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Let's Combinate - Drugs + Devices: Daily Summaries Delivered
by 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!
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- 4 days ago29 min
262 - Pharma Outsourcing in 2026: CDMO Capacity, Trust & AI | Raman Sehgal
Pharma outsourcing, CDMO selection, and contract manufacturing are changing as biotech funding, manufacturing capacity, and sponsor expectations shift. Raman Sehgal joins Subhi Saadeh to discuss the CDMO market in 2026, what makes a reliable manufacturing partner, and how AI in drug discovery could shape demand for outsourced development and manufacturing.Recorded at CDMO Live Americas, this conversation examines what happens when a supplier’s capabilities look right on paper, but the experience of working with them falls short. Raman shares his perspective on how the industry grew, why some biotech clients feel overlooked by large CDMOs, and where smaller providers have an opportunity to compete.We discuss:• How pharma outsourcing evolved from transactional manufacturing to strategic partnerships • What site visits, employee enthusiasm, and company culture reveal about a supplier • Why customer experience matters from the first RFP through batch delivery • How biotech funding and post-COVID changes affected CDMO demand • Differences in capacity across oral solid dose and sterile fill-finish manufacturing • Risk-sharing, pricing models, and aligned incentives between sponsors and CDMOs • How GLP-1s and peptides created opportunities for some manufacturers • AI-driven drug discovery, preclinical research, and the lag before new molecules reach manufacturing • Why Raman recommends starting AI adoption with business processes ABOUT RAMAN SEHGAL Raman Sehgal is the founder of ramarketing and host of the Molecule to Market podcast. He also co-founded Lead Candidate, a talent acquisition business serving the pharmaceutical outsourcing sector. He brings more than two decades of experience working with CDMOs and pharmaceutical service providers.ABOUT SUBHI SAADEH Subhi Saadeh is a combination product quality consultant, founder of Combinate, and host of Let’s Combinate. His experience spans pharmaceutical and medical device quality, supplier and contract manufacturer oversight, audits, and quality systems. He helps pharma companies solve device problems and device companies solve pharma problems.Find Raman on LinkedIn and listen to Molecule to Market. Subscribe to Let’s Combinate for conversations on combination products, drug delivery, pharmaceutical manufacturing, and quality.Thank you to the CDMO Live Americas team for making this conversation possible.
- 1 weeks ago37 min
261 - Getting Pharma/Device Products Into Clinical Trials: INDs, IDEs & FDA Meetings
Getting pharma, medical device, and drug-device combination products into clinical trials takes a clear strategy for INDs, IDEs, FDA meetings, and first-in-human studies. Dr. Robert Bilkovski joins Subhi Saadeh to discuss clinical development, pre-IND meetings, Q-Submissions, clinical trial design, site selection, and sponsor oversight.What should you have figured out before meeting with FDA? How does the clinical strategy change when you pair an existing drug with a new delivery device? And what happens between preparing a submission and enrolling the first patient?IN THIS EPISODE The chief medical officer’s role in clinical development, safety, and medical affairs• Clinical strategy for drugs, medical devices, and combination products• Bridging an existing drug to a new delivery device• INDs, IDEs, and preparing for first-in-human studies• Bringing focused questions and a proposed strategy to FDA meetings• Using early studies to inform endpoints, sample sizes, and labeling• Selecting, qualifying, and activating clinical trial sites• Sponsor oversight and considerations for studies outside the United States ABOUT DR. ROBERT BILKOVSKIContact Robert: http://www.RNBVenturesConsulting.com/podcastDr. Robert Bilkovski is an emergency physician whose industry experience includes Hospira, GE Healthcare, and Abbott Molecular. He advises companies on clinical development as a fractional chief medical officer and is the author of Make Your Story Believable: Diagnosing the Pitfalls of Healthcare Innovation.ABOUT SUBHI SAADEHSubhi Saadeh is the founder of Combinate and host of Let’s Combinate, helping pharmaceutical and medical device companies solve the quality challenges where drugs and devices meet. His career spans engineering and quality roles at Baxter, Pfizer, and Gilead, supporting drug delivery systems and combination products from development and clinical use through launch and commercial manufacturing.His experience includes prefilled syringes, autoinjectors, infusion devices, and a frozen prefilled syringe platform supplying more than 100 million units annually. He has chaired industry working groups through the Combination Products Coalition and Rx-360, contributed to AAMI’s combination product work, and co-created the CQA Master Class. Subhi is an ASQ Certified Quality Auditor and Certified Quality Engineer, an ISO 13485 Lead Auditor, and a bioengineering graduate of the University of Illinois Chicago.WORK WITH SUBHIConsulting, audits, and training:https://letscombinate.com/services/Discuss your project:https://calendly.com/letscombinate/quick-chatLinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21/Email: subhi@letscombinate.comRESOURCESFree guide: Drug vs. Device Qualityhttps://letscombinate.kit.com/216fbfc6c2CQA Master Class:https://cqeacademy.teachable.com/p/the-cqa-master-class-courseFOLLOW LET’S COMBINATEYouTube:https://www.youtube.com/@LetsCombinateSpotify:https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2Apple Podcasts:https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792#ClinicalTrials #CombinationProducts #FDA
- 2 weeks ago19 min
267 - What Pharma Wants from CDMOs: Quality, Pricing & Trust | Kaan Kekec
What pharma companies want from CDMOs, and how closely that matches what CDMOs think matters. Recorded at CDMO Live Americas with Kaan Kekec, Partner at Simon-Kucher, on the CDMO Growth Report 2026: why quality ranked first for sponsors while CDMOs emphasized speed, how to validate a value proposition, and pricing challenges for drug delivery devices.Drawing on research conducted with PharmaSource, Kaan explains the gap between sponsor expectations and supplier perceptions. We discuss why quality needs to be demonstrated throughout a partnership, how companies can validate their value proposition, and what drug delivery device suppliers miss when they don't understand the markets their products ultimately serve.IN THIS EPISODE- Why quality ranked first for sponsors while CDMOs placed more weight on speed- Why your value proposition needs to reflect what customers recognize and value- How customer interviews and competitor comparisons reveal blind spots- Why large pharma and small biotech need different conversations- How access to technical experts can influence customer experience and win rates- Pricing challenges for drug delivery devices across regions and end markets- Integrated device manufacturing, fill-finish, and assembly- Why certifications alone don't tell the whole quality story- How clearer expectations can improve sponsor-CDMO partnershipsABOUT KAAN KEKECKaan-Fabian Kekec is a Partner at Simon-Kucher with 15 years of consulting experience helping pharma services and drug delivery companies improve their commercial strategy, pricing, and customer value proposition.Kaan on LinkedIn:https://www.linkedin.com/in/kaan-fabian-kekec-3b799632/CDMO Growth Report 2026 (Simon-Kucher, with PharmaSource):https://www.simon-kucher.com/en/insights/cdmo-growth-report-2026Thank you to Luke and the CDMO Live team for the opportunity to record this conversation in person.https://pharmasource.global/events/cdmo-live-americas/RELATED VIDEOSWorking with a Device CDMO: Common Sponsor Mistakeshttps://youtu.be/d2SDwndXuCkWhat Is a Quality Agreement? Pharma, Medical Device, and CDMO Responsibilitieshttps://youtu.be/ocohmInoHkECo-Packaged Combination Product Kits: How to Qualify a Finished Device and Its Supplierhttps://youtu.be/BEoEr4ljEo4Need help with CDMO oversight, quality agreements, or supplier audits on a combination product?https://letscombinate.com/services/Free guide: Drug vs. Device Quality comparisonhttps://letscombinate.kit.com/216fbfc6c2ABOUT 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 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/71wYadhCrfLsdYTVachpD2Apple Podcasts:https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792#CDMO #PharmaOutsourcing #CombinationProducts
- 3 weeks ago5 min
259 - The Career Lesson I Learned the Hard Way in Pharma
Career growth in pharma and medical devices takes technical knowledge, leadership, and the ability to earn your team’s trust. In this episode, Subhi Saadeh shares a lesson from leading a drug-device combination product program that changed how he approached his career in quality.Early in my career, I was excited about getting on big projects, gaining exposure, and proving what I could do. But leading a team with deeper technical expertise than I had taught me something I had to learn the hard way: it’s not about you.I share how asking questions, following through, and helping people address their problems helped me earn their respect and become a more effective lead.In this episode:- Understanding what your team and stakeholders need from you- Leading technical experts while building your own experience- Being coachable and following through on what you learn- Applying customer focus beyond the quality system- Building credibility by helping others move their work forward- What a mentor meant by “their cookie, your crumb”Chapters:00:00 The career lesson: It’s not about you00:25 Career exposure and proving yourself00:53 Why people value having you around01:17 Customer focus in quality and leadership02:03 Leading a complex combination product program03:25 Feeling out of your depth03:42 Understanding what your team needs04:02 Being coachable and earning credibility05:07 Rethinking career growth and success06:10 “Their cookie, your crumb”About Subhi:Subhi Saadeh is a Quality Professional, Founder & Principal of Combinate, and host of Let’s Combinate: Drugs + Devices. With a background in Quality, Manufacturing Operations, and R&D, he has works with medical device and pharmaceutical organizations supporting the development and launch of combination products for vaccines, generics, and biologics.Subhi served as the International Committee Chair for the Combination Products Coalition (CPC) and was a member of ASTM Committee E55. He previously served on AAMI’s Combination Products Committee. He is an ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), and ISO 13485 Lead Auditor.Connect and learn more:Website: [letscombinate.com](https://letscombinate.com)LinkedIn: [Subhi Saadeh](https://www.linkedin.com/in/subhi-saadeh-1169aa21/)Email: subhi@letscombinate.comCQA Master Class: [Become a Certified Quality Auditor](https://cqeacademy.teachable.com/p/the-cqa-master-class-course)Watch and listen:[YouTube](https://www.youtube.com/@LetsCombinate)[Spotify](https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2)[Apple Podcasts](https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792)Subscribe for weekly conversations where drugs and devices meet.For questions, inquiries, or suggestions, please reach out at letscombinate.com or email subhi@letscombinate.com.
- Oct 12, 202634 min
258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin
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
- Oct 5, 202612 min
257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products
21 CFR Part 4 sets the CGMP requirements for combination products. If your product has a drug and a device in it, you're on the hook for both sets of regulations. In this video, I walk through Part 4 Subpart A section by section: the scope, the key definitions, which CGMPs apply, and the two ways to comply, including the streamlined approach under 4.4(b).Updated for February 2026, when the device side moved to the QMSR and ISO 13485, plus the new medical gas provisions.Working on your first combination product program? Watch this next: https://youtu.be/uG_Ea__-PjcWant a second set of eyes on your combination product quality system? Book a quick call: https://calendly.com/letscombinate/quick-chatSources21 CFR Part 4 (eCFR): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4FDA Guidance, CGMP Requirements for Combination Products: https://www.fda.gov/media/90425/downloadChapters0:00 Intro0:50 21 CFR Part 4 Subpart A vs. Subpart B2:00 Full compliance vs. the streamlined approach2:39 21 CFR 4.1: Scope (single-entity and co-packaged)3:52 21 CFR 4.2 and 4.3: Definitions and which CGMPs apply4:37 21 CFR 4.4: How to comply with CGMPs for combination products5:38 Drug-based system: ISO 13485 and QMSR provisions to add7:58 Device-based system: 21 CFR 211 provisions to add11:24 Medical gas and 4.4(c)–(e): separate facilities12:10 Wrap-upAbout meI'm Subhi Saadeh. I help companies make drug and device quality systems work together. I'm a consultant, auditor, and trainer focused on combination products, an ISO 13485 Lead Auditor, and an ASQ CQA and CQE. I've worked on prefilled syringes, autoinjectors, IV bags, cartridges, and vial-based systems, from clinical through commercial.🌐 https://letscombinate.com📅 https://calendly.com/letscombinate/quick-chat💼 https://www.linkedin.com/in/subhi-saadeh-1169aa21✉️ subhi@letscombinate.com#CombinationProducts #21CFRPart4 #QMSR
- Sep 28, 20269 min
256 - The New FDA Inspection Playbook: Where to Start with QMSR
QMSR became effective on February 2, 2026. Alongside that change, FDA retired the Quality System Inspection Technique (QSIT) and began using the inspection process described in Compliance Program 7382.850.What does that mean for industry and how should we use the new program to prepare?In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh introduces a four-part series on QMSR inspection readiness. We compare QSIT’s four major inspection subsystems with the new program’s six QMS areas, explore how risk informs inspection coverage, and identify where industry should start reading.The episode also features an excerpt from Subhi’s conversation with Eric Pittman, a former FDA investigator who spent a decade as editor-in-chief of FDA’s Investigations Operations Manual.IN THIS EPISODE• What replaced QSIT and where to find it• Why Part III is a useful starting point for industry• How FDA reorganized inspection coverage into six QMS areas• How product risks and risk management documentation help guide record selection• What’s coming in the QMSR inspection readiness seriesTIMESTAMPS00:00 QSIT is gone: What changed with QMSR00:50 The new FDA inspection program01:39 The four-part inspection readiness series02:47 Eric Pittman: Where industry should start04:14 Will FDA publish a new QSIT guide?05:06 Comparing the old and new inspection approaches05:47 Four major subsystems to six QMS areas06:57 Inspection models and record selection07:37 Risk, controls, and inspection evidence08:08 What’s next in the seriesTHE SERIES1. QSIT to QMSR: Understanding the new inspection program2. Inspection models, coverage, and record selection3. The six QMS areas and how they connect4. Inspection readiness: Preparing people, processes, and records, with lessons from early QMSR warning lettersRESOURCESFDA Compliance Program 7382.850 — Inspection of Medical Device ManufacturersPart III begins on page 20. Attachment A details the QMS areas, elements, and requirements.https://www.fda.gov/media/80195/downloadFDA Investigations Operations Manual — Chapter 5https://www.fda.gov/media/166533/downloadFDA QMSR Frequently Asked Questionshttps://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questionsABOUT 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. His experience spans quality, R&D, and commercialization, with 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.CONNECT WITH SUBHIConsulting, audits, and training:https://letscombinate.comLinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21/Schedule a quick chat:https://calendly.com/letscombinate/quick-chatEmail:subhi@letscombinate.comFOLLOW LET’S COMBINATEYouTube:https://www.youtube.com/@LetsCombinateSpotify:https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2Apple Podcasts:https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792
- Sep 21, 202611 min
255 - Audit Interview Techniques: How Good Auditors Get Better Evidence
A huge part of the job is knowing how to interview people, understand how work is actually performed, and corroborate what you hear against records, observations, and other objective evidence.In this episode, I pulled one of the lessons from the auditing course Andy Robertson and I developed and walk through some of the fundamentals of audit interviewing: building rapport, asking open-ended questions, avoiding overly checklist-driven interviews, corroborating information, managing group interviews and translators, and handling some of the situations that make interviews difficult.If documents and records alone were enough to understand the quality of an organization, every audit could be a desktop audit. People are a huge part of what makes an audit work.Full CQA Master Class:https://cqeacademy.teachable.com/p/the-cqa-master-class-courseChapters0:00 Intro1:39 Interviewing Fundamentals3:04 Conversational vs. Checklist3:49 Building Rapport4:29 Focus on the Process5:30 Open-Ended Questions5:58 Corroborating Information6:44 Group Interviews7:29 Using Translators8:20 Interview Challenges10:29 Time Management11:16 ClosingAbout SubhiSubhi Saadeh is the Founder and Principal of Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across pharma, biotech, medical devices, and combination products.Learn more about Let’s Combinate:https://letscombinate.com/Connect with Subhi on LinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21Need help?https://calendly.com/letscombinate/let-s-combinate-intro-session#Quality #Auditing #QualityAssurance #CQA #Pharma #MedicalDevices #CombinationProducts
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About Let's Combinate - Drugs + Devices
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!
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