Let's Combinate - Drugs + Devices

Subhi Saadeh
  • 4.9 (13)
  • LIFE SCIENCES
  • UPDATED WEEKLY

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. 13H AGO

    219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness

    In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh is joined by Ben Locwin to break down what’s changing in FDA pre-approval and pre-license inspections—and why the “inspection side” of approval is becoming a bigger conversation. They cover how PAIs and PLIs fit into the approval pathway, why Complete Response Letters (CRLs) can be driven by inspection outcomes, and what it would mean to “decouple” approval decisions from inspection timing. The conversation also explores the pros and cons of unannounced inspections, the realities of FDA capacity and scheduling, and how FDA’s PreCheck program is shaping the onshoring/manufacturing-readiness narrative in the U.S. Finally, they zoom out to compare international inspection approaches and what global trends could signal for industry. What you’ll learn -The difference between Pre-Approval Inspections (PAIs) and Pre-License Inspections (PLIs) -How inspection outcomes can lead to CRLs—even when the application looks strong on paper -Why industry is talking about decoupling approval from PAI timing -The idea behind FDA PreCheck and what “facility readiness” looks like -Unannounced inspections: where they help, where they create risk -How inspection expectations compare across global regulators Chapters 00:00 Introduction and Guest Welcome 00:10 Understanding Pre-Approval and Pre-License Inspections 01:54 Challenges and Industry Perspectives 03:08 FDA Complete Response Letters (CRLs) 05:23 Unannounced Inspections: Pros and Cons 08:55 Economic and Regulatory Considerations 12:37 Onshoring and the PreCheck Program 22:51 Global Regulatory Landscape 25:11 Conclusion and Farewell Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

    26 min

  2. DEC 17

    218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)

    In this short episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh breaks down ICH Q13 and what “continuous manufacturing” actually means. He compares batch vs. continuous, explains how a batch still exists in continuous manufacturing, and covers the essentials quality teams care about: RTD/traceability, control strategy, and disturbances/diversion plus a quick high-level note on validation, release, and lifecycle. Timestamps 00:00 Intro 01:00 Batch vs. continuous (and batch definition) 03:00 Modes of continuous manufacturing (ICH Q13 examples) 04:30 RTD & traceability 06:00 Control strategy 07:30 Disturbances & diversion 09:00 Validation / release / lifecycle (high level) 10:00 Wrap-up Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks and host of the Let’s Combinate: Drugs + Devices podcast/Youtube Channel. With experience across Quality, Manufacturing Commercialization, Sustaining and R&D, Subhi has helped industrialize and launch drug delivery systems for biologics, vaccines, and generics at leading organizations such as Pfizer, Gilead, and Baxter. Subhi focuses on bridging the disconnect between drug and device development and specializes in harmonizing internal systems, aligning internal and external partners, and helping combination product teams move from siloed execution to scalable, compliant, and patient-ready solutions. He currently chairs the Rx-360 Combination Product Working Group and was the International WG Chair at the Combination Product Coalition. He has contributed to global harmonization efforts through BIO, ASTM, and AAMI. He is a certified ISO13485 Lead Auditor, CQA and CQE. For questions, inquiries, or suggestions, please reach out at letscombinate.com or on the show’s LinkedIn Page.

    9 min

  3. DEC 10

    217 - 5 Fixable Problems Holding Back Drug–Device Programs

    In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh addresses five significant quality issues in the combination product space. This episode provides practical insights and strategies for overcoming these common hurdles to enhance quality and efficiency in developing combination products. 00:00 Introduction and Host Background 00:43 Overview of Development Processes 01:51 Issue 1: Documentation Approach in Design Transfer 04:45 Issue 2: Early Input from Manufacturing and Assembly SMEs 07:26 Issue 3: Control Strategies and Sampling Plans 10:23 Issue 4: Method Transfer and Control Planning 12:02 Issue 5: Qualification of Supplied Components 14:47 Issue 6: Monitoring Expectations in Combination Products 16:55 Conclusion and Summary Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks and host of the Let’s Combinate: Drugs + Devices podcast/Youtube Channel. With experience across Quality, Manufacturing Commercialization, Sustaining and R&D, Subhi has helped industrialize and launch drug delivery systems for biologics, vaccines, and generics at leading organizations such as Pfizer, Gilead, and Baxter. Subhi focuses on bridging the disconnect between drug and device development and specializes in harmonizing internal systems, aligning internal and external partners, and helping combination product teams move from siloed execution to scalable, compliant, and patient-ready solutions. He currently chairs the Rx-360 Combination Product Working Group and was the International WG Chair at the Combination Product Coalition. He has contributed to global harmonization efforts through BIO, ASTM, and AAMI. He is a certified ISO13485 Lead Auditor, CQA and CQE. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

    18 min

  4. DEC 3

    216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke

    In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. They discuss: - The hidden costs of regulatory failure and how to avoid them - Why early engagement with regulatory agencies is critical - Global regulatory models, including emerging markets like China and the UAE - A clear explanation of UDI and serialization - How regulatory impacts extend beyond compliance teams - The role of LinkedIn and storytelling in regulatory careers - Steven’s experience running for the European Parliament and what it taught him about policy Timestamps 00:00 – Introduction and Guest Welcome 00:38 – The Hidden Costs of Regulatory Failure 03:47 – Engaging with Regulators Early 05:26 – Global Regulatory Models and Emerging Markets 10:07 – Understanding UDI and Serialization 15:16 – The Power of LinkedIn and Personal Stories 17:11 – Running for European Parliament and Policy Insights 21:18 – Conclusion and Contact Information Connect with Steven O’Rourke Website: https://clarifi.fi LinkedIn: https://linkedin.com/in/sorourkde Subscribe to Let’s Combinate for more conversations exploring combination product development, quality systems, and regulatory strategy. Stephen O’Rourke is a regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. Based in Helsinki, Finland, his work spans UDI, 510(k), EU MDR, combination products, and novel ingredient safety. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

    22 min

  5. NOV 26

    215 - Why Aren’t Technical People Leading Drug-Device Audits?

    In this episode of Let’s Combinate, Subhi Saadeh breaks down why more engineers in pharma, medical devices, and combination products should seriously consider becoming auditors. Sparked by a question at a PDA conference: “Why don’t more technical people lead audits?” This episode explores the gap between technical expertise and true audit competency. Subhi explains how engineers who combine their technical background with audit training often become the most effective auditors. They gain a system-level perspective, understand how design decisions ripple through the QMS, and can identify systemic root causes that others overlook. He also clears up common misconceptions about auditing, including the idea that it’s just paperwork or checklist work, and reframes it as one of the fastest ways to build regulatory fluency, strengthen quality systems understanding, and expand career versatility across industries. The episode closes with practical steps for how engineers can get started: shadowing internal audits, learning audit frameworks and methodologies, taking formal training, and seeking mentorship from experienced auditors. Timestamps: 00:00 – Why Engineers Should Consider Auditing 01:10 – How Auditing Expands Technical Perspective 05:26 – Misconceptions & Why Engineers Avoid Auditing 11:25 – How to Start Your Audit Journey 13:27 – Final Thoughts: Seeing the System, Not Just the Spec Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks and the host of Let’s Combinate: Drugs + Devices. With a background spanning Quality, Manufacturing Operations, and R&D, he has supported the development and launch of hardware devices, disposable systems, and drug–device combination products across vaccines, generics, and biologics at some of the industry’s largest medical device and pharma organizations. Subhi currently serves as the Working Group Chair for the Rx-360 Combination Products Working Group and previously served as the International Working Group Chair for the Combination Products Coalition (CPC). He has also contributed to ASTM Committee E55 and AAMI’s Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

    14 min

  6. NOV 19

    214 - The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More)

    In this episode of Let's Combinate: Drugs + Devices host Subhi Saadeh welcomes back Andy Robertson, founder of CQE Academy. Andy shares his transformative journey involving CQE certification and how it boosted his confidence and expertise in quality engineering. They explore the practical applications of Design of Experiments (DOE), including a real-life example where Andy applied DOE concepts at work. Andy also discusses the value of various ASQ certifications, including CQE, CQA, CQM/OE and Six Sigma Green Belt, emphasizing their importance for career growth. The conversation extends to non-ASQ certifications such as PMP, highlighting their relevance for leadership roles. By comparing practices from various industries, including automotive and medical devices, they underscore the importance of cross-industry learning. Andy concludes by inviting listeners to join his courses to further their own professional development. 00:00 Welcome and Introduction 00:48 The Impact of CQE Certification 02:23 Applying DOE in Quality Engineering 05:42 Top ASQ Certifications 13:35 Non-ASQ Certifications and Leadership 15:55 Cross-Industry Learnings 18:45 Conclusion and Contact Information Andy Robertson is the founder of CQE Academy and a leading educator in the quality profession. With a background in medical devices and years of hands-on experience as a quality engineer, he built a global audience through his practical, passionate approach to teaching CQE, Green Belt, and quality systems fundamentals. Andy’s work centers on helping professionals gain confidence, accelerate their careers, and master the core tools of quality through clear, accessible education. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

    19 min

  7. NOV 12

    213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site

    What happens when you go all in on a generic injectable that no one else wants, and it turns into a one hundred million dollar product in the first year? In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Usman Ahmad, former CEO of Nexus Pharmaceuticals and now CEO of Quetzal Therapeutics. Together they trace his journey from corporate finance to building a generics powerhouse with his parents, scaling a sterile injectable facility, and ultimately selling it to Eli Lilly for just under one billion dollars. They discuss the philosophy of finding the "right to win," what most companies miss about manufacturing capacity and equipment selection, how to build a team with deep industry know-how, and why Usman is now focused on bringing therapies to patients with rare diseases. This is a practical, personal, and strategic look at building something from the ground up, deciding not to sell too early, and learning how to do the hard things with intention. Topics include: -How to select the right generic molecules beyond patent expiry -Early success with isoproterenol and API sourcing -Why Nexus turned down acquisition offers -Building a commercial salesforce from scratch -Designing a facility with high speed prefilled syringe and lyo capacity -Why most other sterile sites failed -The billion dollar sale to Lilly -Launching Quetzal and developing oral arsenic for APL -The brain-eating amoeba drug and ultra rare disease strategy -Faith, confidence, and decision making under pressure Timestamps: 00:00 Introduction and Guest Welcome 00:24 From Wall Street Finance to Pharma 01:42 How Usman Selected Winning Generics 02:58 Early Challenges Building a Generics Company 05:29 Family R&D Expertise and Business Dynamics 11:44 First Generic Launch and Commercial Impact 16:28 Building Sterile Injectable Manufacturing Capacity 18:16 Sterile Facility and Equipment Strategy 22:40 Prefilled Syringe and Vial Line Capabilities 23:07 Big Pharma Interest and Selling the Facility 26:02 Nexus Pharma Services and the Lilly Deal 27:23 Post‑Sale Reflections and New Ventures 28:30 Launching Quetzal Therapeutics and Rare Disease Focus 33:30 New Challenges and Confidence in Drug Development 39:55 Importance of People, Teams, and Relationships 41:40 Books That Shaped Usman’s Thinking 42:29 Where to Connect with Usman Learn more: https://quetzaltx.com Connect with Usman: https://www.linkedin.com/in/usman-ahmed-a351b928 More episodes: https://letscombinate.com Usman Ahmad is the Founder and CEO of Quetzal Therapeutics, and former CEO of Nexus Pharmaceuticals, where he led the company through explosive growth and the billion-dollar sale of its manufacturing facility to Eli Lilly. With a background in finance and a deep passion for healthcare innovation, Usman now focuses on bringing treatments to patients with rare and underserved diseases. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

    44 min

  8. NOV 5

    212 - What 6 of the World’s Biggest Companies Taught Him About Combination Products

    In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional who has worked with global leaders including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic. Leonel shares how integrating Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) is essential to successful combination-product development. He discusses his journey from chemist to regulatory-affairs expert, uncovering common disconnects between pharma and device cultures, and the critical role of design controls, risk management, and timelines. The conversation also explores GMP and process validation, IDE vs. IND pathways, the challenges of rare-disease programs, and how understanding the cost of quality can reshape testing strategies. Leonel closes by reflecting on becoming a Lean Six Sigma Black Belt and what continuous improvement really looks like in combination-product development. ⏱ Timestamps 00:00 – Welcome & Introduction 00:52 – Integrating GLP, GCP & GMP 02:22 – Challenges in Developing Combination Products 04:02 – Device-Led Combination Products 07:35 – Working with Rare Diseases 09:58 – GMP & Process Validation 15:08 – Clinical Trials: Drug vs Device 19:22 – Cost of Quality & Six Sigma 25:12 – Conclusion & Contact Information Leonel Venegas is the Founder of Precision Regulatory Consulting LLC and an expert in quality and regulatory affairs with over two decades of experience across six global pharma and medtech leaders, including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic. He is certified by ASQ as a CMQ/OE, CQE, CBA, and CSSBB, and holds an M.S. in Regulatory Affairs. Leonel specializes in combination products, medical devices, and IVDs, integrating GLP, GCP, GMP, and GVP principles into complex global development programs. 📩 Connect with Leonel: leonel@precisionregulatory.com Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

    26 min
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Ratings & Reviews

4.9
out of 5
13 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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