The development strategy of "Made in China 2025" indicates that the transformation and upgrading of China's medical device industry is accelerating, and the trend of research and development is also moving closer to the international. At present, domestic medical device products are still concentrated in the low-end varieties, and high-end implantable devices are in a key competitive period from imitation and innovation to partial replacement of imports. The domestic medical device industry is gradually increasing the dimension of product innovation. Due to the high precision of high-end implantable medical devices, the corresponding manufacturing and processing technology requirements are also getting higher and higher. It is difficult for traditional processing methods to meet the requirements for rapid innovation of implantable medical devices To find innovative precision machining methods has become an urgent need for industry innovation.
Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including required computer software. Among the many segments of medical devices, based on multi-dimensional analysis of market size and growth rate, competition pattern, and policy support, implantable devices are one of the most potential segments, and policy support is also a An important factor in the rapid development of implanted devices. In recent years, in the field of innovative medical devices, China has issued a number of powerful policies to promote the innovation capability and industrialization level of local medical devices, and implanted devices have clearly appeared in such as the "Thirteenth Five-Year Plan" outline, national scientific and technological innovation Planning and other documents are encouraged and supported.
With the improvement of the economic living standards of our residents, the awareness of medical care is gradually strengthened, so the demand for medical device products is also rising. Despite the rapid expansion of the market capacity of China's medical device industry, due to the backwardness of relevant basic science and manufacturing processes, domestic medical device products are still concentrated in low-end products, and high-end medical devices mainly rely on imports. The proposal of "Made in China 2025" indicates that the transformation and upgrading of China's medical device industry is accelerating, and the trend of research and development is also moving closer to the world. In the future, with the support of national policies, expanding market demand, the acceleration of China's aging population, and the technological development and industrial upgrading of the medical device industry, medical devices will be expected to continue to maintain a good momentum of rapid growth and achieve a high-end market Market import substitution vision.
In recent years, China's medical device industry has continued to develop rapidly. Among them, the growth rate of the high-value medical consumables market ranks in the forefront of the industry, with an average annual growth rate of over 20%, and has achieved remarkable results. The implantation market as a high-value medical The largest segment of consumables has always been the industry's attention. Implantable devices are currently in a critical period of reshaping the competitive landscape from imitation and innovation to import substitution and even international leadership. Domestic medical device companies are also gradually increasing the intensity of product innovation and creation. Due to the precision of implanted medical devices, the corresponding manufacturing and processing technology requirements are also getting higher and higher. It is difficult for traditional processing methods to keep up with the speed of implanted medical devices. The pace of innovation and the search for innovative precision machining methods have become their urgent needs.
market Overview
According to the medical device market released by AiMedia Consulting, on the global side, the global medical device market exceeded 400 billion U.S. dollars in 2017, and the global medical device market was 427.8 billion U.S. dollars in 2018. The compound growth rate in 2024 is 5.6%. China has become the fourth largest medical device market after the United States, Western Europe and Japan. The overall market size of China's medical devices has increased from 255.6 billion yuan in 2014 to 530.4 billion yuan in 2018, with an average annual growth rate of around 20%, and operating income and net profit have maintained rapid growth, belonging to the development of the medical device industry gold It is expected that the Chinese medical device market will exceed 900 billion yuan by 2022.
At present, the basic composition of China's medical device market is that high-end products account for 25%, and low-end products account for 75%; while the international medical device market basically constitutes high-end products with a share of 55%. Low-end products account for 45%. And in the high-end product market that accounts for 25% of China's medical equipment, 70% is occupied by foreign capital. These 70% foreign-funded enterprises have a market share of more than 80% in areas with high technical barriers such as medical imaging equipment and in vitro diagnostics. Medical device companies mainly produce low-end varieties. In the market of high-end medical devices such as implantable implants, due to the high technical content and added value of its products, it is not easy to research and manufacture, and the technical level restrictions and resource monopolies in developed countries account for only about 30%, so The high-end products in the industry are still mainly dependent on imports. The high-end product market is mostly occupied by foreign companies such as Medtronic, Stryker, Abbott, GE Healthcare and Boston Scientific.
Based on multi-dimensional analysis of market size and growth rate, competitive landscape, policy support and other dimensions, implantable devices are one of the most promising subdivision directions for medical devices. In terms of market size and growth rate, according to a report released by Evaluate MedTech, by 2024, in the global medical equipment market with a scale of US $ 600 billion, cardiovascular, neurological, orthopedic, oral, and ophthalmic equipment closely related to implantable devices, All will be in the stage of big market and high growth. Insufficient investment in innovation, poor technology research and development capabilities, and unclear business models have become obstacles to the future development of domestic implantable medical device industry companies. Benefiting from market demand and policy guidance, China's implanted interventional medical device companies will increase and pay attention to layout technology innovation in the next 10 years, thus releasing the innovative dimension of implantable medical devices.
Application of high-precision 3D printing in implantable medical device industry
In recent years, the aging of the population has intensified, unreasonable eye habits have increased, and there is a high incidence of ophthalmic diseases in China, showing a trend of early age, rapid progress and deep degree. Although the number of ophthalmic patients is growing rapidly, it is limited by the level of technology and economic development, and the market penetration rate of ophthalmic products in China is still relatively low. Ophthalmology is a highly sophisticated subject with a high industry threshold, especially in the field of high-value medical consumables, which requires a high degree of refinement of materials and technologies. Therefore, the current global market is mainly concentrated in the hands of several large international medical equipment companies. low. The picture below is an implantable deflector nail cooperated by Shenzhen Mofang and the top ophthalmic hospitals in China. The size of this product is 2.647 * 1.347mm. The Shenzhen Mofang S140 printing device can form nearly 2000 products at a time. The model has very fine and tiny And complex structure, which contains a spring and ball valve. Glaucoma is mainly caused by high intraocular pressure that oppresses the optic nerve. At present, this kind of diversion nail is formed by machining titanium alloy at a price of 3,500 yuan. Due to the freedom of machining and forming, the traditional diversion nail structure is relatively simple. Drainage nails with micro springs can release intraocular pressure steadily and improve the implantation experience and patients of glaucoma patients. With its breakthrough precision manufacturing capabilities, the Moroccan side provides revolutionary minimally invasive treatment options for glaucoma treatment.
In 2016, nearly 180 million people died of cardiovascular disease worldwide, accounting for 31% of all deaths. According to the "China Cardiovascular Disease Report", the prevalence and mortality of cardiovascular disease in China are on the rise, and the number of patients is about 290 million; the early treatment of cardiovascular disease mainly depends on drugs, and the middle and late stages require surgical interventions, such as blood vessels Stents, heart valves, pacemakers and other instruments. Vascular stents are the most widely used products in cardiovascular implantable devices, and are mainly used to treat vascular occlusion or stenosis. The current mainstream stents are drug-loaded metal stents. However, due to the non-degradability of metals, which can lead to inflammation of blood vessels, a new generation of drug-loaded polymer-degradable stents will become the mainstream of future research. The picture below is a polymer vascular stent processed with biocompatible materials in our Shenzhen Mofang S140 equipment. The height is 12mm, the diameter is 2mm, and the rod diameter is 0.15mm. The printed stent has good retractability.
With the deepening of the world's aging trend and the increasingly serious environmental problems, the incidence of diseases such as digestive tract and respiratory tract continues to increase, and the demand for endoscopy is also increasing. Medical endoscopy technology has received extensive attention from the medical community due to its high accuracy of diagnosis and treatment, small trauma, not easy to be infected, fast postoperative recovery and almost no scars. It is also one of the fastest growing products in the global medical device industry. With the advent of miniaturization and customization, the product structure is getting smaller and thinner, and endoscope companies are committed to finding matching precision machining methods. For the end seats of precision endoscopes with a wall thickness of less than 0.15mm, traditional machining methods such as CNC and mold injection are difficult to form, especially for thin-walled parts with a large aspect ratio. In the picture below, the wall thickness of the round tube in the endpiece of the endoscope is 70 microns, the diameter of the tube is 1 mm, the height is 4 mm, and the accuracy requires ± 10 ~ 25 microns. CNC and open mold injection are difficult to process such an approaching limit The structure, the P140 equipment of Shenzhen Mofang Company can process high-quality qualified products in about two hours, and can be delivered within the fastest day.
At present, China's medical and beauty service consumer groups are relatively young, which creates conditions for the formation of medical and aesthetic consumption habits and the creation of longer consumption cycles. The Deloitte report shows that in 2017 China's medical beauty market was 176 billion. According to ISAPS forecast, by 2020, the Chinese medical beauty market is expected to reach 315 billion yuan. As the Chinese increasingly respect the medical beauty industry, the medical beauty industry will become a hot industry in the future. The following picture shows the beauty microneedles of the array structure processed by the S130 equipment of Shenzhen Mofang. The bottom of the microneedle is straight 0.198mm, the height is 0.572mm, the width of the tip of the needle tip is only 0.006mm, the surface of the processed microneedle is smooth, and the details of the needle tip are more clear . The microneedle printing material belongs to acrylic polymer microneedles. Usually, the polymer is used to print out the male form of the needle tip shape, and the actual required medical polymer needle tip structure is formed by secondary inversion, for example, to form a dissolvable microneedle. Through the Mofang precision 3D printing equipment, it can solve the limitation of processing microneedles in the traditional way, which has a very significant and positive impact on the development of the medical beauty industry.