Overall, the policy orientation is to gradually improve regulatory efficiency, encourage innovation, especially domestic key innovation, and strengthen quality and sex.

Improving the efficiency of supervision is mainly reflected in the hierarchical supervision and management of production enterprises. The first-class devices are changed from registration to filing, and from prior approval to post accountability. It does not reduce the quality requirements of the first-class devices, but enables the regulatory authorities to free up more energy to supervise the second and third-class devices with higher risks. This is a major change in regulatory thinking, and it is also conducive to the regulatory authorities to improve the approval speed of the second and third-class.

Encouraging innovation is mainly reflected in the issuance of several regulations and regulatory documents. First of all, the medical device registration management method requires that a production plant must be established before medical device registration. For some early start-up companies, it reduces operating costs and facilitates them to spend more The money is spent on the research and development of key technologies. In addition, the establishment of special approval procedures for innovative medical devices, commonly known as green channels, has also increased the speed of major innovations and inspired more companies to engage in key innovations.

Strengthening quality is mainly reflected in the formulation of quality norms and standards. Among them, it is worth mentioning the release of medical device production quality management norms and operation quality management norms, the renewal of medical device classification standards, and the new release of more than 100 medical device industry standards, which have established quality standards for the industry. Although there is still a certain gap between some standards in the corresponding quality standards and developed countries, at least it has taken a solid step, lay a good foundation for the subsequent improvement and optimization.

The rapid approval policy for innovative medical devices stipulated in the "Special Approval Procedure for Innovative Medical Devices (Trial)" has become an important highlight. Enterprises entering the green approval channel can obtain early intervention from the Food and Drug Administration. Local bureaus will have special personnel responsible for communication with enterprises in research and development, clinical practice and registration. There is no need to queue up during the registration process, including review. For small and micro enterprises, the first registration fee for products is even exempted.

However, the conditions for evaluating innovative medical devices are relatively harsh. To sum up, the applied product needs to have the core technology invention according to law, the product is the first in China, and the international leader, has significant clinical application value, and needs the product to be basically finalized. From the data point of view, since the implementation of the regulations in 2014, the overall application and pass rate is about 5:1. From the perspective of the application regions, Beijing, Jiangsu, Guangdong and Shanghai are the most provinces and cities, which is also directly related to the deep industrial foundation and entrepreneurial atmosphere of these places.

On October 3 this year, the advanced manufacturing in the medical field listed in the "China Manufacturing 2025 Key Areas Technology Roadmap" includes two directions, namely biomedicine and high-performance medical devices. For this field, the relevant national plan is: "to improve the innovation capacity and industrialization level of medical devices, focusing on the development of imaging equipment, medical robots and other high-performance medical equipment, fully degradable vascular stents and other high-value medical consumables, wearable, remote diagnosis and other mobile medical products. To achieve breakthroughs and applications of new technologies such as bio-3D printing and induced pluripotent stem cells."

Market status: imported brands dominate the high-end market, the number of domestic enterprises, technology is not strong

At present, domestic medical device enterprises have the characteristics of large number and generally weak technology. Specific to the business scope of the enterprise, it can be found that Class I production enterprises contain a large number of bandages, gauze, and disposable medical fabrics, and Class II production enterprises contain a large number of customized denture and other dental material processing plants. Most of these companies have small turnover, mainly to meet the needs of regional sales, and there is still a lot of room for improvement in quality.

If the total sales revenue of medical devices in 2014 is 255.6 billion yuan divided by 15698 manufacturing enterprises, the average sales volume of each enterprise is 16.28 million yuan. Obviously, such a market is a relatively scattered market. In particular, it is worth noting that after years of development, many foreign companies have set up factories in China. The products are not only for domestic sales, but also for export. These companies are also counted as domestic medical device companies and have contributed considerable Sales, so the average sales of completely domestic companies are obviously lower.

At present, the high-end of the domestic medical device market is still occupied by imported brands. The high-end market is mainly concentrated in some products with higher technical content in tertiary hospitals and secondary hospitals in some wealthy areas, such as automatic immune equipment in laboratory, cardiac intervention products, high-end medical imaging equipment, orthopedic spine and joints, and soft intraocular lenses in ophthalmology, OCT and other equipment, dental implants and orthodontic equipment, flexible endoscopes in digestive department, and endoscopic consumables and staplers, etc., endoscopic equipment and energy equipment and power equipment in other surgeries, hemodialysis in nephrology department, CRRT, brain pacemakers outside the brain, intracranial electrodes, microscope outside the brain, cochlear implants and high-end hearing aids in otology, respiratory anesthesia in operating rooms, extracorporeal circulation equipment, and other equipment such as radiotherapy equipment, precision infusion equipment and so on.

In the past few years, domestic manufacturers have begun to increase R & D investment in high-end fields, hoping to challenge imported brands in the future, and imported brands are also penetrating the grassroots market through localized factories and mergers and acquisitions of domestic companies. The future market competition pattern will become More complex and intense, increasing R & D investment, expanding mergers and acquisitions, and going overseas may occur frequently.

From the perspective of the development of laboratory equipment, the development of companion diagnostic products will be faster and faster. The 2014 FDA issued companion diagnostic guidance stipulates that the approval or delisting of therapeutic drugs and companion diagnostic products should occur at the same time. This move has greatly promoted the growth of companion diagnostics. At the same time, in recent years in the United States, the rapid introduction of various molecular targeted therapy drugs has also expanded the market for companion diagnostics. However, in China, the correlation between companion diagnosis and molecular targeted therapy drugs has not been determined by relevant laws, so companion diagnosis will also be an attractive market in China, but the rapid growth of the market depends on the speed of research and development, approval and marketing of corresponding drugs in China, as well as the supporting implementation of relevant policies.

From the perspective of the development of cardiovascular diagnosis and treatment equipment, various smaller damage and more precise treatment methods have gradually developed into the mainstream of the future. At present, it includes bio-absorbable stent, percutaneous aortic valve replacement, interventional or minimally invasive treatment of mitral valve, tricuspid regurgitation and other innovative treatment methods, as well as more objective cardiovascular function evaluation methods, such as single photon tracer technology for evaluating myocardial ischemia and ischemic site. It is expected that the cross cooperation between cardiovascular department, imaging department and nuclear medicine department will be further developed in the future.

In terms of the development of orthopedic equipment, robot-assisted precision orthopedic minimally invasive surgery, more minimally invasive arthroscopy and intervertebral foramen, minimally invasive treatment of vertebral compression fractures, and the application of 3D printing technology in orthopedic field, which is very hot in many other fields, are very potential directions. Overall, orthopedics is also developing rapidly in the direction of more accurate matching and faster recovery.

The development of instruments in the field of ophthalmology has also been rapid in recent years. The application of femtosecond laser in cataract surgery has greatly improved the accuracy of cataract surgery, the new ultrasonic emulsification equipment has improved the efficiency of nucleus fragmentation, the new coherent optical imaging equipment may improve doctors' understanding of fundus photography, and the application of the latest corneal collagen cross-linking technology in the field of refraction.

In the field of neurology, neuromodulation technology is showing great development potential. In addition to the traditional deep brain stimulation for the treatment of Parkinson's disease, spinal cord electrical stimulation for the treatment of pain, sacral nerve stimulation for the treatment of incontinence and irritable bowel syndrome, vagus nerve stimulation for the treatment of epilepsy, etc., as well as the brain-computer interface technology under study, all give unlimited imagination to the future of this field.

In the field of obstetrics and gynecology, various types of accurate diagnosis and minimally invasive treatment equipment for breast cancer are booming. The new trend is to find accurate diagnosis as soon as possible, accurate positioning, reduce wounds, and maximize breast conservation. In response to these needs, new targeted tumor positioning systems, targeted lymphatic mapping systems, and high-precision stripping equipment are all booming.

In terms of information equipment, new clinical decision-making and analysis systems based on big data are developing rapidly, rapid transmission and sharing of medical image data, and preoperative surgical site models based on accurate image modeling are becoming popular. Overall, sharing data faster and more easily, analyzing data, and using data to know accurate diagnosis and treatment is the direction of development in this field.

According to the disclosure of NVCA and ThomsonReuters database in the United States, venture capital in the field of medical devices showed an upward trend in 2014. There were more than 200 investment and financing cases in total. The good trend continued in the first half of 2015. On average, the amount of individual investment and financing projects was between 8 million and 9 million US dollars, and the investment and financing amount of the medical device industry accounted for about 30% of the total investment and financing amount of the overall medical industry, the increase in the amount of investment and financing in the medical device industry mainly comes from increased investment in medical diagnostic equipment and advanced treatment equipment, and from past return statistics, minimally invasive treatment equipment in the cardiac and neurological fields is significantly changing the existing treatment process, while bringing high returns to venture capital institutions.

Another feature is that foreign medical device investment and financing exit channels are very diversified. Among them, being acquired by a listed company to become a new product line is a very important exit way. Most companies do not have the resources to develop their own market, and are listed at the same time. The company's acquisition also reduces the investment exit cycle, which is a positive signal for stimulating industry investment. It is expected that more similar acquisitions and investments will be made by domestic listed companies in the future.

Medical device enterprises are relatively small in scale, and the overall valuation price is relatively small compared with pharmaceutical enterprises, but their profitability is strong, and there are many enterprises with higher profit margins in the industry, so they have become ideal targets for mergers and acquisitions of all kinds of listed companies. Not only large medical device group companies mergers and acquisitions of small medical device companies such as industry mergers and acquisitions continue to occur, but also pharmaceutical companies outside the industry and other non-medical industry companies have a strong interest in mergers and acquisitions of medical device companies.

In the future, mergers and acquisitions targeting medical device companies will continue to increase. Among them, medical device companies with unique technologies and strong advantages in certain segments will become popular M & A targets. At the same time, because the overall level of domestic medical start-ups is still a certain gap compared with similar overseas companies, and the valuation of the domestic capital market is still relatively high, domestic companies will go overseas to acquire distinctive medical device start-ups and productive companies. It is another hot trend.

Compared with the ups and downs of the domestic stock market, the equipment investment in the past period of time still showed stable development. The product types of the invested companies are richer and more diversified than ever before, and new investment directions such as hardware, surgical robots, and sequencing products continue to emerge. The market is gradually realizing that it is also a feasible strategy to invest in some small-scale markets and exit through mergers and acquisitions by large companies. Therefore, the target of investment is also concentrated in certain larger device market segments.