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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 series TIMESTAMPS 00:00 QSIT is gone: What changed with QMSR 00:50 The new FDA inspection program 01:39 The four-part inspection readiness series 02:47 Eric Pittman: Where industry should start 04:14 Will FDA publish a new QSIT guide? 05:06 Comparing the old and new inspection approaches 05:47 Four major subsystems to six QMS areas 06:57 Inspection models and record selection 07:37 Risk, controls, and inspection evidence 08:08 What’s next in the series THE SERIES 1. QSIT to QMSR: Understanding the new inspection program 2. Inspection models, coverage, and record selection 3. The six QMS areas and how they connect 4. Inspection readiness: Preparing people, processes, and records, with lessons from early QMSR warning letters RESOURCES FDA Compliance Program 7382.850 — Inspection of Medical Device Manufacturers Part III begins on page 20. Attachment A details the QMS areas, elements, and requirements. https://www.fda.gov/media/80195/download FDA Investigations Operations Manual — Chapter 5 https://www.fda.gov/media/166533/download FDA QMSR Frequently Asked Questions https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions ABOUT SUBHI SAADEH Subhi 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 SUBHI Consulting, audits, and training: https://letscombinate.com LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/ Schedule a quick chat: https://calendly.com/letscombinate/quick-chat Email: [email protected] FOLLOW LET’S COMBINATE 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

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

Quality has a reputation for saying no. Sometimes that’s exactly the right call. Other times, “no” is just the easiest answer. In this episode, Subhi breaks down four situations where Quality should absolutely stop the train, and a few where it’s worth stepping back and asking what’s really driving the no in the first place. Subhi covers: when there is real patient or product risk when the evidence doesn’t support the decision when moving forward would clearly violate requirements or SOPs when schedule or business pressure is pushing a team to close something that isn’t actually closed He also talks through some weaker reasons Quality says no, including: personal preference or “this is how we’ve always done it” uncertainty from lack of technical familiarity applying more GMP rigor than the stage of development actually requires If you work in quality, combination products, development, manufacturing, or technical leadership, this is a practical look at how to think about “no” in a more risk-based way. Timestamps 00:00 Why Quality Says No 00:45 Channel Intro and Setup 02:02 No When Risk Is Real 03:06 No When Evidence Fails 05:02 No When Requirements Break 05:44 No to Schedule Pressure 07:48 Bad No From Preference 08:33 Bad No From Uncertainty 09:20 Overkill and Phase GMPs 10:08 Build Flexible Quality Culture 12:16 Wrap Up and Takeaways 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 and navigate the intersection of drugs, devices, quality, and regulatory requirements. Connect with Subhi Saadeh LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/ Website: http://letscombinate.com/ Book a quick chat: https://calendly.com/letscombinate/quick-chat Email: [email protected] Listen / Follow Let’s Combinate 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 #Quality #CombinationProducts #Pharma #MedTech #RiskManagement #GMP #DesignControls #SupplierQuality #QualitySystems #LetsCombinate

FDA is changing how it organizes and deploys its investigators but it isn’t simply returning to the old generalist model. Eric Pittman spent more than 20 years at FDA, conducted approximately 800+ inspections, led the Bioresearch Monitoring Division West, and served for a decade as editor-in-chief of FDA’s Investigations Operations Manual. In this episode, Eric explains how FDA investigators are trained to think, the difference between technical expertise and inspection skill, why investigators sometimes “phone home,” and what the transition from ORA to OII means for the agency’s inspection model. We also discuss BIMO inspections, the difference between inspections and investigations, the end of QSIT, and how companies can use FDA’s Investigations Operations Manual and compliance programs to prepare more effectively. Timestamps 00:00 Introduction00:48 FDA’s generalist and specialist inspection models03:52 What is Bioresearch Monitoring (BIMO)?05:03 What makes someone an effective FDA investigator?08:39 Technical expertise versus auditing and inspection skills11:25 What FDA investigators are actually looking for14:07 Eric’s experience conducting 800–1,000 inspections15:11 How investigators prepare, inspect, and write reports19:44 Why FDA investigators sometimes “phone home”23:35 The transition from ORA to OII28:00 What responsibilities remain within OII?30:31 FDA inspections versus investigations33:05 The IOM, QSIT, and investigator discretion38:25 How industry should use FDA compliance programs44:13 What companies waste time preparing for45:55 Where to find Eric About Eric Pittman Eric Pittman is Vice President of Quality Assurance and Regulatory Affairs at Project Farma. Before moving into industry, he spent more than 20 years at FDA across drugs, devices, foods, biologics, and bioresearch monitoring. He served as Division Director for Bioresearch Monitoring West, was the U.S. delegate to the OECD Working Party on Good Laboratory Practice, and spent a decade as editor-in-chief of FDA’s Investigations Operations Manual. Eric is also an adjunct professor in Temple University’s QA/RA graduate program. Connect with Eric LinkedIn: https://www.linkedin.com/in/ericspittmanmba-fdaProject Farma: https://projectfarma.com About Subhi Saadeh Subhi Saadeh is a combination-product quality professional, consultant, and host of Let’s Combinate: Drugs + Devices. His work focuses on the intersection of pharmaceutical and medical-device requirements, including combination-product quality systems, design controls, supplier quality, manufacturing, inspection readiness, and regulatory strategy. Through Let’s Combinate, Subhi brings together regulators, industry leaders, and technical experts to make complex drug-device topics easier to understand and apply. Connect with Subhi LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/YouTube: https://www.youtube.com/@LetsCombinateWebsite: https://letscombinate.com

Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality. In this video, I break down the fundamentals of acceptance sampling: what it is, what an AQL actually means, the difference between sampling by attributes and variables, and the risk involved when we use a sample to make an accept/reject decision about an entire lot. We’ll also introduce Operating Characteristic (OC) curves, producer risk, and consumer risk — because acceptance sampling is probability-based and every sampling plan comes with tradeoffs. This is the first video in a series on acceptance sampling. Future videos will go deeper into attribute sampling, variable sampling, and how to select and apply sampling plans in practice. Topics Covered: * What acceptance sampling is * Why acceptance sampling is probability-based * AQL — Acceptance Quality Limit * Why AQL does not simply mean “allowable percent defective” * Attribute vs. variable acceptance sampling * ISO 2859-1 / ANSI-ASQ Z1.4 * ISO 3951 / ANSI-ASQ Z1.9 * Operating Characteristic (OC) curves * Producer risk vs. consumer risk * How overly tight or overly loose sampling plans can create problems Chapters 00:00 Introduction 01:30 Why Acceptance Sampling Matters 01:45 Perfect World vs. Reality 02:49 What Is Acceptance Sampling? 03:53 Attributes vs. Variables 05:21 What Is AQL? 07:05 Risk & the OC Curve 09:57 Producer & Consumer Risk 12:05 Practical Takeaway About Subhi Saadeh Subhi Saadeh is the Founder and Principal of Let’s Combinate, an independent media, education, and consulting company focused on drug device combination products, quality systems, and quality engineering. Subhi is a consultant, trainer, and auditor with a background spanning R&D, industrialization, commercialization, and quality across the pharmaceutical and medical device industries. He is also the host of Let’s Combinate: Drugs + Devices where he talks with industry leaders and breaks down complex quality, regulatory, device, pharma and combination-product topics. **Need help with consulting, training, or auditing?** Learn more at: [https://www.letscombinate.com](https://www.letscombinate.com) **Connect with Subhi:** LinkedIn: [https://www.linkedin.com/in/subhi-saadeh-1169aa21](https://www.linkedin.com/in/subhi-saadeh-1169aa21) Email: [[email protected]](mailto:[email protected]) #AQL #AcceptanceSampling #QualityEngineering #Pharma #MedicalDevices #CombinationProducts #ISO2859 #ISO3951

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: [email protected] 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: [email protected]

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.

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

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/ [email protected] Connect with Subhi on LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21

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

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.

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.

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.

Download the free Drug vs. Device Quality comparison guide here: https://letscombinate.kit.com/216fbfc6c2 In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same and highlights five key areas where they differ for combination products. Drug quality often focuses on consistently remaking the product that was proven clinically, using critical quality attributes, specifications, analytical methods, stability, process validation, and batch release. Device quality emphasizes design robustness and intended use through design controls and product realization, from user needs and design inputs to validation and design transfer. This episode covers five major differences: Quality philosophy and evidence Development approach Risk management Regulatory submission focus Lifecycle management and change control The goal is not to force one system onto the other. The goal is to understand the differences early enough to intentionally integrate drug and device quality across development, manufacturing, regulatory strategy, and lifecycle management. Chapters 00:00 Drugs vs. Devices: Why Quality Differs 00:20 Intro and Practical Guide 00:50 Quality Philosophy and Evidence 02:27 Development Approach Differences 03:56 Risk Management Mindsets 05:48 Regulatory Submission Focus 06:23 Lifecycle and Change Control 08:03 Summary and Next Steps 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.

Chat with Subhi: https://calendly.com/letscombinate/let-s-combinate-intro-session Finished medical devices can create a lot of surprises when they are added to combination product kits. A needle, vial adapter, filter, or transfer device may already be sterile, cleared, qualified, and sold at massive scale. But already on the market does not automatically mean ready for your combination product. In this episode, I talk through the challenges of selecting finished medical devices for combination product kits and the three lifecycle moments that usually determine whether qualification goes smoothly or turns into a late-stage problem. We cover: * Why “already approved” does not mean combination-product ready * Why you inherit the supplier’s design, QMS, packaging, validation, change control, and outsourcing decisions * What to think about before supplier selection * How to set expectations during supplier selection * Why structured qualification matters * How PPAP concepts like process flow, PFMEA, control plans, inspections, sampling, and validation evidence can help The main point: A commercially available device may be qualified for someone else’s intended use. Your job is to determine whether it is qualified for yours. Chapters: 00:00 Device Selection Stakes 02:05 Common Supplier Myths 03:54 Inheriting the Device QMS 04:53 Three Crucial Moments 05:51 Before Selection: Intended Use 07:21 Packaging, Markets, and Risk Flags 08:55 During Selection: Set Expectations 10:33 Qualification: Use a Structured PPAP Approach 14:12 Wrap Up and Next Steps Subhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, supplier quality, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics. Let’s Combinate helps teams develop and control drug-device combination products by aligning quality systems, development, supplier quality, and regulatory expectations across drug and device domains. #CombinationProducts #MedicalDevices #PharmaQuality #SupplierQuality #DrugDeviceCombinationProducts #PPAP #QualitySystems