Let's CombinateL Drugs + Devices

Episodes

Jan. 29, 2025

173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barrie…

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...

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Jan. 22, 2025

172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intel…

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 ro...

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Jan. 13, 2025

171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or …

In this episode of 'Let's Combinate,' host Subhi Saadeh delves into the challenges and complexities of working with prefilled syringes in regulatory, quality, and product development settings. Subhi, who has worked on vaccine...

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Jan. 8, 2025

The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)

By viewing ISO 13485 through the lens of interconnected Plan-Do-Check-Act (PDCA) cycles, Subhi offers a fresh perspective that simplifies the implementation of this quality management standard. He explains the structure of IS...

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Jan. 1, 2025

169 - Should You Study Bioengineering in 2025? My Decade-Long Perspec…

In this episode, Subhi Saadeh, a seasoned professional in the pharma and medical device industry, shares his insights on whether choosing bioengineering is the right career path. Drawing from his 10+ years of experience, Subh...

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Dec. 25, 2024

168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devi…

In this episode of Let's Combinate, host Subhi Saadeh discusses the significance of audits as a key appraisal activity and draws parallels with personal self-assessment inspired by Peter Drucker's book, 'Managing Oneself.' He...

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Dec. 18, 2024

167 - Smart Pills, Digital Drug Delivery Systems, and How Technology …

In this episode of Let's Combinate, host Subhi Saadeh dives into the world of digital transformation in healthcare with Dr. Timothy Aungst, a visionary pharmacist and digital health expert. Dr. Aungst breaks down digital ther...

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Dec. 11, 2024

Sync or Sink: 3 Levels of Harmonization for Combination Product Succe…

Subhi proposes a broader definition of harmonization, not just aligning regulations but also fostering synergy among drug and device teams. Subhi emphasizes the importance of creating seamless ecosystems for operational harmo...

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Dec. 4, 2024

165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLA…

In this episode of Let's Combinate, host Subhi Sadeh is joined by Marta New, CEO of Radyus Research, to discuss the importance of Target Product Profiles (TPPs) in drug development and combination products. Marta, with her un...

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Nov. 27, 2024

164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790

In this episode, Subhi Saadeh delves into the specifics of USP chapters 788 and 790, which focus on the testing and acceptance criteria for sub-visible and visible particles in injectable drug products. He explains the import...

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Nov. 20, 2024

163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's…

In this episode of Let's Combinate, host Subhi Saadeh delves into the significance of ICH Q12 for the pharmaceutical industry, especially concerning established conditions and drug-device combination products. Subhi explains ...

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Nov. 12, 2024

162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid T…

In this episode, Subhi delves into 'Quality is Free' by Philip Crosby, a seminal book in quality management. Highlighting its personal significance, the host discusses the core concept that quality, when properly managed, inc...

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Nov. 6, 2024

161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in M…

In this episode of Let's Combinate, host Subhi Saadeh explores the essential frameworks of risk management in medical devices and pharmaceuticals: ISO 14971 and ICH Q9. He discusses the origins, key elements, similarities, an...

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Oct. 30, 2024

160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!

In this episode of *Let's Combinate*, Subhi delves into the critical distinctions between drug tech transfer and device design transfer, especially pertinent to combination products. Sue comprehensively outlines the regulator...

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Oct. 23, 2024

159 - Centralized, Decentralized & Federated Quality Models, McKinsey…

In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across various organizational structures. Through their engaging discussion, they highl...

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Oct. 16, 2024

158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Proces…

In this episode, host Subhi reflects on three years of podcasting, drawing analogies to strength training and discussing the incremental progress achieved. The episode highlights the importance of consistency in podcast produ...

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Oct. 9, 2024

157 - Design Inputs that Don't Suck, Risk Control Measures and Proble…

In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked topic of design inputs in product development. Chuck highlights how poor d...

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Oct. 2, 2024

156 - Combination Product Governance, Big Pharma to Medical Device St…

On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc. On this episode, Laxman, highlights the differences in regulatory oversight and risk management bet...

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Sept. 25, 2024

155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led In…

On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combina...

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Sept. 18, 2024

154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinic…

On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs,...

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Sept. 11, 2024

153 - USP 382, Elastomeric Component Functional Suitability, Delivery…

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 38...

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Sept. 4, 2024

152 - Global Medical Device Podcast Interview: Behind the Combinate P…

This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru (Episode #380) . In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Po...

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Aug. 28, 2024

151 - Primary Packaging/Container Closure Change Guidance, Post-Appro…

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses: 00:00 Introduction 02:29 Unders...

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Aug. 21, 2024

150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, G…

On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses: 00:00 Welcome to Episode 150! 03:00 Challenges and Innovations in Ocular Drug Delivery 09:30 Un...

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