Medical equipment is an important foundation of the national health security system, and is also one of the key high-tech industries in China. The reporter recently found that many domestic innovative medical devices have made great progress in quality and performance. However, there are still a series of complicated procedures and processes to enter the clinical application link, which affects the play of the 'import substitution' effect.

Domestic medical instruments have changed from 'following' to 'running together'

A watch sized cardiac pacemaker has a volume of only 8 cubic centimeters and a service life of 10-12 years. This is a new domestic pacemaker developed by Shanghai Chuangling Heart Rate Management Medical Device Co., Ltd., which was approved by the State Food and Drug Administration last September.

As a high-end medical device, more than 95% of the Chinese cardiac pacemaker market is held by foreign investors. The main suppliers include Medtronic, St. Juda, Boston Science, etc. Due to the high cost, China has about 80000 pacemakers implanted every year, while the United States, which has less than a quarter of China's population, has about 300000 pacemakers implanted every year.

Dr. Wang Li, CEO of Chuangling Heart Rate and a special expert of the National Thousand Talents Program, said that the purpose of developing domestic cardiac pacemakers is to provide more and better choices for domestic patients. 'In addition to the internationally advanced quality, domestic pacemakers are 20% - 30% cheaper than imported brands of the same grade.'

The pacemaker is just a miniature. In recent years, the influx of a large number of talents and capital has promoted the domestic medical device products to gradually change from 'follow' to 'run together' and move towards the direction of 'lead'.

At the recent China International Medical Device Expo, Lian Ying Medical released an artificial intelligence platform to preview chest films based on deep learning algorithms, accurately screen and shunt abnormal images, and provide doctors with an 'AI assistant'. Yisi Medical has launched a near-infrared fluorescence camera system to help doctors 'navigate surgery' and accurately remove tumors or separate tissues with the help of fluorescent developer.

The rapid progress of domestic medical devices has attracted foreign attention. Duan Xiaoying, president and CEO of GE China, said that China is the largest single market outside the United States. More than half of GE's new medical devices are launched simultaneously in China, which was unimaginable a few years ago.

Slow clinical application of registration and approval

It is only the first step to develop domestic innovative medical devices and obtain the approval of the State Food and Drug Administration. There is still a long way to go for relevant market players to enter the clinical application link and benefit domestic patients.

'Since it was approved in September last year, the number of domestic pacemakers operated by Chuangli in China has not reached 40, and most of them are purchased by hospitals temporarily.' Zhu Xiaoming, the marketing director of Chuangli Heart Rate, said that the cost of a single cardiac pacemaker could not be diluted due to the lack of clinical application, which brought great challenges to the subsequent R&D and innovation of enterprises.

While enterprises are worried about the difficulty of product promotion and application, doctors are also feeling that there is no good equipment to choose from. Tao Yong (a pseudonym), the director of cardiology department of a top three hospital, said that many domestic medical devices, including congenital heart disease occluders and interventional valves, could not only meet the requirements of clinical use, but also provide more model choices, but the problem was that they could not enter the hospital late.

'Indonesian doctors coming to the hospital for further study asked that many medical devices made in China have good performance, some are better than foreign ones, and Indonesia is also using them. But why do Chinese hospitals need to import in large quantities? We have no answer.' Tao Yong said.

Where is the crux of the disconnection between supply and demand? Wang Li analyzed that from research and development to clinical use, medical devices can be divided into two stages: pre registration and post registration, with the approval of the Food and Drug Administration as the boundary.

In the previous stage, with the support of national policies, the speed was significantly increased. For example, the special approval procedure for innovative medical devices was the way to lead the pacemaker. The latter stage is still very complex in terms of procedures and processes, which affects the implementation and application of innovative products.

Take the cardiac pacemaker as an example. When it comes to clinical application, it will go through a number of links with high uncertainty factors, such as medical insurance approval, bidding at all levels, hospital variety selection, and these processes have a window period. Once it is missed, it will wait for the next window. If several key points are not followed correctly, innovative products may have to wait more than 2 years to enter the market.

'Only widely used medical devices are good products. Although many regions have proposed to encourage hospitals to purchase domestic consumables, there are still a series of joints that need to be bridged when they are really implemented,' said Wang Li.

Take multiple measures to get through the 'last mile'

As a high-tech industry covering life science, machinery, electronics and other disciplines, the development and expansion of the medical device industry is of great significance to the 'Healthy China' strategy. At present, new technologies in the field of medical devices emerge in endlessly, and corresponding innovative achievements are implemented, which requires the policy to play the role of 'midwife'.

Nie Honglin, founder of Yisi Medical, believes that we can learn from the experience of quality consistency evaluation of generic drugs to carry out quality consistency evaluation of domestic medical devices, which is both a missed lesson and an innovation in China. If domestic medical devices and imported medical devices are replaced each other clinically, it will not only help reduce the total medical expenditure, but also help eliminate backward production capacity and improve the competitiveness of domestic medical device industry.

Many enterprises expect that under the premise of fair competition, domestic medical devices can be timely included in the hospital's consumables list, so that domestic devices 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. Many domestic medical devices are not that doctors and patients do not want to use them, but they have no choice at all.' Wang Li said that relevant departments should greatly simplify the process and procedures for the introduction of domestic innovative medical devices into clinical applications, giving doctors and patients more choices.

Some experts believe that the policy of controlling medical insurance fees and 'consumption proportion' can be used to guide hospitals and doctors to use domestic devices. Zhang Hua, deputy director of the Shanghai Drug Evaluation and Verification Center, said that domestic medical devices have advantages in cost performance compared with imported products. Strictly control the proportion of medical consumables in medical income, which will provide an important opportunity for domestic medical devices with low price and high quality. This will not only encourage domestic medical device enterprises to innovate in science and technology, but also promote them to go global.