x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

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

00:22:30

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

en

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

en

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

en

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

en

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

en

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

en

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

en

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

en

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

en

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

en

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

en

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

en

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

en

00:13:50

197 - Quality Agreements Explained: How to Protect...

Let"s Combinate - Drugs + Devices ·

2025/07/16

In this episode of Let’s Combinate, host Subhi Saadeh breaks down the critical role of quality agreements in the pharmaceutical and medical device industries.A quality agreement is a written document that defines GxP responsibilities between parties—such as sponsors, product owners, and contract partners. It doesn’t cover business terms like payments or IP: instead, it focuses on quality responsibilities and operational accountability.Subhi explores regulatory expectations from the FDA, ICH Q10, and

en

00:08:21

Combi Crumbs: Clinical Trials 101 – From Safety to...

Let"s Combinate - Drugs + Devices ·

2025/07/12

From Episode 195 with Archana SahIn this clip of the larger interview with Archana Sah, she covers the critical phases and elements of clinical trials—from phase one focusing on safety to phase three assessing effectiveness in diverse populations. Key aspects include the importance of the trial design, the role of comparator arms, regulatory requirements, patient recruitment, and the cultural preferences that influence trial protocols. The episode provides an in-depth look at how data is collected

en

00:09:38

196 - How to Win Your First 90 Days in Pharma and...

Let"s Combinate - Drugs + Devices ·

2025/07/09

In this episode, I go over 8 lessons to maximize your first 90 days in Life Sciences. These include understanding the impact of their roles, adopting a professional mindset, passing the first 90-day test, avoiding the 'silent trap,' finding mentors, valuing feedback, mastering systems, and taking responsibility for their careers. Subhi emphasizes that these lessons can significantly accelerate growth and career advancement for newcomers to the industry.Link to course:

en

00:47:41

195 - Clinical Trial Design, Oncology Innovation &...

Let"s Combinate - Drugs + Devices ·

2025/07/02

In this episode of Let's Combinate, Archana shares her insights on the critical factors involved in designing clinical trials, from phase one safety profiling to pivotal phase three trials. She also discusses the importance of patient diversity, the ethical considerations in clinical research, and the future of clinical trials, including decentralized trials and the use of advanced technologies. The conversation highlights the intricate balance between maintaining rigorous scientific standards and

en

00:19:32

194 - Drug Delivery Innovation, Networking in Pharma,...

Let"s Combinate - Drugs + Devices ·

2025/06/25

In this episode I sit down with Mike Denzer, a mechanical engineer, inventor, and trusted leader in the combination product space. We talk about the power of networking not just as a tool for finding your next job, but as a foundation for building a meaningful and resilient career in pharma and medtech.Mike shares what it’s like to develop life-changing devices like Amgen’s Auto Click autoinjector, how he built credibility across R&D and regulatory teams, and why asking good questions and being

en

00:47:17

193 - Bioengineering Grads: Here’s What Recruiters...

Let"s Combinate - Drugs + Devices ·

2025/06/18

In this episode of Let’s Combinate, host Subhi Saadeh is joined by Kirk Petyo, Managing Partner at Talent Factory Medical and founder of Talent Factory Recruiting. If you're a bioengineering student, recent grad, or early-career professional trying to break into medical devices, biotech, or pharma—this one's for you.With extensive experience recruiting for regulated industries like aerospace, medical devices, and pharmaceuticals, Kirk offers grounded, actionable insights for early-career

en

00:04:35

192 - What Is a Drug/Device Combination Product?...

Let"s Combinate - Drugs + Devices ·

2025/06/11

If you’ve ever wondered what a combination product is—or how to explain it—this video breaks it down clearly and simply. This is a non-technical, high-level explanation of what a combination product is. It’s meant for anyone who works in or around pharma, medtech, or biotech and wants a clear, shareable reference—without getting into detailed regulatory definitions or region-specific nuances.I’m Subhi Saadeh, and I’ve spent my career in drug-device combination products. In this short reference

en

86 results

Similar Podcasts

X Minus 1 - Old Time Radio Show

Inception Point Ai

Science, Spoken

WIRED

This Week in Space (Audio)

TWiT

DarshanTalks Podcast

Darshan Kulkarni

The Best of Coast to Coast AM

iHeartPodcasts and Coast to Coast AM