Under the leadership of the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM in Hannover, the Fraunhofer Institute for Surface Engineering and Thin Films IST in Braunschweig and the Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE in Lübeck have joined forces to form the High-Performance Center Medical and Pharmaceutical Engineering. "With this High-Performance Center, we want to close the gap between basic research and the practical use in patients: in other words, to manage the transfer from research, including process and production optimization, to proof-of-concept and clinical trials, with patient safety being top priority. By acting together as a one-stop shop, we will help companies navigate the choke point of translation," explains Prof. Theodor Doll, member of the management team of the High-Performance Center and Head of Department of Implant Systems at Fraunhofer ITEM.

Further partners include several companies as well as site-specific research partners such as the Hannover Medical School (MHH), the Leibniz University Hannover (LUH), the Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE), Technische Universität Braunschweig with its Center of Pharmaceutical Engineering (PVZ), and the BioMedTec Science Campus in Lübeck with the University of Lübeck, TH Lübeck, and the University Medical Center Schleswig-Holstein (UKSH).

In the future, the partners will be collaborating in the joint transfer infrastructure to serve as a point of contact in northern Germany in the fields of biomedical engineering and pharmaceutical technology for external industry and research partners. To this end, the partners will set up so-called translation laboratories, where crucial steps in process and product development and in regulated product testing can be accomplished. "During a start-up phase, a testing laboratory will be set up at Fraunhofer IMTE in Lübeck to support in particular the development of processes for certification and conformity assessment of medical devices in preparation for clinical testing and market launch," explains Prof. Thorsten Buzug, Executive Director of the Fraunhofer Research Institution IMTE.

In parallel, the High-Performance Center will establish scaling platforms that will enable testing of respiratory technology, validation of 3D printing technology taking into account biocompatibility, and testing of long-term functionality of neural implants. In addition, the consortium's combined know-how on regulatory requirements for pharmaceuticals and medical devices provides the necessary background to support regulatory affairs. “The High-Performance Center Medical and Pharmaceutical Engineering is an ideal setting for us to pool our Fraunhofer expertise with that of our local research partners and industry and thus quickly put innovative ideas into practice," says Prof. Michael Thomas, Head of Department of Atmospheric Pressure Processes at Fraunhofer IST.

The Fraunhofer High-Performance Centers are transfer-oriented. They bring together competent partners and as innovation guides help navigate ideas to market launch. They represent excellent, cross-organizational use of infrastructure, continuing education concepts and know-how. With its strengths in neurotechnology, inhalation technology and pharmaceutical process engineering and with the expertise available at the sites in Lübeck, Braunschweig and Hannover, for example in the fields of imaging, additive manufacturing of precision medicine devices, drug formulation and aerosol technology, the High-Performance Center Medical and Pharmaceutical Engineering addresses the future-oriented field of health.

Visit the website of the High-Performance Center.