Medical device manufacturing covers every aspect of medical device fabrication, from designing a particular manufacturing process to scaling up and the continuous improvement of processes. Medical devices include a variety of instruments, implants, and equipment used for tasks such as monitoring, diagnostics, and treatment. 

Many of these devices rely on materials such as polyurethane and epoxies to produce durable and efficient designs. 

Benefits of Polyurethane and Epoxies in the Medical Industry

Polyurethanes and epoxies offer numerous benefits for use in medical device manufacturing over other materials. Thermoset polyurethanes can be formulated to feature the strength of plastic, the elasticity of rubber, or a combination of both. Unlike other plastics or rubbers, polyurethane’s unique molecular structure makes it strong, flexible, and highly resistant to abrasion, chemicals, and UV degradation. In addition, polyurethane’s durability makes it ideal for medical devices that face extreme frictional forces or stress.

Stainless steel and titanium are both corrosion-resistant, but not rust-proof. They’re also more expensive and costly to machine. Steel and aluminum materials will increase your overall manufacturing costs significantly while not providing significant advantages in terms of durability or performance compared with components made from thermoset polyurethanes and epoxies.

Polyurethanes might be more expensive than other polymers, but they work in ways that other polymers do not. Using materials such as silicone or PVC can lead to issues such as decreased performance when exposed to cold temperatures, lack of adhesion to other substrates, and the leaching of toxic chemicals. Because polyurethanes have so much versatility and compatibility with the human body, the higher price-per-pound is worth it for manufacturers. 

Steralloy Products From Hapco, Inc. 

If you want to experience the benefits of polyurethane and epoxies for use in medical devices, look no further than the Steralloy™ products from Hapco, Inc. Steralloy™ is a type of specialty polymer series that Hapco produced for use in the medical industry. It’s specifically formulated for various applications requiring biocompatibility testing. The material is ideal for many types of medical components and devices, making it a suitable alternative to other less reliable materials. Our Steralloy™ materials are all made with 100% solids and contain no VOCs or mercury.

Steralloy R-Series Applications

Depending on the needs of a particular application, Hapco offers two different types of Steralloy™ materials: the Steralloy™ E-Series and R-Series. Our line of E-Series products features colorless flexible hybrid elastomers, which can be pigmented using our color dispersions. The Steralloy™ E-Series is also made up of both polyester and polyether-based polyurethanes in durometers from 25A to 72D. The R-Series is made up entirely of epoxy-based formulations.

Some of the applications for Steralloy™ in the medical industry include:

  • Surgical instruments
  • Test models
  • Biomedical containers
  • Diagnostic equipment
  • Single-use filter cartridges

These and other medical products made with polyurethane and epoxy materials benefit from increased longevity, durability, sustainability, and safety compared to other materials such as silicone, PVC, and more.

It’s important to note that polyurethanes and epoxies in their two-component liquid state have not been given approval by the FDA, but some medical devices made from them have. Most of our products that have passed FDA approval and meet biocompatibility requirements are made from epoxies. Medical components made using Hapco products have all required some form of testing. Because of the numerous techniques, equipment, and potential contaminants present in different manufacturing facilities, it’s always the customer’s responsibility to have their finished products tested.

Partner with Hapco, Inc.

For over 50 years, Hapco, Inc. has provided top-quality materials and equipment to customers across a wide range of industries and applications. With unparalleled technical expertise, our knowledgeable and experienced employees can help you find the ideal polyurethane or epoxy materials for use in nearly any type of medical application. We’re backed by an ISO certification to help ensure consistent quality and efficiency across all of our solutions. 

For additional information about our products, contact us today or request a quote to get started.