Let's Combinate - Drugs + Devices

🚀 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. Ben Locwin discusses the science, quality, and future...

🚀 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 Saa...

🚀 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 Sad...

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 vaccines, biologics, and small molecules in prefilled syringe systems He explores what makes a prefilled syringe a combination product and explains the varying regulatory requirement...

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 ISO 13485, highlighting how each clause aligns with PDCA, and provides practical examples of applying this cycle to different processes within the standard. Subhi emphasizes tha...

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, Subhi discusses the differences between bioengineering and biomedical engineering, the pros and cons of studying bioengineering, and how to approach this field in 2025. He emphasi...

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 emphasizes the value of understanding one's learning style and values in personal development. Subhi delves into the different types of audits, including internal, second-par...

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 therapeutics, smart drug delivery systems, and wearable technology. He elaborates on the nuances of digitalization, digital transformation, and how these concepts are reshaping th...

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 harmony, addressing both internal and external collaborations. Additionally, Subhi explores the complexities of regulatory differences between regions, advocate for standardized qu...

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 unique background as a venture capitalist turned CRO founder, shares her insights on how TPPs serve as strategic documents that align clinical goals, regulatory requirements, an...

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 importance of these standards in preventing health risks such as embolisms and allergic reactions. The episode outlines the methods used for testing, including light obscuration and...

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 how Q12 enhances lifecycle management, streamlines post-approval changes, and improves regulatory alignment. He breaks down critical concepts such as established conditions, p...

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, incurs no extra cost, aligning with prevention rather than fixing issues. The episode dissects five erroneous beliefs about quality, including the idea that quality equates to lu...

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, and differences of these standards and guidelines, explaining their application in the development and manufacturing of combination products. Saadeh also highlights the definiti...

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 regulatory frameworks governing each process—ICH Q10 for drug transfer and ISO 13485 for device design transfer. The episode discusses key elements like analytical method transfer and...

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 highlight the independence of quality units to prevent conflicts of interest, drawing parallels with finance and HR functions. They examine models like centralized, decentralized,...

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 production, inspired by Robert Greene's 'Mastery,' and outlines plans for the show's future evolution. 00:00 Welcome and Podcast Journey 00:39 Strength Training Analogy 02:10 Refle...

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 design inputs can slow down product development and lead to issues in market compliance. He stresses the importance of spending adequate time on creating design inputs and the...

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 between medical devices and pharmaceuticals, the trend towards home administration of drugs, sustainability goals, and the challenges posed by longer-acting drugs, higher viscosi...

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 combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie discusses the definitions, scope, and expectation...

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, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma environments and startups, shedding light on the sig...

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 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system and the impact of sterilization processes on...

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 Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and Definitions 13:46 Challenges and Misconceptions...

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 Understanding the FDA's New Guidance: 05:05 Challenges in Supplier Management and the 08:22 Navigating Change Management 11:43 Insights on Regulatory Compliance 25:26 The Im...

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 Understanding Intravitreal Injections 13:26 Regulatory Considerations for Ocular Products 20:48 Innovations in Glaucoma Treatment 29:18 The Personal Impact of Vision Loss 35:...