Slow Application of Domestic Medical Devices Affects Innovation | Need to Get through | 'Last Kilometer'

Medical Network June 8 hearing medical equipment is an important basis for the national health protection system, is also one of the key high-tech industries developed in China. Reporters recently found that many domestic innovative medical device products, has made great achievements in quality and performance. Progression. However, to enter the clinical application, it is also facing a series of complicated procedures and processes, which affects the exertion of the "import substitution" effect.

A watch-sized pacemaker, with a volume of only 8 cubic centimeters, has a service life of 10-12 years. This is a domestically produced new type of cardiac pacemaker developed by Shanghai Chuangxin Heart Rule Medical Devices Co., Ltd. It won the national food in September last year. Approved by the General Administration of Pharmacy.

As a high-end medical device, more than 95% of China’s cardiac pacemaker market is in the hands of foreign investors. Major suppliers include Medtronic, St. Jude, Boston Scientific, etc. Because of the high cost, China's annual pacemaker implantation About 80,000 units, and the United States with a population of less than 1/4 of the United States, the annual pacemaker implantation of about 300,000 units.

Dr. Wang Li, who led the heartbeat and CEO of the National Thousand Talents Program, said that the development of domestic pacemakers is to provide domestic patients with more and better choices. 'Doesn't make domestic pacemakers meet international advanced standards, The price is also 20%-30% cheaper than the imported brands of the same grade. '

Pacemakers are only a microcosm. In recent years, a large number of talents and capital influx, to promote domestic medical device products gradually from 'to follow' to 'run and run', and toward the 'leader' direction.

At the recent China International Medical Equipment Expo, United Medical Imaging released an artificial intelligence platform to perform pre-reading of chest X-rays based on deep learning algorithms to accurately screen and divert abnormal images to provide doctors with an 'AI assistant'. Smythology has introduced a near-infrared fluorescence imaging 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 Xiaolu, president and chief executive officer of GE China, said that China is the largest single market outside GE USA, and GE now has more than half of new medical device products starting simultaneously in China. The former is less imaginable.

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

'Since last year's approval in September last year, we have created less than 40 units of domestic pacemakers throughout the country. Most of them have taken the hospital's temporary procurement route.' Zhu Xiaoming, Marketing Director of the Leading Heart Rhythm, said: Clinical application If you can't go up, the cost of a single pacemaker can't be diluted, which will bring great challenges to the follow-up R&D and innovation of the company.

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

“Indonesian doctors who came to the hospital asked: Many medical devices made in China are performing well, some are better than foreign ones, and Indonesia is also used. Why can Chinese hospitals also import a lot? We are speechless.” Tao Yong Said.

Demand is out of line, where is the crux of the problem? According to Wang Li, medical devices from R&D to clinical use can be divided into pre-registration and post-registration phases. The previous phase is in the country. With the support of policies, there is a marked acceleration. 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 procedures, which affects the application of innovative products.

Taking a pacemaker as an example, it has entered the clinical application, undergoing medical insurance approval, bidding at various levels, selection of hospital varieties, and other factors with high uncertainties, and these processes have window periods, waiting to be missed. 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 offer to encourage hospitals to purchase domestically produced consumables, there are still a series of joints that need to be opened in order to be truly implemented.' said Wang Li.

As a multi-disciplinary high-tech industry covering the life sciences, machinery, electronics, etc., the development 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 to the fore. Need policy to play the role of 'midwife'.

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 both a supplementary course and an innovation in China. If domestic medical devices are clinically implemented with imported medical devices Instead, it will help reduce medicine The total expenses will also help eliminate backward production capacity and improve domestic production. medical instruments Industry competitiveness.

Quite a few enterprise Looking forward to ensuring timely access to domestically produced medical devices on the premise of fair competition hospital The list of consumables has made it possible for domestically produced devices 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 total. Many domestic medical devices do not want to be used by doctors and patients, but simply do not Selection. 'Wang Li said that the relevant departments should greatly simplify the process and procedures for the introduction of innovative medical devices in China into clinical applications, giving doctors and patients more options.

Some experts believe that medical insurance control fees and 'rate of consumption' policies can be used to guide hospitals and doctors to use domestically produced devices. drug Zhang Hua, deputy director of the review and verification center, said that domestic medical devices have advantages in cost performance compared with imported products. Strictly controlling the proportion of medical supplies in medical income, for domestic medical devices that are inexpensive and of high quality, Provide important opportunities. This will encourage domestic medical device companies to innovate at the same time, it will also promote it to the world.