Podcast
Let's Combinate - Drugs + Devices
Hosted by Subhi Saadeh · EN
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!
42episodes
Episodes
Newest firstAll episodes
221 - What Is ICH and Why It Matters
Jan 700:14:30Tap to summarizeIn this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh kicks off a new series focused on the International Council for Harmonisation (ICH) and its impact on drug and drug–device combination products.Subhi introduces what ICH is, why it was created, and how its guidelines shape global expectations for pharmaceutical quality, safety, efficacy, and lifecycle management. He walks through the historical challenges that existed before harmonization, explains how ICH guidelines are developed through the five-step process, and outlines why these standards matter—especially for teams working at the intersection of drugs and devices.The episode also sets the roadmap for the series, including upcoming deep dives into the ICH Quality guidelines (Q1–Q14) and how they apply in practice to combination products.00:00 Welcome to Let’s Combinate00:37 Why ICH Matters for Drug–Device Products02:22 What Is ICH?05:21 Evolution of ICH Guidelines10:18 The Five-Step ICH Guideline Process11:38 How This Series Will Work14:09 Wrap-Up and What’s NextSubhi Saadeh is a Quality Professional, Founder of Let's Combinate BioWorks 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.
Transcribe →182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma
Apr 2, 202500:18:42Tap to summarizeIn this episode of Let's Combinate, Subhi Saadeh shares personal insights and seven crucial lessons on finding the right mentors in the pharmaceutical and medical devices sectors. Subhi emphasizes the transformative impact mentors have had on his life and career, breaking down the types of mentors one can have, such as teachers, sponsors, and peer mentors. He provides practical advice on lowering your expectations, focusing on value and repetition, being mentor-able, and leveraging non-traditional forms of mentorship, like books and advanced tools. Subbi concludes that mentorship is about being open, curious, and willing to learn from various sources.00:00 Introduction: The Power of Mentorship02:06 Lesson 1: Different Types of Mentors05:04 Lesson 2: Lower Your Bar for Mentors07:51 Lesson 3: Focus on Value and Repetition09:37 Lesson 4: Be Mentor-able11:37 Lesson 5: Look Sideways, Not Just Up12:58 Lesson 6: Don't Wait for a Formal Title15:01 Lesson 7: Mentors Can Be Dead16:41 Conclusion: Recap and Final ThoughtsSubhi 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.
Transcribe →181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?
Mar 26, 202500:20:14Tap to summarizeDiscover how ampoule(ampule) drug delivery systems could revolutionize the pharmaceutical industry in this eye-opening video. Learn about the potential impact of this innovative technology on drug administration and patient care.In this episode of 'Let's Combinate Drugs and Devices,' host Subhi Saadeh is joined by Eric Suglalski, Founder and CTO of Archimedic, to discuss the often-overlooked role of ampules in drug delivery. Eric highlights the stability and contamination resistance benefits of ampules, despite the industry's shift towards vials and pre-filled syringes. He elaborates on the time and cost factors that make transitioning to pre-filled syringes challenging for pharmaceutical companies. The discussion also covers Eric's work on the Ampule Filled Syringe (AFS) system, which aims to combine the usability of pre-filled syringes with the stability of ampules. They delve into the historical context of ampules, global usage patterns, and the hurdles faced in implementing ampule-based technologies. Eric invites interested pharma companies to explore potential collaborations with Ampulous.00:00 Introduction and Guest Welcome00:17 The Overlooked Potential of Ampoules02:11 Challenges with Vials and Prefilled Syringes05:01 The Cost and Time Barrier to Prefilled Syringes08:29 Introducing Ampulous: A New Solution10:36 Technical Details of Ampule Filled Syringes14:39 Historical Context and Global Use of Ampoules16:38 Addressing Concerns and Resistance18:01 Human Factors and Usability19:44 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application. 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.
Transcribe →180 - MIT Leadership Expert Reveals Management Secrets for Scientists!
Mar 19, 202500:25:18Tap to summarize🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this episode of Let's Combinate, host Subhi Saadeh interviews Gwen Acton, author of Leadership for Scientists and Engineers. Acton, an MIT Ph.D. turned leadership coach, discusses her book's key topics, including effective hiring, delegation, transitioning from individual contributor to team manager, and managing different personalities. They delve into the challenge of balancing technical work and leadership, the importance of defining leadership, and practical tips for delegation. Acton emphasizes that leadership skills can be learned and provides strategies for managing team goals and career development.Amazon: https://www.amazon.com/Leadership-Scientists-Engineers-Transforming-Brilliant-ebook/dp/B0DYWCDVRV?ref_=ast_author_dpBarnes and Noble: https://www.barnesandnoble.com/w/leadership-for-scientists-and-engineers-gwen-acton/1147071445?ean=979899239330900:00 Introduction and Guest Overview01:56 Gwen Acton's Leadership Journey04:30 Defining Leadership08:18 Optimizing Group Output09:30 Challenges in Leadership Transition12:35 Leadership vs. Technical Skills13:05 Transitioning from Technical to Leadership Roles14:18 Challenges of Dual Roles15:42 The Art of Delegation16:53 Motivating Your Team21:21 Balancing Trust and Oversight24:58 Conclusion and Final ThoughtsDr. Gwen Acton is a leadership expert specializing in the biotech and pharmaceutical industries. With a PhD in biology from MIT and years of experience guiding scientists and technical professionals into leadership roles, she helps individuals transition from expert contributors to effective managers. As a sought-after speaker, consultant, and author, Gwen provides practical strategies for navigating the complexities of leadership in highly regulated, innovation-driven environments.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.
Transcribe →179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing
Mar 12, 202500:09:27Tap to summarizeIn this episode of Let's Combinate, host Subhi Saadeh, a seasoned quality professional, delves into the concept of 'everyone owns quality' and explains why this notion is flawed. Subhi recalls his eye-opening experience with Joanna Gallant's article on quality ownership and discusses the importance of clear accountability within organizations. The episode emphasizes that while all employees play a role in quality, true ownership lies with top management. Subhi also highlights regulatory frameworks like ISO 13485 and 21 CFR 820, noting how they mandate management's responsibility for quality systems. The discussion extends to real-world examples, including the Ranbaxy scandal, to illustrate the dire consequences of poor quality management. The episode concludes with a call to shift the mindset from 'everyone owns quality' to 'leadership owns quality.' 00:00 Introduction to Quality Ownership04:10 Regulatory Frameworks and Quality Management05:14 The Flaws in 'Everyone Owns Quality'06:45 Case Study: Ranbaxy Laboratories08:49 The Importance of a Strong Quality CulturePrevious Episodes:Joanna Gallant: https://www.letscombinate.com/076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant/Katherine Eban: https://www.letscombinate.com/115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pros-with-nyt-be/Links: ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdfISO13485: https://www.iso.org/standard/59752.html21CFR820: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-B/section-820.20BBC Article: https://www.bbc.com/news/world-asia-india-22520953Bottle of Lies: https://www.amazon.com/Bottle-Lies-Inside-Story-Generic/dp/0062338781Subhi 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.
Transcribe →178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know
Mar 5, 202500:31:22Tap to summarizeIn this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action). They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory contexts. Aaron explains how U.S. regulations describe deviations on the pharma side and non-conforming products on the MedTech side, and how these are handled differently under respective quality systems. The conversation also touches on topics like root cause analysis, verification of effectiveness, and the importance of management support in making CAPA systems effective. Aaron highlights the value of continuous improvement and debunks common misconceptions about CAPA in both industries.00:00 Introduction and Guest Introduction00:33 Understanding CAPA in Pharma and MedTech01:08 Regulatory Differences and Their Implications03:12 Event Handling and Investigation Processes08:13 CAPA System Effectiveness13:57 Quality System Approaches in Pharma and MedTech26:22 Root Cause Analysis and Continuous Improvement30:43 Conclusion and Contact InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.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.
Transcribe →177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED
Feb 26, 202500:10:58Tap to summarize🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.This episode dives into the world of GXPs, the essential guidelines for ensuring quality and safety in pharmaceutical and medical device industries. The host explains various GXPs, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Pharmacovigilance Practices (GVP), and Good Automated Manufacturing Practices (GAMP). Each GXP covers different stages from preclinical research to post-market safety, ensuring that products are produced safely, effectively, and consistently. The episode emphasizes the importance of understanding these regulations to guarantee the delivery of high-quality products to patients.00:00 Introduction to GXPs02:06 Understanding Good Manufacturing Practices (GMP)03:27 Exploring Good Laboratory Practices (GLP)04:35 The Importance of Good Clinical Practices (GCP)05:44 Ensuring Safety with Good Distribution Practices (GDP)06:55 Monitoring with Good Pharmacovigilance Practices (GVP)07:48 Good Automated Manufacturing Practices (GAMP)08:45 How GXPs Work Together10:45 Conclusion and Final ThoughtsSubhi 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.
Transcribe →176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski
Feb 19, 202500:26:20Tap to summarizeIn this episode of Let's Combinate Drugs and Devices, host Subhi Siddhey welcomes Eric Sugalski, founder and CTO of Archimedic. Eric shares insights into the complexities of working as a CDMO, emphasizing the importance of recognizing whether a sponsor company needs overflow capacity or specialized expertise. They discuss common pitfalls, such as companies getting in their own way by misaligning their needs with their outsourcing strategy and the detrimental effects of premature concept lock. Eric highlights the value of giving design firms creative space, the importance of early user research, and the impact of timing and market readiness on project success. He also elaborates on the benefits of open-source quality management systems and hands-on market research to bridge the gap between engineers and users. Together, they explore how to set up projects for success through balanced, well-researched approaches.00:00 Introduction and Guest Welcome00:13 Challenges in Outsourcing for Pharma and Med Device Companies01:04 Importance of Expertise in Outsourcing03:27 Effective Collaboration with CDMOs04:41 Concept Development and Design Requirements05:38 Balancing Innovation and Practicality07:48 Commercialization and Product Development09:57 Understanding User Needs in Design20:47 Advice for Aspiring Engineers25:15 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application.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.
Transcribe →175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau
Feb 12, 202500:39:49Tap to summarize🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.In this episode of Let's Combinate, host Subhi Saadeh interviews Bill Facteau, President and CEO of Earlens Corporation, who has over three decades of experience in the medical device industry, focusing on hearing innovations. Bill discusses his journey in the ear, nose, and throat field, including his motivation to improve hearing aid technology due to personal experiences and unmet needs in the market. The conversation covers the limitations of traditional air conduction hearing aids, the unique advantages of Earlens' technology, and the broader industry challenges such as lack of education and reimbursement issues. Bill also highlights the critical importance of treating hearing loss to prevent cognitive decline and other health issues.The episode concludes with leadership advice and a discussion on books that have influenced Bill's career.00:00 Introduction and Guest Welcome00:42 Bill Facto's Career Journey03:01 Challenges in Hearing Aid Technology08:15 Preventing Hearing Loss12:05 Ear Lens Innovation33:03 Hearing Loss and Cognitive Health35:01 Leadership and Personal Insights39:36 Conclusion and Contact InformationBill Facteau is the President and CEO of Earlens Corp, which is focused on transforming the hearing aid industry with its novel and proprietary light-based technology. Prior to joining Earlens, Mr. Facteau served as President and CEO of Acclarent, the company that created Balloon Sinuplasty, which was ultimately acquired by JNJ for $800M. Mr. Facteau has served as a Board Director on a number of successfully acquired ventures including Acclarent, Neotract, CVI, Cabachon and ExploraMed.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.
Transcribe →174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin
Feb 5, 202500:23:57Tap to summarize🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.Ben Locwin discusses the science, quality, and future of GLP-1 receptor agonists, revolutionary drugs used in diabetes and obesity treatment. The episode explores the history and development of GLP-1s, their commercial viability, manufacturing challenges, and regulatory landscapes. Ben dives into the mechanisms of GLP-1s, including their influence on appetite, blood sugar, and gastrointestinal effects. They also touch on the capacity issues in production, the impact of compounding, and the sustainability concerns associated with injector pens. The conversation provides an in-depth look at the pharmaceutical industry’s response to the surge in GLP-1 demand, highlighting the broader implications for patient care and market trends.00:00 Introduction to GLP Receptor Agonists00:46 Guest Introduction: Ben Locwin01:48 Historical Context of GLP-1 Development05:54 Mechanisms and Effects of GLP-109:51 Market Impact and Manufacturing Challenges11:16 Regulatory and Advertising Considerations17:44 Sustainability and Injector Pen Issues19:40 Risk Management and Future Directions23:31 ConclusionBen 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.
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