Let's Combinate - Drugs + Devices

Subhi Saadeh
  • 5.0 (4)
  • Life Sciences

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!

  1. 2d ago

    251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy

    In this episode, Subhi Saadeh sits down with Steven Kaufman, Founder of Combination Product Solutions, Inc. and fractional Chief Commercial Officer at Portal Instruments, to discuss where the drug delivery device market is headed and what it takes for new technologies to actually make it to patients. Steven brings more than 21 years of experience across drug delivery and combination products, spanning strategy, business development, commercialization, consulting, and executive leadership. The conversation explores what makes a drug delivery device commercially successful in 2026, why pharma companies can be hesitant to adopt unproven technologies, and how device companies can differentiate in an increasingly crowded market. Steven also discusses the growth of larger-volume subcutaneous delivery, the tradeoffs between reusable and disposable devices, sustainability, primary container strategy, and the changing role of sales and business development in drug delivery. Subhi and Steven also dig into oral GLP-1s and whether oral drugs could ultimately displace injectables. Steven explains why route of administration alone does not determine the better solution — efficacy, patient adherence, cost, usability, and the overall treatment experience all matter. The episode closes with Steven looking ahead to 2035 and explaining why he believes sustainability will be one of the major forces shaping the next generation of drug delivery devices. Timestamps 00:00 Introduction and Steven’s Drug Delivery “Bookshelf” 02:24 From Marketing to Drug Delivery Strategy 06:10 What Makes a Device Commercially Successful in 2026? 11:11 Is the Large-Volume Injection Market Getting Crowded? 14:28 The Chicken-and-Egg Problem With New Device Technologies 19:25 CDAs, Proprietary Information and Working With New Suppliers 22:31 How Do You Sell a Drug Delivery Device in 2026? 29:17 Why Drug Delivery Is Still “Sexy” 31:20 Oral Drugs, Adherence and the Mucinex Horse Pill 33:18 Reusable Devices and Human Factors 35:22 Sustainability as a Drug Delivery Market Force 39:32 Cartridge vs. Prefilled Syringe 43:57 If You Had to Bet on One Drug Delivery Trend Through 2035 46:55 IV Drugs and the Shift Toward Subcutaneous Delivery 49:15 Steven’s Book Recommendation: Make Your Bed 51:22 Where to Find Steven Steven Kaufman Bio Steven Kaufman is the Founder of Combination Product Solutions, Inc. and a drug delivery and combination product executive with more than 21 years of industry experience. His career has spanned device strategy, commercialization, business development, consulting, executive leadership, and entrepreneurship. Steven has held senior roles across the drug delivery industry and today works with device companies, biotech and pharmaceutical organizations, and investors on commercialization, technology strategy, platform evaluation, and bringing new drug delivery technologies to market. Steven also serves as fractional Chief Commercial Officer at Portal Instruments. Connect with Steven Website: Combination Product Solutions Email: info@combinationproductsolutions.com LinkedIn: Steven Kaufman on LinkedIn Subhi Saadeh Bio Subhi Saadeh is a Quality Professional and host of Let’s Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large medical device and pharmaceutical organizations supporting the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics. For questions, inquiries, consulting, or episode suggestions: Website: Let’s Combinate LinkedIn: Subhi Saadeh on LinkedIn Email: subhi@letscombinate.com

  2. Aug 18

    I'm Changing The Podcast

    After 250 straight weeks of publishing Let’s Combinate every Wednesday, I’m making a change. Starting now, new episodes will go live Mondays at 5:00 AM CT. To everyone who watches, listens, shares, or has been part of the journey: thank you. This podcast has been one of the most enriching things I’ve ever done. See you Monday. 🌐 https://letscombinate.com 📅 https://calendly.com/letscombinate/let-s-combinate-intro-session 💼 https://www.linkedin.com/in/subhi-saadeh-1169aa21 About Subhi Saadeh Subhi Saadeh is a combination product quality and compliance professional, consultant, auditor, trainer, and host of Let’s Combinate: Drugs + Devices, where he explores the intersection of pharmaceutical and medical device quality.

  3. Aug 12

    250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

    PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualification and validation are approached today. In this video, I walk through where PI 006-4 fits within the broader GMP framework, how it relates to EU Annex 15, and the sections I think are most worth paying attention to. A few of the major themes include a much stronger emphasis on quality risk management and lifecycle thinking, more explicit expectations around statistics, sampling, variability, and process capability, a move away from treating three validation batches as a default answer, and clearer discussion of traditional validation, continuous process verification (CPV), hybrid approaches, and ongoing process verification (OPV). The goal isn't to suggest that all of these concepts are brand new. Many have been developing across the industry for years. What is interesting is seeing how PIC/S has now pulled them together into an updated recommendation that reflects current qualification and validation thinking. Chapters 00:00 Big Update Overview 01:02 Who PIC/S Serves 01:28 Annex 15 Relationship 02:12 Scope and Exclusions 02:39 Why Update Now 04:05 Four Key Changes 04:47 Risk and Lifecycle Shift 06:43 Statistics and Sampling 07:48 Rethinking the Three-Batch Rule 08:30 Ongoing Process Verification 09:11 Traditional, CPV and Hybrid Approaches 10:45 Key Takeaways About Subhi Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution. Connect With Let’s Combinate Website:https://www.letscombinate.com Schedule an intro call:https://calendly.com/letscombinate/let-s-combinate-intro-session LinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21 Apple Podcasts:https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792 Spotify:https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2 Documents Discussed PIC/S PI 006-4 — Recommendations on Qualification and Validation (2026)https://picscheme.org/docview/11277 PIC/S PI 006-3 — Validation Master Plan, IQ/OQ, Non-Sterile Process Validation & Cleaning Validation (2007)https://picscheme.org/docview/3447 EMA / PIC/S Concept Paper — Revision of Annex 15: Qualification and Validation (2026)https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation_en.pdf PIC/S Publications Pagehttps://picscheme.org/en/publications

  4. Aug 5

    249 - The Best Audit Advice Nobody Told Me

    Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may need to improve. In this video, I share the lessons I learned as I moved from being audited and supporting audit rooms to conducting audits as a certified lead auditor: 1) Audit the system, not the person: The goal is to understand how the system operates, not to catch an individual making a mistake. 2) Look for patterns, not isolated errors: One typo is different from a recurring or systemic problem, unless the individual event is critical. 3) Scope the audit before you start: The objective, criteria, time, resources, and agenda need to align before the audit begins. 4) Technical expertise is not the same as audit skill: Auditing requires its own tools, tactics, strategies, interviewing skills, and qualification. 5) Lower the temperature to get better evidence: People communicate more clearly when the auditor reduces unnecessary anxiety, although assertiveness is sometimes necessary when information is being withheld. Chapters 00:00 Audits Aren’t Gotchas 00:38 Audit the System, Not the Person 03:16 Look for Patterns, Not Isolated Mistakes 05:27 Set a Clear Audit Scope 08:21 Auditing Is Its Own Skill and Being Technical Helps 11:11 Lower the Temperature and Be a Human About Subhi Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical-device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution. Learn more: https://letscombinate.com/ subhi@letscombinate.com Connect with Subhi on LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21

  5. Jul 29

    248 - What Is a Quality Unit? QA vs. QC Explained

    What is a Quality Unit and how do Quality Assurance and Quality Control fit within it? In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, medical-device, and combination-product companies. We’ll look at the Quality Unit’s major responsibilities, why QA is generally system- and process-focused, why QC is generally testing- and product-focused, and why the organizational structure varies between companies. CHAPTERS 00:00 What is a Quality Unit? 01:18 The Quality Unit as the umbrella function 01:55 Three major Quality Unit responsibilities 03:08 What functions may sit within Quality 04:08 Establishing, operating, and releasing 04:37 Quality Assurance vs. Quality Control 05:38 Common QA responsibilities 06:16 Common QC responsibilities 06:53 Why pharma and device companies look different 07:32 Drug vs. device terminology 08:06 How QC supports product release 08:26 Final QA vs. QC summary KEY TAKEAWAYS • The Quality Unit provides overall quality oversight. • QA primarily focuses on systems and processes. • QC primarily focuses on inspection, measurement, and testing. • QC testing provides essential evidence supporting product disposition. • Exact responsibilities and reporting structures vary by company and industry. How are QA and QC organized at your company? Share your experience in the comments. #QualityAssurance #QualityControl #QualityUnit #Pharma #MedicalDevices #qualitymanagement Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution. Learn more about Let’s Combinate: https://www.letscombinate.com Schedule an introductory call: https://calendly.com/letscombinate/let-s-combinate-intro-session Connect with Subhi on LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21 Listen to Let’s Combinate on Apple Podcasts: https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792 Listen on Spotify: https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2

  6. Jul 22

    247 - Why Everyone in Pharma and MedTech Should Work in Quality

    Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of how regulated businesses actually operate. In this video, Subhi Saadeh explains three reasons everyone in the industry should consider spending time in quality: You learn how the business works. Quality follows the product across its lifecycle from development and suppliers through manufacturing, operations, regulatory changes, and post-market activities. You develop judgment. Quality professionals regularly make structured, risk-based decisions in gray areas and document those decisions so they can withstand audits, inspections, and future review. You learn to influence without owning everything. Quality is often accountable for outcomes without directly controlling every activity, which requires strong questions, clear communication, and the ability to help teams navigate competing priorities. Even if you do not spend your entire career in quality, the experience can make you a stronger decision-maker, collaborator, and leader throughout the rest of your career. 00:00 Why Quality Matters 00:35 Why Work in Quality 01:41 Reason One: Learn How the Business Works 02:47 Reason Two: Make Defensible Decisions 05:23 Reason Three: Influence Without Authority 07:43 Key Takeaways About Subhi Subhi Saadeh is a consultant, trainer, auditor, and the founder and principal of Let’s Combinate. He has spent his career across medical devices and pharmaceuticals, with experience spanning research and development, industrialization, quality systems, and combination products. Through Let’s Combinate, he helps professionals and organizations better understand the intersection of drugs, devices, quality, and regulatory requirements.

  7. Jul 15

    246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

    Most discussions about One QMS focus on harmonization. But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organizations structure a QMS. In this episode, I compare centralized, decentralized, and federated (hybrid) Quality Management System models, including the trade-offs of each in terms of ownership, standardization, flexibility, governance, and decision-making. We also walk through how the document hierarchy typically differs across each model—from the Quality Policy and Quality Manual to standards, SOPs, work instructions, and records—and discuss why governance often has a greater impact on success than the operating model itself. Timestamps 00:00 Why "One QMS" Is Trending 01:33 The Three Primary QMS Models 01:50 Centralized QMS 02:01 Decentralized QMS 02:28 Federated (Hybrid) QMS 03:50 Comparing the Document Hierarchy 04:14 Centralized Document Structure 05:04 Decentralized Document Structure 05:22 Federated Standards, SOPs, and Governance 06:50 The QMS Tree: Philosophy, Governance, and Execution 08:20 Why Governance Matters More Than the Model Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

  8. Jul 8

    245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

    In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and what it takes to build a drug-device combination product from a patient need. Julia was born with salt-wasting congenital adrenal hyperplasia, a life-threatening form of adrenal insufficiency. Because her body cannot make cortisol, she takes cortisol replacement daily and may need an emergency hydrocortisone injection during a crisis. The problem? The current emergency injection can take upto 14 steps to prepare, mix, and administer. Julia explains why the liquid and powder need to stay separate for stability, why the current process is so difficult during an emergency, and how Solution Medical is developing a proprietary dual-chamber primary container to simplify reconstitution while maintaining shelf life without refrigeration. We also discuss how the company evolved from a device idea into a drug-led 505(b)(2) NDA program, the development of a four-step prefilled syringe and two-step auto-injector, human factors testing with both patients and injection-naive users, manufacturing challenges in aseptic processing, supplier trust, regulatory strategy, and the broader platform potential for other mix-before-inject drugs. Chapters 00:00 Meet Julia Anthony 01:04 Living Without Cortisol 02:03 The 14-Step Injection 05:01 Building a Combination Product 07:54 From Device Concept to Pharma Company 10:06 Needles, Steps, and Testing 13:25 Patient Insights and Human Factors 16:58 Real-World Access Challenges 21:50 Why Not a Liquid Formulation? 24:15 Regulatory Pathway: 505(b)(2) 25:13 Manufacturing and Partner Trust 27:32 Rare Disease and Supplier Power 31:53 Platform Vision Beyond Adrenal Insufficiency 38:05 Reconstitution Is the Hard Part 41:12 COVID Tailwinds and Timeline 43:38 Where to Find Solution Medical 44:42 Final Thoughts on Cortisol About Subhi Subhi Saadeh is a consultant, trainer, and auditor focused on quality, regulatory, manufacturing, and supplier challenges for drugs, devices, and combination products. Through Let’s Combinate, Subhi helps companies navigate the messy intersection of pharmaceutical and medical device requirements through consulting, training, audits, and practical education. He also hosts Let’s Combinate: Drugs + Devices, where he speaks with leaders building, regulating, manufacturing, and improving combination products.

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5
out of 5
4 Ratings

About

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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