Hardware Podcasts

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

Let's Combinate · 5 Nov 2025 · 25m

What this episode covers

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.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Alexion, Merck, Johnson & Johnson, Ethicon, Cordis, Amgen, Medtronic, Precision Regulatory Consulting LLC, Boston Scientific
Also
FDA, CDRH

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