Defining & Demystifying Medical Grade Polymers
The healthcare and medical device industry is heavily regulated to ensure quality, sustainability and most importantly safety of human life.
Read on to hear Siobhan Bastiansen, Medical & Market Manager at IMCD Germany, explain how specialised medical polymer producers have risen to the challenge to create indispensable value for processors and OEMs.
Setting the stage
The challenges of the past
Application restrictions as self-protection for polymer suppliers
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:
- not permitted to be used in medical applications
- skin contact only
- no direct contact with fluids entering the blood stream
- maximum 24 hours inside the body
- maximum 29 days inside the body
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.
MDR and its impact for medical device manufacturers
First step towards definition of medical grades
Change management and long-term commitment as key differentiators
However, several of these ‘industrial grade’ resins have made their way into products that are considered as medical devices and as such are subject to MDR or FDA conformity. For medical device manufacturers, on the other hand, this holds several risks and challenges; once they have carefully chosen and tested a material to comply with all the complex laws and guidelines for medical plastics, and to meet the requirements for their specific application, they need to rely on long-term supply and predictability.
Polymer suppliers that develop and provide specialised polymers for medical applications have discovered a significant gap in this complicated situation to add value for the manufacturer. Suppliers we have been cooperating with for many years have already put transparent mechanisms into place to ease the process of change control for the OEMs and to also secure a long-term supply. This way, both parties benefit from a close cooperation with mutual insight and knowledge exchange and protect their business and products from expensive failures.