Medical Network December 20th The level of medical device manufacturing represents a certain level of industrial technology in a country. In the past November, domestic medical devices shined on the international stage, whether it was the first China International Import Expo held in Shanghai at the beginning of the month, or the North American Radiology Annual Conference (RSNA), which was held at the end of the month in Chicago, representing the current medical device frontier. The high-profile appearance of domestic large-scale high-end medical equipment such as PET-CT and PET-MR, which are technological trends, is exciting.
After nearly five years of double-digit high-speed growth, what are the characteristics of China's medical device industry structure? Recently, China Medical Device Industry Development Report 2018 (hereinafter referred to as the "Report") issued by China Medical Device Industry Association, From the aspects of policy and innovation, it is analyzed.
Compared with medicines, the medical device industry that started late is always in a situation of “small and scattered” and insufficient innovation. According to the "Report", at present, China's medical device industry presents an overall dispersed and partially concentrated competitive landscape.
"Many companies are small in scale and cannot be industrialized on a large scale, resulting in high product costs and low profits, and further lead to homogenization competition." The relevant person in charge of the China Medical Device Industry Association said.
According to statistics, in 2014, the output value of 40 large medical device companies in the United States accounted for 20% of the global medical device industry output. In the same period, there were more than 14,000 medical device manufacturers in China, but the output value accounted for only 13%.
The medical device industry is characterized by diversification, rapid innovation, and cross-border difficulties. It is difficult for enterprises to form large-scale industries through their own strength. Therefore, M&A is one of the fastest and most effective ways to obtain economies of scale and scope. In addition, many medical device segments have small capacity and high professional barriers. Only by endogenous growth, companies cannot achieve rapid growth.
Accordingly, the "Report" predicts that medical device enterprises will accelerate the pace of mergers and acquisitions through various means such as industrial funds, listing financing, and introduction of foreign capital, continuously improve the level of organization of the industry, and realize large-scale and intensive management, which will be the industry in the next few years. An important trend in development.
In the three years from 2013 to 2015, the number of medical device mergers and acquisitions occurred in China was 45, 69 and 80 respectively; the transactions of more than 50 million US dollars were 2, 8 and 15 respectively. This fully shows that the M&A in the medical device industry is increasing year by year, and the scale of funds is also growing. In 2017, there were 84 financing incidents in the medical device industry, with a cumulative total of nearly $1.6 billion.
According to the "Report", after years of development, despite the emergence of a number of representative enterprises such as Mindray Medical, Shanghai Lian Ying, Xinhua Medical, Yuyue Medical, Neusoft Group, Lepu Medical, Weigao Group, and MicroPort Medical, However, most of the production enterprises with annual sales exceeding 100 million yuan are joint ventures and foreign-funded enterprises. The Japanese medical device market has annual sales of 25 billion to 26 billion US dollars, of which only 60 are the main enterprises. Although more than 2,000 companies in China have obtained export certification, they are still dominated by small and medium-sized enterprises. In 2016, the market value of Lepu Medical exceeded RMB 50 billion. Compared with Johnson & Johnson and Medtronic, there is still a big gap.
Building a cluster, accelerating innovation
The reporter learned that with the development of China's medical device industry, the country has formed some medical equipment industry clusters and manufacturing development zones, such as the Pearl River Delta, the Yangtze River Delta, and the Beijing-Tianjin-Hangzhou Bay, and has become the local three. Large medical equipment industry gathering area.
According to incomplete statistics, the sum of the total output value and sales of medical devices in the three regions accounted for more than 80% of the national total. Because of the different conditions, these three industrial clusters have shown obvious regional characteristics. In addition, the Chongqing-centered Chengdu-Chongqing area, which is centered on Wuhan, is also an emerging industrial cluster, featuring biomedical materials, implantable devices and tissue engineering.
On November 25th, at the RSNA held in Chicago, a series of products representing the cutting-edge technology of medical devices appeared in the competition. Among them, PET-MR, which was independently developed by Chinese companies, attracted more attention and attracted many professional audiences in the “friend circle”. "Share this grand event.
According to the "Report", in the domestic medical device innovation, China's medical device industry has basically formed a multi-disciplinary research and development system, and has entered the development of mid-end products to high-end products, from small to large, from weak to strong. The new stage. The domestic medical device industry is also gradually forming a technological innovation system that takes enterprises as the mainstay, is market-oriented, and combines production, learning, research, and use.
According to the "Report", in the face of the highly homogenous competition in the market, medical device companies will continue to innovate, speed up the upgrading of products, and actively explore new products. In terms of policies, the implementation of the special approval procedures for innovative medical devices has accelerated the speed of listing of domestically produced innovative medical devices.
It is understood that since March 2014, the number of products that have entered the priority review every year has gradually increased. Up to now, more than 50 innovative products have been approved. In addition, with the advancement of the new medical reform, the hospital's income structure has changed, and the hospital's demand for medium and high-end domestic medical devices is gradually increasing. Various provinces (autonomous regions and municipalities) have also introduced policies and measures to support the development of domestic medical devices. For example, in 2016 and 2017, Sichuan, Zhejiang, Hubei, Guangdong, Anhui, Hebei, Fujian, Liaoning and other provinces have explicitly encouraged the use of domestic medical equipment. .
On November 28th, the official website of the State Food and Drug Administration issued the "Points and Judging Principles for Clinical Tests for Medical Devices", which attracted attention in the industry and everyone rushed to forward learning.
In fact, since the promulgation and implementation of the “Regulations on the Supervision and Administration of Medical Devices” revised in 2014, the accompanying regulatory documents have been published intensively, reflecting the scientific concept of medical device supervision and highlighting the reform and innovation of medical device supervision.
The "Report" pointed out that in order to improve medical device product standards and ensure quality, the State has established 24 medical device related technical standardization committees, responsible for standard revision and revision work. Since China became a member of the International Organization for Standardization (ISO) in the 1980s, the international standard rate has been nearly 80%, which has promoted the internationalization of medical device product standards.
The medical device inspection and testing institution is the technical support unit for medical device supervision. According to the "Report" analysis, there are dozens of state-approved medical device inspection and testing institutions, which can basically meet the needs of medical device testing and supervision and management in China. In November 2015, the former State Food and Drug Administration established the “Qualification Conditions for Medical Device Inspection Organizations”, which further strengthened the management of medical device inspection organizations and standardized the qualification certification of medical device inspection organizations. The promulgation and implementation of this series of measures have made China's medical device supervision and management increasingly perfect and accelerated its integration with the international community.