Critical failure factors for continuous improvement methodologies in the Irish MedTech industry

The main objective of this study is to investigate what are the critical success factors that exist for continuous improvement (CI) methodology deployment in the Irish medical technology (MedTech) industry. The research will, in particular, seek to establish if the highly regulated nature of the global MedTech industry is an additional critical failure factor (CFF) for the deployment of CI methodology. The study involves the analysis of the benefits, challenges, CFFs and tools most utilised for the application to the deployment of CI methodologies in the Irish medical device (MD) industry. Design/methodology/approach A quantitative survey was utilised in this study. The main participants were made up of senior quality professionals working in operational excellence, quality consultants, quality directors, quality engineers, quality managers and quality supervisors working in both manufacturing and service sectors from Irish MD companies. A total of 94 participants from the Irish MedTech industry responded to the survey. Findings The main finding of this study is that 42% of participants perceived that a highly regulated environment was a CFF to CI, whilst 79% of respondents utilised Lean Six Sigma in their organisations, and productivity and financial factors were found to be the highest reasons for CI deployment amongst the Irish MedTech industry. The top CFFs highlighted for CI in regulated industries were fear of extra validation activity, compliance versus quality culture and a regulatory culture of being ¿safe¿. Another relevant finding presented in this paper is that just over 48% of participants felt that CI tools are very strongly integrated into the industries quality management systems (QMSs) such as the corrective and preventative action system, non-conformance and audit systems.peer-reviewe