The aim of the project was to develop a technical-methodical approach that supports the approval and certification process as well as the risk management of networked medical devices in integrated operating theatres and thus also enables small and medium-sized companies in the medical technology sector to access the market.
2017 – 2019
For this purpose, a test platform including suitable protocols, test scenarios and test fields as well as corresponding approval strategies will be developed which is able to test the networking of medical devices and software components in various simulated scenarios and to validate them with regard to various parameters. The networking is based on the now approved IEEE 11073 SDC standard family (SDC for short). SDC stands for service-oriented device connectivity. Due to the intensive work of the colleagues from OR.NET e.V. and the participating colleagues from the MoVE consortium (AP 12), the IEEE 11073-20701 standard has also been adopted since September 2018 and is now being prepared for publication. The first partial standard IEEE 11073-20702 was already declared an ISO standard at the end of 2018. This is also to be expected for the other partial standards in the coming period.
In December 2019, we were able to present the results of the research project to 50 representatives of industry and research in a noble ambience at the New City Hall Leipzig. With the support of ICCAS Leipzig, the event could be recorded. The resulting videos of the demos and presentations are now available here.
The welcome of the event by Prof. Thomas Neumuth (OR.NET e.V. and University of Leipzig, ICCAS) as well as the contentwise classification of the project by Max Rockstroh (OR.NET e.V. and University of Leipzig, ICCAS).
Presentation of the current status (December 2019) of standardization as well as future developments by Björn Andersen (University of Lübeck, Institute for Medical Informatics).
Practical presentation of the SDC Requirement Test Tool for testing basic conformance to the IEEE11073 SDC family of standards by Nikolas Knickrehm (Unitransferklinik Lübeck GmbH) and David Caraveo (University of Lübeck, Institute for Software Engineering and Programming Languages).
Presentation of the overall concept as well as the different simulator concepts and their implementation by Martin Kasparick (University of Rostock, Institute for Applied Microelectronics and Data Technology).
Practical presentation of the simulation framework including abstract and product-driven simulators to support the device manufacturer at development time by Dr. Stefan Franke (University of Leipzig, Innovation Center Computer Assisted Surgery).
Support during the development process by generating complex (dynamic) deployment scenarios presented by Dr. Stefan Franke (University of Leipzig, Innovation Center Computer Assisted Surgery).
Presentation of the approval problem for openly networked medical devices incl. first evaluation results by Dr. Armin Janß (RWTH Aachen, Faculty of Mechanical Engineering at the Helmholtz Institute for Biomedical Engineering).
Practical presentation of the overall framework incl. evaluation during testing in the test house by Thomas Geib (GADV mbH) and Dr. Stefan Franke (University of Leipzig, Innovation Center Computer Assisted Surgery).
Presentation of the test framework for the evaluation and control of the test platform to support the test house in the approval of open networked medical devices by Thomas Geib (GADV mbH) and Sebastian Bürger (SurgiTAIX AG).
Fritz Stephan GmbH
HEBU Medical GmbH
steute Technologies GmbH & Co. KG
Aachen University Hospital, Medical Technology Section
University of Leipzig, ICCAS
University of Lübeck, IMI
University of Lübeck, ISP
University of Rostock, IMD
University Transfer Clinic Lübeck (UTK)
RWTH University of Aachen, meditec