Confluent Medical Technologies has done it again and has pushed the boundaries of historical limits in polymer tubing by developing the strongest Polyimide Tubing in the industry, Ultra Polyimide. This latest development of Ultra Polyimide is about 2x stronger than traditional polyimide and is manufactured without the use of any REACH-restricted solvents.
Although traditional polyimide is known for its strength, with the constant evolution of medical device designs, there is an increased demand for a tubing solution with decreased wall thickness without compromising strength. Confluent’s Ultra Polyimide offers about double the strength of traditional polyimide without limiting the real estate inside the tube. Ultra Polyimide will allow design teams to reduce the amount of material needed in a new medical device while providing the same column and/or tensile strength required for the application. This solution allows customers greater flexibility to address other design constraints by creating additional space within the device.
Polyimide is the preferred material for devices where exceptional column and/or tensile strength is required. It can be manufactured as a discrete tube or built into a composite construction. Polyimide also has excellent dielectric properties and thermal resistance, and is resistant to a wide range of chemicals.
Ultra Polyimide is manufactured without the use of any REACH and/or EU MDR-restricted solvents. Polyimide suppliers have historically used NMP (n-Methyl-2-pyrrolidone) as a solvent in the manufacturing process. In a recent finding that could have ramifications in the industry, the EPA has found that NMP, as a whole chemical substance, presents “an unreasonable risk of injury to human health when evaluated under its conditions of use.” This finding determined that NMP posed an unreasonable risk to health in 29 of 37 use cases, which include domestic manufacturing, import, processing in plastics manufacturing, various other industrial uses, as well as disposal. The EPA is expected to propose a set of risk management actions, which will then be followed by a public comment period. There is still substantial uncertainty as to the final restrictions, which puts the established filmcast polyimide supply chain in question.
To mitigate this risk to the medical industry’s supply chain, Confluent has developed an NMP-Free option with equivalent performance to historical polyimide along with a stable supply chain. This material meets Europe’s REACH compliance requirements, avoids the impending EPA findings against NMP, and provides improved safety for our employees, vendors, and patients.
The development of Ultra Polyimide and a REACH Compliant supply chain allows Confluent to offer customers the latest advancements in polymer tubing without disruption to the supply chain. With the fastest lead times in the industry of 3-4 weeks, Confluent is committed to empowering their customers to create life-saving devices through innovation, exceptional quality, and operational excellence.