Université de Bordeaux, I2M, Esplanade des Arts et Métiers, 33405 Talence, France.
Arts et Métiers, I2M, Esplanade des Arts et Métiers, 33405 Talence, France.
J Healthc Eng. 2019 Feb 3;2019:3513947. doi: 10.1155/2019/3513947. eCollection 2019.
The orthosis is considered a class 1 medical device which often originates from a nonstructured development process. As these devices are mainly developed by small- and medium-sized enterprises, with no standard research method, the result can be an unadapted device which may not respond to the user's needs and which in the short term may be abandoned. One way to solve this problem is to define and apply standard rules and procedures throughout the development/design process. Although methodologies may solve the "empiricism" in orthosis design problems, these design strategies are not applied during orthosis development due to the particularities of this field and the difficulties in linking the required knowledge and the actors that may be present during the orthosis development. The objective of this work is to develop a methodology to structure the orthosis design process that takes into account both the device life cycle and the different stakeholders involved in the design process. A case study was used to validate the proposed methodology. It was applied to the development of an orthosis to treat a specific postural disorder called camptocormia, also known as bent spine syndrome. This disorder is characterized by the anteroflexion of the trunk and especially affects elderly people. Contrary to scoliosis, the characteristics of camptocormia are not permanent, which means that the patient is able to straighten his posture. A postural brace is used to treat this disorder which enables the patient to redress and maintain the correct upright posture of the trunk.
矫形器被认为是一类 1 级医疗器械，通常源于非结构化的开发过程。由于这些设备主要由中小企业开发，没有标准的研究方法，因此可能会开发出不适应的设备，无法满足用户的需求，并且在短期内可能会被放弃。解决这个问题的一种方法是在整个开发/设计过程中定义和应用标准规则和程序。虽然方法学可以解决矫形器设计问题中的“经验主义”问题，但由于该领域的特殊性以及在矫形器开发过程中难以联系所需的知识和可能存在的参与者，这些设计策略并未应用于矫形器开发中。本工作的目的是开发一种方法来构建矫形器设计过程，该方法既考虑了设备的生命周期，又考虑了设计过程中涉及的不同利益相关者。使用案例研究来验证所提出的方法。它被应用于一种矫形器的开发，以治疗一种称为 camptocormia 的特定姿势障碍，也称为弯曲脊柱综合征。这种疾病的特征是躯干前屈，尤其是老年人。与脊柱侧凸不同，camptocormia 的特征不是永久性的，这意味着患者能够挺直姿势。使用姿势矫正器来治疗这种疾病，使患者能够重新矫正并保持躯干的正确直立姿势。
