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(This is an expert post in both Chinese and English.)
3D打印骨科植入物在中国的应用概况以及商业转化中的挑战
3D打印技术在制造多孔结构、拓扑优化结构以及梯度材料领域具有技术上的优势，同时与传统制造技术相比，3D打印技术更易于实现植入物的批量定制化生产。这些优势为3D打印技术在骨科植入物制造中的应用发展带来了潜力，骨科植入物制造业是3D打印技术最早实现产业化应用的领域之一。
3D printing technology has technical advantages in the manufacture of porous structures, topologically optimized structures, and gradient materials. At the same time, compared with traditional manufacturing techniques, 3D printing technology is easier to achieve mass customization of implants. These advantages have brought potential to 3D printing technology in the manufacture of orthopedic implants. The orthopedic implant manufacturing industry is one of the earliest fields of industrial application of 3D printing technology.
截至2017年底获得FDA 医疗器械注册证的3D打印医疗器械已超过了100个，其中包括了多款由不同品牌制造的3D打印脊椎植入物和关节植入物。
More than 100 3D printing related medical devices have received FDA medical device registration certificates by the end of 2017, including a variety of 3D printed spinal implants and joint implants made by different brands.
相比之下，中国骨科医疗器械制造商在3D打印骨科植入物商业转化方面的进展较慢。截至2018年，中国有3个3D打印骨科植入物产品获得了医疗器械注册证，包括：
In contrast, Chinese orthopedic medical device manufacturers have made slow progress in the commercial conversion of 3D printed orthopedic implants. As of 2018, China has three 3D printed orthopedic implant products that have obtained medical device registration certificates, including:
- 2003年，上海交通大学医学院附属第九人民医院与上海晟实医疗器械科技有限公司合作获得个体化人工假体注册许可证（包括髋、膝、肩、踝、腕关节）。
- In 2003, Shanghai Ninth People’s Hospital cooperated with Sheng Shi Med to obtain individualized artificial prosthesis registration licenses (including hip, knee, shoulder, ankle, wrist).
- 2015-2016年，北京爱康宜诚医疗器材股份有限公司获得了三个金属3D打印植入物注册证：髋臼部件和椎体假体、椎间融合器。
- 2015-2016，AK Medical has three 3D printing products approved by CFDA.
- 2018年，西安科谷智能获得了个体化下颌骨重建假体注册证。其材料为Ti6Al4V铸造钛合金材料，通过与个体病患骨缺损形态匹配的铸造型壳（3D打印光敏树脂型消失型）铸造而成。
- In 2018, the personalized mandibular reconstruction prosthesis of Xi’an Kegu Intelligent Machine Co., Ltd was approved. The material used is a Ti6Al4V cast titanium alloy material, which is cast by a casting shell (3D printing photosensitive resin type disappearing type) matched with the shape of the individual patient’s bone defect.
与商业转化情况不同的是，3D打印骨科植入物在中国骨科临床治疗中的应用是处于国际先进水平的。中国部分三级甲等医院在临床中应用3D打印植入物已有多年历史，例如：上海交通大学附属第九人民医院在2014年就已将金属3D打印个性化假体用于骨盆肿瘤切除与重建手术。此后，上海第九人民医院在腕关节、踝关节、胸骨、髋关节等复杂骨科手术中又多次应用了3D打印的个性化金属植入物。除此之外，北京大学第三医院、空军军医大学唐都医院、广东省骨科医院等三级甲等医院（见图1）也陆续在复杂骨科疾病的治疗中应用了3D打印骨科植入物。
In contrast to the commercialization of 3D printed implants, the application of 3D printed orthopedic implants in the clinical treatment of orthopedics in China is considered at the advanced level internationally. Several lower-level hospitals in China have applied 3D printed implants in clinical practice for many years. For example, the Ninth People’s Hospital affiliated to Shanghai Jiaotong University has used metal 3D printed personalized prosthesis for pelvic tumor resection and bone reconstruction in 2014. Since then, the hospital has applied 3D printed personalized metal implants in complex orthopedic operations such as wrist joints, ankle joints, sternum, and hip joints. In addition, Peking University Third Hospital, Air Force Military Medical University Tangdu Hospital, Guangdong Provincial Orthopaedic Hospital, and other lower level hospitals (see Figure 1) have also applied 3D printed orthopedic implants in the treatment of complex orthopedic diseases.
Figure 1
可见，临床对于3D打印植入物存在多样化的需求，特别是在进行骨肿瘤治疗等复杂疾病修复治疗领域对于3D打印技术存在刚性需求。那么，在这种情况下，是什么原因导致3D打印植入物在中国的商业化进展缓慢呢？
影响3D打印骨科植入物商业转化的因素可以归纳为以下几点（见图2）：
Therefore, it is evident that there is a diversified demand for 3D printed implants in clinical practice, especially in the field of complex disease repair and treatment such as bone tumor treatment, which has a solid demand for 3D printing technology. So, in this case, what is the reason for the slow progress of commercialization of 3D printed implants in China?
Factors affecting commercialization
- 技术因素 Technical factors
- 管理因素 Management factors
- 意识层面接受度 acceptance factors
- 法律法规的支持 Policy support
- 人才与教育 Talen & Education
Figure 2
结合中国的具体情况，在临床需求端，虽然3D打印骨科植入物在部分治疗中得到了应用，但3D打印技术并没有成为国内医生所普遍接受的技术，这是该技术商业化的其中一个挑战。
Combined with China’s specific situation, although 3D printed orthopedic implants have been applied in some treatments at the clinical demand side, 3D printing technology has not become a technology widely accepted by domestic doctors. This is one of the challenges for commercialization.
从企业方来看，无论是增材制造技术的人才、医工结合的人才、打印材料、打印设备，还是后处理工艺，都没有做好植入物大规模制造的准备；另一方面是针对个性化植入物而言，在制造一些复杂个性化植入物时，对3D打印技术是刚性需求，但是由于这些个性化需求为企业带来的利润有限，这使得有实力的传统骨科医疗器械企业进入该领域的动力不足，而凭借3D打印技术生存的初创型医疗器械企业，也存在着实现盈利的挑战。
From the enterprise perspective, whether it is lack of talents in additive manufacturing, lack of talents with combined medical science and rehabilitation engineering backgrounds, lack of appropriate printing materials or equipment, or lack of post-processing technology, there is subsequently a lack of readiness for large-scale implant manufacturing. In terms of personalized implants, there is a definite need for 3D printing technology. However, because of the limited profit, the powerful traditional orthopedic medical devices manufacturers do not have enough motivation to enter this space, and medical device startups that survive with 3D printing technology also have the challenge of realizing profitability.
在医疗器械审批法律法规方面，国内法律法规的设置相对滞后，也是3D打印骨科植入物商业转化所面对的挑战之一。不过利好的一面是，相关法规、标准正在完善中，比如说CFDA已发布了“定制式增材制造医疗器械注册技术审查指导原则（征求意见稿）”。
In terms of medical device laws and regulations, the setting of the Chinese domestic laws and regulations is relatively lagging behind, and it is also one of the challenges faced by the commercialization of 3D printed orthopedic implants. However, the positive side is that relevant regulations and standards are being improved. For example, CFDA has issued the “Guidelines for the Review of Technical Registration for Customized Additive Manufacturing Medical Devices (Draft for Comment)”.
尽管存在着种种挑战，中国3D打印领域的先行者们仍在政策法规、行业标准的完善、临床应用、产品研发等领域推动着3D打印骨科植入物技术的发展。根据3D科学谷的市场观察，目前有一批新的3D打印定制化植入物正在进行商业转化，这些企业主要集中在中国华东、华中区域，预计2020年左右这些植入物将陆续获得医疗器械注册证。
Despite the challenges, the pioneers in China’s 3D printing industry are still driving the development of 3D printed orthopedic implant technology in areas such as policy and regulation, industry standards, clinical applications, and product development. According to the market observation of 3D Science Valley, a number of new 3D printed customized implants are currently undergoing commercialization. These enterprises are mainly concentrated in East China and Central China. It is expected that these implants will get registered around 2020.
About the Author:
Daisy Zhu is co-founder of 3D Science Valley , a commentary media platform focusing on additive manufacturing. She is responsibe for the publication of white paper of 3D printing in dental industry, orthopedic industry as well as rehabilitation appliances industry. She is one of the authors of the book ‘ 3D Printing in Automotive Inudstry Technology and Development Report’ and ‘3D Printing and Industrial Manufacturing’. She has been the keynote speaker at several medical forums , entrepreneurship salons and popular science activities.
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