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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

00:13:09

191 - If It’s Not ALCOA+, It Didn’t Happen: The Real...

Let"s Combinate - Drugs + Devices ·

2025/06/04

You’ve heard it before: If it’s not documented, it didn’t happen. But in life sciences, documentation isn’t just a formality—it’s the foundation of trust, compliance, and product quality. In this episode, Subhi Saadeh breaks down what documentation actually means by exploring the principles of ALCOA and ALCOA+.Learn where these principles come from, how they’re applied, and why they still matter—even in today's digital systems. From FDA guidances to $500M data scandals, this episode covers what

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00:15:17

190 - Harmony, Not Sameness: What Drug-Device Teams...

Let"s Combinate - Drugs + Devices ·

2025/05/28

Episode is based on a talk Subhi Saadeh gave at CPHI. In this episode, Subhi Saadeh breaks down the three levels where true harmonization must happen for drug-device products to succeed:-Global regulatory alignment-Effective sponsor-CXO collaboration-Cross-functional teamwork between drug and device stakeholders inside companiesSubhi covers why regulatory misalignments across countries create uncertainty, how disconnected sponsor-CXO relationships lead to delays and inefficiencies, and how internal

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00:17:14

189 - FDA, ISO, ICH, USP, PDA - What Are These Groups...

Let"s Combinate - Drugs + Devices ·

2025/05/21

Ever wondered who’s really behind the regulations you follow in pharma and medical devices? In this episode of Let’s ComBinate, Subhi Saadeh breaks down the five categories of organizations that influence how we develop, test, and release products:Regulatory Authorities (like FDA, EMA, PMDA)Harmonization Bodies (like ICH, IMDRF, and PIC/S)Standards Organizations (ISO, ASTM, etc.)Pharmacopoeias (USP, JP, Ph. Eur.)Industry Groups (like PDA, MDIC, PhRMA, and more)Subhi dives into how each type

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00:15:39

188 – Certified Quality Auditor(CQA) and Audits in...

Let"s Combinate - Drugs + Devices ·

2025/05/14

In this episode of Let’s Combinate, Subhi Saadeh—an ISO 13485 certified lead auditor, CQA, and CQE—dives into the evolving role of auditing in the medical device and pharmaceutical industries. He reflects on his journey to becoming a Certified Quality Auditor and asks a timely question: in the age of AI, will audits—and auditors—still matter? Subhi outlines what separates good auditors from great ones, shares lessons from his own audit experiences, and breaks down how AI might streamline parts of

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00:16:26

187 - Why Drug and Device Development Use Different...

Let"s Combinate - Drugs + Devices ·

2025/05/07

What’s the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?In this episode of Let’s Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical device design. Learn how these two approaches tackle product realization, why they're not interchangeable, and how both are essential when building

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00:12:38

185 - 4 Ways to Future-Proof Your Career in Pharma,...

Let"s Combinate - Drugs + Devices ·

2025/04/30

In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly aimed at bioengineering students and early-career professionals. The tips include: publishing early to build visibility, understanding how industry regulations and processes work, developing interdisciplinary skills, and finding mentors for guidance. Subhi emphasizes the importance of

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00:25:51

185 - ISO 10013, Document Control in Pharma &...

Let"s Combinate - Drugs + Devices ·

2025/04/23

In this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in quality systems, which serves as the backbone of compliance. Key topics include the hierarchy of regulations, document management best practices, the intricacies of quality manuals, and the critical distinctions between SOPs and work instructions

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00:30:37

184 - Program Management in Pharma & Devices: Phase...

Let"s Combinate - Drugs + Devices ·

2025/04/16

In this episode of Let's Combinate, host Subhi Saadeh welcomes back Skip Creveling, a global expert in program management and Six Sigma methodologies.Skip shares his extensive experience helping Fortune 500 companies optimize design processes, reduce risks, and drive innovation—especially in highly regulated industries like medical devices, pharmaceuticals, and aerospace.The discussion explores Skip’s career transition from Eastman Kodak to the medical device sector, the importance of structured

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00:37:11

183 - GxP Explained: A Complete Guide to Good...

Let"s Combinate - Drugs + Devices ·

2025/04/09

Understanding GXPs: Essential Good Practices for Bioengineering ProfessionalsIn this episode of Let's Combinate, host Subhi Saadeh, a seasoned bioengineer with ten years of experience in the pharma and medical device industries, provides an in-depth exploration of good practice guidelines (GXPs). Subhi covers various GXPs including GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), and GDP (Good Distribution Practice), explaining their roles,

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00:18:42

182 - 7 Powerful Ways to Find Amazing Mentors in...

Let"s Combinate - Drugs + Devices ·

2025/04/02

In 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

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00:20:14

181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE...

Let"s Combinate - Drugs + Devices ·

2025/03/26

Discover 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

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00:25:18

180 - MIT Leadership Expert Reveals Management...

Let"s Combinate - Drugs + Devices ·

2025/03/19

🚀 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

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00:09:27

179 - Quality is NOT Everyone’s Job—Why That’s a GOOD...

Let"s Combinate - Drugs + Devices ·

2025/03/12

In 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

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00:31:22

178 - CAPA Face-Off: Pharma vs. MedTech – Key...

Let"s Combinate - Drugs + Devices ·

2025/03/05

In 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

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00:10:58

177 - The GXPs That Run Pharma & Medical Devices:...

Let"s Combinate - Drugs + Devices ·

2025/02/26

🚀 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

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00:26:20

176 - The Fastest Way to Ruin Drug/Device Development...

Let"s Combinate - Drugs + Devices ·

2025/02/19

In 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

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00:39:49

175 - Hearing Aid Innovations and Why Hearing Loss Is...

Let"s Combinate - Drugs + Devices ·

2025/02/12

🚀 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

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00:23:57

174 - How GLP-1s Like Ozempic & Wegovy Are Changing...

Let"s Combinate - Drugs + Devices ·

2025/02/05

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

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00:32:58

173 - Shelley Amster on 45 Years Trailblazing: IUD’s,...

Let"s Combinate - Drugs + Devices ·

2025/01/29

In this episode of Let's Combinate, host Subhi Saadeh interviews Shelly Amster, a trailblazer in reproductive health with over 45 years of experience. Shelly shares her journey from being one of the first IVF lab directors in the U.S. to her role as an advisor at 3 Daughters. They discuss the early days of IVF, overcoming career-related insecurities, and the challenges and advancements in fertility treatments. Shelly also talks about her experience in managing technical conferences and offers

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00:34:19

172 - Regulatory AI Innovations, Drugs@FDA Database,...

Let"s Combinate - Drugs + Devices ·

2025/01/22

In this episode of Let's Combinate, host Subhi Sadeh welcomes regulatory expert Doug Mead. Doug, who brings extensive experience in regulatory affairs for medical devices and combination products, discusses the significant role of the 'Drugs at FDA' database in navigating submission strategies. They explore how AI is being used to search through this database efficiently and reveal both the benefits and limitations of AI in regulatory processes. Doug also shares insights into the evolution of FDA’s

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86 results

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