The applicability of modelling and simulation : A case study within the medical device industry

The medical device industry has for a long time lagged behind other industries in terms of adopting new tools for process improvements. Despite showing promising results from various industries, some more heavily regulated than others, modelling and simulation has not yet gained traction within the medical device industry for performing production improvements. The industry has instead relied upon proven improvement philosophies which are believed to generate a desirable outcome. With the purpose of investigating how this novel tool can be combined with current improvement efforts as well as understanding why it has not yet been accepted, a case study was conducted at the Uppsala facility of Johnson & Johnson Vision. A mixed methodological approach was used, where quantitative and qualitative data was analyzed in combination. Semi-structured interviews and structed observations provided empirical evidence for a thematic analysis and a simulation-based bottleneck analysis. Rather than proving that a simulation-based bottleneck was possible in this particular setting, it was used to confirm its applicability in combination with other tools and improvement philosophies. The study concludes that the issue is not strictly related to the use of modelling and simulation but is rather related to the reactive mind-set which has become a consequence of the rigorous regulatory landscape that the industry is encompassed by