Medical devices are an important foundation for the National Health Insurance System and one of the key high-tech industries in China. Recent research by the reporter found that many domestic innovative medical device products have made great strides in quality and performance. However, in order to enter the clinical application link, it also faces a series of complicated procedures and procedures, which affects the exertion of the "import substitution" effect.

　　Domestic Medical Devices Turn from "Follow-up" to "Run together"

　　A watch-sized pacemaker with a volume of only 8 cubic centimeters and a service life of 10 to 12 years. This is a domestically produced new pacemaker developed by Shanghai Chuangling Heartbeat Management Medical Devices Co., Ltd., which was approved by the State Food and Drug Administration in September last year.

　　As a high-end medical device, more than 95% of the pacemaker market in China is under the control of foreign investors. Major suppliers include Medtronic, St. Jude, and Boston Scientific.Due to the high cost, China's annual cardiac pacemaker implantation is about 80,000 units. In the United States, where the population is less than 1/4 of China's, about 300,000 pacemakers are implanted each year.

　　Dr. Wang Li, CEO of the Chuangling heartbeat and who leads the National Thousand Talents Program, said that the development of domestic pacemakers is to provide more and better choices for domestic patients.”In addition to the quality of domestically-made pacemakers reaching internationally advanced standards, the price is also 20% to 30% cheaper than imported brands of the same grade. ”

　　Pacemakers are just a microcosm. In recent years, the influx of a large number of talents and capital has driven domestic medical device products to gradually shift from “follow-up” to “run together” and move in the direction of “leadership”.

　　At the recent China International Medical Equipment Expo, United Imaging Medical released an artificial intelligence platform to perform pre-reading of chest radiographs based on deep learning algorithms to accurately screen and divert abnormal images and provide doctors with an “AI assistant”.Yisi Medical has launched a near-infrared fluorescence camera system that uses fluorescent imaging agents to help doctors "surgically navigate" to accurately remove tumors or separate tissues.

　　The rapid progress of domestic medical devices has attracted foreign attention. Duan Xiaoying, president and chief executive of GE China, said that China is the largest single market outside of the United States of GE. GE now has more than half of new medical device products in China simultaneously. This was unimaginable a few years ago.

　　Registration approval speeds clinical application delay

　　The development of domestic innovative medical devices and the approval of the State Food and Drug Administration is only the first step. To enter the clinical application link and benefit domestic patients, the relevant market players still have a long way to go.

　　 "Since the approval in September last year, the number of surgical procedures for domestically produced pacemakers in China has been less than 40, and most of them have taken the hospital's temporary procurement route."According to Zhu Xiaoming, the market manager of chaungling heartbeat, the cost of a single cardiac pacemaker cannot be diluted even if clinical application fails. This poses great challenges for the company's follow-up research and innovation.

　　While enterprises are concerned about difficulties in product promotion and application, doctors are also feeling that there is no good device to choose from.Tao Yong (a pseudonym), director of the Department of Cardiology at a top-level hospital, said that many domestic medical device products include congenital heart disease occluders and interventional valves, etc.Not only can it meet the requirements of clinical use, but it also provides more model choices, but the problem is that it will not be able to enter the hospital.

　　“Indonesian doctors who study in the hospital asked many medical devices manufactured in China are performing well. Some are better than foreign ones and Indonesia is also used. Why do Chinese hospitals still need to import large quantities? We are speechless.” Tao Yong Indicated.

　　Supply and demand out of line, where is the crux of the problem? According to Wang Li, medical devices can be divided into two stages, pre-registration and post-registration, from R&D to clinical use, with the approval of Food and Drug Administration.The previous stage was significantly accelerated under the support of national policies. For example, the creation of a pacemaker is a special approval procedure for innovative medical devices.The latter stage is still very complicated in terms of procedures and processes, which affects the application of innovative products.

　　Taking a pacemaker as an example, it has to undergo medical insurance approval, various levels of tendering, selection of hospital varieties, and other uncertainties that have a relatively high degree of uncertainty. These processes have a window period, once missed you will have to wait for the next window.If several key points are not calibrated, innovative products may have to wait for more than two years before entering the market.

　　“Only widely used medical device products are good products. Although many regions have proposed encouraging hospitals to purchase domestic consumables, there are still a series of joints that need to be opened in order to be truly implemented.” Wang Li said.

　　Take measures to open up the "last mile"

　　As a multi-disciplinary high-tech industry covering the life sciences, machinery, and electronics, the development and expansion of the medical device industry is of great significance to the strategy of "Healthy China."At present, new technologies in the field of medical devices emerge in an endless stream, and corresponding innovations have come out.They need policies to play the role of “midwives”.

　　According to Nie Honglin, the founder of Yisi Medical, we can learn from the experience of consistency evaluation of generic drugs and conduct quality assessment of domestic medical devices. This is not only a supplemental lesson but also an innovation in China.If domestic medical devices are mutually substituted clinically with imported medical devices, it will not only help reduce the total expenditure on medical expenses, but also help eliminate backward production capacity and increase the competitiveness of the domestic medical device industry.

　　Many companies expect that under the premise of fair competition, they will ensure that domestic medical devices can enter the consumables list of hospitals in a timely manner, so that domestically produced devices will have the opportunity to compete with imported products on the same platform. “In the domestic high-end medical device market, foreign capital accounts for more than 80% of the market share. Many domestic medical devices are not doctors and patients who do not want to use it, but have no choice at all.” Wang Li said that relevant departments should greatly simplify the processes and procedures for the introduction of domestic innovative medical devices into clinical applications, giving doctors and patients more options.

　　Some experts believe that it is possible to use the policy of controlling medical expenses and the “rate of consumption” policy to guide hospitals and doctors to use domestically produced devices. Zhang Hua, deputy director of the Shanghai Center for Drug Evaluation and Verification, said that compared with imported products, domestic medical devices have advantages in terms of cost performance.Strictly controlling the proportion of medical consumables in medical income will provide important opportunities for cheap and high-quality domestic medical devices. While encouraging domestic medical device enterprises to innovate in science and technology, it will also push them towards the world.