Following several high-profile and costly litigations in the '90s, companies that actively market their polymers for medical applications typically have developed policies regarding restricted or permitted applications. “There is a wide variety of ‘rules’ from polymer producers concerning which applications are allowed. Often the restrictions may not be related to expected performance of the polymer in the target application, but rather reflect the corporate environment and legal department’s decisions. The restrictions can have much more to do with perceived risk exposure to litigation down the line. Some examples of guidelines are:
Of course, it is very challenging for medical device manufacturers and OEMs, especially the specialised small and medium-sized businesses, to keep track of all the different and complex policies and disclaimers. As a specialist medical polymer distributor, we see our role as the critical bridge between our polymer principals and our customers, the device manufacturers, to make the right polymer choice process a safe, successful, sustainable and convenient one. For instance, currently, there are very few polymer choices for medical device manufacturers designing products to remain in the body longer than 30 days, and where the customer wants the confidence and support of the raw material supplier. “Our partner Lubrizol Life Science- Health is one of the very few polymer suppliers who do not restrict the use of their TPUs to 30 day implants but instead have a disclaimer reminding that the choice of polymer is up to the device manufacturer.
Medical device designers are free to select from a wide TPU portfolio the most suitable grades to be tested and considered for each specific application. But on the other hand, if we have a customer who has very low volume demand for a coloured material for a non-invasive device, we can offer a range of options advising MOQs of coloured resins direct from the producer, or assist in finding a long-term sustainable solution with our medical compounding partner IPC.