With the gradual maturity of 3D printing technology and the promotion of application, the development and production of personalized orthopedic medical devices have become possible, in order to meet the needs of orthopedic patients for personalized customized prostheses.
Research the application of 3D printing technology in orthopedic medical devices, and establish a 72-hour full-chain complete solution of "prosthesis demand - rapid preparation - clinical application" as the process. Through the whole chain of complete solutions, standardize the process of interaction between doctors and workers, make the communication between engineers and doctors more effective, formulate reasonable surgical methods, meet the needs of different orthopedic patients for personalized implantation of prostheses, and quickly and accurately transform the clinical needs of doctors into products.
According to the personalized clinical image data for data collection and analysis, quickly and accurately complete three-dimensional reconstruction, build personalized customized prosthesis product form, form the prosthesis preparation data basis, through the study of 3D printing product materials microporous structure, chemical composition, mechanical properties, metallographic structure and other properties, to ensure the material stiffness, toughness and fatigue resistance of the product, design a composite 3D printing prosthesis framework with biological characteristics.
And through clinical trials to verify the safety and effectiveness of the product. Finally, the personalized prosthesis production process is established, the GMP system is established, the 3D printing equipment is industrialized, the prosthesis production line is planned, and the production process is verified. The application of 3D printing technology has improved the original fixed-specification production mode.
Establish a 3D printing GMP system, optimize the R&D and manufacturing process of personalized orthopedic medical devices from the aspects of time limit, material saving and precision manufacturing, make it easier to achieve and more applicable, formulate technical standards for personalized customized prosthesis products, test the preclinical biology and function of 3D printed prostheses, and evaluate the safety, effectiveness and controllability of personalized prosthesis implantation. Finally, the expected 72-hour full-chain complete solution was achieved.
background
According to reports, the total domestic medical device market in 2014 was about 255.6 billion yuan, and in the first half of 2015, the cumulative revenue of the domestic medical device market reached 108.092 billion yuan, the total profit accumulated 9.244 billion yuan, and the cumulative revenue and profit growth rate were 12.05% and 4.71% respectively. With the gradual improvement of the living standards of the mainland people, the mainland has gradually entered an aging society, the people's living standards and quality of life have improved, and the demand for health has gradually increased.
In the future, the mainland medical device industry will surely achieve rapid development, and the new medical reform policy will also greatly stimulate the rapid development of the medical device industry. Products such as artificial joint prostheses and spinal plants in high-tech, personalized and miniaturized medical devices will surely be one of the most profitable varieties in the medical device industry, but most of the current orthopedic medical device products adopt modeled and standardized designs, which is difficult to meet the personalized needs of patients and the needs of biological function reconstruction.
The overall development of China's orthopedic medical device industry is not long, and the development of orthopedic industry is only more than 30 years. In the 90s of the 19th century, China's orthopedic medical devices were just getting started, and the research and development capabilities of enterprises were poor, and the products provided could not meet the clinical needs at all. Orthopedic surgeons can only find manufacturers to help try to make products according to their own needs, and ask manufacturers to make some products that can meet clinical needs.
It was not until the 90s that foreign-funded enterprises gradually entered the country, and with the establishment and growth of some domestic orthopedic enterprises, the situation began to improve slightly. Orthopedics specializes in the study of the anatomy, physiology and pathology of the human skeletal and muscular systems, and its treatment methods mainly include drug treatment, physical therapy and surgical treatment, maintaining and developing normal morphology and function, and treating diseases. Surgery is more commonly used among the above three treatments, with surgery accounting for the largest proportion.
Orthopedic medical devices can be divided into two fixation methods, internal fixation and external fixation, both of which are designed to fix the patient's fracture and promote the rapid formation of callus and early healing. The implantation of medical devices into the patient's body for fixation is called internal fixation, which mainly includes artificial joints, spinal screws, trauma steel plates and other products.
External fixation is a way to select external fixation brace materials for fixation treatment outside the human body, and common products include thermoplastic splints, gypsum bandages, external fixation brackets, polymer splints, etc. Compared with the two methods, internal fixation occupies a larger proportion.
From the perspective of anatomy and treatment, orthopedic medical device products can be mainly divided into joint products, spine products, trauma products, and even subdivided into foot and ankle products, sports trauma products, etc. in recent years. Joints mainly include hip and knee joints, and niche products include shoulder joints, elbow joints, and even knuckles. Spine products include product demand caused by trauma and degenerative diseases, and even some hospitals are more detailed, such as subdividing spine products into cervical, thoracic and lumbar spine products.
Trauma products are mainly product demand caused by fractures caused by external forces, such as limb fractures, which are the most common and the most basic. Orthopedic medical devices account for about 6% of the overall medical devices, and orthopedic medical devices have a high technical content and are managed as high-value medical consumables in the medical device industry.
Industry research reports show that in the past few years, the orthopedic medical device industry market has reached a compound growth of more than 20%, although it has slowed down slightly in the past two years, but the compound growth rate in 2018 has basically remained at about 15%, and the market size has exceeded 21 billion, of which the faster growth is joint products and spine products, which can reach more than 20%. It was in this environment of opportunity and that WGGK was founded in 2004.
Affiliated with the WG Group, it is a company specializing in the development, production and sales of products such as spine, trauma, joint and sports trauma. In terms of sales share in recent years, WGGK is currently the fastest growing and largest orthopedic implant manufacturer in China, especially in the spine and trauma market classification, occupying the largest domestic market share. In order to adapt to market changes, in the past four years, WGGK has begun to increase its efforts and invest heavily to build domestic joint brands.
Although WG joint products started relatively late, its YH and HX joint products have occupied a relatively large market share in the market. In the 21st century, with the adjustment of national policies, personalized diagnosis and treatment will be one of the important directions of medical development in the future, hoping to change the previous average and standardized treatment mode through precision medical plans, and consider more individual differences and take into account individual genes.
Different living habits and the influence of living environment, we carry out disease prevention, diagnosis and treatment with personalized characteristics. Precision and personalization will be an important direction for the development of orthopedic medical devices in the future. The use of personalized prostheses will simplify the surgical steps, reduce tissue damage, make the prosthesis fit better with the bone surface, and perfectly solve the problem that traditional prostheses cannot be completely matched with the patient's bones.
On March 8, 2016, the Ministry of Science and Technology announced the Notice on Issuing the 2016 Application Guidelines for Key Projects such as Precision Medicine Research of the National Key R&D Plan, which clearly listed "precision medicine research" as a priority key project and entered the implementation stage. In the clinical treatment of various bone defects caused by trauma, tumor resection, tuberculosis, or congenital developmental malformations, surgery is required to repair the bone defects and restore their normal function and structure.
However, at present, the vast majority of orthopedic medical devices adopt modeled and standardized design, and standardized and single design can meet the needs on a large scale and reduce production costs, but the differences in the structure of each body of patients, as well as the clinical needs of patients due to different diseases, the product structure and size are different, which cannot meet the needs of clinical individualization and biological function reconstruction.
Moreover, the preparation of personalized customized prostheses by traditional process methods has a long preparation cycle, and the structure is difficult to match with the original bones of patients, so it cannot be quickly put into clinical application. How to quickly manufacture personalized orthopedic prostheses with biological functions is the main problem faced by the preparation and clinical application of prostheses. In the design and development, process technology, manufacturing level is increasingly mature today, 3D printing technology provides an opportunity for the rapid realization of the manufacture of personalized customized prosthesis.
Biomimetic structures are rapidly prepared to match the patient's original bones. Moreover, the development of CT and other imaging technologies, the maturity of image processing technology and the rapid development of computer technology have also laid the foundation for the digital manufacturing of 3D printing, and improved the feasibility of personalized customization and research and development for individual anatomy and pathology of patients. Therefore, the research and development and production of personalized customized medical devices have also been paid more and more attention, and research work has been put on the agenda.
Focusing on personalized orthopedic medical device customization and biological function reconstruction, it is of great significance to study the rapid prototyping technology of 3D printing of personalized orthopedic prosthesis with biological functions and lead the technological progress of 3D printing medical industry and biomedical materials industry.
The industry is increasingly interested in the application of 3D printing technology in medical devices, and many medical device manufacturers at home and abroad have explored various application fields, including many international large companies, such as Johnson & Johnson, Stryker, Zimmer Bangmei and so on. WGGK is not to be left behind, and is also actively carrying out research on 3D printed orthopedic prosthesis.
resource allocation
The establishment of a GMP system for the production of personalized implanted prostheses and the completion of 3D printing production line planning and process verification shall comply with the requirements of the Good Manufacturing Practice for Medical Devices and related appendixes, and meet the requirements of YY/T0287-2017 "Medical Device Treatment Management System for Use Regulations".
Establish a 3D printing manufacturing team, including digital modeling team, prosthesis and tool design team, testing and numerical simulation team, 3D printing team, processing technology team, manufacturing team and quality assurance team, and clarify the responsibilities of relevant personnel. Through the industry-university-research cooperation model, 3D printing orthopedic medical device professionals are cultivated, and relevant personnel have corresponding theoretical knowledge and practical operation ability, and formulate corresponding operating procedures for relevant personnel for pre-job training and implementation.
Establish a suitable plant and facility environment for 3D printing personalized orthopedic medical devices. Environmental requirements for 3D printing plants: temperature 20-25 °C, relative humidity below 60%, magnetic field fluctuation range within 2.5 meters of the machine is less than 0.2uT Tesla.
All software used is verified, including not only the software used for 3D modeling and the software used in the printer processing process, but also the software related to patient image data collection, processing, transmission, 3D modeling, etc., to ensure software compatibility, data integrity and accuracy.
conclusion
Although 3D printing orthopedic medical devices have been explored and researched for many years, although the current 3D printing technology has also had preliminary experience accumulation, personalized orthopedic medical devices are still a small range of development in the foreseeable future, but it is necessary to grasp the development direction of the industry in advance and master advanced industry technology in order to be invincible in the field of medical devices.
Through the study of the process of medical-worker interaction and the performance of 3D printing products, combined with the application in practical work, the summary is as follows: establish the process and specification requirements of medical-worker interaction. From the perspective of personalized customized orthopedic medical devices, combined with clinical needs, from the situation that conventional products such as skull plates, pelvic prostheses, and talus prostheses cannot be met, we provide personalized customized prostheses for clinical needs for clinical practice.
Through the means of medical-worker interaction, clinical needs, clinical data collection, product design and development, and design verification are formed to form a standardized process of personalized customized prosthesis medical-worker interaction. 3D printing product standards have been established for 3D printing product design verification. The three-dimensional structure of the prosthesis and the biomechanical satisfaction are verified, the microporous structure of the product surface is verified, and the biological reconstruction is studied.
The conversion process and the production and processing process of personalized customized medical device products are verified, so that the performance of the product meets the requirements of biomechanics, and the mechanical strength can be comparable to that of conventional processed products, so as to ensure that the final product meets clinical needs and meets the safety and effectiveness.
Taking the personalized customization of talus prosthesis as an example, the customized prosthesis completed by clinical needs, clinical data collection, product R&D and design, 3D printing, and final processing is applied in clinical practice, and the product is evaluated in the form of postoperative follow-up, and finally ensures that the 3D printed personalized customized prosthesis meets clinical needs through clinical confirmation. Establish a standardized 3D printing personalized prosthesis GMP system for standardizing the entire customization process between the hospital and the factory.
Through the combination of medical-engineering interaction, product R&D and design, processing verification, and finally clinical confirmation. Finally, a GMP system is established for the entire production process of personalized customized 3D printed medical devices, and a series of standards and specifications are formed. Industrialize the 3D printing equipment used in the production process, plan product production lines, and verify the production process.
And the technical standards, preclinical biology and functional testing of personalized customized prosthesis products to evaluate the safety, efficacy and controllability of personalized prosthesis after implantation. Communicate with clinicians to confirm the expected 72-hour full-chain complete solution from diagnosis of patient to surgical plan, to product design, to production and processing, and finally completion of implantation. Up to now, dozens of cases of clinical implantation of personalized customized prostheses have been completed. The expected effect of the challenge was achieved.