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
230 - How Pharma Misses Critical Market Signals with Joe Luminiello
Mar 2300:30:38Tap to summarizeIn this episode of Let’s ComBinate, Subhi Saadeh sits down with Joseph Luminiello, CEO and Co-Founder of RCG Intel, to break down how competitive intelligence is actually used in biopharma and why most companies get it wrong.Joe introduces a practical framework built on three pillars: data (scientific publications and congresses), signal intelligence (press releases and filings), and human intelligence, which provides the context needed to interpret what those signals actually mean. While data and AI tools are becoming more accessible, Joe explains why interpretation and real-world insight remain the true differentiators in strategic decision-making.The conversation covers real-world applications across pharma strategy, including evaluating low-cost API suppliers, make-versus-buy decisions, competitor assessments, and forecasting. Subhi and Joe also discuss how cultural incentives and assumptions often shape forecasts more than data, and why even well-built models can miss significantly.Timestamps00:00 Introduction00:51 What is competitive intelligence02:57 Human intelligence in practice05:37 How insights are sourced07:59 Validating and triangulating data12:37 Forecasting and key assumptions18:01 Common client blind spots20:31 Speed of change in pharma23:56 Why context matters more than raw data27:27 Tools, congress strategy, and wrap-upLinksRCG Intel:https://rcgintel.com/Joseph Luminiello on LinkedIn:https://www.linkedin.com/in/joeluminiello/Joseph Luminiello is the CEO and Co-Founder of RCG Intel, a boutique competitive intelligence consultancy serving the pharmaceutical and biotech sector. With more than 40 years of experience across healthcare, biopharma, and strategic intelligence, Joe has built his career around what he calls prescience, the ability to synthesize disparate data points and anticipate how they will shape the future. Before launching RCG Intel, Joe served as CEO of multiple biopharma companies, including AVM Biotechnology and Third Coast Therapeutics, where he raised capital and advanced drug development programs. As Founder and CEO of SmartHealth Catalyzer, he built a 150-member senior executive operations team and sourced over 130 intellectual property projects from Midwest universities. Earlier in his career, he spent six years at Takeda Pharmaceuticals, where he rose to Vice President of Business Development, contributed to diligence for Takeda’s acquisition of Nycomed, and helped launch Takeda Canada as its second employee.Subhi Saadeh is the Founder and Principal at Let’s ComBinate BioWorks. He is a Certified Quality Auditor and ISO 13485 Certified Lead Auditor with leadership experience at Baxter, Pfizer, and Gilead Sciences. Subhi has extensive experience across drug-device combination products, including supplier quality, development quality, design controls, purchasing controls, audits, and management of contract manufacturers and external partners. Through Let’s Combinate, he is focused on bridging the gap between pharma and devices by creating educational content, participating in industry groups, and providing consulting support to align development, quality, and regulatory expectations.
Transcribe →229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products
Mar 1100:31:15Tap to summarizeIn this episode of Let’s Combinate, Subhi Saadeh speaks with Jen Riter about analytical method validation for drug device combination products. The discussion explores how traditional drug analytical validation under ICH Q2 differs from validating functional and mechanical performance methods used for combination products. These methods often require an engineering mindset that incorporates measurement system analysis (MSA), gage R&R studies, and the use of fabricated surrogate standards when devices cannot be reused for testing.They also discuss platform test methods and how standards such as ISO 11040 and other ISO references can serve as starting points for method development. The conversation touches on the evolving alignment between ISO based device methods and pharmacopeial expectations such as USP <382>. The episode also covers make vs buy testing decisions, when to outsource specialized testing such as CCIT and extractables and leachables, and how sponsors manage oversight of contract testing laboratories.Timestamps00:00 Welcome and Guest Introduction00:53 ICH Q2 vs MSA Mindset Shift04:37 Surrogate Standards for Mechanical Testing11:12 Platform Methods and ISO 1104015:14 ISO vs USP Verification Debate20:06 Outsourcing Analytical Testing Strategy24:07 Choosing the Right Test Lab26:20 Sponsor Oversight of Contract Labs30:09 Wrap UpAbout Jen RiterJen Riter is an analytical testing and laboratory leader with nearly three decades of experience working in pharmaceutical packaging, drug delivery systems, and combination products. She has held leadership roles at West Pharmaceutical Services and Kindeva Drug Delivery, where her work has focused on analytical method development, validation, and testing strategies for drug delivery systems and injectable combination products. She is also a contributor to the Combination Products Handbook, where she authored a chapter on analytical testing and method validation for combination products.About Subhi SaadehSubhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks, where he helps companies close the gaps between drug and device development, quality systems, and regulatory expectations. He is a Certified Quality Auditor and ISO 13485 Lead Auditor with leadership experience at Baxter, Pfizer, and Gilead Sciences including responsibility for management and oversight of assemble label pack sites and working with device primary, secondary and tertiary packaging suppliers. Subhi previously chaired the Combination Product Working Group for Rx-360, served as International Committee Chair for the Combination Products Coalition, and served on AAMI’s Combination Products Committee. He also hosts the Let’s Combinate podcast and is a writer and speaker on quality at the intersection of drugs and devices.
Transcribe →228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently
Mar 400:06:17Tap to summarizeContinuing the ICH Q series with ICH Q5. This episode explains why Q5 exists, how to read it, and what it means for combination products. Q5 addresses quality challenges unique to biologics made in living systems where products cannot be fully characterized by physical and chemical testing alone and show inherent variability. It harmonizes expectations for viral safety, cell substrate controls including master and working cell banks, stability, and comparability after manufacturing changes. For combination products, Q5 mainly applies to the biologic drug constituent through stability and change impact rather than device requirements.00:00 Intro to ICH Q500:25 Meet the Host00:32 Why Biologics Need Q500:56 Key Risks Explained02:11 What Q5 Covers02:40 Scope and Structure03:19 Q5 A to E Breakdown04:19 How to Read Q505:05 Q5 for Combination Products05:59 Wrap Up and Next EpisodeSubhi Saadeh is the Founder and Principal at 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 →227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics
Feb 2400:28:05Tap to summarizeSubhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements.Timestamps00:00 Welcome and Guest Intro00:53 The Hairiest CAPA Case03:02 Human Error Root Cause04:58 Common CAPA Misconceptions06:11 Why Root Cause Fails12:16 When to Open CAPA17:26 CAPA Inputs and Triggers19:28 One Process or Two22:28 How to Investigate Properly25:09 Tools for Root Cause26:20 Problem Statement Basics27:48 Wrap Up and Where to FindGeorg Digel is the founder of Elevate CAPA and works with medical device quality leaders to make nonconformance and CAPA systems faster, stronger, and more audit-ready. He brings hands-on experience from early work on the production line through roles across consulting, startups, and larger organizations, with a focus on root cause and investigation quality. He also shares practical NC and CAPA breakdowns and training content with the MedTech community. LinkedIn: https://www.linkedin.com/in/georgdigel/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 →226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification
Feb 1800:29:15Tap to summarizeIn this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance under the NMPA.The conversation explores why Western companies often underestimate China’s regulatory expectations — particularly when assuming EU or U.S. approvals, ISO standards, or FDA clearances will translate directly. Elaine explains how China requires demonstration of safety and effectiveness against applicable local standards primarily GB (national standards) and YY (medical device industry standards) including both mandatory and recommended variants (e.g., GB vs GB/T, YY vs YY/T).The episode dives into China’s local type testing model and the role of Product Technical Requirements (PTRs) in defining test methods, parameters, accessories, and applicable standards for registration.Elaine also outlines how China’s quality system expectations align to China Medical Device GMP rather than ISO 13485 including major GMP updates taking effect in November 2026 and discusses implications for foreign manufacturers.Additional discussion topics include China agents and authorized representatives, clinical evaluation expectations, post-market reporting requirements, and how China’s device classification system can influence regulatory strategy.⏱️ Timestamps00:00 Welcome + Meet Elaine (MedTech Chopsticks)00:38 Why China Is Different: Local Standards vs EU/US Assumptions03:35 GB & YY Standards Explained (National vs Industry Standards)05:07 Local Type Testing & PTRs: Building China Product Technical Requirements06:52 China GMP Updates: Key Differences vs ISO 1348512:42 China Agent vs EU Authorized Rep: Roles & Responsibilities15:19 Choosing Local Test Labs: NMPA-Designated Testing Considerations18:42 Planning Early: Standards Gaps, Clinical Evaluation & PMS Risks24:43 China Certification & Device Classification Changes (Class I/II/III)28:38 Where to Find Elaine + ClosingSubhi Saadeh is the Founder and Principal at 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 →226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions
Feb 1100:08:15Tap to summarizeIn this episode of the ICH Q series, Subhi Saadeh covers ICH Q4, which focuses on pharmacopeial harmonization. He explains why ICH Q4 exists, the problem it was created to solve, and how the ICH Q4 framework, Q4A, Q4B, and the Q4B annexes work together to determine when pharmacopeial test methods are considered interchangeable across ICH regions. The episode also explains the role of the Pharmacopoeial Discussion Group (PDG) in technical harmonization and walks through practical examples, including ICH Q4B Annex 3.ICH Guidelines (Quality): https://www.ich.org/page/quality-guidelinesICH Q4B Annex 3(R1) – Tests for Particulate Contamination (Subvisible Particles): https://database.ich.org/sites/default/files/Q4B%20Annex%203%28R1%29%20Guideline.pdfTimestamps00:00 Introduction to the ICHQ Series00:03 What Pharmacopeial Harmonization Means00:42 Why ICH Q4 Exists01:55 ICH Q4 Framework and Structure02:54 Understanding Q4A, Q4B, and the Annexes03:59 Practical Examples (Particulates, Disintegration)08:05 Conclusion and Next StepsSubhi Saadeh is the Founder and Principal at 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 →225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes
Feb 400:09:27Tap to summarizeIn this episode of Let’s ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are identified, evaluated, and controlled in drug substances and drug products.Subhi explains what impurities are, why zero impurities is unrealistic in scalable manufacturing, and how ICH Q3 establishes a risk-based framework to protect patient safety and product quality. The episode walks through the structure of Q3A through Q3E, covering impurities formed during drug substance synthesis, degradation in drug products, residual solvents, elemental (metal) impurities, and extractables and leachables highlighting where drug delivery systems and combination products explicitly come into scope under Q3E.This episode is a high-level, practical overview focused on how to read ICH Q3, how the sections fit together, and where the guideline applies and stops across the drug product lifecycle.⸻Timestamps00:00 Welcome to Let’s ComBinate00:12 Introduction to ICH Q300:25 What Are Impurities and Why They Matter00:51 Sources of Impurities and Risk-Based Control02:11 Structure of ICH Q3 (Q3A–Q3E)05:30 How to Read and Use ICH Q307:22 Q3E, Extractables & Leachables, and Drug Delivery Systems09:21 Wrap-Up and Next Episode PreviewSubhi Saadeh is the Founder and Principal at 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 →224 - ICH Q2 Explained: What Analytical Validation Really Requires
Jan 2800:10:43Tap to summarizeIn this episode of Let’s Combinate, host Subhi Saadeh breaks down the ICH Q2 guideline with a practical focus on analytical procedure validation. The discussion covers key definitions, core validation characteristics, and how ICH Q2 applies to drug delivery systems and drug-device combination products.Subhi explains how the revised ICH Q2 guideline aligns with ICH Q14 and what that alignment means for harmonizing analytical validation expectations across regions and regulatory authorities. The episode walks through key validation characteristics including accuracy, precision, specificity, linearity, and range, and clarifies the relationship between ICH Q2 and ICH Q14. Practical guidance is also provided on how to read and apply ICH Q2 efficiently, particularly for teams working with combination products.Timestamps00:00 Introduction to Let’s ComBinate00:42 Purpose and importance of ICH Q203:11 Scope and product coverage06:10 Key validation characteristics08:15 Practical application and reading ICH Q210:23 Conclusion and next stepsSubhi Saadeh is the Founder and Principal at 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 →223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations
Jan 2100:09:39Tap to summarizeIn this episode of Let’s Combinate: Drugs and Devices, host Subhi Saadeh breaks down the 2025 draft update to the ICH Q1 guideline and explains what has actually changed and what has stayed the same.ICH Q1 is the core stability guideline, and with the consolidation of multiple legacy guidelines into a single document, many readers have found the draft overwhelming. In this episode, Subhi steps back from line-by-line commentary and instead focuses on how to think about ICH Q1, how to read it efficiently, and how stability decisions are expected to be made.The discussion covers why stability was one of the first topics harmonized by ICH, the fundamental stability concepts that still anchor the guideline, and how the revised structure emphasizes lifecycle management and data evaluation rather than introducing new science. Subhi also explains how ICH Q1 applies to drug-device combination products, including the role of the device as part of the container-closure system and why in-use stability often matters more than long-term storage.This episode is part of an ongoing series walking through the ICH Q guidelines and is intended to help listeners navigate regulatory expectations with clarity and confidence.Timestamps00:00 Introduction00:36 What ICH Q1 Is and Why It Exists02:59 Core Stability Concepts in ICH Q104:51 What’s Changing in the 2025 Draft05:35 How to Read ICH Q107:16 ICH Q1 and Drug-Device Combination Products09:09 Closing and What’s NextSubhi 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 →222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series
Jan 1400:12:13Tap to summarizeIn this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh continues the Combinating with ICH series by breaking down how the International Council for Harmonisation (ICH) guidelines are organized and why that structure matters for drug and drug-device combination products.Subhi walks through the four main ICH guideline families, Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M), and explains how each fits into the broader product lifecycle. The episode places particular emphasis on the Quality guidelines, which form the backbone of pharmaceutical development, manufacturing control strategies, and lifecycle management.Rather than a deep dive into requirements, this episode is designed to orient listeners to the full ICH landscape. It helps teams understand where different guidelines apply, who typically owns them, and how they collectively shape regulatory expectations. Future episodes in the series will explore individual Quality guidelines in detail.In this episode, you will learnWhat an ICH guideline is and how it differs from regulations and standardsWhy guidelines still matter during inspections and enforcementHow ICH organizes its guidance into Q, S, E, and M categoriesA high-level overview of the Quality Guidelines (Q1 through Q14), including:Stability (Q1)Analytical validation and development (Q2 and Q14)Impurities (Q3)Quality by Design and risk management (Q8 and Q9)Pharmaceutical Quality Systems and lifecycle management (Q10 through Q12)Continuous manufacturing (Q13)How different functional teams interact with different parts of the ICH frameworkThe next episode begins the deep dive into the Quality Guidelines, starting with ICH Q1 on Stability.Timestamps00:00 Introduction to the Series00:48 Overview of ICH Guidelines01:36 What an ICH Guideline Is and Is Not03:04 The Four ICH Guideline Categories04:08 Quality Guidelines Overview08:46 Safety Guidelines Overview09:28 Efficacy Guidelines Overview10:33 Multidisciplinary Guidelines Overview11:28 Wrap-Up and Next StepsSubhi 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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