Fraunhofer ITEM scientists are currently developing long-term test methods to guarantee the safety of implants which exceed the known standards of temperature acceleration. Such research is geared towards preventing repeat surgery, minimizing the risk of implant failure, and reducing innovation constraints for new developments.
Although as many as almost 100,000 cochlear systems are implanted every year, the need for innovation remains high, as current solutions so far are not able to meet the provisioning requirements. The clinical application of retina implants is still in its infancy and issues primarily related to implant life span continue to have high priority.
Besides this development and manufacturing expertise, the Fraunhofer ITEM scientists have special experience in the testing of medical devices, allowing reliable accelerated life cycle testing in artificial body fluids such as liquor or perilymph.
Bridging the gap: from academic research to clinical trials
We support small and medium-sized enterprises to bring their medical device innovations into clinical testing. Even though processes take place at different sites, they can all be managed under an umbrella of medical device manufacturing complying with ISO 13485. Our portfolio comprises:
- Atomic layer deposition (ALD) of alumina barrier layers in the nm size range
- Parylene C layers for active implant encapsulation
- 3D medical grade silicone rubber printing for individualized implant manufacture
- Femtosecond laser processing
- Plasma functionalization