Blu-ray development (13.06, -0.780, -5.64%) recently announced a renewed focus on the medical 3D printing industry. The company announced that it has developed a 3D printer that prints artificial blood vessels.
The medical 3D printing market is the main battlefield for the development of the 3D industry and the most promising field. The personalized needs of medical care and high value-added features make this field the most suitable area for using 3D printing technology. The unanimous consensus in the industry is that 3D printing costs are relatively high, and only the medical field is not so sensitive to cost. Moreover, the individualized demand in the medical field is very high, and the first industrial field in which 3D printing can be widely promoted is the medical field.
Medical 3D printing is the main battlefield of the industry
3D printing, also called additive manufacturing technology, is a kind of rapid prototyping technology. It is based on three-dimensional digital model files, through software layered discrete and numerical control molding system, using laser, hot melt, etc. to metal, ceramic, plastic, A technique in which a material such as a cell is deposited layer by layer to form an object. The 3D printing industry chain can be divided into upstream modeling tools, software, materials, midstream printing equipment, downstream applications and services. Medical 3D printing adds medical and biological attributes to this.
At present, the 3D printing industry has unanimously agreed that medical 3D printing is the main direction of the industry.
What is medical 3D printing? It is the use of 3D printing to shape biomaterials, especially cellular materials, to make artificial tissues and organs, as well as a variety of prosthetics, surgical guides and other products in the field of biomedical applications. It is the most advanced field in 3D printing research. At this stage, medical 3D printing applications include: vascular printing, cell printing, tissue engineering scaffolding and implant printing, prosthetic printing, and surgical instrument printing.
Why develop medical 3D printing? Xu Mingen, a professor at Hangzhou University of Electronic Science and Technology, believes that there are three major reasons.
The first is that the size of the medical field is particularly large. A survey conducted by the US Department of Health in 2009 showed that US health expenditures amounted to 2.5 trillion US dollars per year, accounting for 17.6% of US GDP and 40% of gross national income. The US Department of Health further predicts that by 2018, the US spending on medical care will reach 20.3% of GDP. This is a very huge market. "As human material wealth becomes more affluent and the standard of living is getting higher and higher, the amount of money human beings are willing to spend on life will increase. In the United States, we can clearly see this trend." Xu Mingen said.
Secondly, 3D printing has broad application prospects in the medical field. The rapidity, accuracy, and expertise of biological 3D printing technology make it a very broad application prospect in the medical field. "We look at our body structure. Everyone's body structure is different. There are specialities and differences in pathological conditions. It is often seen in the clinic that even if the same part of the body is disabled, its length and position of the disability. It's different.†Xu Mingen explained that 3D printing has a personal manufacturing capability and will be very popular in the medical field. The combination of 3D printing and traditional medical image acquisition, such as CT and ECT, combined with 3D modeling technology, will have a huge driving effect on the manufacture of artificial prostheses and artificial tissues.
Furthermore, medical 3D printing is the most important testing ground in the field of 3D printing, which is related to the survival of the industry. Compared with the current traditional manufacturing technology, although 3D printing has the advantages of individualization, there is no advantage in production cost. Furthermore, are there so many sexual demands in the various products that we are exposed to on a regular basis? For example, the water cup does not require too many personalized elements in actual use. Therefore, 3D printing has no competitive advantage in most manufacturing fields. However, there are two areas in the world that do not cost and do not consider cost performance. One is medicine and the other is military. The individualized needs in the medical field are very high and are areas where cost performance is not considered. There is a consensus in the 3D printing industry that the first big industry area where 3D printing can be promoted on a large scale is the medical field.
Cell printing the most imaginative space
In medical 3D printing, the most mysterious, cutting-edge, and coolest segment is cell 3D printing. This is a new technology that accepts control commands, positioning assembly, and organ production of cell materials by 3D printers under the guidance of a three-dimensional model of tissue organs.
The formation of this technology, first of all, has a fundamental principle. Around 2000, scientists cut human arteries into a ring-shaped structure, and then placed these rings on a line. After 72 hours, they found that the blood vessels were merged together to form a new blood vessel. . This experiment tells us that in vitro, if different cells can be placed together in space according to the cell arrangement requirements of human tissues and organs, these cells will soon migrate, spread, self-organize, and reconstitute an organ. In other words, it can create a brand new organ.
Academic institutions such as Tsinghua University and Massachusetts Institute of Technology have explored in the field of cell 3D printing. Its technical principle is to print cells layer by layer on special heat-sensitive materials. After the film is finished, the materials can be stacked to obtain the desired structure. . Xu Mingen said that the first cell 3D printer was modified with a normal printer and was the first commercial 3D printer. However, due to the lack of reserves of some technologies, the commercialization of this machine is not good.
The best commercialization at present is the 3D Bioplotter technology, which combines cells and agar-based composites and extrusions onto a layer of a substrate with a crosslinker. Professor Sun Wei of Drexel University in the United States has developed a three-jet 3D printer capable of continuous extrusion molding. This technology can perform drug toxicity liver cell structure testing.
What are the applications of cell 3D printing? The first area of ​​application is the laboratory. It can provide a very good research tool for life science-related fields such as regenerative medicine, tissue engineering, stem cells, cancer, etc. It can even be considered as great as traditional biomedical PCR technology and patch clamp technology. Promote the development of life sciences. The latter two technologies not only formed two huge industries, but also won the Nobel Prize respectively.
The second thing that can be done is to build and repair tissue organs and provide new clinical medicine techniques. This is also a very huge market. As people gradually age, the liver, kidneys, heart, and lungs will age. This is like a car. When the car's engine is broken, the tires are broken, there are accessories to buy, or they can be removed from other cars. An accessory is coming down. So what if the human organs are broken? Of course, the kidneys can be transplanted, but rejection occurs during the transplant process, and more importantly, there are not as many transplant donors. There are 30,000 to 50,000 patients who need kidney transplants every year. The existing donors are not enough, and they are used for life-long anti-immunization rejection drugs. The best way is to use the patient's own cells to produce the organs it is missing. For example, using the cell 3D printing technology, an artificial liver unit is printed. In addition to the liver, 3D printing technology can also produce artificial fat. For example, breast augmentation, most of the current breast augmentation is filled with silica gel, which will eventually cause side effects. The best way is to use your own fat cells to make repairs.
Third, cell 3D printing technology can also be used as a drug screening model in the field of drug discovery. In 2014, the US Pharmaceutical Industry Association's investment in new drug research and development was about $70 billion, of which only the Pfizer family invested $10 billion. With such a huge investment, how many new drugs can be produced each year? Probably only 2-3 truly original new drugs are produced each year worldwide. This may be the area with the largest investment in R&D and the lowest output. Why is the success rate so low? For example, if I have 10,000 compounds in my hand, I need to screen out 10,000 compounds for drugs that can treat diabetes. The easiest way is to find 10,000 patients with diabetes to do experiments. However, can you quickly find 10,000 diabetic patients at low cost? Moreover, some compounds are toxic, what should I do if I die? Scientists use animals to do it, but they are also very hard, and the genes of mice are different from those of humans. Drugs that are useful to mice may have no effect on people. In the 1980s, scientists proposed a high-throughput screening method that uses cells or individual proteins to model them. However, thirty years have passed and the speed of drug development has not accelerated. Because the human body is a complex regulatory network, the rise or fall of a single factor may be diametrically opposed in the overall environment of the human body. Therefore, if artificial tissue organs can be made by 3D printing, artificial tissue organs can be screened, which can greatly improve the process of drug screening.
Listed company
Domestic enterprises began to enter the 3D printing field on a large scale in 2008-2012, and the investment is very hot. After several years of market cultivation, investment enthusiasm has gradually become more rational. At present, the scale of the 3D printing industry has not yet developed. There are no enterprises with annual sales exceeding 200 million yuan in the industry, and only a few ten million companies. Moreover, there are fewer national platforms for promoting and popularizing the industrial application of 3D printing technology in China. The larger ones are Nanjing 3D Printing Research Institute, Shaanxi Weinan High-tech Zone 3D Printing Industrial Park, and China 3D Printing Innovation Center.
The five leading figures in the development of domestic 3D printer equipment are Academician Lu Bingheng of Xi'an Jiaotong University, Yan Yongnian of Tsinghua University, Shi Yusheng of Huazhong University of Science and Technology, Wang Huaming of Beijing University of Aeronautics and Astronautics, and Huang Weidong of Northwestern Polytechnical University. 3D printer equipment market promotion companies that achieve 10 million or more revenues include: Taier Times, Huaying Hi-Tech, Shanghai Luen Thai, Jiaotong University Hengtong, Hangzhou Xianlin, Hangzhou Flash Casting, etc. Others include Blu-ray development (13.06, -0.780, -5.64%), Guangyunda (29.70, 0.490, 1.68%), and Cinda.
The most fascinating medical 3D printing technology, research is also a step by step listed company, non-blue light development. On January 18 this year, Inno Bio of the Blu-ray development subsidiary invested 50 million yuan with Huaxi Hospital to explore the road medical 3D printing business. Founded on September 16, 2014, Inno Bio is a high-tech enterprise that develops and produces biotechnology products. According to the agreement, Blu-ray Yingnuo invested funds to launch 3D bio-printing product development projects; Huaxi Hospital gave academic and technical teams, space equipment resources support, and implemented application research and development with the support of enterprise project funds. The two parties will use the theme of “Regeneration and Reconstruction 3D Printing†to gradually select and sign specific R&D projects in batches to carry out strategic cooperation of engineering technology oriented by clinical application products.
On October 25th, Blu-ray Development announced that the “National High-Tech Research and Development Program (863 Program)†3D bio-printing vascular project has achieved a major breakthrough, and the world's first 3D biovascular printer with complete independent intellectual property rights has come out. This marks an important step in the development of precision light in the field of precision medicine.
“The breakthrough significance is that Blu-ray Inno has a complete 3D bio-printing technology system using stem cells as the core, including medical imaging cloud platform, bio-ink, 3D bio-printer and post-printing system. The organ reconstruction will become the future. Maybe.†Yang Lan, chairman of the company, said that China’s first A-level medical imaging data cloud center will be built in Chengdu, Sichuan. "The completion of this platform not only provides a viable digital model support for 3D bioprinting, but also provides an effective tool for precision medical care to solve future development bottlenecks."
The team of scientists behind Blu-ray development is very strong: Chief Scientist, Professor Kang Yujian, Dean of the Blu-ray Inno 3D Bioprint Industry Technology Research Institute, participated in the world's first heart-changing operation, manufacturing and installing the world's first test pig. 3D print pig heart. Professor Zhou Huixing, who is responsible for the manufacture of Blu-ray Inno 3D bio-printer, is the director of the 3D Printing Engineering Technology Research Center of China Agricultural University. Kang Yujian and Zhou Huixing are all special experts in the “Thousand Talents Programâ€, and the “3D Bio Print Vascular Project†has been included in the National 863 Program.
“In the past 15 years, I have only done one thing – focusing on regenerative medicine and stem cell research.†Kang Yujian concluded. And its 15 years of precipitation has made the "bio-brick" technology: not only study the microenvironment of stem cells to transform into blood vessels, but also provide a structure that allows stem cells in the microenvironment to be printed as organs, tissues, and normal human organs and tissues. Features.
"Biobrick" is the Chinese translation of "Biosynsphere", which is actually a biologically active synthetic sphere. Kang Yujian said that it has a biodegradable, mechanically strong and mechanically resistant outer shell with cell growth factors and nutrients, as well as stem cells. And ordinary masonry is the same as the building foundation. In the technical system constructed by Kang Yujian team, “bio brick†is the masonry used to build the “building†of tissues and organs.
Compared with a single product that has yet to be clinically validated, the Kang Yujian team has actually established a 3D bioprinting platform system and technical route by releasing 3D printed blood vessels and printers, including medical imaging cloud platform, bio-ink, and 3D bio-printer. , print the post-processing system four core parts.
If you continue to develop along the above routes, 3D bioprinting will probably extend from vascular printing to liver and spleen and stomach printing based on the “bio-brick†system. “'Biobrick' is the development platform we provide, and we need a lot of application developers.†Kang Yujian said that “bio-bricks†containing different micro-environments, in addition to the “vascular “bio-bricks†prepared by Blu-ray Inno It may form "heart "bio brick"", "liver 'bio brick'", and then print out the biological heart and biological liver through the corresponding 3D printing module, and truly realize the customization of human organs.
"Our team is doing blood vessels and can put blood vessels in people's bodies within two years. But this does not mean that the task of our blood vessels is completed, because every inch of blood vessels is different. For us, blood vessel research is Endless work." Kang Yujian said.
As for how to meet the printing of different "bio-bricks" and different tissues and organs, Zhou Huixing said: "In general, our idea is modular design. The basic platform of the printer is universal. When the blood vessels are printed, the blood vessels are added. annex."
However, there are also "organ reconstruction" skeptics believe that human simulation of stem cell differentiation microenvironment is difficult, or 3D bioprinting of complex organs is difficult to achieve.
In fact, 3D bioprinting now has a distance from clinical trials. But Kang Yujian is very confident in printing organs out of 3D creatures. "I can tell you responsibly that we can print blood vessels, and we think that using bio-bricks to hit any organ can make it work."
Medical 3D printing related information
Time core content
In January 2015, the National Health and Family Planning Commission and the Ministry of Science and Technology held several meetings to demonstrate and launch the “precise medical†program. The Ministry of Science and Technology held the first “National Precision Medical Strategy Expert Meetingâ€. Experts in the medical field suggested that precision medicine runs through the entire process of diagnosis, treatment, medication and other medical treatments. In addition to medical technologies such as gene sequencing and genetic diagnosis, 3D with more personalized features is more unique. Printing technology will also play an important role in personalized precision treatment.
In February 2015, the Ministry of Industry and Information Technology and the Ministry of Finance issued the “National Additive Manufacturing Industry Development Promotion Plan (2015-2016)â€. It is proposed that by 2016, a relatively complete additive manufacturing industry system will be established, and the industrial sales revenue will grow rapidly. The average annual growth rate is over 30%, and the overall technical level is synchronized with the international level. Among them, the development goal of the medical field is: to become a tool for new drug research and development, clinical diagnosis and treatment; to form a batch of application demonstration centers or bases throughout the country. The planned application materials for medical additive manufacturing include breakthrough biomimetic tissue repair, personalized tissue, functional tissues and organs, etc.; the material materials planned to break through include synthetic polymers such as polyglycolic acid and polyetheretherketone. , bioactive ceramic materials such as hydroxyapatite, medical metal materials such as cobalt-nickel alloy; equipment that plans to accelerate development includes bionic tissue repair scaffold additive manufacturing equipment, medical personalized additive manufacturing equipment, cell active material additive manufacturing equipment, etc. .
In June 2015, the 3D printing approval seminar sponsored by the Medical Device Registration Management Department of the State Food and Drug Administration was held in Beijing. The main purpose of the seminar was to promote the discussion and approval of innovative product review and approval methods in related fields, and to improve the 3D printing medical devices. The level of review and approval of products.
In July 2015, China's first 3D printed human implant artificial hip joint product was approved by the State Food and Drug Administration. The product is also the first 3D printed artificial hip prosthesis registered in the world after clinical validation. The product belongs to three types of orthopedic implants, developed by the Department of Orthopaedics of Peking University Third Hospital, Zhang Ke, Liu Zhongjun, Dr. Cai Hong and the artificial joint manufacturer Beijing Aikang Yicheng.
In August 2015, Li Keqiang, member of the Standing Committee of the Political Bureau of the CPC Central Committee and Premier of the State Council, presided over a special lecture by the State Council to discuss 3D printing technology. The Prime Minister pointed out that 3D printing is a representative subversive technology in the manufacturing industry. It has achieved a major change in manufacturing from the same material, from the material to the additive, and changed the concept and model of traditional manufacturing, which is of great value. As an important pillar industry of the national economy, manufacturing must seize opportunities.
Existing regulations can manage medical 3D printing
â–¡ reporter Xiao Xiaohe
At present, many hospitals such as Peking University Third Hospital and Shanghai Ninth Hospital have been treating bones with 3D printing technology to save lives. While people have a lot of expectations for this technology, what other legal thresholds do they need to go through in practical applications? The legal person pointed out that the application of 3D printing technology in the medical field does not require the formulation of new legal norms to regulate, the technological means are innovative, the legal rules have not changed, and there is no need to change. It does not bring challenges to the law. It is how the law enforcement and control mechanisms should be followed up to reduce the possible negative impact of 3D printing technology.
What kind of "legal hurdles" need to be taken?
There are many legal issues associated with 3D printing. For example, is the bone made by 3D printing technology applicable to the requirements of the three types of medical device products to be controlled in the Medical Device Supervision Regulations? Is the product manufactured by 3D printing technology a "product" in the sense of "Product Quality Law"? Is it illegal to use a printer to directly manufacture a three-dimensional product created by another person without authorization? Does the 3D printing world touch the legal edge of intellectual property protection? Who should be responsible for the medical damage caused by 3D printed products in medical institutions?
It is said that 3D printing technology is an emerging technology for the benefit of mankind. The state should introduce policies and regulations for 3D printing as soon as possible to ensure its healthy development. However, Xu Qingsong, director of the Law School of the Second Military Medical University, believes that the legal problems caused by 3D printing technology can be adjusted in China.
It is understood that the current medical institutions use 3D printed bones, although the medical staff in the medical institutions use 3D printing equipment to manufacture, but because the medical institutions themselves do not have the production qualification of medical device products, the medical practice of 3D printing technology in practice The organization is customized on-demand by entrusting qualified medical device manufacturers. For example, the artificial bone of 3D printing printed by Shanghai Jiuyuan Rehabilitation Surgery was completed by entrusting Shanghai Bilcom Biomedical Technology Co., Ltd., which fully complies with the Regulations on the Supervision and Administration of Medical Devices for the third category (ie implanted into the human body, used for Supporting the maintenance of life; medical devices that are potentially dangerous to the human body, medical devices that must be strictly controlled for their safety and effectiveness) are subject to the classification management of medical devices, and the research project is approved by the former State Food and Drug Administration. It can be seen that although the products manufactured by 3D printing technology are different from the products mass-produced in the factory in the traditional sense, they are still defined as the “products†stipulated in the “Product Quality Lawâ€. “The products referred to in this Law refer to the processing and production. Products for sale."
Xu Qingsong believes that the existing laws can also be completely solved in terms of intellectual property protection related to 3D printing technology. The "Copyright Law" stipulates: "The works referred to in this Law include works of literature, art and natural sciences, social sciences, engineering and other works created in the following forms... engineering drawings, product design drawings, maps, schematics, etc. And model works.†It can be seen that protected by copyright law includes not only traditional graphic works, but also “model works†with three-dimensional angles. Therefore, for a commercial purpose, a 3D printer directly "manufactures" a three-dimensional product created by another person, which is not authorized, constitutes an infringement.
As for the legal responsibility of medical institutions to use 3D printed products for damage caused by patients, Xu Qingsong believes that Article 59 of the Tort Liability Law clearly states: "Don't pass the defects of drugs, disinfectants, medical devices, or input. If the blood causes damage to the patient, the patient may request compensation from the producer or the blood supply institution, or may request compensation from the medical institution. If the patient requests compensation from the medical institution, the medical institution has the right to pay the responsible producer or The blood supply agency recovers."
Law enforcement and control mechanisms must be innovative
At present, the application of 3D printing technology in the medical field has just started, and the development momentum and prospects cannot be underestimated. Xu Qingsong suggested that the relevant departments need to clarify and clarify the following issues in law enforcement in order to achieve innovation in the management mechanism.
One is the restraint and regulation of 3D printer manufacturers. At present, 3D printers used by domestic medical institutions are mainly imported from abroad, but the future does not rule out the emergence of domestic 3D printer manufacturers. It is recommended that relevant national departments include 3D printer manufacturers in the special industry for management and restraint, and strictly regulate and supervise the types, procedures and uses of printing equipment, as well as production, sales, purchase, use and maintenance; 3D printing technology The more sensitive and specialized materials and auxiliary materials involved are also strictly managed.
The second is the constraints and controls on the use of 3D printer users and technology. The National Health and Family Planning Commission shall make provisions as soon as possible which medical institutions are eligible to purchase 3D printing equipment, which medical institutions and personnel are qualified to carry out and use 3D printing technology, and apply 3D printing technology to clinical practice. At the same time, the establishment and establishment, holding and use of data models and design drawings for 3D printing products should be established, and their channels of communication should be strictly regulated.
The third is the constraints and regulations on 3D printer manufacturing products. Different types of products manufactured by medical institutions using 3D printers are included in the Regulations on the Supervision and Administration of Medical Devices. For the 3D products that are generally managed to ensure their safety and effectiveness, the first category is applicable; if the safety and effectiveness should be controlled, the second category is applicable; for the implanted human body, the third type must be strictly controlled. class. The specific classification catalogue is formulated, adjusted and announced by the State Food and Drug Administration according to the medical device classification rules. The daily supervision is the responsibility of the food and drug supervision department.
(Editor)
Toilet Trash Bin,Sterilite Trash Can,Stainless Steel Dustbin,Trash Bin With Toilet Brush
ZHEJIANG ERHUI TECHNOLOGY CO.,LTD , https://www.jahhome.com