# 136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-05-15
- Length: 39m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-15-136-systems-engineering-for-combination-products-user-needs-design-inputs-design
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/136---Systems-Engineering-for-Combination-Products--User-Needs--Design-Inputs--Design-Changes--Risk-Management-Files-and-Avoiding-HUGE-Traceability-Mistakes-with-Chuck-Ventura-e2jl116

## Summary

Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek, discusses systems engineering challenges for combination products, emphasizing the importance of robust traceability between user needs, design inputs, and risk management files. He advises on managing legacy Design History Files (DHF) by using a configuration management approach to remediate only affected subsystems rather than entire documents, and highlights the specific regulatory complexities when applying off-the-shelf drug delivery systems to new biologic or small molecule products. Ventura also evaluates traceability tools like DOORS and Polarion, arguing that manual methods using Excel and Word can be efficient for simple devices if trace links are centralized to avoid duplication errors.

## Chapters

- [2:43](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-15-136-systems-engineering-for-combination-products-user-needs-design-inputs-design#t=163) Introduction: Chuck Ventura and HemoTek
- [6:13](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-15-136-systems-engineering-for-combination-products-user-needs-design-inputs-design#t=373) Managing Legacy DHFs and Design Changes
- [15:13](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-15-136-systems-engineering-for-combination-products-user-needs-design-inputs-design#t=913) Functional Decomposition and Use Cases
- [17:21](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-15-136-systems-engineering-for-combination-products-user-needs-design-inputs-design#t=1041) Pharma vs. Device Design Inputs
- [20:35](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-15-136-systems-engineering-for-combination-products-user-needs-design-inputs-design#t=1235) Risk Management for Off-the-Shelf Delivery Systems
- [24:31](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-15-136-systems-engineering-for-combination-products-user-needs-design-inputs-design#t=1471) Traceability Tools: DOORS, Excel, and Manual Methods

## Topics

- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [EDA & CAD tools](https://hardwarepodcasts.com/topic/eda-and-cad-tools)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Ventura Solutions (company)
- HemoTek (company)
- Baxter Healthcare (company)
- DOORS (tool)
- Polarion (tool)
- Excel (tool)
- Word (tool)

## Related episodes from other shows

- [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)
- [Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-23-building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs) (Global Medical Device Podcast)
- [34 - DocXellent and GlaxoSmithKline - packaging specs!](https://hardwarepodcasts.com/podcast/people-of-packaging/2020-10-15-34-docxellent-and-glaxosmithkline-packaging-specs) (People of Packaging)
- [Meet a Guru: Karen Schuyler](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler) (Global Medical Device Podcast)
- [E94 Requirements Engineering, part 1: Fundamentals](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals) (The Pragmatic Embedded Podcast)

## Citing this page

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