Medical device regulation (MDR) in health technology enterprises - perspectives of managers and regulatory professionals.

BACKGROUND: In the European Union (EU), there are over half a million medical devices, varying from pacemakers to software. Medical devices play an important role in health care as they are used in diagnosis, prevention, monitoring, prediction, prognosis, treatment, or to alleviate disease. Medical devices are regulated in the EU by the Medical Device Regulation (MDR), which came into force on 25 April 2017 and into application on 26 May 2021. The demand for regulation arose from the need to establish a transparent, robust, predictable, and sustainable regulatory framework. This study aims to examine how the managers and regulatory professionals in health technology enterprises perceived the application of the MDR and what were their information needs regarding the MDR. METHODS: A link to an online questionnaire was sent to 405 managers and regulatory professionals representing health technology enterprises in Finland. The study included 74 respondents. Descriptive statistics were used to describe and summarise the characteristics of the dataset. RESULTS: Information related to the MDR was fragmented and the necessary information was sought from multiple information sources, while the Finnish Medicines Agency (Fimea) was regarded as the most important source of information and training provider. To some extent, the managers and regulatory professionals expressed their dissatisfaction with the performance of Fimea. The managers and regulatory professionals were not very familiar with the ICT systems provided by the EU. The size of an enterprise affected how many medical devices it manufactures and generally affected the views about the MDR. CONCLUSIONS: The managers and regulatory professionals understood the role of the MDR regarding the safety and transparency of medical devices. The available information regarding the MDR did not properly fit the needs of users and there seemed to be a gap in information quality. The managers and regulatory professionals had some difficulties understanding the available information. Based on our findings, we believe it is paramount to evaluate the challenges faced by Fimea and how it could improve its performance. To some extent, the MDR is regarded as a burden for smaller enterprises. It is important to highlight the benefits of ICT systems and to develop them to better meet the information needs of enterprises.

The Guiding Role of a Paradigm in Informatics Education and Research.

This study presents the current status of a paradigm used in informatics education and research in the health and human services fields. The aim is to synthesize the research focuses of students' theses and evaluate the current situation. The paradigm models informatics research. The research focus, questions and applied research methods were coded for 144 Master's degree theses. Based on the results, the theses could easily be coded for the paradigm concepts and research focuses. The most often used concept was data, which was connected to steering and organizing information management in work processes.

Knowledge Management in Health Technology SMEs.

The purpose of this study was to examine knowledge management's (KM) role in small and medium-sized (SMEs) health technology enterprises, which employ fewer than 250 employees. In this study, KM is understood as the ability to achieve competitive advantage by utilizing management knowledge and making it profitable. The health technology enterprises use modern technology to resolve health-related issues. The research data was acquired from Finnish health technology SMEs. The questionnaire was sent to 140 enterprises, generating 25 responses, or a 17.9% response rate. According to the results, health technology enterprises have not adopted KM concepts, nor do they have the necessary resources to do so. SMEs' KM use is informal: information is transferred informally through human interaction, rather than through information systems. In the SMEs, KM is not perceived as important, although it is seen as associated with the enterprise's financial performance through the potential in making the knowledge profitable.