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Let's Combinate - Drugs + DevicesAuthor: Subhi Saadeh
Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating! Language: en Genres: Life Sciences, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin
Sunday, 11 October, 2026
Combination product quality with Ben Locwin: why drug and device quality systems differ, how human factors studies are designed, what to do when a CDMO's clean audit doesn't match its performance, and how ISO 14971 risk management compares with ICH Q9.This conversation was recorded for Ben Locwin's Life Science Shifts podcast from Reliant Life Sciences, with Subhi Saadeh as the guest. It covers where pharma and medical device thinking diverge, and what that means when one product has to satisfy both.IN THIS EPISODE- Why drugs and devices prove safety and effectiveness in different ways- Drug development (clinical, nonclinical, CMC) vs. device design controls- Why the same syringe can need new human factors work for a different user- How human factors studies are built: patient and caregiver arms, trained and untrained users- CGMPs for combination products: QMSR, ISO 13485, ICH, and PIC/S- Global harmonization: IMDRF for devices, ICH for drugs, and the gap for combination products- CDMO oversight when the supplier scorecard and the audit result don't match what you see- ISO 14971 and ISO/TR 24971 vs. ICH Q9: initial and updated probability- FMEA as a living documentTIMESTAMPS0:00 Pharma vs. medical device quality: two philosophies2:10 Drug development vs. device design controls4:29 Why device trials rarely use placebo controls9:52 Platform technology and delivery devices12:10 Same device, different user: bracketing and generic platforms14:14 Human factors studies: recruitment, study arms, formative studies15:40 CGMPs for combination products: QMSR, ISO 13485, ICH, PIC/S16:58 Harmonization: IMDRF and ICH19:12 Conway's Law and organizational inertia22:06 Staying objective as a consultant25:10 CDMO oversight: when the scorecard doesn't match reality30:18 Scoring bias in subjective weighting31:14 ISO 14971 vs. ICH Q9 risk management32:32 FMEA as a living documentRELATED VIDEOSPharma vs. Medical Device Quality Systems: 5 Differenceshttps://youtu.be/xG0htEu0ph4Working with a Device CDMO: Common Sponsor Mistakeshttps://youtu.be/d2SDwndXuCkICH Q9 Explainedhttps://youtu.be/Is67hbh71RYDesign Controls Explained for Pharma and Combination Product Teamshttps://youtu.be/f7esiLpUhfMNeed help with CDMO oversight, supplier audits, or risk management on a combination product?https://letscombinate.com/services/ABOUT BEN LOCWINBen Locwin is Vice President at Reliant Life Sciences and host of the Life Science Shifts podcast. His work spans drug therapies, vaccines, and medical devices, and he is a frequent industry speaker and commentator on pharma and medical device quality.Reliant Life Sciences:https://www.reliantlifesciences.com/ABOUT SUBHI SAADEHSubhi Saadeh is the Founder and Principal of Let's Combinate, a consultant, auditor, and trainer specializing in drug-device combination products, medical devices, and pharmaceutical quality systems. He has held quality and engineering roles at Pfizer, Gilead, and Baxter, with experience spanning quality, R&D, and commercialization and a focus on design controls, supplier quality, inspection readiness, and translating regulatory expectations into practical execution.Subhi is an ISO 13485 Lead Auditor and an ASQ Certified Quality Auditor and Certified Quality Engineer. He has chaired the Combination Product Working Group for Rx-360, served as International Committee Chair for the Combination Products Coalition (CPC) and as a member of ASTM Committee E55, and served on AAMI's Combination Products Committee.CONNECT WITH SUBHIConsulting, audits, and training:https://letscombinate.com/services/Discuss a project:https://calendly.com/letscombinate/quick-chatLinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21/Email:subhi@letscombinate.comFOLLOW LET'S COMBINATEYouTube:https://www.youtube.com/@LetsCombinateSpotify:https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2#CombinationProducts #HumanFactors #RiskManagement
