Developing A Model on SME Innovation Strategies—Empirical Evidence and Confirmatory Analysis from Medical Device Industry in Germany

Abstract

The European Union's regulatory system significantly modified the medical device industry by implementing the updated regulation (EU) 2017/745. The research investigated the implications of applying a new regulation to medical companies in southern Germany by creating a model utilising study variables with collected primary data to evaluate the implementation of a regulation. The research design applied correlational research methodology with simple random sampling techniques. Data collection involves a survey administered to 112 respondents from medical device companies in southern Germany, incorporating descriptive and inferential research methodologies. The study finding has been validated statistically by exploratory factor analysis, composite reliability, and confirmatory factor analysis. The primary study variables are business performance, financial situation, and regulation implementation process. The main finding of a study detected the negative impact of applying the regulation Eu (2017/745) on an organisation's financial performance, innovation, environmental process, and business. In contrast, the study found that transparency factors are an effective part of medical regulation.