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首页> 美国卫生研究院文献>Springer Open Choice >Robot-Assisted Fracture Surgery: Surgical Requirements and System Design
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Robot-Assisted Fracture Surgery: Surgical Requirements and System Design

机译：机器人辅助骨折手术：手术要求和系统设计

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The design of medical devices is a complex and crucial process to ensure patient safety. It has been shown that improperly designed devices lead to errors and associated accidents and costs. A key element for a successful design is incorporating the views of the primary and secondary stakeholders early in the development process. They provide insights into current practice and point out specific issues with the current processes and equipment in use. This work presents how information from a user-study conducted in the early stages of the RAFS (Robot Assisted Fracture Surgery) project informed the subsequent development and testing of the system. The user needs were captured using qualitative methods and converted to operational, functional, and non-functional requirements based on the methods derived from product design and development. This work presents how the requirements inform a new workflow for intra-articular joint fracture reduction using a robotic system. It is also shown how the various elements of the system are developed to explicitly address one or more of the requirements identified, and how intermediate verification tests are conducted to ensure conformity. Finally, a validation test in the form of a cadaveric trial confirms the ability of the designed system to satisfy the aims set by the original research question and the needs of the users.Electronic supplementary materialThe online version of this article (10.1007/s10439-018-2005-y) contains supplementary material, which is available to authorized users.
机译：医疗设备的设计是确保患者安全的复杂而关键的过程。已经表明，设计不当的设备会导致错误以及相关的事故和成本。成功设计的关键要素是在开发过程的早期就吸收主要和次要利益相关者的意见。他们提供了有关当前实践的见解，并指出了当前使用的过程和设备的特定问题。这项工作展示了在RAFS（机器人辅助骨折手术）项目早期进行的用户研究中的信息如何为该系统的后续开发和测试提供了信息。使用定性方法捕获用户需求，并根据从产品设计和开发衍生的方法将其转换为运营，功能和非功能需求。这项工作提出了需求如何利用机器人系统为关节内关节骨折的减少提供新的工作流程。还显示了如何开发系统的各个元素以明确解决一个或多个已识别的需求，以及如何进行中间验证测试以确保符合性。最后，以尸体试验的形式进行的验证测试证实了所设计系统满足原始研究问题和用户需求所设定目标的能力。电子补充材料本文的在线版本（10.1007 / s10439-018 -2005-y）包含补充材料，授权用户可以使用。

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