At the end of 2017, 3D printing technology, which has been developing for many years, has ushered in a series of major positive policies. The Ministry of Industry and Information Technology and the National Health and Family Planning Commission and other 12 departments jointly issued a notice on the "Incremental Manufacturing Industry Development Action Plan (2017-2020)", and listed "3D printing + medical " as one of the key tasks. . For the needs of personalized medical devices (including medical non-medical devices), rehabilitation devices, implants, soft tissue repair, and new drug development in the medical field, we will promote the improvement of personalized medical additive manufacturing products in classification, clinical testing, registration, and market access. Other aspects of the policy and regulations, research and determine the medical service project fee standards and medical insurance support standards for medical additive manufacturing products and services. Industry experts believe that the 3D printing technology that has been used in the field of orthopedics such as artificial joints and artificial vertebral bodies will expand into more medical fields in the future, setting off a new era of personalized medical care for the people.
3D printing "private customization" makes orthopedic surgery more precise
In recent years, with the improvement of people's living standards, the aging process, and the rising number of “low-headed, violent peopleâ€, the prevalence of diseases such as knee joints and cervical vertebrae has also increased rapidly. The knee joint is the largest and most complex important joint in the human bone, and it is also a sensitive part with more chances of injury. Once the knee joint has symptoms such as arthritis, it will directly affect people's normal life and physical health.
Additive manufacturing (also known as 3D printing) is an emerging manufacturing technology based on a digital model that builds up materials to build physical objects layer by layer. It is a representative subversive technology in manufacturing. In recent years, 3D printing technology has been widely explored and clinical practice in the medical field, especially the use of 3D printing technology in the treatment of knee bone defect treatment, femoral head necrosis, cervical lumbar vertebrae disease and other orthopedic fields, helping many patients who cannot walk normally "Go back" to a healthy life.
Professor Wang Yijin, who is the first in China to introduce 3D printing technology into the knee joint clinical treatment, said that the incidence of joint damage in the middle-aged and elderly population is as high as 80%, the degree is light or heavy, and it is caused by ischemia. Cases of femoral head necrosis have also increased in recent years. Recalling the case of the first "3D printing" knee bone defect treatment in the Department of Bone and Joint Surgery of the Second Hospital of Shandong University in 2013, Wang Yujin was still quite emotional. He said that traditional osteoarticular prostheses and implants are manufactured in a batch, fixed model, and each person's bone shape is different, and the prosthesis and implant are difficult to match with everyone. After obtaining the patient's consent, the doctor performed a CT scan of the bone defect site, established a digital model based on the scan data, and then used the titanium alloy powder as the raw material to "tailor-fit" the bone defect filling metal pad with the 3D printing technology. After that, Wang Haojin underwent surgery on the main knife. After two weeks, the patient was able to walk freely. Two weeks later, the patient was discharged home. After 3 months of follow-up, the patient was in good condition. Wang Yujin said, "3D printing technology has realized the individualization of implants, from human bone adaptation to prosthesis to prosthesis to adapt to human bone, reducing bone loss. 3D printing technology is a revolution in manufacturing, will also bring revolution to the medical world Sexual progress, and individualization is undoubtedly a development trend in orthopedic treatment."
Let 3D printing benefit more patients and need more policies to “landâ€
Since the National Food and Drug Administration (CFDA) registered and approved China's first 3D printed human implant, the artificial hip joint product, the CFDA has approved three 3D printing products, including hip replacement implants. Spinal interbody fusion cage and artificial vertebral body. Compared with traditional manufacturing processes, metal 3D printing products with new technologies and new processes have high production costs, involve many basic research, do clinical trials, and complete the registration process. The research investment is large and the cycle is long. Does this mean that the cost of treatment for orthopedic diseases in the general population increases?
Professor Sun Zhuqing from Shenyang Orthopaedic Hospital said that in the orthopedic surgery, the emergence of 3D printing technology has solved many incurable diseases, and the clinical demand continues to grow. The use of 3D printing technology to print out the orthopedic model shortens the operation time, reduces the surgical bleeding, and shortens the anesthesia time. It has practical effects in solving the patient's pain, restoring normal functions, and improving the quality of life. However, compared with the imported products currently used in China, the price can be as low as half.
Professor Miao Jun of the Department of Spinal Surgery of Tianjin Hospital said that the two most prominent functions of 3D printing technology are the printing model, which can accurately analyze the unknown surgical risks in advance; the printed prosthesis can replace the damaged human body structure. In some complex surgery of spinal surgery, 3D printing can help experts to develop the best surgical plan, achieve "integrated" treatment, greatly reduce the risk of surgery and medical costs, and benefit patients.
Although the development of 3D printed artificial hip joints in China started earlier in the world, the registration approval process for 3D printed implants is relatively long. There is still no relevant regulatory measures for 3D printing technology, such as charging standards, uneven surgical levels, and qualification certification. Management methods are still unclear.
On December 5, 2017, the CFDA issued a 3D printed medical device manufacturing guidance to provide medical device manufacturers with advice on 3D printing technology, as well as what the manufacturer needs to include when submitting 3D printed medical device approvals. Includes considerations for various 3D printing methods, equipment design, functionality, durability testing, and quality system requirements. This is another initiative to promote the further development of 3D printed medical devices following the CFDA's release of a draft guide for 3D printing for medical manufacturers in May last year. At the same time, this also reflects the country's emphasis and practice on the important emerging technology of 3D printing.
In fact, all countries in the world, especially developed countries, have already cultivated 3D printing (additive manufacturing) as a new growth point for future development, and formulated a national strategy and specific driving strategy for developing additive manufacturing, striving to seize the future technology and The commanding heights of the industry. In addition to the United States, Europe, Japan, Australia, etc. have also developed and launched their own 3D printing development strategy plan.
Wang Yujin said that letting 3D printing benefit more patients will require more policy and management.
Source: Xinhuanet
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