User involvement in the electromedical device development process of small companies
Carina Campese, Ana Paula Siqueira Silva de Almeida, Janaina Mascarenhas
Abstract
To ensure good usability of electromedical devices (EMD) and to mitigate problems of misuse, IEC 60601-1-6 was implemented in Brazil, which refers to the usability engineering process of IEC 62366. With the mandatory application of such standards, the importance of user involvement throughout product development becomes even more evident, a practice that is already considerably stressed in the literature. In this context, this paper aims to investigate how the user is involved in the development of EMD, in light of the IEC 60601-1-6 requirements, mainly to understand if the obligation of the standard promotes user involvement. By means of case studies, it has been identified that the companies involve the user in a few phases of the product development. Further, although there are few methods applied for such, it is concluded that the standard of usability is being followed, but is not being applied effectively. It is necessary to develop a model that guides and encourages the companies of EMD to involve the user in the development of their products.
Keywords
References
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