3D printing medical devices still take time
Whether the traditional regulatory model can adapt to this highly efficient and highly specific 3D printed medical device still needs to be verified. At the same time, because 3D printed medical devices integrate the whole process from clinical diagnosis to material processing and surgical treatment, how to safely and effectively track and supervise the whole process also requires relevant departments to adjust and adapt.
3D printing has the advantages of personalization, small batch size and high precision.
3D printing makes the product from the design to the manufacturing distance of only one button. With the help of 3D printing technology, the future production mode of medical devices will also be customized from the traditional assembly line.
At the 2015 New Medical Materials and 3D Printing Forum held recently, Wang Chunren, a researcher at the China Food and Drug Control Research Institute, gave a set of data: the ratio of drug and medical device consumption in developed countries is 1:1, while China is 10:7; the world The medical device market has an annual growth rate of 5% to 8%, compared with 13% to 15% in China.
This also indicates that China's medical device market still has a lot of profit margins. In the view of most participants, the development of 3D printing technology and new biomaterials will become a new engine for the development of medical devices.
R&D enters the "fast lane"
3D printing technology has become a popular trend, especially in the field of medical devices. The advantages of 3D printing, such as individualization, small batch size and high precision, just cater to the requirements of medical equipment tailoring and tailoring.
Yan Tingfei, director of the Center for Biomedical Materials and Tissue Engineering at the Institute of Advanced Interdisciplinary Studies at Peking University, told reporters that the current applications of 3D printing in the field of medical devices include: in vitro medical devices, such as medical models, prosthetics, dental surgery templates, etc.; Implants, such as skull repair, cervical artificial vertebral body and artificial joints; conventional implants, such as surface modification of the joint shank, dental implants, patches, etc.; 3D printing of human organs by adding cells.
Personalized orthopedic implant prostheses are one of the successful cases of 3D printing for medical devices. For example, pelvic tumor surgery and other difficult orthopedic surgery, the past customized design can only be based on plane X-ray film, data accuracy is also questioned, 3D printing can accurately customize a pelvis exactly the same as the patient, the custom cycle is only one week about.
In addition to orthopedics, 3D printing can play a unique role in orthopedics, dentistry, and ophthalmology. Chen Jimin, a professor at the Institute of Laser Engineering at Beijing University of Technology, said that in the mature market-oriented oral implants, 3D printing technology will replace the CNC machine tools to make dental molds. Perhaps in the near future, customized implants will also become the norm.
In addition, 3D printing also has a unique advantage in the construction of cardiovascular tissue. Zhu Chuhong, a professor at the Third Military Medical University, pointed out that the bottleneck in the construction of vascular networks is how to implant cellular oxygen and nutrient supply, while 3D printing can ensure porosity at both micrometer and millimeter scales - micron-scale porosity provides space for cell growth, mm The gauge aperture guarantees the supply of oxygen.
For 3D printing of living tissues and organs, the difficulty lies in the accurate positioning and culture of cells, and it is necessary to ensure that the formed structure is biologically active.
Hydrogel is one of the key materials for living cell materials. In order to make the 3D printing hydrogel biologically active, Liu Dongsheng, a professor of chemistry at Tsinghua University, designed a polypeptide-DNA hybrid hydrogel by DNA sequence design. The material not only has the characteristics of second-order molding, high strength, self-healing and good permeability, but also the printed cells maintain high survival rate, have normal biological morphology and cell function, and are a live transplant for 3D printing organs. Created conditions.
Face many challenges
Although 3D printing technology is nearing maturity, its commercialization has just started. For the Chinese market, it is extremely urgent to solve the problem of localization of printing materials.
The raw materials for 3D printing are special and must be liquefied, silked, powdered, and re-combined after printing. For metal powders, the material's particle size distribution, bulk density, oxygen content, fluidity and other properties are more demanding; for living organs, how to maintain cell activity and its function is particularly important. In particular, for medical device-specific materials, most of them require rigorous biological evaluation to prevent various biological risks.
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