3D打印技术与骨科植入物研发现状及其瓶颈突破思路

Research and Development Status and the Bottleneck Breakthrough Ideas of3D Printing Technology and Orthopaedic Implants

植入物是骨肌系统治疗的核心要素,其社会及经济影响巨大。骨科植入物国产化及个体化需求倒逼研发工作;在骨科植入物研究领域中,3D打印技术的临床应用已经铺平了道路,基于3D打印技术的骨科植入物研发亟待法治化保障。个体化生产是3D打印技术的优势也是法律限制的瓶颈,需改革创新方能突破3D打印技术医疗应用瓶颈。破解3D打印技术个体化生产医疗器械难题的思路:第一,报请国家食药监局批准在上海建立3D打印技术临床应用试点;第二,建议签署《合作共识备忘录》共同防范风险;第三,建议开发特殊意外保险推进科学技术创新。

Implants are the core elements of skeletal muscle treatment system with enormous social and economic effects. The localized and individualized demand for orthopaedic implants forced its research and development work. In the research field of orthopedic implants, the way for clinical application of 3D printing technology has been paved, and the research and development of orthopaedic implants based on 3D printing technology need legal guarantee. Individualized production is the advantage of 3D printing and the bottleneck of legal restrictions as well, so reform and innovation are needed to break through its application bottleneck. And the following are the solutions to the problems in individualized production of medical equipments by 3D printing technology： 1. Submit to the National Food and Drug Administration for approval of setting up 3D printing pilot clinical application in Shanghai; 2. Suggest signing Consensus Memorandum of Cooperation to prevent common risks; 3. Suggest developing special accident insurance to promote science and technology innovation.