The material you choose for your medical devices can have a big impact on your brand’s image. In today’s healthcare environment, not all plastics can withstand exposure to the aggressive disinfectants being used in hospitals. If your device is showing outward signs of suffering from exposure to effects of disinfection, including yellowing, cracking, crazing, or paint peeling, it’s time to reconsider material selection.
Educating product managers about the attributes of different plastics can help better shape brand positioning. For example, cracks and crazes can lead to pooling of aggressive disinfectants and leakage into the sensitive electronics that make the device function. Choosing a more chemically resistant polymer prevents this by strengthening device durability and reducing maintenance time. As a result, the working life of the device increases and maintenance and replacement costs go down.
With this information, the product manager can position the brand as being resistant to the physical handling or moving of devices despite more frequent cleaning and use of harsh disinfectants. They can present brand devices as having a longer service life, keeping their “new” look longer, and being more durable. This positioning can also be used by hospitals and clinics, which can improve their image by purchasing more durable equipment that looks better because it is better.
By choosing materials with better quality and performance, manufacturers can help product managers position the brand as having those qualities as well.
Medical device failures are a common—and costly—occurrence. They can lead to a product recall, affect the product development cycle, and result in extra expenses for manufacturers. The reasons devices fail can be complex, making it difficult for quality engineers to classify the problem.
What can quality engineers do to remedy this problem? Consider these factors:
- Understand why failures occur: Most device failures are caused by a misunderstanding of how a material’s properties, processing, and environment work together. In many cases, failures can result from a combination of wrong material selection, poor chemical resistance, high-stress design, or inconsistencies in manufacturing processes.
- Collaborate with your supplier: Working with material suppliers on material selection, testing, part and tooling design review, and secondary operations can give quality engineers access to knowledge and resources they may not otherwise have.
- Test your materials: Find a testing method that helps you choose the best plastic for your project. Eastman’s 4-step test for chemical resistance, for example, helps predict the reliability of a material after exposure to harsh cleaners and drugs commonly used in hospital settings.
Understanding the root causes of failures and working with industry experts to make better material choices can help quality engineers improve device design, have a more successful product launch, and save on costs.
Eastman Tritan™ copolyester is resistant to a wide array of medical fluids, such as oncology drugs, drug carrier solvents, and lipids. Along with its toughness, low residual stress, and color stability post-sterilization, Tritan is an excellent choice for fluid management components.
Regulations in the medical market are constantly changing. When Elcam Medical, a world-class manufacturer of disposable medical devices for the OEM market, wanted to further improve the safety and efficacy of its fluid management devices, they turned to Eastman to find a polymer that complies with new regulations while still optimizing performance.
Working with our technical experts, Elcam developed drug- and lipid-resistant BPA-free stopcocks and connectors made with Tritan. They are designed to meet new ISO 80369 standards, which encourage worldwide consistency in small-bore connectors for liquids and gasses in healthcare applications to reduce the risk of misconnections between medical devices and accessories.
Join us for Tritan on Tour—an exclusive event showcasing how new materials and manufacturing processes can improve medical device performance.
Hear new information about simulating, molding, bonding, and welding Eastman
Gain key insights on the latest with Tritan material and case studies; learn about speed to market through design for manufacturing/design for reliability (DFM/DFR).
Observe a Tritan tool running at the press and on-site presentations/demos from Nexeo Solutions, Beaumont Technologies, Henkel and Dukane!
Plus, we’ll begin the day with donuts and end with cocktails! Hope you can join in the fun!
Advanced Molding Technologies
8700 Rendova Street NE
Circle Pines, MN 55014
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Global design standards for tubing connectors are now helping improve patient safety and device efficacy. ISO 80369 requires small-bore connectors to be made of semirigid and rigid materials, making incorrect interconnections less likely. Enteral devices were the first of all the clinical applications to undergo this change.
To meet this standard, you may have to adjust your design, which means you may need a new mold or new materials. Eastman Tritan™ copolyester is a rigid material with the properties needed to comply with these regulations.
BPA-free Tritan demonstrates excellent chemical resistance, toughness, and color stability post-sterilization. It also helps maintain device safety and efficacy by ensuring that connecting parts retain their shape, dimension, and clarity during and after sterilization.
Using a rigid material that won’t be compromised by sterilization helps ensure patient safety and the efficacy of your device. Contact us for more information on switching to Tritan.