The 2016 Blue Book on the Development of China's Medical Device Industry was released

On February 26, the China Medical Materials Association released the 2016 Blue Book on the Development of China's Medical Device Industry (hereinafter referred to as the Blue Book) in Beijing.
according to a sample survey conducted by the Branch of the China Pharmaceutical Materials Association, the total size of China's medical device market in 2016 was about 370 billion yuan, up 62 billion yuan from 308 billion yuan in 2015, an increase of about 20.1%, according to the Blue Book. Among them, the medical device market is about 269 billion yuan, accounting for about 72.70 percent, and the home medical device market has exceeded the 100 billion yuan mark for the first time, about 101 billion yuan, accounting for 27.30 percent.
the total market size of 370 billion yuan, China's medical device manufacturers 142,000, an average of about 26.06 million yuan per household, compared with 21.69 million yuan in 2015, an average increase of about 4.37 million yuan. The number of operating enterprises was 186,300, with an average of about 1.99 million yuan per household, an increase of about 340,000 yuan, compared with 1.65 million yuan in 2015.6 Major Obstacles to the Development of the Medical Equipment Industry
The Blue Book points out that with healthy China 2030 and China Manufacturing 2025 as a national strategy, the development of China's medical device industry is generally in a benign trend, but there are still many problems that need to be improved.
1, the same product production industry too much, only its shape, not its meaning
At present, more than 10,000 domestic medical device manufacturers, but the same product production enterprises often more than a dozen, dozens or even hundreds of enterprises, the production of products are different enterprises have different standards, the overall water level is not in line with international standards, resulting in waste of resources, production of products are mostly put together, improve the shape of packaging, while ignoring product quality and higher research and development capabilities. This results in a process that only weighs its shape and does not.
2, medical device research and development and clinical integration is not close
enterprises in the product development process and clinical integration is not close, often only focus on the registration link, from the clinical evaluation to get the product registration certificate, most links doped with human factors. And in the research and development process and clinical trial process of the number of tests is not enough, to obtain the recognition of industry experts is not enough, in the production, research and medical examination of the linkage testing is not enough, and ultimately too much imitation of imported equipment, and compared with its function, there are still many shortcomings in detail.
3, the standardization and automation of industrial production is not high
many small and medium-sized enterprises production workshop is still stuck in the degree of hand workshop, do not have automatic production capacity. In particular, there is no standardized production and operation process, medical equipment in the assembly process there are many problems, resulting in the use of equipment quality problems, which is also one of the reasons why some domestic enterprise products are not recognized.
4, in line with the policy of graded diagnosis and treatment, the effective allocation of medical devices is inadequate
Some hospitals over-invest in equipment, resulting in waste of resources. Some hospitals are under-equipped to carry out corresponding examinations. To carry out effective medical device configuration according to local conditions, according to the actual situation of the hospital to configure the corresponding medical equipment. Hospitals that cannot do the corresponding examination can be referred through graded consultations and effectively configure large-scale medical equipment in hospitals with high-quality resources according to the number of people and the degree of specialist construction.
5, domestic medical devices in the triple-A hospital ratio is insufficient
The key is not to trust the quality of domestic products and the criteria for diagnosis or treatment. Failure to gain more clinical expert recognition is one of the reasons. However, some large enterprises have reached the international leading level of integration, should be combined with the characteristics of the use of products in hospitals to support, the provision of the use of standardized large-scale medical device production enterprises equipment a certain ratio, to excellent national industrial production products in the clinical opportunity for continuous improvement. In this way, the national industry can grow more robustly.
6, medical device approval and registration name and price of the relationship between confusion
the development of China's medical devices, formulated a policy of independent pricing of enterprises. It was meant to be a rapid development of industry and decentralization. Enterprises can operate the market according to their own research and development costs and market demand balance between supply and demand, but often some enterprises drill policy gaps to make a lot of fish mixed beads products, which is one of the reasons why many hospitals refuse to apply domestic medical equipment.
, for example, is the same as the "functional accessories" this registered name, the material is not the same, the price is very different. Production enterprises are also like cow hair, sizes vary. caused a lot of fish mixed beads situation. Leading to the impression that the overall level of domestic medical equipment is not high, there are actually a lot of products to achieve standardized production enterprises are very quality assurance, after research and development registration. Many small businesses are also registered under the same name, and the profit gap in the market is wide. As long as the small business products produced by the distributors to clinical use, it will produce high rebates, corruption breeding. To this end, in the registration name and pricing to achieve a national product networking mechanism and regulatory mechanism, effectively alleviate the chaotic situation.Obsolete intensified, the industry will usher in oligarchs
China Pharmaceutical Materials Association vice president, medical device branch president, said that the phenomenon of small, multi-, scattered and low-level competition in medical device enterprises has not been fundamentally changed, the future industry will be from the "flowers in full bloom" to a more concentrated direction of development, domestic medical device industry mergers and acquisitions demand is strong, the industry will also usher in oligarchs, industry integration is the inevitable direction of future development.
believes that China's pharmaceutical equipment industry to go through a process from "a hundred flowers in one place" to gradually concentrated. But from China's current market point of view, many, small, scattered, chaotic situation will continue for a considerable period of time, and then concentrated development, and finally left a few better-developed oligarchs, will be focused on a certain area of unique enterprises.
" such as the wheelchair industry, there are now hundreds of brands in the wheelchair industry, but in the past two years, I know that there are more than a dozen closed wheelchair brands, each year will be eliminated from the industry behind 10%, the last fewer and fewer. Berger said.
said that the medical device giant's birth, the need for greater transparency in the market, some industry brands to stand out from the crowd, increasing influence. At the same time, coupled with various domestic and overseas mergers and acquisitions, eventually, the sub-sector will appear leading enterprises. (Cypress Blue Equipment)