Custom Medical Equipment Gaskets for Ambulatory Infusion Pump Applications
Medical devices must meet stringent performance, reliability, and safety standards to ensure patient safety and optimal functionality. One critical component in many medical devices is the gasket. Gaskets often play a crucial role in ensuring tight and waterproof seals, protecting sensitive internal components, and maintaining the functional integrity of medical devices. When partnering with a manufacturer of custom medical equipment gaskets, OEMs and their suppliers should prioritize precision, quality, repeatability, and adaptability.
See how H-O Products, a leading manufacturer of custom-engineered tapes, pads, and gaskets, supported a medical device OEM, developing a highly precise manufacturing process for gaskets for an ambulatory infusion pump. Through collaboration, attention to detail, and commitment to quality, we successfully respecified materials, solved production challenges, achieved budgetary goals, and reshored the production of parts for this medical project.
Explore our range of standard and custom gaskets and contact us for expert support for your custom gasket project.
The First Challenge - Precision & Compliance in Medical Equipment Gaskets
Medical equipment gaskets serve several vital functions in devices such as ambulatory infusion pumps, insulin pumps, metering devices and advanced imaging equipment. These gaskets act as tight seals that prevent fluid or gas leakage, metering medication dosage, and providing protection against environmental factors, such as moisture and dust. In life-saving devices like ambulatory infusion pumps, the slightest variation in gasket performance can affect device functionality, making precision and reliability critical.
When a medical device OEM needed 13 custom gasket parts, as well as custom medical packaging foam that protected the final pump product against impact, vibration, and contaminants during transport – they looked to H-O Products.
While this project presented a variety of challenging requirements, a major key to success was the development of a gasket manufacturing process that could achieve the OEM’s tight dimensional requirements – with tolerances as strict as +/- .001 inches.
The H-O Products team needed to develop prototypes and ultimately deploy a scalable, large volume process that could manufacture these medical equipment gaskets with repeatability, precision and compliance to help ensure the device’s consistent and safe operation.
The Second Challenge – Reshoring and Material Substitution
The ambulatory infusion pump was previously manufactured overseas, and the medical device OEM was looking to reshore production. As part of this process, the H-O Products team received technical drawings in Chinese, which needed to be translated and also adapted to U.S. manufacturing standards.
Leveraging the team’s engineering expertise as well as translation resources, H-O Products was able to accurately interpret the drawings. But this successful translation presented new challenges, as the team now needed to find equivalents for the specified materials that would be available in the United States. This included the foam and gasket materials, as well as the adhesive required for assembly.
A major component of success was H-O Products’ ability to substitute acrylic foam tapes specified in the original design with U.S.-sourced materials. Through careful research of adhesive options, the team identified and selected low surface energy (LSE) adhesives that would correctly bond the gaskets to the surface materials used in the ambulatory infusion pump. Each material had to be respecified, tested, and approved by the OEM, ensuring compliance with stringent medical standards.
The Solution: Engineering a Precision Manufacturing Process
H-O Products’ approach to manufacturing the medical equipment gaskets involved a combination of cutting-edge techniques, including steel rule cutting, precision rotary tools, and laser cutting. These methods allowed the company to produce gaskets with the necessary accuracy, even for components that required very tight tolerances.
One of the key gaskets in the pump – a foam gasket designed for use on low surface energy thermoplastic polyolefin (TPO) material - posed a particular challenge. The stock material available in the U.S. did not match the exact thickness specified in the original design. While the variation was within standard tolerances, the critical nature of the ambulatory infusion pump meant that H-O Products needed to match the thickness precisely.
To overcome this, a specialized process was utilized to hold the tight gauge tolerance of the gasket. This involved buffering the raw material with a specialized machine that had to be adapted for this program. This delicate process allowed H-O Products to hold the very tight gauge tolerance specifications of the device.
100% Inspection for Quality Assurance
In the medical field, there is no margin for error, especially for components for life-critical devices like ambulatory infusion pumps. For one particular gasket, H-O Products implemented a 100% inspection process for every part produced. In this case, each gasket was automatically inspected as it came off the production line, ensuring it met the required tolerance levels before being shipped to the customer. This level of scrutiny is crucial, as it assures compliance, even before the customer conducted their own inspections upon receipt of the gaskets, after installation, and as part of the overall system during assembly.
This comprehensive quality assurance process was one of the many ways H-O Products proved itself as a reliable, leading manufacturer of medical equipment gaskets. Learn more about our commitment to continuous improvement and quality or reach out to our team to discuss your unique project requirements.
Collaborative Development and Industry Expertise
H-O Products’ collaboration with the medical OEM spanned several months, as the team worked to refine designs, material selection, and manufacturing processes for the medical equipment gaskets. With close communication between engineering teams and designers, H-O Products was able to leverage its deep industry knowledge to provide valuable input on material selection, prototype development, and tolerance, ultimately delivering a superior product.
The OEM engineering team was particularly involved in decisions about the gauge of the material and the process for creating the gaskets. At several points, the H-O team modified machinery to accommodate the unique properties of the foam and adhesive materials. These adjustments were critical to achieving process validation with the necessary precision and to ensure that the gaskets meet the high-performance standards required for the medical device.
Learn more about our manufacturing capabilities and prototype development processes and see how our expertise can benefit your project.
Leverage Our Medical Equipment Gasket Manufacturing Expertise
For OEMs and component suppliers looking for a trusted partner to supply custom medical equipment gaskets, H-O Products offers unparalleled expertise, state-of-the-art manufacturing processes, and a commitment to delivering parts that meet the most stringent performance requirements. Whether you are reshoring production or developing new medical devices, our team is ready to collaborate to deliver the engineered solutions you need. Contact us today or fill out the form below and a member of our team will be in touch shortly.
About H-O Products
Our engineered products – including foam, rubber, polymeric and composite tapes, pads and gaskets – offer reliable sealing, cushioning, mounting and assembly in harsh environments, while minimizing downtime and maintenance costs. From prototype through final product, our customers can be confident in performance, reliability, and the continued support of our expert team. Learn more about H-O Products and how we can give your company a competitive edge in today’s global marketplace.