# How to Select a Contract Manufacturer

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-02-02
- Length: 42m
- Episode: 245
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-02-how-to-select-a-contract-manufacturer
- Listen: https://podcast.greenlight.guru/episode/how-to-select-a-contract-manufacturer

## Summary

Mark Rutkiewicz, VP of Quality at Innovize and founder of Consiliso LLC, explains how medical device companies should select and manage contract manufacturers (CMs). He emphasizes the importance of supplier quality agreements, risk-based criticality levels, and the use of MedAccred for auditing. The discussion covers the trade-offs between manual and automated processes, the necessity of master validation plans, and the need for transparent communication regarding patient impact and product usage.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-02-how-to-select-a-contract-manufacturer#t=0) Introduction: Mark Rutkiewicz and Innovize
- [2:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-02-how-to-select-a-contract-manufacturer#t=151) The Outsourcing Model and Automation Trends
- [6:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-02-how-to-select-a-contract-manufacturer#t=382) Evaluating Contract Manufacturers: Cost, Location, and Services
- [14:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-02-how-to-select-a-contract-manufacturer#t=858) Supplier Quality Agreements and Risk-Based Criticality
- [23:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-02-how-to-select-a-contract-manufacturer#t=1399) MedAccred Audits and Supplier Certification
- [27:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-02-how-to-select-a-contract-manufacturer#t=1651) Scaling Production and Process Validation
- [35:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-02-how-to-select-a-contract-manufacturer#t=2110) Process Failure Modes and Effects Analysis (PFMEA)

## Topics

- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [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)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Innovize (company)
- Consiliso LLC (company)
- MedAccred (other)
- Greenlight Guru (company)
- FDA (other)
- PFMEA (tool)

## Related episodes from other shows

- [155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p) (Let's Combinate)
- [How to Evaluate Suppliers and Manufacturers with Mike Morena and Shawn Litingtun](https://hardwarepodcasts.com/podcast/predictable-designs-podcast/2020-04-10-how-to-evaluate-suppliers-and-manufacturers-with-mike-morena-and-shawn-litingtun) (Predictable Designs Podcast)
- [S3 E8: Navigating and Managing Contract Manufacturers with Peter Russo](https://hardwarepodcasts.com/podcast/the-builder-circle/2026-01-27-s3-e8-navigating-and-managing-contract-manufacturers-with-peter-russo) (The Builder Circle)
- [197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-16-197-quality-agreements-explained-how-to-protect-yourself-when-things-go-wrong) (Let's Combinate)
- [093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti) (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/2022-02-02-how-to-select-a-contract-manufacturer. 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.