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PODCAST

Let"s Combinate - Drugs + Devices

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

science life sciences

All Episodes

00:21:51

216 - How UAE and Singapore Are Redefining Regulatory...

Let"s Combinate - Drugs + Devices ·

2025/12/03

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

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00:13:59

215 - Why Aren’t Technical People Leading Drug-Device...

Let"s Combinate - Drugs + Devices ·

2025/11/26

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

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00:19:15

214 - The Best 5 Certifications for ANY Quality...

Let"s Combinate - Drugs + Devices ·

2025/11/19

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

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00:43:30

213 - From Generic Underdog to Billion‑Dollar Exit:...

Let"s Combinate - Drugs + Devices ·

2025/11/12

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

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00:25:42

212 - What 6 of the World’s Biggest Companies Taught...

Let"s Combinate - Drugs + Devices ·

2025/11/05

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

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00:46:24

211 - Inside FDA’s Office of Combination Products:...

Let"s Combinate - Drugs + Devices ·

2025/10/30

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 questions such as: What challenges did industry and the FDA face in the early days of combination products? How

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00:19:21

210 - The 8 Roles You MUST Understand in Pharma &...

Let"s Combinate - Drugs + Devices ·

2025/10/22

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 to think about which one might fit your strengths and interests.If you’re trying to figure out where you

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00:22:30

210 - How AI Is Rewriting GMP: Smarter CAPA, PAT,...

Let"s Combinate - Drugs + Devices ·

2025/10/15

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, including CAPA and deviation management- The role of validation and why algorithmic opacity poses regulatory

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00:22:59

209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong...

Let"s Combinate - Drugs + Devices ·

2025/10/08

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 structure: data integrity at the top, CSV & validation as elements • ALCOA++ and traceability in

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00:28:43

208 - How Drugs Are Designed, Targets, Phenotypes,...

Let"s Combinate - Drugs + Devices ·

2025/10/01

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 conversation also explores the challenges of crossing the blood-brain barrier, the importance of

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00:23:35

207 - What 99.999% Reliability Really Means

Let"s Combinate - Drugs + Devices ·

2025/09/24

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 tree analysis, robust process controls, and challenge testing—without needing impossible sample sizes.If

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00:31:59

Will AI Decide Your Next Drug/Device Approval?

Let"s Combinate - Drugs + Devices ·

2025/09/17

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 submissions, and quality oversight — and what strategies regulators and companies need to make sure speed

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00:35:15

205 - Why Less Than 20% of Companies Have Started...

Let"s Combinate - Drugs + Devices ·

2025/09/11

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 digital twins, data continuity, culture change, and Larry’s Quantum Quality Management (QQM) framework as

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00:32:44

204 - The Dictionary & Thesaurus of Combination...

Let"s Combinate - Drugs + Devices ·

2025/09/03

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 true progress requires a science- and risk-based perspective. The discussion also covers how GMP

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00:45:50

203 - Drug Delivery, Platforms, IP Battles, Supply...

Let"s Combinate - Drugs + Devices ·

2025/08/27

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, supply chain risks that pharma still underestimates, and why platform strategy is one of the most important

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00:32:12

202 - Becoming an Expert in the Work Nobody Wants to...

Let"s Combinate - Drugs + Devices ·

2025/08/20

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 risk processes across different organizations and the importance of adaptable strategies. He also recounts

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00:34:25

201 - Inside a $300M FDA Remediation, Lessons from...

Let"s Combinate - Drugs + Devices ·

2025/08/13

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 over decades, the high-stakes negotiations with FDA, and the critical role of containment, third-party

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00:17:08

200 - MedTech and Pharma After 200 Episodes…..

Let"s Combinate - Drugs + Devices ·

2025/08/06

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 credentials and true insight this episode is about what finally clicked… and what still hasn’t.It’s a thank-you to

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00:42:37

199 - How Modeling Can Cut in Half for Combination...

Let"s Combinate - Drugs + Devices ·

2025/07/30

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 prototyping cycles, support regulatory submissions, and lower test burden when applied appropriately.Mark

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00:10:51

198 - QMSR Explained, ISO 13485 Compared, and 5 Key...

Let"s Combinate - Drugs + Devices ·

2025/07/23

In this episode of Let's Combinate, host Subhi Saadeh highlights five critical aspects of the FDA's new Quality Management System Regulation (QMSR) that you may have missed. Subhi explains the historical context of QSR and ISO 13485, their 1996 origins, and the drive for harmonization that began in 2018. Key insights include the alignment with ISO 13485, additional FDA-specific expectations, the continued importance of risk management, the removal of certain industry exemptions, and the

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93 results

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