Shim Kyu Won
Department of Pediatric Neurosurgery, Severance Children's Hospital, Yonsei University College of Medicine, Seoul, Korea.
Brain Tumor Res Treat. 2023 Jul;11(3):159-165. doi: 10.14791/btrt.2023.0001.
The three-dimensional (3D) printing itself is not a novel technology, it is more than 30 years old. Stereolithographic (SLA) technology has been used as the first and popular technology for medical application of 3D printing. Since 1991 and have published articles about SLA for rapid prototyping anatomical 3D models. Medical applications of 3D printing have been popularizing and stabilizing so far. Implantable medical devices such as metal or absorbable implants, surgical guide systems, prosthesis and orthosis, and 3D anatomical models for normal or diseased anatomy have been developing and expanding its markets so far. There are many obstacles, such as insurance, authorization as a medical device, and lack of standards technology for further expansion of medical applications. Many technical specifications and guidelines for authorization as medical device have been published by regulatory bodies from many countries. Even though international standards for 3D printing have been developing more and more, there have been few standards for medical application of 3D printing. In this harsh environment academia, company, research institute, regulatory bodies, and government have been doing good job for the development of 3D printing industry.
三维（3D）打印本身并不是一项新技术，它已有30多年的历史了。立体光刻（SLA）技术一直是3D打印在医学应用中的首个且流行的技术。自1991年以来，已有关于SLA用于快速成型解剖学3D模型的文章发表。迄今为止，3D打印的医学应用一直在普及并趋于稳定。诸如金属或可吸收植入物、手术引导系统、假体和矫形器等可植入医疗设备，以及用于正常或患病解剖结构的3D解剖模型，一直在不断发展并扩大其市场。目前存在许多障碍，如保险、作为医疗器械的授权以及缺乏进一步扩大医学应用的标准技术。许多国家的监管机构已经发布了许多作为医疗器械授权的技术规范和指南。尽管3D打印的国际标准越来越多，但3D打印医学应用的标准却很少。在这种严峻的环境下，学术界、公司、研究机构、监管机构和政府一直在为3D打印行业的发展做出积极贡献。
