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Subhi Saadeh

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$Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices200 - MedTech and Pharma After 200 Episodes…..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 you, the listener, and a remind...2025-08-0617 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices199 - How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark BurchnallIn 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 disucsses:Why modeling is often misunderstoodWhen it can replace (or complement) traditional te...2025-07-3042 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve MissedIn 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 urgent two-year compliance timeline ending in February 2026. Subhi emphasizes the necessity of updating internal quality management systems and training staff to meet these new regulatory requirements.Timelines:00:00 Introduction to...2025-07-2310 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices197 - Quality Agreements Explained: How to Protect Yourself When Things Go WrongIn 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 ISO 13485, emphasizing that even when work is outsourced, responsibility always stays with the product owner. He outlines five key sections every quality agreem...2025-07-1613 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices196 - How to Win Your First 90 Days in Pharma and MedTechIn 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: subhisaadeh.gumroad.com/l/6figurebiomedical00:00 Introduction: Starting Your Career Journey00:54 Lesson 1: Your Role Can Have a Big Impact02:55 Lesson 2: Adopting a Professional Mindset04:06 Lesson 3: The First 90 Days Are Crucial05:09 Lesson 4...2025-07-0909 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana SahIn 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 adapting to new methodologies to enhance patient recruitment and data integrity. Time Stamps: 00:00 Welcome and Introduction 00:28 Understanding Clinical Trial Design 00:58 Phases of Clinical Trials 02:27 Oncology Trials and Patient Pathways 05:00...2025-07-0247 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike DenzerIn 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 generous with your time pays off more than any formal title. If you’ve eve...2025-06-2519 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices193 - Bioengineering Grads: Here’s What Recruiters Actually Want to See in 2025In 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 professionals and hiring managers alike.This episode covers how to craft a strong resume, the importance of knowing your career “why,” how to stand...2025-06-1847 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)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 video, I walk through:- What defines a combination product- Two key factors: primary mode of action and how compon...2025-06-1104 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data IntegrityYou’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 goes wrong when data integrity isn’t taken seriously.⏱️ Timestamps:00:00 – Introduction: Why Documentation Still Matters01:24 – Defining Data Integrity in...2025-06-0413 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting WrongEpisode 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 friction between pharma and device functions can stall programs even when the science is sound.Timestamps:00:00 – Introduction: The Reality of Drug-Device Combination Products00:39 – Identifying the Core Issues in Combination Product Development01:38 – What Are Drug-Device Combination Produc...2025-05-2815 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?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 contributes to the rules, expectations, and gray areas that define your work — and how to figure out which ones really matter when y...2025-05-2117 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices188 – Certified Quality Auditor(CQA) and Audits in the FutureIn 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 the audit process. But he makes a clear case: while AI can assist, it can’t repl...2025-05-1415 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)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 safe, effective, and compliant combination products.Whether you work in drug development, medical devices, or the sp...2025-05-0716 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTechIn 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 learning for its own sake and seeking out diverse experiences to enhance one's career prospects in the highly regulated field of bioengineering.00:00 Introduction...2025-04-3012 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron SnyderIn 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. Additionally, they explore the interconnectedness of document control and training, emphasizing the importance of defined roles and responsibilities within organizations. Listeners are provided with insights into establishing...2025-04-2325 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs ExplainedIn 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 program management, phase gate processes, and the balance between going fast and ensuring thorough planning.Skip also delves into the differences between simple and comp...2025-04-1630 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated ProductsUnderstanding 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, regulations, and importance in ensuring the safety, efficacy, and quality of medical devices and pharmaceuticals. He discusses how these frameworks integrate to form a comprehensive approach that governs the lifecycle of medical products from...2025-04-0937 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and PharmaIn 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 forms of mentorship, like books and advanced tools. Subbi concludes that mentorship is about being open, curious, and willing to learn from various sources.2025-04-0218 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?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 ampules, despite the industry's shift towards vials and pre-filled syringes. He elaborates on the time and cost factors that make transitioning to pre-filled syringes challenging for...2025-03-2620 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices180 - MIT Leadership Expert Reveals Management Secrets for Scientists!🚀 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 leadership coach, discusses her book's key topics, including effective hiring, delegation, transitioning from individual contributor to team manager, and managing different personalities. They delve into the challenge of balancing technical work...2025-03-1925 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices179 - Quality is NOT Everyone’s Job—Why That’s a GOOD ThingIn 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 like ISO 13485 and 21 CFR 820, noting how they mandate management's responsibility for quality systems. The discussion extends to real-world examples, including the Ranbaxy scandal, to illustrate the dire...2025-03-1209 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to KnowIn 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 handled differently under respective quality systems. The conversation also touches on topics like root cause analysis, verification of effectiveness, and the...2025-03-0531 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED🚀 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 explains various GXPs, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Pharmacovigilance Practices (GVP), and Good Automated...2025-02-2610 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric SugalskiIn 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 highlights the value of giving design firms creative space, the importance of early user research, and the impact of timing and market readiness on...2025-02-1926 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau🚀 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 experience in the medical device industry, focusing on hearing innovations. Bill discusses his journey in the ear, nose, and throat field, including his motivation to...2025-02-1239 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin🚀 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 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 influenc...2025-02-0523 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's🚀 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 Shelley Amster, a trailblazer in reproductive health with over 45 years of experience.Shelley shares her journey from being one of the first IVF lab directors in the U.S. to her role as an advisor at 3Daughters...2025-01-2932 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead🚀 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 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...2025-01-2234 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?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 requirements across different regions, including the US, EU, China, and Japan. The episode emphasizes the importance of understanding these differences to ensure success in product development and market approval. Saadeh also invites viewers to engage and provide feedback in the comments section.00:00...2025-01-1307 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices170 - 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 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 that ISO 13485 is more than a rule book; it's a guide for continuous improvement and real-world application in the medical device field. 00:00 Introduction to Game-Changing ISO 13485 Insight 01:24 Understanding ISO 13485 as a Guide 02:11 ISO 13485 Structure and Clauses 03:56 Plan, Do, Check, Act (PDCA) Cycle Explained 05:44 Applying PDCA...2025-01-0809 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices169 - Should You Study Bioengineering in 2025? My Decade-Long PerspectiveIn 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 emphasizes the importance of technical skills, networking, and adapting to a competitive, fast-paced, and evolving industry. Additionally, Subhi provides practical advice for high school and early college students considering this major, highlighting key skills to develop and strategies to stand out in...2025-01-0116 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal GrowthIn 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-party, and third-party audits, and explains their unique purposes and importance. The episode highlights the relevance of audits in maintaining quality and compliance in the pharma and medical device industries, while also offering best practices for effective audit management. Subhi invites listeners...2024-12-2513 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy AungstIn 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 the pharmaceutical and healthcare industries. The discussion also touches on the evolving role of pharmacists in a tech-driven healthcare landscape, the impact of AI, and the regulatory challenges in adopting new technologies. 00:00 Introduction to Digital Apothecary with Dr. Timothy Ongst 01:00 Understanding Digital...2024-12-1841 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices166 - Sync or Sink: 3 Levels of Harmonization for Combination Product SuccessSubhi 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 quality agreements, and stress the significance of relationship management between sponsors and contract organizations (CXOs). The ultimate goal is to achieve regulatory and operational harmony within the combination products space. 00:00 Introduction and Personal Insights 00:28 Defining Harmonization 02:38 Challenges in Regulatory Harmonization 03:43 Operational Harmony and Internal Collaboration 10:38 Sponsor and CXO Harmonization 14:15...2024-12-1120 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta NewIn 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, and market strategies. The discussion delves into the key sections of a TPP, such as target indication, efficacy benchmarks, safety and toxicology, and regulatory strategy. Marta emphasizes the critical role of TPPs in preclinical stages and their impact...2024-12-041h 10 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790In 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 microscopic particle count tests, as well as the required visual inspections for visible particles. Subhi also discusses the differences in scope between USP and ISO standards and emphasizes the critical role of operator training and clean handling practices in ensuring...2024-11-2713 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma LifecycleIn 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, product lifecycle management (PLCM), and post-approval change management protocols (PACMPs). Subhi outlines the benefits and challenges of adopting ICH Q12 and encourages listeners to familiarize themselves with its guidelines. 00:00 Introduction and Welcome 00:31 Topic Overview: ICH Q12 and Established Conditions 01:01 Understanding ICH Q12: Life Cycle Management 02:26 Importance of Post...2024-11-2011 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)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 luxury, that it is intangible and immeasurable, and that quality issues stem from workers or are confined to the quality department. Emphasizing a holistic and preventative approach, the discussion reflects on different quality philosophies and the importance of...2024-11-1217 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination ProductsIn 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 definitions of risk, historical developments, and updates in these frameworks, particularly ICH Q9's recent refinements on managing subjectivity and the formality of risk assessments. The episode compares the structured approach of ISO 14971, focused on patient safety through the entire lifecycle of medical devices, with...2024-11-0624 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices160 - 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 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 process validation for drugs, and the DHF and risk management in device design. Subhi looks into the differing complexities, regulatory submissions, and validation requirements for both processes. The episode concludes with commercializing combination products, emphasizing project management, regulatory submissions, and post-market surveillance. 00:00 Introduction to Co...2024-10-3019 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben LocwinIn 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, and federated structures, supported by industry benchmarks and practical experiences. The conversation emphasizes the necessity of centralized ownership for consistent quality outcomes, despite quality being everyone's responsibility. Additionally, they explore the nuances within pharmaceutical companies, referencing a McKinsey study that underscores the importance of...2024-10-2322 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the ShowIn 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 Reflecting on Three Years 04:11 Significant Life Update 05:46 Lessons Learned and Trusting Others 07:37 Podcasting Process and Scheduling 10:34 The Challenges of Editing 11:21 Finding the Right Tools 12:11 Promotion and Growth 12:56 Consistency and Sustainability 13:07 Starting a Podcast: Advice and Reflections 15:52 The Future of the Show 20:12 Engaging with Listeners 21:12 Final Thoughts...2024-10-1621 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck VenturaIn 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 benefits of concurrent engineering to refine specifications. The discussion also covers the relationship between design inputs and risk controls, and Chuck introduces his Design Input Essentials course aimed at helping companies accelerate product development. 00:00 Welcome to the...2024-10-1021 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. CampbellOn 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 significant time and resource investments required for successful IVD development. ---------------------------------- Chapters: Exploring In Vitro Diagnostics with Devin Campbell In this episode of the Combinate Podcast, host Subhi Siddek welcomes back Devin Campbell, founder and managing director of...2024-09-1837 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi SaadehThis 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 in the Industry 20:47 Evolution of Regulations: QMSR and Part 4 22:05 Exploring Unique Podcast Episodes 25:56 The Pyramid of Regulations 30:40 The Role of Coaching and Mentorship 32:59 Trends in Combina...2024-09-0440 min

Global Medical Device Podcast powered by Greenlight Guru

Global Medical Device Podcast powered by Greenlight Guru#380: Navigating the Complex World of Combination Products with Subhi SaadehIn this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Subhi Saadeh, host of the Combinate Podcast and an expert in the field of combination products. They explore the complexities of combination products—those that integrate drugs, devices, and biologics—highlighting the regulatory challenges and industry growth. Subhi shares his personal journey in podcasting, the impact of consistent content production, and the importance of lifelong learning. They also dive into the intricacies of combination product definitions, regulatory pathways, and trends, offering listeners a well-rounded view of the current state and...2024-08-3038 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi SaadehThis is a solo episode. On this episode, Subhi goes through: 01:51 Draft FDA Guidance - Platform Technology Designation Program for Drug Development Guidance for Industry 13:03 EMA Guidance - Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746) 18:25 USP - USP-Listed Device Monographs and Recommendations for Product Quality and Performance Testing of the Drug Component of Combination Products 20:10 Race Recap: Sugar Badger 50K 26:51 Conclusion 2024-06-0527 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi SaadehOn this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024. 0:00 Introduction 05:09 Initial Reactions to the idea of the QMSR 06:57 History of the Device cGMP's, QSR, and QMSR 11:52 What's changing in 21 CFR 820? 24:59 What's changing in 21 CFR 4 and Combination Products 33:20 Comments Review and Final Thoughts Links: QMSR Final Rule Amendments: https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments QMSR Final Rule FAQ: https://www...2024-02-2842 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices120 - EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El AzzouziIn this special episode of the comedy podcast, host Subhi Sade welcomes Munir Al Azouzi, the founder of Easy Medical Device. Munir shares his expertise on the often confusing topic of the EU’s Medical Device Regulation (EUMDR), focusing on the distinctions between roles such as legal manufacturer, distributors, importers, authorized reps, and persons responsible for regulatory compliance. Munir explains the need for compliance checks, supply chain management, traceability documentation, and regulatory responsibilities in the context of the EUMDR. He also discusses his company's role as an authorized representative, importer, and consultant, and the various se...2024-01-2443 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices111 - 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi SaadehOn this solo episode, I go through a list of 7 books I recommend for med tech, biotech and combination product professionals. The books are: Quality is Free by Phillip Crosby The Combination Products Handbook by Susan Needle What Country has the Best Healthcare by Ezekiel Emanuel Switch by Dan and Chip Heath Managing Oneself by Peter Drucker Bottle of Lies by Katherine Evan The Pyramid Principle by Barbara Minto I find that I read a lot more in December so wanted to give you all some recommendations this Thanksgiving week. Happy Thanksgiving!2023-11-2219 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices105 - Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi SaadehOn this episode, I reflect on 8 lessons I learned from recording 100 Episodes of the Combinate Podcast and Ironman Chatanooga. Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a...2023-10-0427 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan NeadleOn this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss: Part 1 of The Combination Products Handbook: A Practical Guide to Combination Products and Other Combined Use Systems: Foundation Subhi's questions on each chapter What she learned from authoring and coordinating of the book Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press. Her leadership, innovation...2023-06-2840 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices088 - Production Part Approval Process(PPAP) with Subhi SaadehOn this episode, I outline an introduction to one of my favorite APQP tools, Production Part Approval Process(PPAP): - What is PPAP - Inputs, Process, Triggers and Interactions - PPAP Elements and Tools - The difference between first article inspection(FAI) and Capability Studies - Applications and Challenges in use Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations t...2023-06-0721 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi SaadehThis solo episode walks through 8 of the quality lessons I learned by losing 100lbs over the last 10 years. They are: Change takes time Change starts from a small decision More pain does not equal more pain/Quality is free. Prevention is part of performance Environment is as critical as habit Managing constraint changes as the quality journey evolves Quality is conformance to requirements Data is important. MY data is the most important. Outperforming a bad process is complacency waiting to happen I hope you enjoyed this solo episode! Wishing you all the best and a happy holiday s...2022-12-2829 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices043 - “Half Knowledge Can Hurt” with Shadeed SalamOn this episode of the podcast, I was joined by Shadeed Salem, the Founder and President of Synergy Bioscience. Shadeed and I discuss: -War Stories in method validation and NCR/OOS's -What is it that you're going to test and what are you testing for? -Differences between drug and device methods including Analytical, Physical, Mechanical and Visual methods -Method Development vs. Method Validation -How to treat compendia methods (USP, ISO, etc) -Specificity, Bias, Linearity, Gage R&R Shadeed Salem MSc MBA CQE CQMOE CQA CSSBB CPGP is an industry matter expert with proven expertise in the establishment and remediation of...2022-07-271h 14 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices042 - “Reproducible within Limits”On this episode of the podcast, I walk through some of the takeaways I got from reading "Statistical Method from the Viewpoint of Quality Control" by Walter A. Shewhart. ---------------------------------------------------------- Who Was Walter Shewhart? Link 2022-07-2020 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices041 - “Health Citizenship” with Jane Sarasohn KahnOn this episode of the podcast, I was joined by Jane Sarasohn Kahn of Health Populi and THINK-Health. Jane and I discuss: - US Healthcare System - Healthcare economics before Healthcare economics - Her Book: Health Consuming - Health Consuming vs. Health Citizenship - US vs. European Healthcare systems Jane is a health economist, advisor and trend-weaver to organizations at the intersection of health, technology and people. Jane founded THINK-Health after working with health care consultancies in the US and Europe. Jane’s clients span the health/care ecosystem: technology, pharma and life sciences, providers, plans, financial services and consumer go...2022-07-131h 09 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices040 - “Good Science is Good Science” with Ben LocwinOn this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - Behavioral Neuroscience and the soft skills of Quality - Quality, Compliance and Risk Management - Pharmacogenomics and Orwell - Combination Products Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.2022-07-0650 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices039 - "The Camera Didn't Make the Artist Obsolete" with John NostaOn this episode of the podcast, I was joined by John Nosta of NostaLab. John and I discuss: -Pharmaceutical Innovation in the last several decades -Patient-Centricity in Pharma -Innovation vs. Implementing Existing Technologies -Genius Being a Birthright & Mediocrity Being Self imposed -Telemedicine & Digital Health -Decentralized Clinical Trials - Artificial Intelligence, Wonder and Fear John Nosta is the founder of NOSTALAB—a digital health think tank recognized globally for an inspired vision of transformation. His focus is on guiding companies, NGOs, and governments through th...2022-06-291h 04 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices038 - "Clinical Trials" with Dan SferaOn this episode, I was joined by Dan Sfera, aka "The Clinical Trials Guru". Dan and I discuss: Clinical Trials from the View of the Patient and the link to Primary Care Institutional Review Boards Informed Consent Patient Accrual, Inclusion/Exclusion and Screen Failure Role of the Sponsor Sponsor/CRO/Study Site Dynamics Roadblocks in Clinical Research Decentralized Clinical Trials Dan Sfera is the Founder and Site Director of Yuma Clinical Trials, Founder of the CRA and CRC Academies, Co-Founder of DSCS Sweat Equity and Investments, and one of the Author's of the Comprehensive Guide to Clinical...2022-06-221h 13 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices037 - Reflections #1 - (Episodes 001-25)On this episode I go through the lessons I've learned through the podcasting process, and reflect on the first 25 episodes of the Combinate Podcast. Constructive Feedback or Guest Suggestions can be made at letscombinate.com 2022-06-1534 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices036 - "Those Moments Keep You Grounded" with Yousef ArmanOn this episode of the podcast, I was joined by Yousef Arman, Founder of The Vial Store. Yousef and I discuss: His background growing up around Pharmacists and Pharmacies What starting a Pharmacy Requires and Day to Day Operations Pharmacy Pricing/Costs and how they make money Demand Planning, Formularies and how pharmacies always seem to have medications The role of Specialty Pharmacies in developing areas The Vial Store and where the idea came from Yousef's Articles: The Evolution of Pharmacy – A Short History Part 1 – The Ancients: Link The Evolution of Pharmacy – A Short History Part 2 – The Middle...2022-06-0842 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices035 - “Safety is Safety” with Khaudeja BanoOn this episode, I was joined by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss: - Safety function (Drug vs. Device) - 21 CFR Part 4 Subpart B - Specific Post-Market Safety Reporting Expectations - Industry Challenges with implementing PMSR Requirements - Working in Quality with a background in Safety - Self Marketing, Toastmasters and Professional Development Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held m...2022-06-0147 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices034 - "Agent" with Mitch RobbinsOn this episode, I was joined by Mitch Robbins, founder of the Anthony Michael Group based in Denver, Co. Mitch and I discuss: - How he got into recruiting - The business model for recruiting (contract, retained, engaged) - Interview Matrix - interview strategies for objective unbiased candidate selection - The overall recruiting/hiring process and some of the tools AMG uses to find the best candidates (Market Mapping, Intake Calls, and More) - How to select the best candidate by using a case study or test drive 2022-05-2554 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices033 - "Specialization" with Erik BarkleyOn this episode of the podcast, we go off our normal topics within BioTech and MedTech and discuss a topic that is near and dear to me; Coffee! I was joined by my friend Erik Barkley, Founder and Owner of Tugboat Coffee Roasters. Erik and I discuss: - How Erik and I met a few years ago - How he works with coffee farms around the globe - The life of a coffee bean: growing, processing, roasting and brewing - The roasting process - What some of the grading...2022-05-181h 10 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices032 - “Quality is Free”In this episode I walk through some of the concepts of the book "Quality is Free" by Phillip Crosby. ------------------------------------------------------------ Amazon Link to the Book: Link ----------------------------------------------------------- Who Was Phillip Crosby(From ASQ): Philip B. Crosby was a legend in the discipline of quality. A noted quality professional, consultant, and author, he is widely recognized for promoting the concept of "zero defects" and for defining quality as conformance to requirements. Crosby's career as a quality professional began in 1952 after serving in World War II and Korea. In 1979, he founded...2022-05-1123 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices031 - "The Five Stages Of Regulatory Grief" with Michelle LottOn this episode of the podcast, I was joined by Michelle Lott of Lean RAQA. Michelle and I discuss: - Her background starting at a manufacturing site and moving into QA and RA - Being Outspoken and Honest - What she's observed between large and small organizations - Her Experience being an industry rep on the FDA Device GMP Advisory Committee - Regulations vs. Guidance's and how they come about - The 5 stages of regulatory grief - QMSR Harmonization - Audit Preparation ...2022-05-041h 19 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices030 - "Why Don't I Try?" with Marc KoskaOn this episode of the Combinate Podcast, I was joined by Marc Koska, Founder of Apiject. Marc and I discuss: The Importance of Understanding a Problem Developing Models for Courtrooms in the US Virgin Islands How he discovered the problem with Syringe Re-Use and HIV The development of the K1 Syringe How he drove the outlawing of reusable syringes in India Some Problems of Pre-Filled Delivery Systems Currently The Apiject BFS Design Future of Apiject and Solving Drug Delivery Challenges The importance of Self Motivation Biomimicry Marc Koska is best known for his breakthrough invention the K1...2022-04-271h 37 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices029 - "Purpose" with Marla PhillipsOn This Episode, I was joined by Marla Phillips of Pathway for Patient Health. Marla and I discuss: Pathway for Patient Health Training the Next Generations - What students can do? Quality for the 21st Century Chief Quality Officer Forum FDA/Industry Collaborations How Xavier Health Came to be and the Future of Xavier Health Supply by Design The importance of doing things with purpose ------------------------------------------------------------- Pathway for Patient Health: Link Pathway for Patient Health Quality Science Program : Link Pathway for Patient Health Hiring Portal: Link Good Supply Practices/Supply by De...2022-04-201h 34 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices028 - "How Much Does Poor Quality Cost?" with H. James HarringtonThis is Part 2 of the episode with H. James Harrington PhD of Harrington Management Systems. On this part of the episode Dr. Harrington and I discuss: His Book - Poor Quality Costs(PQC) Why Cost of Quality has a bad connotation to it Direct vs. Indirect Poor Quality Costs White Collar Poor Quality Costs and Process Ownership/Optimization Burying the problem vs. Putting it to bed Problems and impact on customer retention Starting a PQC System and how to prioritize in implementation Executive Management Errors & PQC --------------------------------------------------------------------------------------------------------------- Dr. H. James Harrington has a decorated career wit...2022-04-131h 10 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices027 - "Become a Historian of the Problem" with Duane ManciniOn this episode, I was joined by Duane Mancini, CEO and Managing Partner of Project Medtech and host of the Project Medtech Podcast. Duane and I discuss: Why he enjoys working with Startups Reimbursement considerations for Startups Importance of Regulatory Strategy for Startups Project Medtech and Medtech Money Podcasts Startup Symposiums Combination Products Startups Startup Symposium in Columbus, OH on 15-Jun-2022 - Register here Book Recommendation: Your Life Depends on It: What You can do to make better choices about your health Link ------------------------------------------------------------------------------------------------------------------------------------------------------ Duane Mancini is a chemist by training and holds a Master of Science degree in Medicinal...2022-04-0659 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices026 - "Quality" with H. James HarringtonThis is Part 1 of the episode with H. James Harrington PhD of Harrington Management Systems. On this part of the episode Dr. Harrington and I discuss: His first experience in Quality at 6 years old The evolution of Quality over the last century Quality in a service vs. a product What the "Gurus" of Quality were like: Juran, Ishikawa, Feigenbaum, and Crosby ISO:56002 and the Innovation Process Considered one of the Quality "gurus" ------------------------------------------------------------------------------------------------- Dr. H James Harrington has a decorated career with 40 years at IBM, 10 years at Erns...2022-03-3050 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices025 - “The Frying Pan to the Fire” with Edwin BillsOn this episode of the podcast we had Edwin Bills, a Risk Management Expert that was on the committees for ISO14971:2019, ISO TR24971:2020 and AAMI TIR 105:2020. Ed and I discuss Combination Products Risk Management including: His background as an educator Entering Quality after being taught by some of the quality gurus in the 1980's The history of Risk Management in medical devices and what it was like before ISO 14971 Advice for how someone new should look at the risk management documents and standards ISO 14971:2019 Medical devices — Application of risk management to medical devices ISO TR 24971:2020 Guidance On The Application Of IS...2022-03-231h 31 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices024 - "Operating Under Constraints "with Naveen AgarwalOn this episode of the podcast, Naveen Agarwal PhD from Creative Analytics Solutions. Naveen and I discuss: Running almost 1500 miles and the importance of constraints Risk Management Vigilance vs. Surveillance Customer Experience focused Quality Improvement and Post-Market Surveillance Common Issues with P1/P2 Implementation Data Based Decision Making Frameworks Methods NIST Malcolm Baldridge Award Appraisal Toastmasters Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved...2022-03-161h 12 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices023 - "The Best is Yet to Come" with David AlbertOn this episode of the podcast we had Dr. David Albert of AliveCor, a medical doctor, scientist and entrepreneur who has founded several successful companies and ventures in MedTech like AliveCor and others that have been acquired by companies like GE Healthcare. Dr. Albert and I discuss: Pursuing a Career and Family Simultaneously Becoming an Inventor Physician by Chance The unexpected reception that started AliveCor His inventions and Patents The importance of being optimistic and opportunistic The lessons he learned having created 4 businesses His amazing fire alarm inventions under Lifetone Technologies Artificial Intelligence in remote patient monitoring devices David Albert, M...2022-03-091h 06 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices022 - "What Chapter are you in?" with Susan NeadleOn this episode, we were joined by Susan Neadle. If you work on Combination Products, Susan is someone you need to know. Her and I discuss: Her career starting in consumer health and pivoting into Medical Devices then Pharmaceuticals Design to Value, Design Excellence and Process Excellence The History of Combination Products regulation and what it was like implementing 21 CFR Part 4 as it was revealed. Creating future plans using tools like the Merlin Exercise, and Future/Back Vocabulary in Combination Products AAMI TIR 48 and TIR 105 Her involvement in ASTM, AAMI, ISPE, FPIA, DIA, AFDA, TOPRA and RAPS Prioritization, Passion and...2022-03-021h 23 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices021 - "Options" with Karandeep Singh BadwalOn this episode of the podcast we had Karandeep Singh Badwal. Karandeep and I discuss: Why QA/RA is the place to be (if you're so inclined) Intended Use, Indications and Use cases Where software startups struggle Eudamed Cybersecurity Artificial Intelligence in Medical Devices SaMD and Digital Health Considerations related to the MDR Impact of Brexit on existing and future products within the EU and UK Robert Green and his books His Podcast: The Med Tech Podcast ------------------------------------------------------------ Karandeep is a QA/RA consultant and host of The MedTech Podcast with a mission to help...2022-02-231h 03 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices020- "The Right Words" with Kathy WalshOn this episode we had Kathy Walsh, Director and Principal at Quality Systems. Kathy and I discuss: Her Book: "Eliminating the Gobbledygook: secrets to writing plain language procedures" Her background starting as a PhD Microbiologist and moving into Quality Systems/Technical Writing Where most companies have issues with their procedures Plain Language Skills: Active voice vs. passive voice, Process Mapping, Inference Building, Sentence Parsing, document structure and more The origins and history of "plain language" The history of Fonts How to make for more efficient document reviews and advice she has for writing technical documents and procedures Dr...2022-02-161h 42 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices019 - "Carrying The Bag" with Omar M KhateebOn this episode of the podcast we had Omar M Khateeb, the host of the State of MedTech, and Founder of Khateeb&Co where he Helps MedTech Companies Grow Sales & Drive Product Adoption Using Social Media. Omar and I talk about him leaving medical school to pursue his purpose, intuition vs. ego, the death of the existing medtech sales process and where it's going post-pandemic, MedTech and the Metaverse, and the power of reading & taking action. Omar M. Khateeb is a marketing leader who has developed marketing strategies at two publicly traded surgical robotic companies through their IPOs as well...2022-02-091h 31 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices018 - "The Optimist Plans for Forever" - with Sarfaraz NiaziOn this episode of the podcast, we had Professor Sarfaraz Niazi, a "Renaissance Man" if I ever met one. We discuss what biosimilars are and how they differ from generics, how he predicted biologics and biosimilars would be the future of medicine, his inventions starting from coffee mugs and hats to bioreactors that don't have an exhaust, how he passed the federal bar exam without attending law school, how he writes 4 to 5 books a year(with more than 50 books published), passions vs. hobbies, how he schedules his day and more. Prof. Sarfaraz K. Niazi, Ph.D., SI, F...2022-02-021h 29 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices017 - "Feet First" with Ahmed ZobiOn the podcast this week, we had Ahmed Zobi, CEO of Syntr Technologies. Ahmed and I talk about jumping into Syntr Technologies feet first, what bootstrapping in medtech looks like, the grant submission process for funding, being a young CEO and figuring out where to trust your gut and where you need help, how Covid impacted his startup, leading with emotional intelligence, and where Syntr is going. Ahmed Zobi is the Founder and CEO of Syntr Health with experience in microfluidics and biomechanics, and has headed research and development, management, and grant submissions. He has successfully attained all funding and ha...2022-01-261h 07 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices016 - "Be More Specific" with Joe HageThis episode of the Combinate Podcast is with Joe Hage. Joe and I talk all things medical device marketing. We discuss how storytelling is even more important for medical devices than other industries, how he helps clients clarify their vision and messaging, the importance of being specific and concise, the medical device marketing process, hist start in the food industry and transitioning into MedTech, a single book recommendation and the 10x Medical Device Conference. Joe Hage leads the Medical Devices Group(MDG) with more than 350,000 subscribers, the most useful website serving the medical device industry. Joe also runs his company...2022-01-1949 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices015 - "Would You Use it on a Family Member?" with Monir El AzzouziOn this episode of the podcast we had Monir El Azzouzi of Easy Medical Device. Monir and I focus on EU MDR and discuss the difference between EU MDR and US regulations, the history of the MDD being updated to MDR in 2017, Notified Bodies(their role and how they are formed), CE Marking and medical device clearance, considerations for CMO’s and private label, the role of Authorized Representatives, books be recommends and the importance of thought and integrity in QA. Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years wit...2022-01-191h 29 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices014C - "The Final P: People" with Larry MagerIn this final segment of the episode with Larry, we discuss the Final P: People. In this episode we discuss skillsets, training and competency, communication for teamwork, establishing a culture of trust and accountability and all of this culminating into the creation of a strong Culture of Quality. Larry ends the episode by giving an example of how he's seen people and the soft science surrounding quality culture applied very well. Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in...2022-01-0549 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices014B - "The Second P: Process" with Larry MagerIn Part 2 of this episode, Larry and I discuss the Second P: Process. I start the episode by asking Larry to explain the difference between a Quality System and a Quality Management System(QMS) to set the foundation. Larry then moves on to explain have a control environment should be well established(policies, standards, procedures, governance, etc), Risk Management for processes and poking holes in your organization's ways of working, control activities, flow of information, monitoring, management review and continuous improvement. Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes...2022-01-0550 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices014A - "The First P: Product" with Larry MagerThis Episode is with Larry Mager of Mgmt-Ctrl. In this episode Larry and I continue where we left off in 002 - "Seeing David in the Stone". In that episode he walked the audience through the importance of having Predictive Quality Management or PQM. That it's not an afterthought, but rather a beforethought. It should be intentional. In this episode, Larry and I chop it up about the well where PQM starts: Product. As Product is the output of the existing Process and People, before an organization moves to attempt to remediate systematic issues like QMS or Competency/Training/Development, it...2022-01-051h 12 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices013 - “Big Rocks and Little Rocks” with Jumha Abu-RazeqThis episode of the podcast was with Jumha Abu-Razeq of Stoopid Fit. I wanted to bring Jumha on in preparation for 2022. Jumha was the first coach I hired and I did so after losing 100 lbs and finding that despite my success in weight loss, my relationship with food still needed a lot of work. I still didn't feel in control. I believe for us to be the best professionals we can be, it’s important to be healthy physically and mentally and in that way health is not defined as the absence of sickness but something that’s more posi...2021-12-291h 01 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices012 - "Asking then Seeing" with Sara Waxberg McnewHappy Holidays everyone! On this episode of the Combinate Podcast, we had Sara Waxberg McNew, Chief Scientific Officer at Design Science. Sara and I talk about her interest in Human Factors and her career, we discuss who is a user and how to get close to them, how to read the ANSI/AAMI HE75:2009 (R2018) and IEC 62366-1:2015 standards, the design validation process and how human factors formative and summative evaluations fit in, human factors considerations for combination products, and figuring out what users need vs. want. Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human...2021-12-221h 16 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices011 - “Long Story Short” with Margot LeitmanHave you ever wondered what goes into a good story? Enter Margot Leitman. Margot and I talk about why people fear story telling, what people can do if they feel they have no good stories, the anatomy of a good story, and the importance of good story telling in business. Margot Leitman is an award-winning storyteller, best-selling author, speaker and teacher originally from Matawan, New Jersey. A leading expert in the growing field of storytelling, Leitman has written two books on the subject: the best-selling, Long Story Short- the Only Storytelling Guide You'll Ever Need and her latest What’s Yo...2021-12-151h 18 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices010 - "Don't Make Assumptions" with David SimoensOn this episode of the Combinate Podcast, we had David Simoens, COO at cGMP Consulting Group. David and I discuss his career, and dive deep into commissioning, qualification, and validation. David outlines the activities in including discussing URS, DQ, FAT/SAT, IQ, OQ and PQ. David outlines the a risk based approach for streamlining commissioning and qualification activities, highlights some important things to watch out for and also gives some great book recommendations! David Simoens is a certified Project Management Professional with over 7 years of project management, engineering, and validation experience. David has a strong, professional background in...2021-12-081h 13 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices009 - “Cutting Through the Noise” with Charles VenturaOn this episode, we had Charles “Chuck” Ventura. Chuck is a the CEO of Hemotek Medical and President of Ventura Solutions. He has extensive product development, commercialization, and business management experience in the Medical Device industry. Chuck is a seasoned Medical Device leader with successful experience in Commercialization, R&D, Project Management, and Manufacturing Support. He also has start up experience in business development and investment management. Chuck received his Bachelor’s degree in Bioengineering with a minor in Electrical Engineering from the University of Illinois at Chicago. He went on to earn his Master’s degree in Mechanical and Aerospac...2021-12-011h 30 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices008 - "Follow the Opportunity" with Marta NewOn this episode, I had Marta New PhD MBA. Marta and I talk about how business school changed her perspective, depth vs. the value of information when it comes to decision making, mentors in her career and their influence on her development, her experience starting a new company, her time in venture capital and the due diligence process, lessons during the pandemic and some of the influences that inspire her. Happy Thanksgiving! Marta is the CEO of Radyus Research. Before starting Radyus, Marta was the co-founding Partner at Agent Capital, a life sciences-focused venture capital firm based in Cambridge, MA...2021-11-2455 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices007 - "Beyond The Obvious" with Miiri KotcheOn this episode we had one of my most impactful engineering professors, Miiri Kotche PhD. In this episode we discuss: Starting as a Validation Engineer and making the decision to go back into academia Teaching engineering students during the pandemic Answering the age old question: "Do you use your degree?" Moving to Finland and her experience as a Fullbright Scholar at VTT STEM Programs and giving back Dr. Kotche is the Associate Dean for Undergraduate Affairs and a Clinical Professor of Biomedical Engineering at the UIC College of Engineering. Her focus is on providing real-world ex...2021-11-1752 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices006 - “The Courage to Start” with John BinghamOn this episode of the Combinate Podcast we have the runner that needs no introduction, John Bingham. John is the best selling author of the books, “The Courage to Start”, “No Need for Speed” and “Marathoning for Mortals”. He is also the man behind the famous Runner’s World Magazine column “The Penguins Chronicles”. On this episode John and I discuss starting running in his 40’s, his favorite of his 45 marathons, his books, owning his own race, the lessons he learned finishing races last or not finishing at all, his career and many more. John can be found at Johnbingham.com For any feedback...2021-11-101h 03 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices005 - “Compassionate Product Development” with Cameron JonesOn this episode we had Cameron Jones PhD, Co-Founder and CEO at Avasys. Cameron holds a PhD from University of Kentucky and did Post-Doctoral work at John’s Hopkins University. He has a passion for innovation and trying to find and address unmet clinical needs by working with the clinicians to craft fit for purpose solutions. In this episode we discuss the relationship between academia and innovation, how he pursued industry in graduate school, his upbringing, compassion and his zest for life. Cameron can be reached at http://www.avasysmedical.com/services/.2021-11-0358 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices004 - “Until They Know How Much You Care” with Andy RobertsonI’m truly happy I discovered Andy Robertson before I took my own CQE exam. His tools, lessons and strategies were crucial in passing the exam on my first try. His passion and love for quality engineering jumped out and after becoming more familiar with his content and style, I thought “I have to meet this guy”. On this episode we discuss study habits, mastery, learning styles, applying CQE principles, and caring as a pillar of leadership. Andy Robertson is a CQE’s CQE. Andy is a career engineer and learner who worked in the medical device industry in various roles in...2021-10-271h 01 $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices003 - “Standard Understanding” with Mark SwansonIn this episode I sit down with Mark Swanson. We discuss Mark’s background and early career, his entrance into QA, his participation on standard work groups for ISO13485 and ISO9001, the standards process and more. Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and a Principal Consultant of Quality and Regulatory Expert Partners (QRx Partners); a partnership consulting firm focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. Mark has more than 20 years of experience in the medical device industry including all quality roles. He is...2021-10-2054 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices002 - “Seeing David in the Stone: Predictive Quality Management” with Larry MagerExcited to drop episode 002- “Seeing David in the Stone: Predictive Quality Management” with Larry Mager from Mgmt-Ctrl. I hope you enjoy this episode! Apple Podcasts: https://tinyurl.com/7y9k5kj8 Spotify: https://tinyurl.com/3w5chwhf Larry and I discuss a lot in this episode, most notably what Predictive Quality Management is and how “Quality is Free”. Larry Mager is the author of the books “The Quality Journey” and “Management Control Quality plan”. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highl...2021-10-1558 min $Let\'s Combinate - Drugs + Devices$ Let's Combinate - Drugs + Devices001 - “Learning Never Exhausts the Mind” with Rick DoeI wanted the first episode to be very special so I invited someone who was instrumental in my development as an engineer and a person. I’d like to introduce you to Episode 001 - “Learning Never Exhausts the Mind” with Rick Doe! https://www.linkedin.com/in/rick-doe-aa312330 2021-10-061h 29