Hardware Podcasts

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

Global Medical Device Podcast · 23 Mar 2022 · 28m · Episode 251

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Innovize, Consiliso LLC, Green Light Guru
Also
Medical Device Company In A Box

Related episodes from other shows

Other shows on the same ground, closest first.

  • OnTrack · 53m

    Simplifying BOM Management with Intelligent Platforms

    Nemanja Jokanovic, VP and General Manager at Breadboard, explains how his platform automates Bill of Materials (BOM) management to bridge the gap between design engineers and procurement professionals. He details features including automated quoting, integration with Octopart and distributors like Digi-Key and TTI, and machine learning for extracting data from cable assembly PDFs. The discussion highlights how Breadboard replaces manual spreadsheets with a cloud-based system that handles attrition calculations, approved vendor lists, and RFQ automation to reduce costly respins and speed up production.

    Sourcing & supply chainEDA & CAD tools
    8 chapters

  • OnTrack · 41m

    AI-Powered PLM: The Future of Hardware Product Lifecycle Management

    Michael Corr, CEO and founder of Duro, explains how his cloud-based PLM platform simplifies hardware product lifecycle management by centralizing bill of materials (BOM) data and integrating with supply chain APIs like Octopart and Nexar. He details the transition from traditional, complex legacy PLM systems to a simplified, opinionated tool that enforces best practices to reduce production errors. The conversation highlights the use of AI to automate data normalization, analyze change orders, and optimize Design for Manufacturing (DFM) by leveraging tribal knowledge. Corr also discusses Duro's Vendor Integration Engine (DVE), which connects directly to contract manufacturers for instant quoting and ordering of PCBAs.

    EDA & CAD toolsSourcing & supply chain
    10 chapters

  • Let's Combinate · 37m

    118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead

    Doug Mead, founder of CP Pathways, explains the regulatory differences between Drug Master Files (DMFs) and Device Master Files (MAFs) for combination products. He details the five types of DMFs and contrasts them with the less formal MAFs, noting that CDRH and CDER often lack cross-access to each other's files. Mead argues that for finished devices or platforms, it is often more efficient to include device content directly in Module 3.2.R of an NDA or BLA rather than maintaining a separate MAF. He highlights challenges such as supplier reluctance to grant Letters of Authorization and the redundancy of updating both a master file and a supplement.

    Certification & complianceMedical & health devices
    8 chapters

  • People of Packaging · 53m

    34 - DocXellent and GlaxoSmithKline - packaging specs!

    Amy Rodriguez of DocXellent and Albert T. from GlaxoSmithKline discuss the migration from legacy systems like Lotus Notes to DocXellent's Insure software for managing packaging specifications. They detail how GSK uses the platform to maintain a single source of truth for engineering BOMs, ensure regulatory compliance in a GMP environment, and accurately calculate packaging taxes based on material weight. The conversation highlights the shift from homegrown databases to a standardized, validated system that supports global collaboration and reduces errors in contract manufacturing.

    Design for manufacturing & NPISourcing & supply chain
    10 chapters

  • Let's Combinate · 39m

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

    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.

    Design for manufacturing & NPIQuality & yield
    6 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.