# Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-03-23
- Length: 28m
- Episode: 251
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-23-building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs
- Listen: https://podcast.greenlight.guru/episode/building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs

## Summary

Mark Rutkiewicz, VP of Quality at Innovize and Founder of Consiliso LLC, explains how to structure a Bill of Materials (BOM) to serve as a single source of truth for Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR). He details the necessary metadata, including part numbers, reference designators, and operational steps, to bridge the gap between design engineering and manufacturing workflows. Rutkiewicz emphasizes designing flexible quality systems that accommodate complex hierarchies, alternate parts, and rules of interchangeability to prevent documentation errors and ensure regulatory compliance.

## Chapters

- [0:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-23-building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs#t=34) Introduction: Mark Rutkiewicz and the BOM Problem
- [1:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-23-building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs#t=78) BOM, DHF, DMR, and DHR Relationships
- [5:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-23-building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs#t=327) The Nightmare of Multiple BOMs and Single Source of Truth
- [9:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-23-building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs#t=565) BOM Metadata: Part Numbers, Reference Designators, and Ops
- [13:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-23-building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs#t=813) Designing for Flexibility and Hierarchical Structures
- [18:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-23-building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs#t=1121) Part Numbering Schemes and Rules of Interchangeability
- [20:15](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-23-building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs#t=1215) Managing Alternate Parts and Subcontractors
- [22:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-23-building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs#t=1351) Ownership of the BOM and Supplier Management

## Topics

- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)

## Most relevant to

early-stage companies

## Mentioned

- Innovize (company)
- Consiliso LLC (company)
- Green Light Guru (company)
- Medical Device Company In A Box (other)

## Related episodes from other shows

- [Simplifying BOM Management with Intelligent Platforms](https://hardwarepodcasts.com/podcast/ontrack/2025-11-11-simplifying-bom-management-with-intelligent-platforms) (OnTrack)
- [AI-Powered PLM: The Future of Hardware Product Lifecycle Management](https://hardwarepodcasts.com/podcast/ontrack/2025-07-01-ai-powered-plm-the-future-of-hardware-product-lifecycle-management) (OnTrack)
- [118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su) (Let's Combinate)
- [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)
- [136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-15-136-systems-engineering-for-combination-products-user-needs-design-inputs-design) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-23-building-your-bill-of-materials-bom-to-accommodate-crossfunctional-needs. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.