# 009 - “Cutting Through the Noise” with Charles Ventura

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2021-12-01
- Length: 1h 30m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-01-009-cutting-through-the-noise-with-charles-ventura
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/009---Cutting-Through-the-Noise-with-Charles-Ventura-e1b2on4

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-01-009-cutting-through-the-noise-with-charles-ventura#t=0) Introduction: Charles Ventura and Hemotek Medical
- [2:54](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-01-009-cutting-through-the-noise-with-charles-ventura#t=174) Ventura's Background: From UIC to Baxter Healthcare
- [12:14](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-01-009-cutting-through-the-noise-with-charles-ventura#t=734) Expectations vs. Reality: The Systems Engineering Role
- [28:44](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-01-009-cutting-through-the-noise-with-charles-ventura#t=1724) Risk Management and ISO 14971 in Practice
- [54:27](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-01-009-cutting-through-the-noise-with-charles-ventura#t=3267) Founding Hemotek and Developing the V Needle
- [1:15:29](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-01-009-cutting-through-the-noise-with-charles-ventura#t=4529) Advice for Entry-Level Engineers: Regulations and Skills
- [1:26:57](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-01-009-cutting-through-the-noise-with-charles-ventura#t=5217) Recommended Books and Final Thoughts

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies, founders before launch

## Mentioned

- Hemotek Medical (company)
- Ventura Solutions (company)
- Baxter Healthcare (company)
- V Needle (product)
- Red Sense Medical (company)
- ISO 14971 (other)
- FDA (other)
- MiniTab (tool)

## Related episodes from other shows

- [S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda) (Being an Engineer)
- [S1E23 A-Team Engineering, From Ireland to the United States | Ronan Jenkinson](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-07-24-s1e23-a-team-engineering-from-ireland-to-the-united-states-ronan-jenkinson) (Being an Engineer)
- [Etienne Nichols | How to Become a MedTech Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer/2023-03-24-etienne-nichols-how-to-become-a-medtech-engineer) (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)
- [#381: MedTech Advice from an Accidental Entrepreneur](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-05-381-medtech-advice-from-an-accidental-entrepreneur) (Global Medical Device Podcast)

## Citing this page

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