Hardware Podcasts
Let's Combinate podcast cover art

Let's Combinate in 2025

54 episodes, newest first.

  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