Risk management prioritization in medical device SMEs based on AHP analysis

Abstract

Purpose - Risk management is crucial for the longevity of companies and it is also required by many standards and regulations, such as ISO 9001 and ISO 13485. Particularly for the medical device industry the standards are stricter, due to the level of risk that products can represent. However, each standard is particular on its requirements and establishing the risk management process can be challenging, namely for small and medium-sized enterprises (SMEs). This research aims to identify and prioritize the key features for the risk management of medical device SMEs. Design/methodology/approach - The Analytic Hierarchy Process (AHP) was applied as follows: from the literature review and the above-mentioned standards the authors defined the problem, objectives, alternatives and identified 5 evaluation criteria and 8 evaluation subcriteria, organized in the hierarchical structuring of four matrices, which were the basis for data collection and analysis. Five experts from Brazilian and Portuguese companies operating in the sector were interviewed and asked to evaluate each of the matrices, establishing the relative importance among the criteria, for the calculation of local priorities. Findings - The results led to the involvement of employees as the most important criterion for risk management, followed by employees training and qualification. Organizational culture was listed as the least important criterion, with four of the five evaluators considering training and qualification as a way to work towards a cultural change and encourage risk-based thinking. Originality/value - Recent researches highlight the need for methodological and scientific support on risk management for the companies. This paper provides discussion regarding whether the literature reflects the reality of organizations and how the process is considered by them.