White Paper

Fastening Solutions For Medical Devices

Source: Spirol International Corp.

By Christie L. Jones, Spirol International Corporation

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.

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