Análise do gerenciamento de riscos no setor de dispositivos médicos por meio do estudo de casos múltiplos

Abstract

Considering its potential for innovation and the large number of micro and small businesses, the medical device sector has become a relevant object of study. Due to the characteristics of their activities, companies are subject to several standards and regulations, such as the ISO 13485 which defines the requirements for Quality Management Systems (QMS) and based on the standard ISO 9001, leaves implicit the need to manage risks. The adoption of risk management practices is considered a major challenge for small companies, and the need for scientific and methodological support for such organizations is evidenced in the literature. In this context, this research aims to propose a systematic approach to risk management, suitable for QMS of innovative companies in the medical device sector, and to compare the proposal with the practices performed by companies, in order to verify its suitability for medical devices SMEs (small and medium sized enterprises). The method applied was the Multiple Case Study, through the following steps: initially a systematic literature review was conducted in order to identify how companies have performed the risk management in the normative and practical contexts, establishing the basis of the proposal and also analyzing the aspects discussed in the literature about this issue; then 11 cases were selected, six Brazilian companies and five Portuguese companies; the case study protocol was elaborated and validated through a pilot test; finally, data collection and elaboration of individual and crossed case reports were performed. Some relations were identified among the cases, suggesting the existence of potential patterns. Among the results we highlight that the normative process in the national scenario is considered by companies as something bureaucratic, and meeting the requirements becomes subject to the auditors' interpretation, which ends up leading companies to opt for the use of FMEA (Failure Modes and Effects Analysis), which is not observed in the international scenario. The study shows that previous experience is always a requirement for risk management, no matter how it is implemented, and it can be a challenge for the companies. Regarding the systematic, it was verified that it can positively impact the guidance and preparation of the team to implement the process, although it may face resistance to change among companies with already structured risk management. The analyses suggest that the systematic may be more beneficial to SMEs that are at the beginning of the process of risk management implementation.