Hardware Podcasts
Let's Combinate podcast cover art

Let's Combinate

Subhi Saadeh with industry guests on drug-device combination products: development, regulatory strategy, human factors and quality for products such as injectors, inhalers and on-body devices.

266 episodes · 158 hours · since 2021

Visit Let's Combinate

Let's Combinate is filed under medical devices, product development and interviews. Its most recent episode published on , so it is still actively publishing. Listeners have left 4 ratings on Apple Podcasts, averaging 5 out of 5.

Start here

Where to begin with Let's Combinate: full episodes about building physical products, award winners first.

  • · 30m

    142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin

    Ben Locwin, Executive SME at Black Diamond Networks, discusses material qualification in regulated industries, contrasting the approaches of pharmaceuticals and medical devices with the automotive industry's PPAP and APQP frameworks. He argues that the life sciences sector is too insular, resisting the adoption of proven quality tools like 6 Sigma and Lean that have been used in automotive and aerospace for decades. Locwin emphasizes that regulations are merely the floor for compliance, not the ceiling, and advocates for a skeptical, testing-driven approach to supplier qualification and material compatibility to ensure patient safety.

    Quality & yieldManufacturing partners & offshoring
    8 chapters

  • · 42m

    199 - How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall

    Mark Burchnall, Director of Engineering at PSN Labs, explains how mechanical modeling and simulation can reduce prototype iterations by 50% in combination product development. He details the use of Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) to support regulatory submissions under ASME V&V 40 standards. Burchnall emphasizes defining a 'question of interest' and assessing model risk to establish credibility, allowing models to replace or complement physical testing for high-risk design decisions.

    Mechanical engineeringValidation & product-market fit
    8 chapters

  • · 29m

    226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification

    Elaine (Yi Ling Tan) of MedTech Chopsticks explains that Western manufacturers often fail in China because they assume EU or US approvals (IEC/ISO, FDA) translate directly, whereas China requires compliance with local GB (national) and YY (industry) standards. She details the necessity of local type testing using Product Technical Requirements (PTRs) and highlights that China’s GMP differs from ISO 13485, particularly with upcoming dual market release requirements in November 2026. The conversation covers the critical role of China agents in managing NMPA-designated testing labs, clinical evaluation predicates, and post-market surveillance, noting that misclassification changes every two years can drastically alter regulatory strategy.

    Certification & complianceManufacturing partners & offshoring
    9 chapters

Hear it in a few minutes

Single discussions from recent episodes, playing the show's own audio from where each begins.

Latest episodes

  • · 34m

    258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin

    Ben Locwin, Vice President at Reliant Life Sciences, and Subhi Saadeh, Founder of Let's Combinate, discuss the divergent quality philosophies of pharmaceutical and medical device industries, focusing on combination products. They explain how human factors studies must account for different user types (HCP vs. lay) even with platform devices, and how CDMO scorecards often fail to reflect operational reality due to subjective weighting. The conversation details the differences between ISO 14971 and ICH Q9 risk management, emphasizing the need for FMEA as a living document updated with real-world data.

    Quality & yieldSourcing & supply chain
    6 chapters

  • · 12m

    257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

    Subhi Saadeh, a consultant and auditor specializing in combination products, explains the CGMP requirements under 21 CFR Part 4 for products containing both drug and device elements. She details the scope of single-entity and co-packaged products, the baseline expectation of meeting all applicable regulations, and the two compliance paths: full integration or a streamlined approach. Saadeh outlines specific ISO 13485 sections required for drug-based systems and 21 CFR Part 211 sections for device-based systems, highlighting complexities like management review differences and reserve sample storage.

    Certification & compliance
    1 chapters

  • · 9m

    256 - The New FDA Inspection Playbook: Where to Start with QMSR

    Subhi Saadeh, founder of Let’s Combinate, introduces a four-part series on FDA inspection readiness under the new Quality Management System Regulation (QMSR), explaining how the retired QSIT framework has been replaced by Compliance Program 7382.850. He highlights advice from former FDA investigator Eric Pittman, who advises industry to focus exclusively on Section III of compliance programs as the primary roadmap for inspections. The episode details the shift from QSIT’s four major subsystems to six QMS areas, emphasizing a risk-based approach where investigators evaluate product risks and control effectiveness.

    Certification & compliance
    3 chapters

  • · 11m

    255 - Audit Interview Techniques: How Good Auditors Get Better Evidence

    Subhi Saadeh, founder of Let's Combinate, explains audit interviewing techniques developed with partner Andy Robertson, emphasizing that interviews are the bridge to verifying quality systems beyond desktop reviews. He details how to build rapport, use open-ended questions, and avoid checklist-driven approaches to get accurate evidence from auditees. The episode covers handling special situations like group interviews and translators, and managing challenges such as uncooperative escorts or time constraints during audits.

    Quality & yield
    1 chapters

  • · 12m

    254 - Saying No Is the Easy Part of Quality

    Subhi Saadeh, founder of Let’s Combinate, outlines four scenarios where quality professionals must firmly say no, including real patient risk, insufficient evidence, requirement violations, and schedule pressure. He contrasts these with three weak reasons for saying no, such as personal preference, technical uncertainty, and applying excessive GMP rigor to early-stage development. Saadeh advocates for a flexible quality culture that distinguishes between rigid compliance and risk-based decision-making, using a drug delivery platform case study to illustrate evidence-based stops.

    Quality & yieldMedical & health devices
    1 chapters

  • · 45m

    253 - FDA Is Making Big Changes to Its Inspection Approach

    Eric Pittman, former Bioresearch Monitoring West Division Director at the FDA and now VP at Project Farma, explains the FDA's transition from a specialized program-aligned inspection model back to a broader, medical-product-specific generalist model under the new Office of Investigations and Inspections (OII). He details the operational differences between routine inspections under Section 704 and undercover investigations under Section 702, emphasizing that investigators prioritize human subject safety over minor regulatory technicalities. Pittman advises industry to focus on the FDA’s Investigations Operations Manual (IOM) and specific compliance programs rather than cosmetic facility improvements, noting that the end of QSIT has shifted focus to broader process evaluation.

    Certification & complianceQuality & yield
    11 chapters

  • · 13m

    252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)

    Subhi Saadeh, founder of Let's Combinate, explains the fundamentals of acceptance sampling, clarifying that it is a probability-based tool rather than a guarantee of quality. He distinguishes between attribute sampling (counting defects) and variable sampling (measuring characteristics), referencing standards like ISO 2859-1 and ISO 3951. Saadeh details how Acceptance Quality Limit (AQL) indexes sampling plans and introduces Operating Characteristic (OC) curves to visualize producer and consumer risk. The episode concludes that selecting a sampling plan is a judgment call to balance the risk of rejecting good batches against accepting bad ones.

    Quality & yieldCertification & compliance
    1 chapters

  • · 49m

    251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy

    Steven Kaufman, Founder of Combination Product Solutions and fractional CCO at Portal Instruments, discusses the evolving drug delivery landscape, highlighting the shift toward larger-volume subcutaneous injections (5-10 mL) and the critical role of sustainability in device selection. He explains that while oral GLP-1s are popular, injectables offer superior efficacy and adherence for many patients, driving demand for both disposable and reusable auto-injectors. Kaufman emphasizes that commercial success in 2026 requires solving specific challenges like high viscosity and injection time, rather than just competing on price or form factor. He predicts that sustainability will be the dominant force shaping the next generation of devices through 2035, with companies like Eco-Injet and Portal leading the way.

    Mechanical engineeringMarketing & brand
    8 chapters

  • · 2m

    I'm Changing The Podcast

    Subhi Saadeh, host of the combination product podcast Let's Combinate, announces a schedule change from Wednesday to Monday after 250 consecutive weekly episodes. He reflects on maintaining consistency through major life events and cites advice from Dr. James Sumaru of Samex and the Health Tech podcast about the importance of creating value even when no one is listening. Saadeh expresses gratitude to his audience for their weekly engagement and confirms the content focus remains unchanged.

    Creator business
    1 chapters

Every episode

266 episodes with a summary and chapters, by year.

202641 episodes
  1. 12 Oct258Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin34m
  2. 5 Oct25721 CFR Part 4 Explained: CGMP Requirements for Combination Products12m
  3. 28 Sept256The New FDA Inspection Playbook: Where to Start with QMSR9m
  4. 21 Sept255Audit Interview Techniques: How Good Auditors Get Better Evidence11m
  5. 13 Sept254Saying No Is the Easy Part of Quality12m
  6. 7 Sept253FDA Is Making Big Changes to Its Inspection Approach45m
  7. 31 Aug252Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)13m
  8. 24 Aug251The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy49m
  9. 18 AugI'm Changing The Podcast2m
  10. 12 Aug250PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?11m
  11. 5 Aug249The Best Audit Advice Nobody Told Me14m
  12. 29 Jul248What Is a Quality Unit? QA vs. QC Explained8m
  13. 22 Jul247Why Everyone in Pharma and MedTech Should Work in Quality8m
  14. 15 Jul246The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)8m
  15. 8 Jul245Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector45m
  16. 1 Jul2445 Critical Quality Differences Between Drugs and Devices8m
  17. 24 Jun243Why Kitting A Finished Medical Device with a Drug Create So Much Work14m
  18. 17 Jun242Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start12m
  19. 10 Jun241ICH Q14 Explained: Have We Been Validating Methods Backwards?10m
  20. 3 Jun240ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy11m
  21. 27 May239ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes10m
  22. 20 May239ICH Q11 in 6 Minutes6m
  23. 13 May2386 Audit Strategies Every Auditor Should Know10m
  24. 6 May237ICH Q10: The Pharmaceutical Quality System8m
  25. 29 Apr236ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences12m
  26. 22 Apr235ICH Q8: How Pharmaceutical Development Actually Works10m
  27. 15 Apr234ICH Q7: The GMP Framework for API Manufacturing13m
  28. 8 Apr233Most Teams Misunderstand SpecificationsICH Q66m
  29. 1 Apr232MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk34m
  30. 25 Mar231Audit Findings Explained: Nonconformity vs Observation (CQA)11m
  31. 23 Mar230How Pharma Misses Critical Market Signals with Joe Luminiello30m
  32. 11 Mar229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products31m
  33. 4 Mar228ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently6m
  34. 24 Feb227When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics28m
  35. 18 Feb226Navigating China NMPA Medical Device RequirementsStandards, GMP Updates, Agents & Classification29m
  36. 11 Feb226ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions8m
  37. 4 Feb225ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes9m
  38. 28 Jan224ICH Q2 Explained: What Analytical Validation Really Requires10m
  39. 21 Jan223What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations9m
  40. 14 Jan222How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series12m
  41. 7 Jan221What Is ICH and Why It Matters14m
202554 episodes
  1. 31 Dec220Managing Oneself, Reflections and a New Series on ICH8m
  2. 24 Dec219FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness25m
  3. 17 Dec218ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)9m
  4. 10 Dec2175 Fixable Problems Holding Back Drug–Device Programs17m
  5. 3 Dec216How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke21m
  6. 26 Nov215Why Aren’t Technical People Leading Drug-Device Audits?13m
  7. 19 Nov214The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More)19m
  8. 12 Nov213From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site43m
  9. 5 Nov212What 6 of the World’s Biggest Companies Taught Him About Combination Products25m
  10. 30 Oct211Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer46m
  11. 22 Oct210The 8 Roles You MUST Understand in Pharma & MedTech19m
  12. 15 Oct210How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield22m
  13. 8 Oct209ALCOA++ EXPLAINEDWhat Everyone Gets Wrong About Data Integrity with Monika Andraos22m
  14. 1 Oct208How Drugs Are Designed, Targets, Phenotypes, and Structure Based Design28m
  15. 24 Sept207What 99.999% Reliability Really Means23m
  16. 17 Sept206Will AI Decide Your Next Drug/Device Approval?31m
  17. 11 Sept205Why Less Than 20% of Companies Have Started Quality 4.035m
  18. 3 Sept204The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle32m
  19. 27 Aug203Drug Delivery, Platforms, IP Battles, Supply Chain Risks with Jim Collins45m
  20. 20 Aug202Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin32m
  21. 13 Aug201Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.034m
  22. 6 Aug200MedTech and Pharma After 200 Episodes…..17m
  23. 30 Jul199How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall42m
  24. 23 Jul198QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed10m
  25. 16 Jul197Quality Agreements Explained: How to Protect Yourself When Things Go Wrong13m
  26. 12 JulCombi Crumbs: Clinical Trials 101 – From Safety to Strategy8m
  27. 9 Jul196How to Win Your First 90 Days in Pharma and MedTech9m
  28. 2 Jul195Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah47m
  29. 25 Jun194Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer19m
  30. 18 Jun193Bioengineering Grads: Here’s What Recruiters Actually Want to See in 202547m
  31. 11 Jun192What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)4m
  32. 4 Jun191If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity13m
  33. 28 May190Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong15m
  34. 21 May189FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?17m
  35. 14 May188Certified Quality Auditor(CQA) and Audits in the Future15m
  36. 7 May187Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)16m
  37. 30 Apr1864 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech12m
  38. 23 Apr185ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder25m
  39. 16 Apr184Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained30m
  40. 9 Apr183GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products37m
  41. 2 Apr1827 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma18m
  42. 26 Mar181Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?20m
  43. 19 Mar180MIT Leadership Expert Reveals Management Secrets for Scientists!25m
  44. 12 Mar179Quality is NOT Everyone’s Job—Why That’s a GOOD Thing9m
  45. 5 Mar178CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know31m
  46. 26 Feb177The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED10m
  47. 19 Feb176The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski26m
  48. 12 Feb175Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau39m
  49. 5 Feb174How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin23m
  50. 29 Jan173Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's32m
  51. 22 Jan172Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead34m
  52. 13 Jan171Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?7m
  53. 8 Jan170The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)9m
  54. 1 Jan169Should You Study Bioengineering in 2025? My Decade-Long Perspective16m
202452 episodes
  1. 25 Dec168Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth13m
  2. 18 Dec167Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst41m
  3. 11 Dec166Sync or Sink: 3 Levels of Harmonization for Combination Product Success20m
  4. 4 Dec165Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New1h 10m
  5. 27 Nov164Tiny Particles, Big Impact: Breaking down USP 788 & USP 79013m
  6. 20 Nov163ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle11m
  7. 12 Nov162Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)17m
  8. 6 Nov161ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products24m
  9. 30 Oct160Drug Tech Transfer vs. Device Design Transfer EXPLAINED!19m
  10. 23 Oct159Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin22m
  11. 16 Oct1583 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show21m
  12. 9 Oct157Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura21m
  13. 2 Oct156Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar33m
  14. 25 Sept155FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach25m
  15. 18 Sept154IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell37m
  16. 11 Sept153USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio21m
  17. 4 Sept152Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh40m
  18. 28 Aug151Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio33m
  19. 21 Aug150Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar38m
  20. 14 Aug149Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens33m
  21. 7 Aug148Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner26m
  22. 30 Jul147URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup23m
  23. 24 Jul146Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens35m
  24. 17 Jul145Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi40m
  25. 10 Jul144Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo35m
  26. 3 Jul143New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young29m
  27. 26 Jun142Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin30m
  28. 19 Jun141Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)23m
  29. 12 Jun140Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa30m
  30. 5 Jun139FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh27m
  31. 29 May138Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager47m
  32. 22 May137The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens18m
  33. 15 May136Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura39m
  34. 8 May135Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson41m
  35. 1 May134ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch41m
  36. 24 Apr133A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell22m
  37. 17 Apr132IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner31m
  38. 10 Apr131Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer42m
  39. 3 Apr130QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder32m
  40. 27 Mar129Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens32m
  41. 20 Mar128Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture52m
  42. 13 Mar127BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal48m
  43. 6 Mar126Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd35m
  44. 28 Feb125Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh42m
  45. 21 Feb1245 Steps to Becoming a Phenom Quality Pro with Andy Robertson31m
  46. 14 Feb123Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker45m
  47. 7 Feb122Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries35m
  48. 31 Jan121Bench Scientist to Commercial Leader, Amgen in the early days, Challenges in Commercialization, Working in Startups vs. Large Companies, and Silos with Sayed Badrawi33m
  49. 24 Jan120EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi43m
  50. 18 Jan119What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens26m
  51. 10 Jan118What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead37m
  52. 3 Jan117Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano34m
202352 episodes
  1. 27 Dec116Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer39m
  2. 20 Dec115Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban33m
  3. 13 Dec114Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer43m
  4. 6 Dec113Pharma/MedTech Market, Why Good People Leave, Finding Motivation, Onshoring in Pharma and Motivation with Ira Mann28m
  5. 29 Nov112Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer47m
  6. 22 Nov1117 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh19m
  7. 15 Nov110CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin31m
  8. 8 Nov109Protecting Patients at All Costs, Being a CQO in Big Pharma, Supply Chain Security and Generic Drugs with Martin Van Trieste42m
  9. 1 Nov108Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins38m
  10. 25 Oct107Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu32m
  11. 24 Oct106FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott33m
  12. 11 Oct106Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman32m
  13. 4 Oct105Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi Saadeh27m
  14. 27 Sept104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew36m
  15. 20 Sept103Prescription Reconciliation, Medication Error Reduction, Automated Home Care, Assisted Robotics, Patient Behavioral Monitoring, and the future of Clinical Trials with Charles Gellman29m
  16. 13 Sept102Human Error, Doing Quality Differently, Defining Accountability, Written Human Guidance, Blue Line vs. Black Line and Categorizing Deviations with Amy Wilson and Cliff Berry32m
  17. 6 Sept101Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano29m
  18. 30 Aug100PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager30m
  19. 23 Aug099Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson40m
  20. 16 Aug098MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi40m
  21. 9 Aug097Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager43m
  22. 2 Aug096Pharma Waste Management, Sustainability, What Happens to Sharps, Disposal and Zero Waste with Heather Johnson20m
  23. 26 Jul095How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal43m
  24. 19 Jul094Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young36m
  25. 12 Jul093Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle25m
  26. 5 Jul092Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder41m
  27. 28 Jun091Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle40m
  28. 21 Jun090Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar44m
  29. 14 Jun089Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch33m
  30. 7 Jun088Production Part Approval Process(PPAP) with Subhi Saadeh21m
  31. 31 May087From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque39m
  32. 24 May086Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with ⁠Fran DeGrazio⁠30m
  33. 17 May085Digital Innovation, Proteomics, Core & Non-Core Innovation, Consulting after Academia, Democratizing Access and Clinical Trials with Jacob Laprote36m
  34. 10 May084Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New50m
  35. 3 May083Holistic Approach to Container Closure Integrity, Capping/Crimping, RSF, and Annex I/USP 1207 Requirements with Derek Duncan27m
  36. 26 Apr082CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R with Niedre Heckman43m
  37. 19 Apr081ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt47m
  38. 12 Apr0809 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan25m
  39. 5 Apr079How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young35m
  40. 29 Mar078Prevention is Not New, Incentives in Health Care, and Integrated Combination Products with Ramin Rafiei42m
  41. 22 Mar0778 Databases and How To Use Them with Michelle Lott22m
  42. 15 Mar076GMP Training, Competence, Human Error and Mentorship with Joanna Gallant28m
  43. 8 Mar075Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin33m
  44. 1 Mar074Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman28m
  45. 22 Feb073Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal19m
  46. 15 Feb072OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa53m
  47. 8 Feb071Steel Industry to MedTech & Important Quality Systems with Etienne Nichols59m
  48. 1 Feb070The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen50m
  49. 25 Jan069EU MDR Extension with Michelle Lott17m
  50. 18 Jan068Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge47m
  51. 11 Jan067mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True47m
  52. 4 Jan066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio55m
202254 episodes
  1. 28 Dec065"8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh29m
  2. 21 Dec064Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling54m
  3. 14 Dec063Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman48m
  4. 7 Dec062Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer37m
  5. 30 Nov061Taguchi, Pugh, DFSS, Robust Design and Tolerancing with Skip Creveling44m
  6. 23 Nov060Why People Leave, Starting Elemed and Trusted Advisory with Elena Kyria42m
  7. 16 Nov059Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower41m
  8. 9 Nov058PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano44m
  9. 2 Nov057Conferences, Expos, LinkedIn and Launching a Podcast with Rizwan Chaudhrey46m
  10. 26 Oct056"Non-Promotional Compliance" with Darshan Kulkarni33m
  11. 19 Oct055"Critical Tasks and Knowledge Tasks" with Alexandra Benbadis50m
  12. 12 Oct054"EUDAMED" with Richard Houlihan28m
  13. 5 Oct053"Duct Tape and Bubble Gum" with Chris Tsai1h 04m
  14. 28 Sept052“All Work is Process” with Larry Mager53m
  15. 21 Sept051"EU MDR" with Bassil Akra44m
  16. 14 Sept050"When No One is Listening" with James Somauroo40m
  17. 7 Sept049"What Does the Data Say?" with Shannon Hoste46m
  18. 31 Aug048"Materials" with Hsinjin Yang34m
  19. 24 Aug047"Truthful Not Misleading" with Darshan Kulkarni1h 00m
  20. 17 Aug046"Inflation Reduction Act" with Sarfaraz Niazi32m
  21. 10 Aug045"Combination Products around the Globe" with Susan Neadle35m
  22. 3 Aug044 -“Market Access” with Kasem Akhras1h 13m
  23. 27 Jul043“Half Knowledge Can Hurt” with Shadeed Salam1h 14m
  24. 20 Jul042“Reproducible within Limits”20m
  25. 13 Jul041“Health Citizenship” with Jane Sarasohn Kahn1h 09m
  26. 6 Jul040“Good Science is Good Science” with Ben Locwin50m
  27. 29 Jun039"The Camera Didn't Make the Artist Obsolete" with John Nosta1h 04m
  28. 22 Jun038"Clinical Trials" with Dan Sfera1h 13m
  29. 15 Jun037Reflections #1 - (Episodes 001-25)34m
  30. 8 Jun036"Those Moments Keep You Grounded" with Yousef Arman42m
  31. 1 Jun035“Safety is Safety” with Khaudeja Bano47m
  32. 25 May034"Agent" with Mitch Robbins54m
  33. 18 May033"Specialization" with Erik Barkley1h 10m
  34. 11 May032“Quality is Free”23m
  35. 4 May031"The Five Stages Of Regulatory Grief" with Michelle Lott1h 19m
  36. 27 Apr030"Why Don't I Try?" with Marc Koska1h 37m
  37. 20 Apr029"Purpose" with Marla Phillips1h 34m
  38. 13 Apr028"How Much Does Poor Quality Cost?" with H. James Harrington1h 10m
  39. 6 Apr027"Become a Historian of the Problem" with Duane Mancini59m
  40. 30 Mar026"Quality" with H. James Harrington50m
  41. 23 Mar025“The Frying Pan to the Fire” with Edwin Bills1h 31m
  42. 16 Mar024"Operating Under Constraints "with Naveen Agarwal1h 12m
  43. 9 Mar023"The Best is Yet to Come" with David Albert1h 06m
  44. 2 Mar022"What Chapter are you in?" with Susan Neadle1h 23m
  45. 23 Feb021"Options" with Karandeep Singh Badwal1h 03m
  46. 16 Feb020"The Right Words" with Kathy Walsh1h 42m
  47. 9 Feb019"Carrying The Bag" with Omar M Khateeb1h 31m
  48. 2 Feb018"The Optimist Plans for Forever" - with Sarfaraz Niazi1h 29m
  49. 26 Jan017"Feet First" with Ahmed Zobi1h 07m
  50. 19 Jan015"Would You Use it on a Family Member?" with Monir El Azzouzi1h 29m
  51. 19 Jan016"Be More Specific" with Joe Hage49m
  52. 5 Jan014A - "The First P: Product" with Larry Mager1h 12m
  53. 5 Jan014B - "The Second P: Process" with Larry Mager50m
  54. 5 Jan014C - "The Final P: People" with Larry Mager49m
202113 episodes
  1. 29 Dec013“Big Rocks and Little Rocks” with Jumha Abu-Razeq1h 01m
  2. 22 Dec012"Asking then Seeing" with Sara Waxberg Mcnew1h 16m
  3. 15 Dec011“Long Story Short” with Margot Leitman1h 18m
  4. 8 Dec010"Don't Make Assumptions" with David Simoens1h 13m
  5. 1 Dec009“Cutting Through the Noise” with Charles Ventura1h 30m
  6. 24 Nov008"Follow the Opportunity" with Marta New55m
  7. 17 Nov007"Beyond The Obvious" with Miiri Kotche52m
  8. 10 Nov006“The Courage to Start” with John Bingham1h 03m
  9. 3 Nov005“Compassionate Product Development” with Cameron Jones58m
  10. 27 Oct004“Until They Know How Much You Care” with Andy Robertson1h 01m
  11. 20 Oct003“Standard Understanding” with Mark Swanson54m
  12. 14 Oct002“Seeing David in the Stone: Predictive Quality Management” with Larry Mager58m
  13. 6 Oct001“Learning Never Exhausts the Mind” with Rick Doe1h 29m

If you like Let's Combinate

Global Medical Device Podcast

Greenlight Guru's interviews with medical device founders, engineers and regulatory experts on design controls, quality systems and getting a device cleared and to market.

medical devicesmanufacturing
Visit Website

Being an Engineer

Aaron Moncur of Pipeline Design & Engineering talks with engineers and engineering leaders about mechanical design, product development, medical devices and what it takes to grow in an engineering career.

engineeringproduct development
Visit Website

Hardware to Save a Planet

Host Dylan Garrett explores the physical technologies being built to fight climate change, pairing one climate challenge with one emerging hardware solution each episode.

climate energyproduct development
Visit Website

The Builder Circle

Designed to empower hardware entrepreneurs, engineers and builders to overcome challenges, reduce risk and succeed in bringing their products to market through expert insights, practical advice, and engaging discussions on relevant topics.

manufacturingfounder stories
Visit Website