Whether the traditional regulatory model can be adapted to this highly efficient and highly specific 3D printed medical device still needs to be verified. At the same time, as 3D printed medical devices integrate the entire process from clinical diagnosis to material processing and surgical treatment, how to safely and effectively track and regulate the entire process will also require adaptation by the relevant authorities.
3D printing enables products to be manufactured from design to manufacturing at the distance of a button. With the help of 3D printing technology, the future production model of medical devices will also move from the traditional assembly line to individual customisation.
At the 2015 Medical New Materials and 3D Printing Forum held recently, Wang Chunren, a researcher at the China Academy of Food and Drug Administration, gave a set of data: the ratio of drug to medical device consumption in developed countries is 1:1, while in China it is 10:7; the annual growth rate of the world medical device market is 5% to 8%, while in China it is 13% to 15%.
This also indicates that there is still a lot of profit space in the Chinese medical device market. In the opinion of most participants, Prosthetic Arm 3D printing technology and the development of new biomaterials will become a new engine to drive the development of medical devices.
R&D in the “fast lane”
3D printing technology has become popular, especially in the field of medical devices. 3D printing has the advantages of personalisation, small batch size and high precision, catering to the requirements of “tailor-made” medical devices.
Xi Tingfei, director of the Center for Biomedical Materials and Tissue Engineering at Peking University’s Institute of Frontier Interdisciplinary Research, told reporters that the current applications of 3D printing in the field of medical devices include: in vitro medical devices, such as medical models, prosthetic limbs, dental surgery templates, etc.; personalized implants, such as cranial bone repair, cervical artificial vertebrae and artificial joints, etc.; conventional implants, such as surface modification of joint stems, dental implants, patches, etc.; and 3D printing of human implants with cells. etc.; and the incorporation of cells for 3D printing of organs in the human body.
Personalised orthopaedic implant prostheses are one of the current success stories in the application of 3D printing to medical devices. For example, in difficult orthopaedic surgeries such as pelvic tumour surgery, where customised designs in the past could only be based on flat x-rays and the accuracy of the data was questioned, 3D printing can precisely customise a pelvis identical to the patient’s and the customisation cycle only takes about a week.
In addition to orthopaedics, 3D printing can also play a unique role in plastic surgery, dentistry and ophthalmology. Chen Jimin, a professor at the Institute of Laser Engineering at Beijing University of Technology, said that in the already mature market of oral implants, 3D printing technology will be the trend to replace CNC machine tools for making dental moulds. Perhaps in the near future, customised implants will also become the norm.
In addition, 3D printing also offers unique advantages in cardiovascular tissue construction. 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 cells with oxygen and nutrient supply, while 3D printing can ensure porosity at both the micron and millimetre scales – micron-scale porosity provides space for cell growth, while millimetre-scale apertures ensure oxygen supply.
For 3D printing of living tissues and organs, the challenge is to ensure that the structures formed are biologically active after the cells have been accurately positioned and cultured.
To make 3D printed hydrogels biologically active, Professor Dongsheng Liu from the Department of Chemistry at Tsinghua University has prepared a polypeptide-DNA hybrid hydrogel through DNA sequence design. The material not only has the characteristics of second-level molding, high strength, self-healing and good permeability, the printed cells also maintain a high survival rate and possess normal biological morphology and cellular functions, creating the conditions for 3D printed organs to be transplanted in vivo.
Facing many challenges
Although 3D printing technology has reached maturity, its commercialisation has only just begun. For the Chinese market, there is an urgent need to address the issue of localisation of printing materials.
The raw materials for 3D printing are special and must be able to be liquefied, filamentised, powdered and reunited after printing. For metal powders, the requirements for the particle size distribution, loose packing density, oxygen content, fluidity and other properties of the material will be higher; for living organs, it is particularly important to maintain the activity of the cells and their functions. Especially for materials dedicated to medical devices, most require rigorous biological evaluation to prevent various types of biological risks.
“With the difficulty of material development and long evaluation cycles, it is both difficult and central to the development of medical 3D printing technology.” A person from the business sector said that metal powder raw materials such as titanium alloys and high-temperature alloys, high specification raw materials can only basically rely on imported solutions, high prices and long lead times. These are objectively restrict the promotion of 3D printing technology in the domestic process.
In addition, the lack of industry standards for 3D printing is also a common embarrassing situation at home and abroad. Wang Chunren said, 3D printing medical materials because and traditional materials are different, the internal structure and mechanical properties of the material is also different, therefore, the existing standards are not applicable to this type of material, need to research and develop the corresponding standards.
In addition, it needs to be verified whether the traditional regulatory model can be adapted to such highly efficient and extremely different specificity of 3D printed medical devices. At the same time, as 3D printed medical devices integrate the whole process from clinical diagnosis to material processing and surgical treatment, how to safely and effectively track and regulate the whole process also needs to be adapted by the relevant authorities.
According to Xi, the US Food and Drug Administration has stressed that when 3D printed medical devices are used for personalised treatment, the quality control of the medical device should capture two points: firstly, the biological evaluation of the materials used should be conducted to ensure the safety of the materials; secondly, the preparation process should comply with GMP (Good Manufacturing Practice) requirements.
According to him, the State Food and Drug Administration (CFDA) has also put the regulation of 3D-printed medical devices on the agenda. In the new Administrative Measures for Registration of Medical Devices, it is clearly stipulated that clinical studies of 3D-printed medical devices must be reported to the CFDA for approval before they can be carried out.
In short, the establishment of regulations related to 3D printed medical devices needs to be promoted by the scientific and legal communities working together. According to Dr. Kerong Dai, an expert in orthopaedic biomechanics and an academician of the Chinese Academy of Engineering, SLA 3D printing has more room for development in the rehabilitation assistive device market than printing bone implants, and it may be easier in terms of policy approval.
Industrialisation requires multiple efforts
Although 3D printing of medical devices has great economic prospects, the expensive investment and long lead time in the process can severely limit the development of the industry.
In the view of Wu Zhanming, general manager of Suzhou Daye 3D Printing Technology Co., Ltd, at present, 3D printing in medical applications is in a small scale, less cooperation, low production value of the state, how to expand the market scale and influence, is the common wish of the industry, and the combination of industry, academia and research is the breakthrough in industrialization.
“Medical institutions generally have the problem of insufficient 3D modeling capabilities, Multicoloured Spray-Painted Cell Desktop Decoration 3D printing companies do not have a deep understanding of medical care, and traditional medical service companies do not have enough accumulation of 3D printing technology capabilities.” Wu Zhanming believes that if cross-border combination can be used, it can make up for the deficiencies of each party and also maximise the benefits of each party.
For example, in order to avoid duplication of investment in equipment, the equipment can be handed over to enterprises for investment and operation, so that other departments can reduce this part of the cost and thus apply the limited funds to other important aspects. In addition, by charging production costs for economic benefits, companies can get to know the latest research results faster, and also enable research institutions to implement their projects faster and more economically, and turn the latest research results into actual productivity faster.
Wu Zhanming said that 3D printing is a new technology and application in healthcare and cannot be profitable in a short period of time, so it is important to have enough patience. From a business perspective, it is important to plan a profit model that is acceptable to multiple parties from the beginning, and a win-win situation is the only way for this industry to develop quickly.