On January 1, the “Regulations on the Supervision and Administration of Customized Medical Devices (Trial)” jointly issued by the State Food and Drug Administration and the National Health Commission was officially implemented, and my country’s 3D printed medical devices will usher in vigorous development.
Recently, the National 3DP Promoting Joint Replacement and Rapid Rehabilitation Forum and the 2019 Medical 3DP Annual Meeting of Chongqing Additive Manufacturing Association were held in Chongqing. The reporter was informed that through the national key research and development project, my country’s 3D printed porous tantalum prosthesis has been the first to achieve clinical application, and this technology is already at the forefront of the world.
Customized medical treatment to meet individual treatment needs
“You can only choose the model when you go to the shopping mall to buy clothes, but going to a tailor shop to make clothes will be more suitable, as is the custom medical treatment.” Dai Kerong, an academician of the Chinese Academy of Engineering, said that medicine is now gradually shifting from general medical care to personalized medicine. It provides an effective treatment method to solve the problem that conventional treatment is ineffective for some patients. Personalized medicine is accurate to the individual and is also called precision medicine. The customized medical model is the manifestation of precision medicine. It can not only tailor the clothes according to the actual situation of the patient, but also tailor the medicine and the equipment according to the actual situation of the patient, so as to make the treatment effect better and have fewer side effects.
Customized medical devices are personalized medical devices designed and produced by medical device manufacturers based on the special clinical needs of medical institutions in order to meet the rare and special diseases of designated patients. For example, after some lesions have been removed, the wound surface has a special shape and size, and medical devices produced according to standard specifications cannot match it.
In medical equipment, 3D printing technology is used. Through computer-aided design and computer-aided processing, rapid prototyping of customized medical machinery can be achieved without increasing costs.
Print with the most suitable metal for the human body
Professor Yang Liu, director of joint surgery at the First Affiliated Hospital of the Army Military Medical University, said that the incidence of osteoarthritis in my country is about 2.2% to 3.5%. According to statistics, the incidence of people aged 40 to 49 and 50 to 59 is about 27% and 62%. Total knee arthroplasty is one of the most effective methods for the treatment of end-stage knee joint diseases. However, traditional techniques such as bone cement, allograft or autologous bone grafting have various problems, which affect the stability and life of the prosthesis. Computer-aided design and 3D printing of personalized graft processing can make the prosthesis fully fill and reconstruct the defective bone structure, better help patients recover and reduce side effects.
Tantalum metal is currently recognized as the hard tissue with the best biocompatibility in the medical community. Its high-porosity porous structure makes its mechanical properties closer to the body’s autogenous bone, and pure tantalum has the best antibacterial performance among all medical metal materials at present, and is more suitable as a metal material implanted in the human body. However, since the melting point of tantalum metal is 2996 degrees Celsius, how to implement 3D printing of tantalum metal has always been a difficult point in the industry.
In 2016, the Department of Trauma and Joint Surgery of the First Affiliated Hospital of the Army Military Medical University took the lead in undertaking the 2016 national key research and development program “Key technology and clinical application of electron beam additive manufacturing of personalized porous tantalum implant prosthesis powder bed” (hereinafter referred to as the special project). The team has overcome a series of key technologies with independent intellectual property rights, such as personalized porous tantalum design, tantalum powder preparation, 3D printing equipment and processes. In 2017, completed the world’s first personalized 3D printed porous tantalum prosthesis implantation artificial total knee replacement revision surgery, and has completed 27 clinical trials of 3D printed porous tantalum. At the same time, through the team’s research, the world’s first electron beam 3D printing metal tantalum 3D printer was manufactured, which realized the additive manufacturing of tantalum powder.
Customized prosthesis is perfectly matched to the defect site
3D printing requires modeling, and how to design a prosthesis suitable for the patient is the key. In this regard, the Institute of Optics and Mechanics of Chongqing Academy of Science and Technology (hereinafter referred to as the Institute of Optics and Mechanics of the Chinese Academy of Sciences), the School of Bioengineering of Chongqing University and Shanghai Fengsuan Computer Technology Co., Ltd. are jointly responsible for the “personalized porous tantalum implant false The research task of “Fast Body Modeling and Analysis Technology” provides scientific basis and data support for the 3D printing of personalized porous tantalum prosthesis.
According to Wu Xianzhe, director of the Institute of Optics and Mechanics of the Chinese Academy of Sciences, the team has established a rapid design method for porous tantalum personalized prostheses based on medical imaging technology through technical research, and established a standard digital model library of hip and knee artificial replacement prostheses. There are a total of 103 kinds of data, which can be used in the process of personalized prosthesis design and implantation plan design. Now it is only necessary to obtain data of normal bones and defects through accurate three-dimensional CT scans of patients before surgery. Using the three-dimensional reconstruction system, the design of porous tantalum implant prostheses can be completed within 72 hours and the customized prostheses can be 3D printed. “This fully guarantees the need for timely treatment of patients, and the customized prosthesis can completely match the defect site.” Wu Xianzhe said.
According to the relevant person in charge of the Chongqing Science and Technology Bureau, Chongqing has always attached importance to the development of 3D printing technology. In the “Thirteenth Five-Year Plan for Scientific and Technological Innovation in Chongqing”, it is clearly stated that it should focus on breakthroughs in 3D printing technology and develop medical 3D printing technology. In recent years, it has supported the R&D and industrialization of more than 100 innovative drugs and new medical devices, including porous materials, surgical robots and other national Class III medical devices.
“On January 1st, the “Regulations on the Supervision and Management of Customized Medical Devices (Trial)” was officially implemented, which will further encourage the innovative research and development of customized medical devices, standardize and promote the healthy development of the industry, and meet the rare and special personalized needs of clinical practice.” Yang Liu Express.
Review the progress of 3D printing medical development
In 2017, twelve ministries and commissions jointly formulated the “Additive Manufacturing Industry Development Action Plan (2017-2020)” (hereinafter referred to as the “Plan”.
Among them, the content of “3D printing + medical treatment” is listed as one of the key tasks. The “Plan” pointed out: in response to the needs of personalized medical equipment (including medical non-medical equipment), rehabilitation equipment, implants, soft tissue repair, and new drug development in the medical field, promote the improvement of personalized medical additive manufacturing products in classification and clinical testing. , Registration, market access and other aspects of policies and regulations, research and determine the medical service project charging standards and medical insurance support standards for medical additive manufacturing products and services.
It also mentioned the significant deepening of industry applications, promoting the realization of large-scale applications of additive manufacturing in aviation, aerospace, shipbuilding, automobiles, medical care, culture, education and other fields.
Looking at the development status of foreign 3D printing, we will find that in the field of 3D printing medical applications, products in the budding period are still sprouting, products in the overheating period have not matured as expected, and 3D printed implants have not ushered in an overheating period. , And the development is relatively gentle.
In recent years, what breakthroughs have been made in the application of domestic 3D printing in the medical field?
According to arterial network statistics, there are 78 domestic and foreign companies involved in medical 3D printing. Among them, there are 20 companies involved in dental 3D printing; 14 orthopedic implant companies; and 5 biological tissue companies.
From the perspective of financing data, excluding undisclosed financing data, there are 10 Series A companies, and most of the IPO companies have been listed before the development of the 3D printing business. There were 13 financings in 2018 and 18 in 2015.
According to the relevant personnel of Cyber Turquoise Investment, the entire market for 3D printing medical applications tends to be rational. Most of the large number of companies that have emerged in the initial stage have found their own positions, and some companies have their own hematopoietic capabilities.
In an environment where the direction is gradually clear and the market is gradually calming down, the next projects will definitely combine technological breakthroughs with market demand.
Orthopedic implants are popular, approval becomes the final threshold
Among the products for 3D printing medical applications, orthopedics is a more popular field. First, there is still uncertainty in the industry and there is room for breakthroughs. Unlike the dental application market, which is relatively mature, and the technology is not as complete as biological tissue printing. Second, the market size is also large, but there are still many obstacles to large-scale clinical application.
Next, we will clarify the common barriers to the development of the industry from the perspectives of researchers, practitioners and investors in 3D printing orthopedic implants, and look back on the achievements of these years.
In terms of 3D printed orthopedic implants, products that have been approved by the CFDA include 3D printed acetabular cups, 3D printed artificial vertebrae, and 3D printed spinal intervertebral fusion cages jointly developed by Akcome Medical and the Third Hospital of Beijing Medical University.
The application of 3D printing in the field of orthopedics can be divided into two parts: preoperative and intraoperative. Preoperative applications can use CT and MR data to build a three-dimensional model, and then print the 3D printed preoperative model and 3D printed surgical guide. The 3D printed surgical guide can help doctors quickly determine the location of the acetabulum, the size, depth, and angle of the file, and the position, angle, and length of the acetabular screw during the operation, so as to achieve an accurate surgical plan.
Intraoperative applications are mainly personalized orthopedic implants.
3D printed metal implants can form a porous structure, which means that they can imitate the human trabecular structure and allow more bone tissue to grow in. On the other hand, 3D printed orthopedic implants can be customized.
3D printed porous structure of the hip joint
From the perspective of market size and response, orthopedic implants are also worth looking forward to. There is a demand for more than 1 million orthopedic implants in my country every year, and the annual income of Akcome Medical and Chunli Medical exceeds 100 million yuan, and the growth rate is more than 50%. The two institutions have also deployed 3D printed artificial joint applications. Among them, Akcome Medical is also cooperating with GE, and Chunli Medical is cooperating with Hewlett-Packard Medical.
Akcome Medical is known as the first 3D printing unit, but in general, Akcome’s main income is currently derived from conventional knee and hip replacement products. In 2017, conventional products accounted for 87.4% of sales revenue; while 3D printed hip joint and spine replacement products accounted for 9% of sales revenue, with revenue of 33.4 million.
The mid-year report published in 2018 showed that Akcome Medical’s 3D printed orthopedic implant product business grew at a rate of 178.6%, and the sales revenue of 3D printed products in the first half of last year alone reached 27.2 million.
This data and growth rate are sufficient to illustrate the market potential of 3D printing in orthopedic implants. As the only commercial 3D printed orthopedic product in China that has obtained relevant registration certificates (except for 3D printing used to cast mandibles), iKang Medical has a clear first-mover advantage compared with its competitors.
The standard is preliminarily set, and the product certification problem is being resolved
But at present, the common problems faced by the industry are not technical problems but the road to approval, and there is no prior standard specification.
According to industry insiders, there are currently many domestic research on orthopedic implants, and the products can basically meet clinical needs, but the process of getting stuck in the approval process may take about three years.
Aikesailong is a professional service provider of digital orthopedic medical products and solutions. Its founder Zhao Xiaowen mentioned, “We have been in the field of basic research for many years, but in the process of transforming from basic research to clinical, approval and certification The standards are relatively vague and lacking. After the framework is established, there are no detailed rules. This is a very confusing process. Of course, this must also be a process where technology and policy complement each other. If the policy is clear, it is impossible to have no breakthrough in technology. We are in the human skeleton. I have done a lot of basic research on the quantification of physiological structure, but in the process of transformation, there was a problem of no standard. Later in 2018, there was a related document, and we immediately entered the clinic, so I think the process of obtaining certification is a bit more difficult .”
However, this old and difficult problem that has plagued the development of 3D printing medical treatment is gradually being solved. Not long ago, the State Food and Drug Administration issued a public announcement on the establishment of artificial intelligence and other 3 medical device standardization technology focal units, including the plan for the establishment of medical additive manufacturing technology medical device standardization technology focal units. The first batch of customized medical device group standards released last week clearly stated the manufacturing requirements of customized medical products, which means the gradual establishment of my country’s 3D printing medical device standard system.
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