Let's Combinate - Drugs + Devices

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.Timestamps00:00 Intro01:00 Batch vs. continuous (and batch definition)03:00 Modes of continuous manufacturing (ICH Q13 examples)04:30 RTD & traceability06:00 Control strategy07:30 Disturbances & diversion09:00 Validation / release / lifecycle (high level)10:00 Wrap-upSubhi 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.

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 Background00:43 Overview of Development Processes01:51 Issue 1: Documentation Approach in Design Transfer04:45 Issue 2: Early Input from Manufacturing and Assembly SMEs07:26 Issue 3: Control Strategies and Sampling Plans10:23 Issue 4: Method Transfer and Control Planning12:02 Issue 5: Qualification of Supplied Components14:47 Issue 6: Monitoring Expectations in Combination Products16:55 Conclusion and SummarySubhi 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.

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 policyTimestamps00:00 – Introduction and Guest Welcome00:38 – The Hidden Costs of Regulatory Failure03:47 – Engaging with Regulators Early05:26 – Global Regulatory Models and Emerging Markets10:07 – Understanding UDI and Serialization15:16 – The Power of LinkedIn and Personal Stories17:11 – Running for European Parliament and Policy Insights21:18 – Conclusion and Contact InformationConnect with Steven O’RourkeWebsite: https://clarifi.fiLinkedIn: https://linkedin.com/in/sorourkdeSubscribe 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.

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 Auditing01:10 – How Auditing Expands Technical Perspective05:26 – Misconceptions & Why Engineers Avoid Auditing11:25 – How to Start Your Audit Journey13:27 – Final Thoughts: Seeing the System, Not Just the SpecSubhi 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.

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 Introduction00:48 The Impact of CQE Certification02:23 Applying DOE in Quality Engineering05:42 Top ASQ Certifications13:35 Non-ASQ Certifications and Leadership15:55 Cross-Industry Learnings18:45 Conclusion and Contact InformationAndy 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.