Device development and fabrication processes in translational biomedical engineering

Our conceptual development work is reflected in the development of medical devices and test benches. Development of devices is performed either as contract research or supporting other research projects. Whenever required, new test benches are developed in parallel and are made available for testing of newly developed devices.

This allows our clients to substantially reduce the obstacles encountered during development of innovative products and the risk of technology transfer failure. Furthermore, we provide medical engineering systems for demonstration purposes, for prototyping, and manufacturing of very small series for clinical trials.

Development of medical inhalers

Medical inhaler technology is increasingly evolving from simple, constant drug administration to intelligent, breathing-controlled systems for inhalation treatment with pharmaceuticals.

At Fraunhofer ITEM, we develop products and test benches to the point of meeting the requirements for use in clinical trials or as validated measurement systems.

We are thus able to make an important contribution to your development process: from initial explorative research via prototype manufacturing and verification to the first clinical trials. Our aim is to support above all small and medium-sized enterprises in their development projects.

Bringing medical devices into clinic: respiratory devices and drugs

Development of smart inhalation devices: Drug administration, especially in patients with ventilator support, is practically restricted to liquid formulations. Our innovative CPA technology (CPA = continuous powder aerosolization) enables continuous release and measurement of high doses of dry powder. This technology can be used not only in spontaneously breathing patients, but also under respiratory support.

Dry powder inhaler: Development of novel systems and formulations for the generation of medicinal aerosols is a complex process taking place in a highly regulated environment. Supporting our customers with a novel technology approach for the administration of medications at high doses is one of our areas of expertise.

Optimized humidification of aerosols for inhalation: Inhalation of therapeutics can result in adverse reactions like coughing, especially when inhaling dry-powder aerosols. Our novel humidification technology offers the possibility to continuously release high doses of dry powder without causing adverse effects during inhalation.

Development of active implants

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