Measuring and Validating the Factors Influenced the SME Business Growth in Germany—Descriptive Analysis and Construct Validation

Abstract

In Germany, the medical device industry constitutes a cornerstone of the health sector. In this study, we investigated the challenges and factors affecting the present-day performance of German SMEs concerned with medical devices. The research methodology adopted a cross-sectional and correlational research design, with simple random-sampling techniques, to data obtained from 110 mid-level and senior managers in German SMEs by means of an online structured survey in August 2022. We statistically validated our study data using exploratory factor analysis (EFA), Kaiser–Meyer–Olkin (KMO) testing, and Bartlett’s test, to assess the relationship between study variables and measure data adequacy using the R4.1.1(21) software, then carried out principal component analysis (PCA) with varimax factor loading and extracted six factors for use as research variables. The researchers also applied descriptive data analysis techniques using SPSS.21. The main study variables were: (1) the business performance of small and medium businesses (SMP); (2) their financial situation (SMEF); and (3) their implementation of new medical device industry regulations (MDR). By such statistical means, results confirmed poorer business performance and lower anticipated growth amongst SMEs affected by MDR, over and above the impacts of the present-day economic situation. The data can be used by management information systems (MIS) and decision system support professionals for planning and developing practical models about how to cope with current industry challenges. We recommend further research involving inferential analysis and triangulation of these data in the form of a semi-structured qualitative study in the larger scope of the population and different sectors.