OR.NET

The wide variety of devices and the information associated with them can be integrated within this network through dynamic networking and convergence to create new and innovative functions. Innovative starting points for future developments will also be identified.

Based on the approaches developed in the previous projects for the modular and dynamic networking of medical devices in the operating room and based on the paradigm of a service-oriented architecture (SOA), the aim of the project is to develop certifiable, dynamic, manufacturer-independent networking options for existing and future devices and software solutions in the medical environment. To this end, the existing approaches with regard to plug & play networking will be further developed, taking into account the aspects of approvability and risk management, and implemented in commercial medical products of the SME project partners in an exemplary and technical manner during the project.

Thanks to the broad-based consortium of companies, clinicians and R&D institutions, all key areas such as operation planning, operation support, diagnosis/therapy and documentation are taken into account. In addition to the conception and definition of new, cross-sector standards, all necessary considerations regarding risk analysis, security, interoperability of the exchanged data and the developed IT infrastructure are carried out from the beginning of the project and transferred to standardization with the partners (VDE, DIN, DKE, IHE…).

Together with the participating companies, responsible users and operators, operator models are being developed that enable the overall functionality to be transferred. When developing the operator models, the interests and perspectives of the groups involved must be balanced.

There is also a strong dependency between the technical concepts, the boundary conditions to be defined as part of the conformity assessment procedures and the processes on the part of the operators. In addition to the operating processes resulting from the technical development, the boundary conditions specified by the approval must therefore also be included in the operator models.

Through the involvement of leading experts, new validation and testing procedures regarding the approvability of the subcomponents and the overall system are developed in addition to the legal aspects.