In today's evolving healthcare landscape, medical device manufacturers face the complex challenge of delivering high-performance products while addressing demands for durable and sustainably advantaged* solutions. At Trinseo, we are building on our legacy of innovative medical grade materials for today and tomorrow by addressing these challenges head on.
The foundation of medical device success has always been performance and reliability—patient safety depends on it. At Trinseo, we have legacy materials like CALIBRE™ and CALIBRE MEGARAD™ polycarbonates (PC) that have earned the medical industry's trust through decades of consistent performance in critical applications, delivering the mechanical strength and biocompatibility essential for life-saving devices.
Modern medical innovation extends beyond traditional performance metrics. Today's devices must enhance the user experience while maintaining reliability. Materials that provide improved ergonomics, patient comfort and visual monitoring capabilities are becoming standard expectations. Our portfolio of medical solutions has continued to evolve in order to meet these demands, complementing our legacy products. APILON™ thermoplastic elastomers (TPE) materials exemplify this evolution, providing soft touch for ergonomics, while ALTUGLAS™ polymethyl methacrylate (PMMA) delivers essential transparency for visual monitoring applications. Our MAGNUM™ Bio-acrylonitrile butadiene styrene (ABS) demonstrates how materials can maintain the high-performance standards required in medical applications, with capability of using renewable feedstocks and reduced product carbon footprint (PCF) compared to fossil-based solutions.1
Across our solutions, we work with medical device manufacturers to tailor solutions that meet their coloration needs. Our custom coloration capabilities allow precise color matching and visual differentiation while adhering to medical standards. This customization helps improve device usability through color-coded components.
Balancing Compliance with Forward-Thinking Solutions
Alongside durability and use, we must also balance regulatory compliance, like ISO 10993 certified for biocompatibility standards. Medical device manufacturers operate in highly regulated environments, where material changes typically require extensive validation processes. This regulatory complexity often creates tension between innovation and compliance, as manufacturers must balance the desire for improved materials with the practical challenges of requalification.
Material designs that incorporate circularity principles have become one of these topics in medical manufacturing. While recycled content-containing solutions are not widely accepted for medical uses requiring biocompatibility, the mass balance approach offers a unique advantage: manufacturers can incorporate sustainably advantaged materials. Our mass balance bio-ABS and mass balance bio-PC can be substituted for our virgin materials with limited disruptions, as they utilize established processes or requalifying materials. Our MAGNUM™ Bio-ABS not only utilizes bio-based content, but it can offer a lower PCF based on the chemical constituents of the grade compared to our virgin-based equivalents.
Additionally, we see increasing demand for PC and PC/ABS resins that are manufactured without the intentional use of per- and polyfluoroalkyl substances (PFAS) and halogenated additives. In instances where regulatory pressures call for reduced use of PFAS additives, our ignition resistant EMERGE™ PC and PC/ABS resins, including some grades that incorporate up to 65% recycled content, can be substituted for our virgin solution for electrical medical device enclosures.
These seamless integrations into existing supply chains represent the perfect balance between innovation and compliance.
Global Production with Local Understanding
The medical device industry operates globally yet must meet local regulatory requirements and cultural preferences. This creates a need for materials suppliers who can implement consistent quality standards across multiple regions while understanding local compliance variations.
Implementing international sustainability certification systems like ISCC+ mass balance across global production networks ensures consistent quality. By having global production facilities in North America, Europe and Asia, we can deliver certified materials with consistent quality processes. This global approach is supported by local technical teams who understand regional requirements and can provide customized solutions for specific applications. Our decades of experience supplying medical-grade materials have given us unique insights into balancing regional compliance variations with consistent global standards.
This approach demonstrates how the industry can balance global consistency with local regulatory requirements, supported by robust quality processes including notification of change protocols and lot traceability.
The Future of Medical Materials
As healthcare continues to evolve, materials that balance performance, compliance and environmental impact will drive the next generation of medical devices. This is why Trinseo is committed to providing medical device manufacturers with medical material solutions that embrace all three.
*Sustainably advantaged is defined by Trinseo as products that have recycled, renewable or degradable content contributing to a circular economy model; have reduced/eliminated raw material substances of concern; or contribute to greenhouse gas emission reduction or material intensity reduction.
1. PCF study completed in October 2021 by Trinseo reflecting raw materials and production processes of ABS based on the current ABS eco-profile from Plastics Europe and bio-based material profiles from partner bio-feedstock refiners. The percent CO2 reduction in the chemical constituents of ABS and SAN reflects the amount of that chemical in their formulations, making the carbon footprint impact proportionately similar.
