An innovative design approach to develop external articular medical devices

Abstract

The overwhelming majority of the work involved in the development of external medical devices, as orthoses, consists in applying the companies’ empirical knowledge. However, this non structured method, in some cases, may lead to incomplete, inadequate or low products quality. This fact precludes the patient to use the device for long term and consequently the rehabilitation desired effect promoted by the orthosis is compromised. Based on that, to promote a superior product quality, different knowledge from several domains should be considered and should interact in order to achieve a common goal, during the development stages. Additionally, when the development concerns medical devices, the users’ needs and users’ interface and way to use it gain a major importance. The combination of these different factors is a difficult task and is usually overlooked by the companies. This fact demonstrates the importance of the implementation of a design approach for the development of medical devices, which will permit to plan and structure each stage of the products’ development. According to that, the goal of this study was to develop an innovative design approach for the development of an articulated external medical device (articular orthoses) based on the most significant moments during the device’s usage.