Medical and Pharmaceutical Engineering

The development of innovative inhalation technologies has always been a priority at Fraunhofer ITEM. The current focus of research is on the development of novel technologies for administration of therapeutic aerosols towards smart drug/device combination products. In addition, Fraunhofer ITEM researchers explore the field of additive manufacturing of individualized implants, for example from medical-grade silicone rubber. In order to allow the long-term durability of such implants to be evaluated, they develop novel test methods tailored to specific requirements. Besides testing of the osseointegration of orthopedic implants, this includes the testing of active implants in particular, such as evaluation of the long-term performance of neural implants. Another research topic are in-vitro and in-vivo systems for toxicity and biocompatibility testing as well as test systems for functional implants, including ones with anti-infective or anti-fibrotic effects.

For the assessment of medical device safety, the researchers use the new concept of next-generation risk assessment. With this approach, they use modeling parameters that allow them to avoid laboratory experiments and animal testing in particular. They employ methods that are used primarily for risk assessment of industrial chemicals, such as TTC, read-across and QSAR. This approach is all the more relevant in view of the current regulatory requirements for medical devices: The earlier the regulatory strategy is established, the less problematic the performance of the necessary conformity assessment and the shorter the time to market. A comprehensive database of requirements and materials for optimized (re)certification of medical devices is being set up.