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WINTER 2015

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Distributor's Link Magazine Winter Issue 2015 / Vol 38 No1

56 THE DISTRIBUTOR’S

56 THE DISTRIBUTOR’S LINK SPIROL INTERNATIONAL CORP. 30 Rock Avenue, Danielson, CT 06239 TEL 1-860-774-8571 FAX 1-860-774-2048 EMAIL info@spirol.com WEB www.spirol.com FASTENING SOLUTIONS FOR MEDICAL DEVICES by Christie L. Jones, Market Development Manager Even though they tend to be the smallest components in the medical device, fasteners are usually the most important element of the assembly as they literally hold the entire unit together. When a fastener fails in a medical device, this usually means that the device will also fail. The correct fasteners ensure that the device goes together and stays together for the intended life of the assembly, and that the device performs as desired. All too often, these critical elements end up being the very last thing that Engineers consider in the design process. As a result, fasteners used in medical devices are usually specified as extremely tightly toleranced parts. In addition, due to the unfamiliarity of the various fastener industry standards and associated manufacturing processes, Engineers frequently tie the hands of the fastener manufacturer into using high-cost manufacturing processes to meet the specifications. What most people do not realize is that the Design Engineer plays a significant role in the profitability of a company through the fasteners that they select. Fasteners can overcome challenges in assembly, solve quality problems and significantly reduce the total cost of the device. Engineers can lower design and assembly costs by working directly with knowledgeable fastener manufacturers early in the design stage in order to ensure the most cost-effective components are designed into the device without having to go through costly redesigns after the product has launched. Even though the importance of the fastener is evident, surprisingly, traditional Engineering curriculums do not contain any formal instruction on the proper methods of joining and assembly. This article will focus entirely on what designers and manufacturers need to know, avoid, and do, when it comes to pinning and spacing requirements in medical devices. Consider Cold-Headed Versus Machined Pins In the process of working with one surgical device manufacturer, it was discovered that they were using seven different machined Solid Pins as free-fit axles in their surgical stapler. The pins were slip fit into place and held in position by a plastic shroud that went entirely around the outside of the device. The pins were specified with an outer diameter (OD) tolerance of ±.001” and a length tolerance of ±.003”. The material of the pin was specified as 303 stainless steel (SST). Since this type of stainless is only readily available in bar stock, this essentially dictated that the parts had to be machined rather than cold headed or roll formed – two significantly less expensive production methods. After a thorough review of the performance requirements, the medical device manufacturer agreed to widen the length tolerance to ±.010” (the difference of approximately 2 to 3 human hairs), as well as change the material specification from 303 SST to 305 SST so that commercially available wire could be used. These two changes enabled the pins to be cold headed versus machined with no change in performance of the assembly. The cold heading process yields extremely high Cpks. As a result of replacing the machined pins with cold headed pins, the medical manufacturer will save over .3 million dollars annually once the device reaches its full production volume. CONTINUED ON PAGE 160 TECHNICAL ARTICLE

THE DISTRIBUTOR’S LINK 57 Lindstrom Metric, LLC regrets to announce that after sixteen years of outstanding and dedicated service, Mike French made a decision to slow down and smell the roses. Friday October 3, 2014 was Mike’s final day with Lindstrom Metric, thus concluding a successful 42 year career in the fastener industry. Mike was instrumental in the success of the company. During his tenure, the business experienced dramatic growth, due in large part to Mike’s skills and leadership. Mike’s efforts through the years made Lindstrom a recognized and respected name in the fastener business. He is one of the most loyal, dedicated, and hardworking executives the company has ever known, and Mike will be sorely missed. Lindstrom Metric, LLC is the leading domestic supplier of metric fasteners to distributors – with the corporate headquarters located in Blaine, MN and sales/distribution centers in Minneapolis, MN, Greenville, SC, Chicago, IL, and New Windsor, NY. For more information, Lindstrom Metric, LLC can be contacted via phone at 763-780-4200, 1-800-328- 2430 toll free, or by visiting their website at www.lindfastgrp.com. SPIROL International Corporation is pleased to announce the recent achievement of gold level status in the Caterpillar Supplier Quality Excellence Process (SQEP) Recertification. SQEP (Supplier Quality Excellence Process) is Caterpillar’s operational excellence initiative that recognizes a supplier’s commitment to meet and sustain high quality standards to ensure they achieve superior quality and deliver best-inclass performance. Says Gregg Neidlinger, SPIROL’s Global Account Manager for Caterpillar, “Receiving the SQEP gold acknowledgement validates our global commitment to quality, service and support. From technical design and engineering support through delivery, our teams are fully engaged with CAT processes.” Caterpillar’s SQEP certification recognizes their supplier’s dedication to providing excellence in quality, delivery and cost, and is only awarded to those who demonstrate such world-class performance on an ongoing basis. For more information contact Spirol International at Tel: 1-860-774-8571 or visit their website at www.spirol.com.

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