# 212 - What 6 of the World’s Biggest Companies Taught Him About Combination Products

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-11-05
- Length: 25m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-05-212-what-6-of-the-worlds-biggest-companies-taught-him-about-combination-products
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/212---What-6-of-the-Worlds-Biggest-Companies-Taught-Him-About-Combination-Products-e3ah66u

## Summary

Leonel Venegas, founder of Precision Regulatory Consulting, draws on his tenure at Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic to explain the complexities of combination product development. He details the cultural disconnects between pharmaceutical and device teams, emphasizing the need to integrate Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP). Venegas discusses specific regulatory pathways like IDE vs. IND, the unique challenges of rare disease programs, and how Lean Six Sigma Black Belt methodologies can reduce the cost of quality by minimizing appraisal costs.

## Chapters

- [0:07](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-05-212-what-6-of-the-worlds-biggest-companies-taught-him-about-combination-products#t=7) Introduction: Leonel Venegas and Precision Regulatory Consulting
- [0:52](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-05-212-what-6-of-the-worlds-biggest-companies-taught-him-about-combination-products#t=52) Integrating GLP, GCP, and GMP in Combination Products
- [2:28](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-05-212-what-6-of-the-worlds-biggest-companies-taught-him-about-combination-products#t=148) Disconnects Between Pharma and Device Cultures
- [4:02](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-05-212-what-6-of-the-worlds-biggest-companies-taught-him-about-combination-products#t=242) Device-Led Products: Design Controls and Timelines
- [8:01](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-05-212-what-6-of-the-worlds-biggest-companies-taught-him-about-combination-products#t=481) Challenges in Rare Disease Programs and Human Factors
- [10:02](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-05-212-what-6-of-the-worlds-biggest-companies-taught-him-about-combination-products#t=602) GMP, Process Validation, and Clinical Batches
- [15:45](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-05-212-what-6-of-the-worlds-biggest-companies-taught-him-about-combination-products#t=945) IDE vs. IND Pathways and Regulatory Submissions
- [19:22](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-05-212-what-6-of-the-worlds-biggest-companies-taught-him-about-combination-products#t=1162) Cost of Quality and Lean Six Sigma Application

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

large enterprises

## Mentioned

- Alexion (company)
- Merck (company)
- Johnson & Johnson (company)
- Ethicon (company)
- Cordis (company)
- Amgen (company)
- Medtronic (company)
- Precision Regulatory Consulting LLC (company)
- Boston Scientific (company)
- FDA (other)
- CDRH (other)

## Related episodes from other shows

- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)
- [S1E13 A Holistic View on Product Development | Devon Campbell](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-09-s1e13-a-holistic-view-on-product-development-devon-campbell) (Being an Engineer)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-05-212-what-6-of-the-worlds-biggest-companies-taught-him-about-combination-products. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.