When a medical device reaches a patient, whether a surgical instrument, diagnostic tool or fluid management component, it reflects the work of an entire supply chain. Most of that chain is easily recognized—from the raw material selection and manufacturing to packaging and beyond. The manufacturer owns the device, the regulatory submission and the clinical validation. But upstream, largely out of view, is where it all begins: the resin.

At Trinseo, we operate at the very start of that chain. That position carries a critical responsibility. The quality and safety of a device do not begin at final assembly; they begin at the material level. This reality shapes how we develop our resins, how we test them and how we support device manufacturers throughout their development process. It is also why we have made biocompatibility testing under ISO 10993 a core part of our medical offering.

ISO 10993 establishes the global framework for biological safety evaluation of medical devices. It is, by design, device-centric. The regulatory burden sits with the device manufacturer. However, the biological story of a device starts with its material composition. If a resin has not been evaluated, that uncertainty does not disappear downstream—it compounds. It follows the device manufacturer into regulatory review and, ultimately, can affect patient safety.

Our approach is grounded in a simple principle: patient safety begins upstream.

Evolving standards demand more than compliance

The requirements around biocompatibility are evolving. The 2025 revision to ISO 10993-1 marks a shift from a test-driven, checklist approach toward a fully integrated, risk-based lifecycle framework.¹  Device manufacturers are now increasingly expected to build tailored biological risk assessments rather than rely solely on predefined testing matrices.  

This update raises expectations around the type and depth of data required to support a submission. It is no longer sufficient to provide a datasheet and baseline test results. Suppliers must now deliver data that is relevant, well-characterized and aligned with how materials are ultimately used.

At Trinseo, we are actively aligning our capabilities with these shifts. That includes investing in the expertise, testing strategies and data frameworks required to support more sophisticated risk assessments. It also means working closely with device manufacturers to interpret what these changes mean in practice. The goal is to stay ahead of evolving standards.

The test result is only part of the story

Biocompatibility testing under ISO 10993 is often described as a checklist of endpoints: cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity and hemocompatibility. In reality, it is more complex.

Extraction conditions, including vehicle, temperature and duration, determine what is introduced into the biological system. These decisions directly influence outcomes and, ultimately, how risk is interpreted. This is a critical point that can be overlooked.

For inert polymers, the focus of biological risk is not on the polymer’s chemical composition, but rather the low-molecular-weight substances that may be extracted under conditions of use. If the extraction conditions are not representative of real-world use, the data will not be either. Furthermore, the additives present in the test samples must also cover the additives present in the as-sold resins, at their maximum concentrations.

For this reason, transparency is a non-negotiable.

At Trinseo, we provide full visibility into how our testing is conducted: extraction parameters, sterilization methods and study conditions. We work with North American Science Associates (NAMSA), one of the leading contract research organizations for medical device testing in the U.S., to conduct and interpret this work. We also provide test sample and as-sold resin composition data. This level of detail is essential for regulatory and toxicological assessment.  

Building through partnership

Effective biocompatibility strategies cannot be developed in isolation. They must reflect real-world applications, regulatory requirements and evolving customer needs.

Our testing program has been shaped through direct engagement with the device manufacturers who rely on our materials. Their input has influenced which endpoints we prioritize, the extraction conditions, how we evaluate sterilization methods and how we structure our data packages.  

This reflects an ongoing dialogue and partnership with our team and customers

We engage with our customers throughout the development lifecycle, not just at material selection, but as requirements evolve. These conversations surface practical needs: how data will be used, what regulators expect to see and where uncertainty still exists. That insight informs not only what we test, but how we deliver the results.

The role of a medical-grade polymer supplier is changing. What customers need from a supplier has grown—from material performance to regulatory alignment and from basic data provision to meaningful technical partnership.

At Trinseo, we see this shift clearly. We are actively contributing to broader industry efforts, including engagement with the North American Medical Grade Material Consortium (NAMGMC) and ongoing discussions around emerging ASTM standards for medical-grade polymers. These efforts will help define what "medical-grade" truly means in the years ahead.

But in the meantime, we fully support device manufactures by providing confidence in our medical grade materials: in the data, in the process and in the partnership behind it.

Starting at the source

Every medical device has a biological story. It does not begin at regulatory submission or even at design. It begins with the material composition. The decisions made at that stage—what is tested, how it is tested and how the data is generated—carry through every downstream step. Getting it right at the source reduces risk everywhere else.

This is the role we play: as an active partner in enabling safe, effective medical devices. As standards evolve, that role will only become more important.

References

¹ International Organization for Standardization. (2025). Biological evaluation of medical devices—Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025). https://www.iso.org/standard/10993-1