增材制造医疗器械行业的发展现状

The Development Status of Additive Manufacturing Medical Device Industry

随着增材制造(AM)技术的发展和精准医疗概念的推广,AM医疗器械逐渐在定制化齿科及个性化植入领域被广泛应用。但在注册取证环节,国内仍旧缺少AM医疗器械的审评指导原则及针对性国家和行业标准。此外,AM技术本身在制造过程中的不确定性将引入较大风险,因此急需在设计、原料、设备、成型、后处理等医疗器械全生命周期进行质量控制,完善国内AM医疗器械技术标准和监管体系。为此,该研究对AM医疗器械行业发展现状进行了综述,以期助推AM技术在医疗器械行业的高质量发展。

With the development of additive manufacturing(AM)technology and the promotion of precision medicine concepts,AM medical devices are gradually being widely used in the fields of customized dentistry and personalized implantation.However,in the registration and certification process,there is still a lack of evaluation guidelines and targeted national and industry standards for AM medical devices in China.In addition,the uncertainty of AM technology itself in the manufacturing process will introduce significant risks.Therefore,it is urgent to carry out quality control throughout the entire lifecycle of medical devices,including design,raw materials,equipment,molding,and post-processing,and improve the domestic AM medical device technical standards and regulatory system.Based on this,the development status of AM medical device industry was reviewed in this study,in order to promote the high-quality development of AM technology in the medical device industry.