The spring of 2016 is still brewing, but the medical device industry has ushered in the "spring breeze" in advance ". A few days ago, Premier Li Keqiang presided over an executive meeting of the State Council to deploy and promote the innovation and upgrading of the pharmaceutical industry. When referring to the innovation and upgrading of medical devices, the Prime Minister stressed the need to strengthen the research and development and innovation of high-end medical devices; benchmarking the international advanced level, implementing actions to improve medical device standards; and speeding up the review and approval of clinical medical device products in urgent need.

This good news has given domestic innovative medical device companies a dose of "cardiotonic". Zhao Zilin, chairman of the China Medical Equipment Association, said that in recent years, with the continuous growth of the national demand for medical services, the state has introduced a number of policies and measures, and increased capital investment to promote the development and application of new technologies and new products of domestic medical devices. "China is the world's second largest medical device market, and the utilization rate of high-end medical devices is high. The premier also mentioned the need to improve the overall level of medical device production and research and development and speed up review and approval, which means accelerating the integration of the entire industry chain."

Lock-in high-end medical devices

In 2015, the "China Medical Equipment" magazine conducted a survey. The results showed that in several types of large-scale medical equipment such as CT, nuclear magnetic resonance, nuclear medicine, and angiography, the industry called "GPS" General Electric, Three multinational companies, Philips and Siemens, have a market share of more than 80%.

The huge economic burden brought by high imported products has become an important factor in the unreasonable growth of medical expenses and the "difficult and expensive medical treatment" of patients. In addition, Jiang Feng, president of the China Medical Device Industry Association, told reporters: "China has made certain achievements in the production and innovation of low-end medical devices, so now the focus is on high-end medical device products. At the same time, speed up the review and approval of medical devices, for some enterprises to open a 'green channel', so that independent innovation products quickly enter the market, to keep up with the pace of medical device market replacement."

According to statistics, in 2015, the Medical Device Technology Review Center of the State Administration announced the results of the application for the special approval procedure for 8 innovative medical devices. A total of 29 innovative products entered the "green channel" for special approval, involving genetic testing, vascular stents, and tissue engineering products., Surgical robot positioning system, etc.

Enterprise innovation power is insufficient

Under the background of "mass entrepreneurship and innovation", the state pays more and more attention to the innovation of medical device industry, but in Jiang Feng's eyes, the degree of attention is still far from enough. "We have done some work in technology, funds and public opinion guidance, but the environment for supporting innovative products has not been fully formed, and the preferential policies for product registration, procurement, application and promotion are still not strong enough, not enough to stimulate independent innovation."

In the production and research and development of medical devices, the common practice of domestic enterprises is to imitate a certain product with high added value, existing market scale or large potential market of foreign-funded enterprises in China. After completing the product and obtaining a certain sales basis, it is further expanded to other product fields for model replication and diversification. And this practice to a certain extent hit the enthusiasm of enterprises, "many Chinese enterprises want to make quick money, the way to make quick money is to copy other people's products. Blind imitation led to patent protection in vain, suppressed some innovative enterprises, and ultimately led to the lack of enthusiasm of enterprises." Jiang Feng said.

Zhao Zilin also expressed another concern: "The production of products requires talents, and the production of high-end products requires high-end talents. Take watches as an example. Why do some Swiss watches cost as much as one million, while watches produced in my country can only hover at the price level of 10,000 yuan? Because we lack the talent to master the high-end craft. The cultivation of talents is a long process, because it is impossible for foreign companies to produce large quantities of new technology medical device products in China, and they cannot be in line with foreign countries in technology, and they cannot cultivate first-class innovative and qualified talents."

From low-end products to high-end products

Fortunately, with the increasing maturity of the supporting innovation environment, many innovations have also appeared in domestic medical device companies. A large number of mid-to-high-end medical device products with independent intellectual property rights, high performance, and low cost have been introduced to the market. In order to meet the needs of my country's medical and health institution construction and diagnosis and treatment, some of these products can already replace imports.

There are also some enterprises that pay attention to cooperation with medical colleges and universities, as well as docking with foreign R & D institutions, join hands in R & D and innovate on the shoulders of giants. "In the past, medical device companies were relatively closed, but now we are open-minded and willing to receive advanced ideas and practices from others. This way we have a relatively high start, although most of our medical device companies are under the age of 30, but if we start high and make rapid progress, we will one day catch up with foreign standards." Zhao Zilin said.

Jiang Feng suggested that enterprises should focus on product innovation and not blindly pursue business model innovation. "Business model innovation is based on product innovation. Without product innovation, there is no so-called business model innovation. Innovative products may require new business models to promote, which is not contradictory at this time, but if you play tricks in the sales field, it is not conducive to product innovation. Therefore, the current medical device industry does not advocate business model innovation. We just want to start from low-end medical device product innovation step by step and march into high-end medical devices." Jiang Feng said.

High-tech products will become a hot spot

Regarding the technological innovation of medical devices, Jiang Feng said that he is optimistic about the following aspects: small and medium-sized surgical products and consumables, minimally invasive surgical technology; clinical in vitro diagnostic machines and reagents; household medical devices, smart medical products; biological materials; high-end consumables, Implants.

At the 2015 National Science and Technology Awards Conference, Pumen Technology won the first prize of National Science and Technology Progress by virtue of "Research on Innovative Theories and Key Measures for the Prevention and Treatment of Chinese People's Surface Difficult to Heal Wounds", becoming the first in my country's medical device industry The enterprise that won the award. At the same time, five medical device related technologies and three medical device enterprises, including "key technology and industrialization platform for minimal invasive intervention and implantation of medical devices", won the second prize of national scientific and technological progress.

"In line with the needs of precision medicine, the development trend of the medical device industry in the future is becoming more and more obvious, that is, products with high technology as the core will become the focus of industry attention and investment." Zhao Zilin told reporters that as long as we grasp the two points of widespread clinical application and great impact on patients' costs, it is not difficult for enterprises to find innovative breakthroughs.

High quality is always the pursuit

If medical device companies want to make a breakthrough in high-end medical devices, Jiang Feng believes: "Enterprises must first understand what they want to do, whether to make quick money or to do innovation. If it is determined to do innovation, it is necessary to learn to cooperate and pay attention to product quality."

For a long time, China's medical device manufacturers are mostly small-scale and scattered layout. These small enterprises, not only the production technology content is low, the effectiveness of its production process and quality control is a big problem. Jiang Feng believes that enterprises should attach importance to cooperation. "The foreign medical device market has entered a virtuous circle. Small enterprises make innovation and products, large enterprises make improvement and industrialization, and large enterprises give small enterprises living space and orderly cooperation. A few years later, large enterprises will merge small enterprises. However, China's national products account for less than 5% of the global market, but there are dozens of enterprises in production for each product, and there is no big difference in characteristics and performance parameters. Each enterprise is fighting alone and competing in disorder." Jiang Feng said.

Jiang Feng said that Chinese companies do not pay enough attention to product quality. For the same product, the quality of German production and Japanese production is high, and the quality of Chinese production is low because Chinese companies do not pay attention to quality, processes and materials. Zhao Zilin and Jiang Feng agree, "Only when the product is of high quality can it be recognized. If the product is suitable for Chinese patients, the product can be continuously updated and the enterprise can develop continuously. "Zhao Zilin said.

Source: Health News