Date of Conferral
Directive 2007/47/EC of the European Parliament amending Medical Device Directive (MDD) provides medical device manufacturers with a compliance framework. However, the effects of the amendments to the MDD on competition in the U.S. medical device software industry are unknown. This study examined the impact of this directive on the competitiveness of U.S. medical device software companies, the safety and efficacy of medical device software, employee training, and recruitment. The conceptual framework for this study included 3 dimensions of medical device regulations: safety, performance, and reliability. The overall research design was a concurrent mixed method study using both quantitative and qualitative techniques. The qualitative techniques involved case studies of 5 purposively selected companies. Data collection involved both surveys and interviews. The sample consisted of 56 employees within medical device firms with markets around the European regions. Qualitative data analysis consisted of descriptive thematic analysis along the study questions and hypotheses and summative evaluation. Quantitative data analysis included descriptive statistics and correlation to test the 4 hypotheses. The results suggested that the MDD has realigned medical device software manufacturing practices, and US medical device companies have gained global competitiveness in improving product safety and increasing sales revenue. Key recommendations to medical device manufacturers include adopting MDD 93/42/EEC, using model-based approaches, and being comprehensive in model use. Adopting the MDD will provide positive social change to patients, as human safety improves with better product quality while companies experience fewer product recalls.