let’s Combinate, host Subhi Saadeh is joined by Mark Burchnall, Director of Engineering at PSN Labs, to break down the evolving role of mechanical modeling and simulation in medical...
30 Juli 202542min
198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed
In this episode of Let's Combinate, host Subhi Saadeh highlights five critical aspects of the FDA's new Quality Management System Regulation (QMSR) that you may have missed. Subhi explains the histori...
23 Juli 202510min
