Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer Institute for Toxicology and Experimental Medicine

High-Performance Center Translational Biomedical Engineering

From basic research to clinical testing of medical devices

© Fraunhofer ITEM

Our commitment is to close the gap between basic research and first clinical trials with particular emphasis on safety aspects – regarding regulation, quality assurance and manufacturing technology. In cooperation with partner institutions we cover the whole chain from innovation to a CE-compliant product.

We equip companies and entrepreneurs with the technical and regulatory support that will allow their innovations to enter and pass clinical testing. This includes dedicated manufacturing processes that commonly represent substantial economic hurdles for companies. These processes can be provided by our partners and are pooled within the High-Performance Center with corresponding quality and risk management structures for medical devices, supplemented by appropriate process logistics to provide a one-stop shop. In addition, we guide clients along the regulatory pathway including necessary documentation, arrange or conduct the required tests and optimize these according to the requirements of the innovation in close contact with the notified body.

Development of smart drug/device combination products

In our research cooperation network we link biomedical engineering to the strengths of Fraunhofer ITEM, in particular in the fields of aerosol technology and biocompatibility, and those of the partners in the Center in the fields of physics, chemistry, biology, engineering sciences, and materials sciences. With an emphasis on polymers and micro/nanotechnology, we enable realization of sensor-based and actuator-based solutions for medicine, environmental technology, and for habitat safety.

The core competencies of the center for implants and inhalation technology are systematically developed towards smart drug/device combination products.

Aim of the High-Performance Center Translational Biomedical Engineering is to is to close the gap between basic research and first clinical trials.

Our services and expertise include

© Fraunhofer ITEM

3D printing of silicon-based implants with conventional wiring or encapsulated thin-film components

Development of actuator implants that interface directly with the target tissue

Validation of novel electrode materials such as carbon-polymer compounds

Accelerated life cycle testing of polymer-based implants

Development of inhalers for powder and liquid aerosolization

Development of sensor-controlled ventilation and inhalation systems

Development of non-target sensors and cleaning technology for breathing air

Our clients benefit from a long track record of working in compliance with GXP guidelines and from synergies of experimental toxicology, advanced analytical methods, and theory-based modeling and simulation capabilities.

We are happy to assist you in your contact with the authorities and to provide you with access to national and international organizations we cooperate with. Our scope reaches beyond the EU and also includes markets in North America and the Far East.

Fraunhofer High-Performance Centers

The Fraunhofer strategy for sustainable development of its locations does not count on haphazard new formats and instruments, but rather on a new level of quality and reliability in performance and impact. It is based on the existing intensive cooperation with universities and regional networking with industry.

To foster regional development at its locations with their respective local conditions, the Fraunhofer-Gesellschaft is promoting the foundation of so-called “High-Performance Centers”.

The concept of these high performance centers can be seen as a tool of excellence assurance geared to innovation and application. They are the Fraunhofer-Gesellschaft’s contribution to shaping the new excellence initiative. With the High-Performance Center Translational Biomedical Engineering, the Fraunhofer-Gesellschaft as an organization of applied research at the interface of academia and industry is supporting innovation processes in the Hannover area and at the location of the Fraunhofer Institute in Hannover.

Next to Fraunhofer ITEM, collaborators in this new High-Performance Center include the Hannover Medical School, Laser Zentrum Hannover, Leibniz Universität Hannover, and in particular the two clusters of excellence REBIRTH and ”Hearing4all” (in Hannover), besides research consortia such as “Biofabrication for NIFE”.