How to Select a Contract Manufacturer

This is a podcast episode titled, How to Select a Contract Manufacturer. The summary for this episode is: <p>What is the best way for medical device professionals, early-stage, and established companies to select and engage with contract manufacturers? One medtech expert has a winning formula that he wants to share with listeners of the show.&nbsp;</p><p>In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, founder of Consiliso LLC, and author of <em>Medical Device Company In A Box</em>.</p><p>As a contract manufacturer himself, Mark brings a wealth of knowledge and insight to his discussion with Jon and Etienne, helping listeners understand how to navigate the selection process for medical device contract manufacturers.</p><h3><strong>Some of the highlights of this episode include:</strong></h3><ul><li>Characteristics to consider when evaluating a contract manufacturer include cost, plant location, services provided, complexity of product, process validation, and available technology.</li><li>Who’s doing what? Create a quality agreement because the overlap and what’s covered under the contract manufacturer’s and medical device company’s quality management system (QMS) should interact and intermix.</li><li>There are four levels of risk and criticality when selecting suppliers for contract manufacturing: Zero (office supplies) to Level 3 - what you do is going to directly affect the patient experience.</li><li>Some contract manufacturers have dedicated auditors to control information. MedAccred is an outsourced organization that conducts audits of medical devices and products.</li><li>When outsourcing to contractor manufacturers, manual work may be cheaper, but automation provides consistent and better quality products.</li><li>A master validation plan should set expectations of how to validate the product. Modify plan, release reports, and conduct risk assessment to make a product that meets a spec.</li><li>Contract manufacturers need to communicate to share knowledge and understanding of what a medical device/product is used for as well as the scope and process controls.</li></ul><h3><strong>Memorable quotes from Mark Rutkiewicz:</strong></h3><p><em>“You can outsource all these different aspects and that’s all part of contract manufacturing.”</em></p><p><em>“The price of the part and what your volume is going to be is directly related.”</em></p><p><em>“What you do is going to directly affect the patient experience. If you mess up, they might die.”</em></p><p><em>“Contract manufacturers - we just take a little cut. We’re not making huge profits.”</em></p><h3><strong>Links:</strong></h3><p><a href="https://www.linkedin.com/in/mark-rutkiewicz-598a992" rel="noopener noreferrer" target="_blank">Mark Rutkiewicz on LinkedIn</a></p><p><a href="https://twitter.com/consilisomark" rel="noopener noreferrer" target="_blank">Mark Rutkiewicz on Twitter</a></p><p><a href="https://www.innovize.com/" rel="noopener noreferrer" target="_blank">Innovize</a></p><p><a href="https://www.consiliso.com/" rel="noopener noreferrer" target="_blank">Consiliso LLC</a></p><p><a href="https://www.amazon.com/dp/1599328615/ref=cm_sw_r_cp_ep_dp_dP54zb3V0F00B" rel="noopener noreferrer" target="_blank">Medical Device Company In A Box: The Case For Consiliso</a></p><p><a href="https://www.innovize.com/files/2018/03/How-to-Select-a-Contract-Manufacturer-for-your-Medical-Device.pdf" rel="noopener noreferrer" target="_blank">How to Select a Contract Manufacturer for your Medical Device - White Paper</a></p><p><a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing" rel="noopener noreferrer" target="_blank">FDA - Device Registration and Listing</a></p><p><a href="https://lso-inc.com/sterilization-validation-services/iso-standards/" rel="noopener noreferrer" target="_blank">ISO Standards - Sterilization and Validation Services</a></p><p><a href="https://p-r-i.org/medaccred/" rel="noopener noreferrer" target="_blank">MedAccred</a></p><p><a href="http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx" rel="noopener noreferrer" target="_blank">Failure Mode and Effects Analysis (FMEA) Tool</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank">Greenlight Guru Academy</a></p><p><a href="https://www.greenlight.guru/true-quality" rel="noopener noreferrer" target="_blank">True Quality 2022</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a></p>