Hemics has developed, together with TOPIC Embedded Systems, an innovative medical product to reveal the inflammation of the joints in rheumatoid arthritis (RA) in a non-invasive manner. Hemics’product, the HandScan, scans both hands with laser light and visualises the inflammation. A is then kept of the extent of the inflammation which allows a rheumatologist to judge whether treatment is effective. The method used to calculate the inflammation was developed by Hemics and clinically validated through a prototype hand scanner. Michiel van Beek of Hemics: “We were looking for a partner to work together on the optimal implementation of the calculation method in the scanner. We chose TOPIC because of their established experience with implantation of complex algorithms, image processing and medical equipment. Furthermore, their ISO 13485 certification was of importance to us. We knew immediately from their proposal that they had thoroughly listened to our wishes and preconditions and that they had thought along with us to come up with a suitable solution”.
TOPIC Embedded Systems has contributed to the development from prototype to medical product by adding their expertise in the area of innovative hardware and software, medical certification knowhow, the accompanying iterative design process and thorough project management and architectural design. TOPIC’s main contribution to the development of this product is preparing the prototype’s calculation method, arranging the architecture of this method so that it allows future extensions, as well as preparing the documentation for medical certification. Michiel van Beek: “Our intensive collaboration with TOPIC on this project was to our great satisfaction. We had frequent contact about technical topics and were kept well informed with regard to the project´s progress. Communication was always open, clear, and to the point. The project was finalized within both planning and budget. Furthermore, TOPIC has helped us set up an infrastructure for further development such as the setup of a build and test environment and accompanying procedures.”
TOPIC focuses on reliability and quality when developing medical products. The certification process is in accordance with ISO 13485 norms. Quality and reliability are guaranteed through the iterative development process and a system of automatic testing and validation. The iterative project safeguard regular evaluation with a client for timely feedback and adjustments towards the expected final result. The automatic testing system validates algorithms. Clinical data which are automatically validated with the expected output provide the input for the algorithms. This way, errors in the software are automatically detected and prevented, and extensions can be added in a reliable way.