009 - “Cutting Through the Noise” with Charles Ventura

Let's Combinate · 1 Dec 2021 · 1h 30m

What this episode covers

Charles Ventura, CEO of Hemotek Medical and President of Ventura Solutions, discusses his career transition from biomedical engineering at Baxter Healthcare to founding his own companies. He details the development of the V Needle, a safety device for dialysis to prevent venous needle dislodgement, emphasizing the importance of systems engineering, risk management (ISO 14971), and user-centric design. Ventura also provides strategic advice for early-career engineers, highlighting the necessity of mastering regulatory frameworks like FDA 21 CFR Part 820 and ISO 13485, as well as practical skills in statistics and project management to secure their first roles.

Mentioned

Companies
Hemotek Medical, Ventura Solutions, Baxter Healthcare, Red Sense Medical
Products
V Needle
Tools
MiniTab
Also
ISO 14971, FDA

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