258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin

<p>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&#39;s clean audit doesn&#39;t match its performance, and how ISO 14971 risk management compares with ICH Q9.</p><p>This conversation was recorded for Ben Locwin&#39;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.</p><p>IN THIS EPISODE</p><p>- Why drugs and devices prove safety and effectiveness in different ways</p><p>- Drug development (clinical, nonclinical, CMC) vs. device design controls</p><p>- Why the same syringe can need new human factors work for a different user</p><p>- How human factors studies are built: patient and caregiver arms, trained and untrained users</p><p>- CGMPs for combination products: QMSR, ISO 13485, ICH, and PIC/S</p><p>- Global harmonization: IMDRF for devices, ICH for drugs, and the gap for combination products</p><p>- CDMO oversight when the supplier scorecard and the audit result don&#39;t match what you see</p><p>- ISO 14971 and ISO/TR 24971 vs. ICH Q9: initial and updated probability</p><p>- FMEA as a living document</p><p><br></p><p>TIMESTAMPS</p><p>0:00 Pharma vs. medical device quality: two philosophies</p><p>2:10 Drug development vs. device design controls</p><p>4:29 Why device trials rarely use placebo controls</p><p>9:52 Platform technology and delivery devices</p><p>12:10 Same device, different user: bracketing and generic platforms</p><p>14:14 Human factors studies: recruitment, study arms, formative studies</p><p>15:40 CGMPs for combination products: QMSR, ISO 13485, ICH, PIC/S</p><p>16:58 Harmonization: IMDRF and ICH</p><p>19:12 Conway&#39;s Law and organizational inertia</p><p>22:06 Staying objective as a consultant</p><p>25:10 CDMO oversight: when the scorecard doesn&#39;t match reality</p><p>30:18 Scoring bias in subjective weighting</p><p>31:14 ISO 14971 vs. ICH Q9 risk management</p><p>32:32 FMEA as a living document</p><p><br></p><p>RELATED VIDEOS</p><p><br></p><p>Pharma vs. Medical Device Quality Systems: 5 Differences</p><p>https://youtu.be/xG0htEu0ph4</p><p><br></p><p>Working with a Device CDMO: Common Sponsor Mistakes</p><p>https://youtu.be/d2SDwndXuCk</p><p><br></p><p>ICH Q9 Explained</p><p>https://youtu.be/Is67hbh71RY</p><p><br></p><p>Design Controls Explained for Pharma and Combination Produ