# 157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-10-09
- Length: 21m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/157---Design-Inputs-that-Dont-Suck--Risk-Control-Measures-and-Problems-with-Verification-with-Chuck-Ventura-e2pdekg

## Summary

Chuck Ventura, founder of Ventura Solutions and CEO of HemoTek, explains why poor design inputs are a primary cause of delayed product development and verification failures in medical device and combination product projects. He advocates for spending 30% of project time on design inputs using concurrent engineering, where systems engineers collaborate with verification teams early to define clear acceptance criteria. Ventura also clarifies the structural relationship between user needs, risk controls, and design inputs, arguing that risk controls should serve as parent requirements to design inputs to ensure traceability and effective risk management.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific#t=0) Introduction: Chuck Ventura and Ventura Solutions
- [2:14](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific#t=134) The Impact of Poor Design Inputs on Development Speed
- [5:10](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific#t=310) Common Pitfalls: Rushing and Treating Inputs as Paperwork
- [8:29](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific#t=509) Verification Failures and the Need for Clear Acceptance Criteria
- [10:10](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific#t=610) Concurrent Engineering and Refining Specifications with Verification Teams
- [13:32](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific#t=812) Case Study: Sharp Edge Testing and Protocol Validation
- [16:16](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific#t=976) Linking Risk Controls to Design Inputs as Parent Requirements
- [19:41](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific#t=1181) Ventura Solutions Design Input Essentials Course

## Topics

- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- Ventura Solutions (company)
- HemoTek (company)
- UL (other)
- ISO 14971 (other)

## Related episodes from other shows

- [Building Your Design Controls (and Pitfalls to Avoid)](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-29-building-your-design-controls-and-pitfalls-to-avoid) (Global Medical Device Podcast)
- [Determining User Needs for Your Medical Device](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device) (Global Medical Device Podcast)
- [V&V Activities from a Verification Engineer POV - How Hard Could It Be?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be) (Global Medical Device Podcast)
- [#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-22-392-verification-and-validation-in-medtech-a-practical-guide-with-devon-campbell) (Global Medical Device Podcast)
- [Dakota Welker | User Needs, Design Inputs, Verification & Validation](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation) (Being an Engineer)

## Citing this page

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