The golden decade of medical devices has come

The field of biomedicine and high-performance medical devices is one of the key development directions of "Made in China 2025".

According to Shanghai Securities News, the "Thirteenth Five-Year Development Plan for the Pharmaceutical Industry" will be completed this year. According to the ideas that have been determined, biomedicine and high-performance medical devices are identified as key areas for breakthroughs.

Regarding this field, the plan of "Made in China 2025" mainly includes the following two aspects: one is to develop new products of chemical drugs, traditional Chinese medicines, and biotechnology drugs for major diseases, focusing on new mechanisms and new targets of chemical drugs and antibody drugs , Antibody-conjugated drugs, new structural protein and peptide drugs, new vaccines, innovative traditional Chinese medicines with outstanding clinical advantages and personalized therapeutic drugs;

The second is to improve the innovation capability and industrialization level of medical devices, focusing on the development of high-performance diagnostic and treatment equipment such as imaging equipment and medical robots, high-value medical consumables such as fully degradable vascular stents, and mobile medical products such as wearables and remote diagnosis and treatment. Realize the breakthrough and application of new technologies such as biological 3D printing and induced pluripotent stem cells.

mid-to-low hesitation

my country started relatively late in biopharmaceuticals and high-performance medical devices. After nearly 20 years of development, the research, development and industrialization of genetic engineering drugs as the core has reached a considerable scale. At present, the industry is mainly distributed in economically developed areas such as the Bohai Rim, the Yangtze River Delta, and the Pearl River Delta.

The reporter learned from the interview that the medical device industry as a whole is showing a trend of rapid development. However, behind the huge numbers, there is a low level of medical equipment production and technology in my country. Compared with developed countries, my country is still relatively backward in the field of biomedicine and medical devices.

Take the field of medical devices as an example. "In recent years, the development of my country's medical device industry has achieved gratifying results, but from the overall development situation, it is concentrated in the field of low-end products, and the high-end product market has always been dominated by foreign-funded enterprises."

Zhu Xiang, an analyst at Bolong Consulting, said in an interview with a reporter from China Sankei News that from the perspective of the overall strength of the overall development of my country's medical device industry, it is affected by the lack of technological innovation capabilities, the lack of close integration of production, education and research, and the innovation chain and industry. Influenced by factors such as incomplete chains, unsuitable policies and measures, and imperfect application environments, my country's high-end medical equipment, especially advanced digital diagnosis and treatment equipment, still mainly relies on imports, and national health protection is subject to others.

According to public information, my country's medical equipment lacks investment in new product development. In foreign countries, the funds invested in new product development of medical devices generally account for about 10% of sales, while the new product development funds of medical device companies in my country only account for about 1% of sales. Due to the long-term sluggish status of many companies, production is sluggish , so even this ratio is difficult to guarantee. In addition, so far, there is no finished drug production line officially registered with the FDA (Food and Drug Administration) in China, and China has not achieved a breakthrough in the formal export of finished drugs to Europe and the United States.

Zhu Xiang introduced to the reporter that domestic exports are mainly concentrated in raw materials, and they are bulk raw materials with a relatively late life cycle. It can be said that there are very few brand companies that can stand firm internationally. In this regard, Indian pharmaceutical companies are far behind Chinese pharmaceutical companies. In the past 10 years, the export proportion of India's pharmaceutical industry has increased from the original 17% to more than 35%. The export growth rate is more than three times the growth rate of the entire industry, and many international brands have been developed.

In the field of biomedicine and high-performance medical devices, the history and achievements of Indian pharmaceuticals are, to some extent, worthy of reference for our country.

According to relevant data, the Indian pharmaceutical industry has experienced "the export of bulk raw materials in the 1980s; the development of characteristic raw materials in the 1990s; the integration of downstream in the late 1990s, and the internationalization of non-patent drug preparations; The stage of new drug research and development with independent intellectual property rights, so as to carry out the process of brand building.

Luo Gaozhan, general manager of Shenzhen Sigeluo Investment Development Co., Ltd., said in an interview with a reporter from "China Sankei News" that the reason why biomedicine and high-performance medical devices have become key development areas is that this field has high technical content and can drive related industries. The upstream and downstream industrial chains, as well as the development of surrounding industries, such as biotechnology and pharmaceutical engineering, are of great significance to improving the overall level of China's manufacturing industry. At the same time, the market demand for biomedicine and medical devices is large, and the economic value is high, which is of great significance to promoting the growth of the national economy.

"In addition, biomedicine and high-performance medical devices are related to the most important issue of medical treatment for ordinary people, and are related to the improvement of the overall living standards of the people. They are areas of national priority development." Luo Gaozhan further stated.

Yuan Jian, a professor of the China Business Industry Research Institute, said in an interview with a reporter from China Sankei News that my country's economic development has entered a new normal, and the development of traditional manufacturing is facing difficulties. China's extensive development model that mainly relies on resource factor input and scale expansion is difficult to support In the future, it is urgent to adjust the structure, transform and upgrade, and improve quality and efficiency. Biomedicine and high-performance medical devices are an important field for industrial restructuring and accelerated economic growth.

From the viewpoints of the above industry insiders, it can be found that biomedicine and high-performance medical devices are important industries related to the national economy and the people's livelihood, and are key areas for cultivating and developing strategic emerging industries. Whether it is from the perspective of economic development or social benefits, China must There have been developments and breakthroughs in this field.

Of course, no matter what, after years of development, China has greatly improved in terms of talents, capital, technology and scientific research strength. How to make biomedicine and high-performance medical devices under the background of "Made in China 2025" There is a considerable development is worth thinking about in the industry.

The role of the government

To achieve substantial development of biomedicine and high-performance medical devices, the role of the government cannot be ignored. Zhu Xiang said. First of all, create a policy environment that is conducive to enterprises becoming bigger and stronger, and encourage more industry-leading enterprises to be cultivated through mergers and acquisitions. It is necessary to actively adapt to the characteristics and development laws of the biomedical industry, protect and encourage the enthusiasm of enterprises for research and development and innovation, and help enterprises achieve sustainable development.

Secondly, it is necessary to speed up the improvement of policies and measures in various links such as drug and medical equipment project approval, market access, and market development in this city, further optimize the industry management and market supervision environment, and promote the scale, agglomeration and internationalization of the city's biomedical industry. Accelerate the development of the biomedical industry as a strategic emerging pillar industry in the city.

In addition, new capital investment models can also be introduced to change the current situation that my country's biopharmaceutical companies mainly realize production through the purchase of technology, insufficient venture capital mechanisms and too little funds, making it difficult for the biotechnology industry to form a climate.

Some people in the industry also said that government intervention should also include accelerating the establishment of supporting measures related to intellectual property rights, encouraging biopharmaceutical research and production units to increase investment, forming their own "hit products", and allowing products to be monopolized for as long as possible. The market has won huge profits, and the company has invested a huge amount of money from the profits into research and development of innovative drugs with intellectual property rights, and it goes round and round, forming a virtuous circle.

Luo Gaozhan believes that the core of Chinese manufacturing is Chinese innovation, and innovation is the key driving force for the biomedicine and medical device industries. Therefore, it is necessary to increase support for enterprises, promote industry mergers and reorganizations, form leading enterprises in various market segments, enhance technological innovation capabilities of enterprises, and drive industrial development. Through the reform of the system, a forced mechanism for the self-improvement of enterprises has been formed, and enterprises are encouraged to go abroad, create their own blood, and become international large enterprises.

Yuan Jian told the reporter that it is necessary to increase capital investment in this field, strengthen research and development capabilities, especially encourage the use of various resources to promote the industrialization of scientific research results, improve the conversion rate of scientific research results, so that Chinese companies do not blindly imitate or imitate.

"In order to allow more patients to benefit from the help of biological drugs and high-performance medical devices in a timely manner, my country needs to establish scientifically based regulatory requirements, optimize and accelerate the approval speed of innovative biological drugs, such as accelerating the optimization of new drug clinical trial applications (CTA) approval process to ensure that Chinese patients benefit from biomedicine and high-performance medical devices as soon as possible. Yuan Jian further stated."

future expectations

"Made in China 2025" clearly regards biomedicine and high-performance medical devices as one of the ten key areas of development, which will undoubtedly accelerate the pace of development of high-performance, high-tech medical devices in China. Under such a favorable policy situation, what kind of state will biomedicine and high-performance medical devices be displayed in front of the world in the future? "Made in China 2025" outlines a strategy for the development of my country's medical devices in the next 10 years concept map?

"In the next 10 years, the development of my country's medical device industry may usher in earth-shaking changes. The next 10 years will be the golden age of China's medical device development. During this period, the development of China's medical device industry will gradually shift from focusing on quantity and output in the past to The transformation of quality and brand will bring about a fundamental change in the market structure, and innovative enterprises with strong scientific research capabilities and strong brand influence will become the mainstream of the market." Zhu Xiang said.

At the same time, the correlation between China's medical device market and the world market will become increasingly close, and the medical device manufacturing process, new material application, research and development level, and marketing network will also undergo significant changes. High-end products with high-end products will gradually dominate the market. Zhu Xiang further said.

Yuan Jian finally said that from a global perspective, biomedicine and high-performance medical devices are in the ascendant. From a domestic point of view, the biomedical industry and high-performance medical devices, as sunrise industries in the pharmaceutical field, are also in a stage of rapid development. At the same time, relevant national policies are constantly reforming to provide impetus for the development of this field. Industry and high-performance medical devices have good prospects. It is expected that the country will include this field in the top ten key areas of "Made in China 2015", which will promote the rapid development of China's biomedicine and high-performance medical devices, and make China rank among the world's largest in this field. of developed countries.

Just like the views expressed by insiders, "Under the new development situation, innovation in the field of biomedicine in my country has broader and newer connotations."

my country's biomedical field will be guided by "the rapid development of basic life science research and patient-centered medical concepts", and my country's new drug research will move from "chemical drugs with new mechanisms and new targets" to "biopharmaceuticals, vaccines , innovative traditional Chinese medicine, and even personalized treatment" is constantly changing and extending. At the same time, with the improvement of my country's scientific and technological level, medical devices will also change from low-end equipment to high-performance equipment, from low-tech medical materials to high-tech medical materials, and the localization process will continue to advance .