Risk management as a crucial and challenging process for medical devices SMEs: evidence from a multiple case study on Brazilian and Portuguese startups

Abstract

Purpose The medical devices industry has many small businesses with innovation potential, and managing risks is a crucial process required by the different regulations applied to them. In this context, this research aims to investigate the risk-management practices of technology-based small and medium-sized enterprises (SMEs) in the sector, to identify characteristics and possible difficulties in structuring and carrying out the process, providing support based on literature discussions. Design/methodology/approach The authors adopted a qualitative methodology based on a multiple case study. The exploratory research included six Brazilian and five Portuguese companies from the medical devices sector, whose risk-management approaches were described and analyzed through semi-structured interviews. The interviews were conducted with experts who work in companies’ quality management systems. Findings The results suggest that different risk-management methods can be applied to products regardless of their risk classification. There is a need for continuous employee training in risk-management techniques, as previous experience tends to impact overcoming implementation challenges. It was also identified that, especially in Brazil, the auditors’ risk-management analysis is subjective and that more standardization of audits of medical device companies’ quality management systems should be considered. Originality/value The study emphasizes the development of a structured systematic for implementing risk-management processes, which is especially beneficial for SMEs. The case studies provide practical knowledge for other companies to evaluate risk-management practices. Although the results cannot be generalized, this original research supports the existing gaps and excites new discussions in the field.