Cooperation agreement between the Fraunhofer Research Institution for Individualized and Cell-based Medical Engineering IMTE and the Technische Hochschule (TH) Lübeck deepens collaboration.

What has worked well for a long time within the framework of project-related cooperation is now being put on an institutional basis between TH Lübeck, Faculty of Applied Natural Sciences, and Fraunhofer IMTE.

The Faculty of Applied Natural Sciences (AN) at TH Lübeck and the Fraunhofer institution IMTE in Lübeck sign a cooperation agreement to deepen their collaboration in the field of medical technology. TH Lübeck President Dr. Muriel Helbig and the Dean of the Faculty of AN, Prof. Stephan Klein, say of the signing: "We are delighted about this outstanding cooperation."

The agreement essentially revolves around the establishment of the subject area "Regulatory Affairs" and the necessary focus professorship in the person of Prof. Dr. sc. hum. Folker Spitzenberger. In addition to his teaching activities at the TH Lübeck, the professor is to accompany and support the IMTE in setting up a research group for the field of regulatory affairs.

"The new IMTE research group "Regulatory Affairs" is to accompany the basic research of the Fraunhofer IMTE. For example, to lead innovative products to market maturity," says Folker Spitzenberger about the future tasks. Another point concerns regulatory scientific research, he adds.  "We are working on areas where there has been a need for improvement so far with regard to regulatory requirements in order to improve the efficiency of a regulatory strategy and thus ultimately to increase patient safety on the one hand, but also to enable rapid market access for innovative products on the other," says Spitzenberger.

The field of Regulatory Affairs deals with the extremely important issues of approval or conformity assessment in medical technology. In this context, quality and safety concepts for medical devices as well as knowledge of the medical-technical, chemical, biological, toxicological and clinical contents play an increasingly important role. After a development, they are not only essential for the technical documentation, but also for an optimal approval strategy for the application of medical devices.

Since 2016, TH Lübeck has had its own chair for Regulatory Affairs for Medical Devices. This relatively new field has become increasingly important in recent years because the requirements for approval and conformity assessment procedures for medical devices, including in vitro diagnostics, are increasing significantly not only in the European Union but also worldwide.

The Fraunhofer Research Institution for Individualized and Cell-based Medical Engineering IMTE in Lübeck focuses on holistic research and development in individualized medical technology, from basic research and integrated development of medical devices for diagnostic and therapeutic applications to device construction and the application of personalized instrumentation in clinical and commercial settings. Prof. Dr. Thorsten Buzug, Managing Director of IMTE, underlines the relevance of the cooperation: "Basic medical technology research only gains its value when we can apply it for the benefit of patients. This means that we have to keep an eye on the approval process. This cooperation will enable us to do that in an ideal way. The new "Regulatory Affairs" group will be the point of contact for small and medium-sized companies planning development projects with IMTE that are close to the market."

Both cooperation partners see the establishment of the subject area of Regulatory Affairs as an ideal complement to the existing research and development initiatives of the two scientific institutions. In the cooperation agreement, both partners also declare their intention to further expand cooperation in the field of medical technology, which is important in Lübeck both in research and in industry.

Fraunhofer IMTE

The Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE focuses on the integrated development of medical devices for diagnostic and therapeutic applications. With expertise in biosensor technology, cell technology, imaging, magnetic methods and mechatronics, in combination with interdisciplinary cross-sectional topics such as additive manufacturing, artificial intelligence, systems engineering and regulatory affairs, IMTE offers a unique service portfolio for the medical device industry.

TH Lübeck

Technische Hochschule Lübeck: Around 5,000 students study here in the fields of technology, natural sciences, economics and architecture. Around 130 professors teach and conduct research in four departments and in numerous research areas, supported by around 300 employees. The regional roots typical of a technical university are reflected in successful collaborations with partners such as the BioMedTec science campus, regional companies and scientific institutions.

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