Maciej Piwowarczyk vel Dabrowski will defend his PhD thesis on June, 2 at 13:00 in room 001, Konrad-Zuse-Building. Maciej’s PhD topic is „Partial Reference Enterprise Architecture for Market Introduction of Digital Health Applications“.

Abstract

The market introduction and regulatory assessment of ICT-enabled medical devices in the European Union is very complex due to a multitude of regulations that need to be considered during requirements development and product management. This situation is exacerbated by the fact that there are no established standards, best practices or tools for the market launch of medical devices.

This dissertation provides methodological support for the market launch and evaluation of medical products. The problem relevance is justified and the necessary processes and requirements for the formation of a partial reference enterprise architecture for the market launch of telemedicine systems in Germany and Europe are analysed and integrated into a conceptual model of an enterprise architecture. The research follows the principles of literature research, deductive reasoning, action research and design science research. During and at the end of the model development, the result was evaluated both artificially and naturalistically, as well as formatively and summatively. The research objectives of comprehensibility, completeness, relevance, cost-effectiveness and adaptability were demonstrably achieved.

The main contributions of this research are (1) the analysis and structuring of existing standards and the definition of a concept of how they should be implemented by manufacturers of ICT-based medical devices, (2) a partial reference enterprise architecture model for manufacturers of ICT-based medical devices in Europe and Germany, and (3) highlighting the advantages and disadvantages of applying the model and proving that the application of this model is both possible and beneficial from the perspective of market participants.