Let's Combinate - Drugs + Devices

In 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 Multidiscipl...

In 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 t...

🚀 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 end of year episode of Let’s Combinate: Drugs...

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 wou...

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,...

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...

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 regu...

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...

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...

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...

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 Prac...

In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh welcomes Mark Kramer, the founding director of FDA’s Office of Combination Products (OCP). Mark takes us on a deep dive into the history of how combination products have been regulated in the U.S., starting with the Safe Medical Devices Act of 1990 and how the process evolved into the formation of OCP in 2002. We explore questi...

I get a lot of questions from students and early-career professionals about what different industry roles actually mean: what does a Quality Engineer do? What’s Regulatory Affairs? How does R&D fit in? In this video, I walk through eight of the most common roles you’ll find in pharma, medtech, biotech, and diagnostics companies. We’ll talk about what each team does, how they connect, and how t...

As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, Ben Locwin and Subhi Saadeh discuss the intersection of AI, GMP, and Quality 4.0, exploring both the promise and the challenges of applying intelligent systems in regulated environments. Key topics covered: - Current applications of AI in GMP, includi...

In this episode, I talk with Monika Andraos of Dunamis Compliance about how organizations can navigate group think and approach data integrity the right way. We cover risk culture, CSV vs. data integrity, ALCOA++, data governance, and practical tips for newcomers. Key topics include: • Encouraging diverse perspectives to combat group think • Why data integrity is broader than CSV • The pyramid str...

In this episode, Jesse Gordon-Blake, PhD, delves into the intricacies of medicinal chemistry, particularly focusing on drug discovery for ALS (amyotrophic lateral sclerosis). Jesse explains the process of discovering molecules that modulate biological pathways, the difference between structure-based and phenotype-based drug design, and the role computational methods play in drug development. The c...

In this episode, Subhi Saadeh sits down with Alan Stevens, CAPT, to break down the concept of five nines (99.999% reliability) in medical devices. They cover where the standard came from, why FDA introduced it in their 2020 draft guidance, and what it means for life-saving products like epinephrine and naloxone injectors. Alan explains how manufacturers can demonstrate reliability through fault tr...

Artificial Intelligence is moving fast but how do you regulate it in industries where precision and risk management are everything? In this episode of Let’s Combinate, Subhi Saadeh sits down with Dominick Romano, founder of Drainpipe.io, to unpack the future of AI in pharma, medtech, and drug/device regulation. The conversation goes deep into how AI could reshape dossier preparation, regulatory su...

Nearly two-thirds of companies believe Quality 4.0 will transform their operations in the next five years yet fewer than 20% have started, and most haven’t even reached the planning stage. In this conversation, Larry Mager breaks down what Quality 4.0 really is, why life sciences lag other industries, and how to move from compliance-only thinking to a business-driving quality strategy. We cover di...

In this episode of Let’s ComBinate: Drugs + Devices, we welcome back Susan Neadle, author of The Combination Products Handbook. Susan explores the persistent and evolving challenge of terminology in combination products—a problem that continues to create confusion and regulatory risk even in 2025. Susan emphasizes the need for alignment on terminology and regulatory expectations, highlighting that...

In this episode of Let’s Combinate, Subhi Saadeh sits down with Jim Collins, a leader in drug delivery with over 30 years of experience at Eli Lilly, Sanofi, and now as an advisor and board member. Jim shares the history of combination products before the term even existed, from insulin pens in the 1990s to modern platforms and on-body injectors. We cover IP battles that reshaped the industry, sup...

In this episode of Let's Combinate, host Subhi Saadeh is joined by long-time friend and Senior Technical Program Manager Joey Frechin, who brings a wealth of experience in med tech consulting. They discuss the intricacies of risk assessments for medical devices and drugs, focusing on differences and improvements in methodologies over the years. Joey shares insights on the challenges of aligning ri...

In this episode of Let’s ComBinate, Subhi Saadeh sits down with Jeff Gensler, a quality and regulatory leader with 30+ years in MedTech, pharma, and combination products. Jeff takes us inside FDA warning letters, consent decrees, and massive remediation efforts—including the 1,400 DHF Zimmer Biomet project and achieving 99.999% reliability with the EpiPen. He shares the CAPA playbook he’s refined...

In this milestone episode, I reflect on what it’s taken to record, edit, and release 200 episodes focused on medical devices, pharma, and combination products. I share three hard-earned lessons not just about the industry, but about how we grow, lead, and keep learning inside it. From the sheer scope of the work to the surprising, non-linear paths people take, and the difference between credential...

In this episode of Let’s Combinate, host Subhi Saadeh is joined by Mark Burchnall, Director of Engineering at PSN Labs, to break down the evolving role of mechanical modeling and simulation in medical device and combination product development. Mark, an expert in mechanical modeling & finite element analysis (FEA) and a licensed professional engineershares how modeling can dramatically reduce...