Strengthening innovative power of German medical technology industry

Nowadays products are becoming more and more complex - different disciplines with networked applications must work together during product development. This is especially true for new products in medical technology. In particular, small and medium-sized enterprises (SMEs) are often not sufficiently prepared for this increasing complexity. The new European Medical Device Regulation (MDR) increases the challenge of SMEs with regard to the certification of new and existing products. For example, existing medical devices have to be recertified, modified and verified or validated at great expense. This increases the development times and costs for individual products.

Over the next three years, a European consortium in the new BMBF joint project "EUREKA-AMeLie" will develop an architecture framework for medical technology SMEs and develop or revise concepts, guidelines and directives for the introduction and implementation of Advanced Systems Engineering (ASE). Classical approaches and methods of systems engineering along the V-model will be tested for their applicability and will be interpreted and redeveloped in a contemporary way by means of occupational science aspects. The developed concepts will be implemented in the form of software-based application tools and will be tested, demonstrated and validated in four real-life application cases from the fields of in-vitro diagnostics, medical devices and implants together with the participating medical technology companies. The products of all application cases have in common that previous production processes are to be replaced by printing methods in order to reduce production costs and achieve greater design flexibility. A further technical goal is to develop more robust solutions for the electrical connection of flexible thin-film electrode structures to low-resistance and less flexible supply lines.

The Fraunhofer IBMT expects that the "EUREKA-AMeLie" research project will provide new methods and tools that can be used advantageously in future bilateral projects with industry to better master the complex development of medical technology products.

In the "EUREKA-AMeLie" project, the Fraunhofer IBMT is researching processes for printing electrodes on polyurethane substrates using conductive polymers. Furthermore, a process for printing a polyimide substrate and the electrodes, leads and insulation layers is to be developed. In addition to that, the focus is on the development methodology using the example of microfluidics and its combination with printed electrodes as well as the development of an assembly and interconnection technology compatible with this system for modern cell diagnostics.

In the transnational funding project "EUREKA-AMeLie", six research groups from Germany will work together with four research groups from Israel (two SMEs, one university, one research institute). The participating German SMEs benefit from the European cooperation with the EUREKA partners through their international business relations and access to foreign markets. Especially in the field of medical technology, Israeli companies and universities are known for their high innovative strength.

COMPAMED-tradefair.com; Source: Fraunhofer-Institut für Biomedizinische Technik IBMT