López Gualdrón Clara-Isabel, Bravo Ibarra Edna-Rocío, Murillo Bohórquez Andrea-Patricia, Garnica Bohórquez Israel
Industrial Design School, Universidad Industrial de Santander, Bucaramanga, Colombia.
Industrial and Business Studies School, Universidad Industrial de Santander, Bucaramanga, Colombia.
Med Devices (Auckl). 2019 Aug 7;12:253-273. doi: 10.2147/MDER.S215947. eCollection 2019.
The main purpose of this investigation was to systematically review the literature regarding case studies on patient-specific implants and devices, with the goal of analyzing the process of developing custom-made medical devices. A content analysis was performed to identify design processes and methodologies implemented to develop devices such as implants adapted to bone geometries. Reverse engineering, computer-aided design, simulation of assets, and rapid prototyping technologies were selected according to their interoperability in a process framework for developing new products. Finally, results from the case studies and process stages identified in the consulted research were analyzed. These results showed a relationship between the scope and complexity of the process and the stage of technology integration of the patient-specific device development. The analyzed case studies were characterized by technical, scientific, and multidisciplinary components to achieve research goals. Likewise, integration of technologies using patient-specific technologies is needed for product development that converges into designing devices, such as implants, biomodels, and cutting drilling guides.
本调查的主要目的是系统回顾关于患者特异性植入物和器械的案例研究文献，以分析定制医疗设备的开发过程。进行了内容分析，以确定为开发诸如适应骨骼几何形状的植入物等设备所实施的设计过程和方法。根据逆向工程、计算机辅助设计、资产模拟和快速成型技术在新产品开发过程框架中的互操作性进行了选择。最后，对所查阅研究中确定的案例研究和过程阶段的结果进行了分析。这些结果表明，该过程的范围和复杂性与患者特异性设备开发的技术集成阶段之间存在关联。所分析的案例研究具有技术、科学和多学科组成部分，以实现研究目标。同样，产品开发需要使用患者特异性技术进行技术整合，从而汇聚到设计植入物、生物模型和切割钻孔导向器等设备中。
