Incorporação de métodos de engenharia de usabilidade no desenvolvimento de dispositivos médicos com foco em certificação

Abstract

Regulatory agencies concerned with controlling the new Medical Devices (MD) that go on the market started to require that manufacturers follow standards. Among these, an IEC 62366 standard establishes a Usability Engineering (UE) process. Within the scope of the scientific literature, authors present ways of including the user in product devel-opment and point out practical difficulties in the selection and execution of different methods, in understanding the requirements and in inserting the EU process in existing processes. These difficulties can be aggravated by deficiencies in capacity and cultural aspects, treating or topic only as documentary compliance. This thesis presents a model of UE methods for the development of MD, with a primary focus on meeting regulatory requirements. To assess the suitability of the proposal, case studies were planned in four different companies, first the goal was to apply the model by outsourced specialists into two companies and then to apply in another two companies, by the internal com-pany team. It was possible to conclude by the first application of the model that the results contributed to the certification of products in the studied companies. For a mod-el application in the second stage of verification, as teams of companies passed through a process of training in the methods and structuring of the model. In both companies, an UE process was established for a product under development, with the creation of a documentary procedure, plan and auxiliary documents. Some of the proposed methods have been successfully implemented by the teams. It was possible to conclude that the model showed a good option for MD companies to implement the EU process according to IEC 62366, even if they do not have specialists or professionals with experience in this area. It was possible to observe that, when a company implements the model, applies the proposed methods, the results can generate not only regulatory compliance, but also a cultural transformation. The companies that applied the model based on internal training, after the results, mentioned that they could do more than what was proposed in the model, in order to go beyond compliance with requirements, impacting general use and innovation.