Where Is The Development Path Of High Quality Medical Devices In China?

"China's medical industry has a long way to go in the world, but innovation and high-quality development must be the development path we need to uphold." Recently, at the second session of the Boao Forum for Asia Global Health Forum, Meng Dongping, Secretary of the Party committee of China Chamber of Commerce for import and export of medical and health products, pointed out to the media including the 21st century economic report that innovation and high-quality development can bring endless impetus to the development of the industry.

However, compared with foreign countries, there are still gaps in innovation ability and quality standard system of Chinese enterprises. Cui Jinhai, chairman of Ogilvy Medical Products Co., Ltd., said that innovation and quality should be reflected in the source, including R & D, design, manufacturing, transportation and comprehensive capabilities.

Long term sustainable and stable supply chain is very important for the survival of enterprises. Enterprises can effectively prevent relevant risks by extending industrial chain or maintaining good relationship with suppliers. In addition, the state should also support the relevant key parts manufacturing enterprises, gather the strength of the industry, and gradually realize the goal of controlling the safety of key parts in China.

In fact, the formulation of standards is the only way to achieve high-quality development, and effective regulatory measures are an important guarantee for the implementation of standards. Liu Jingqi, deputy director of the International Cooperation Department of the State Food and drug administration, said that strong supervision promotes strong industry, and strong industry promotes strong supervision“ We hope to promote the high-quality development of the pharmaceutical industry through regulatory capacity-building and policies, and also expect the high-quality development of the industry to provide assistance for the improvement of regulatory level. "

Enterprise survival foundation: supply chain security and stability

Meng Dongping introduced that in fact, many medical material enterprises are facing the risk of supply chain and industrial chain interruption. Many enterprises encountered the problem of supply chain instability in the process of promoting the resumption of work and production during the epidemic period. During the epidemic period, the Chinese government has been adhering to the open and inclusive attitude of cooperation even though there is a shortage of epidemic prevention materials in China; However, many European and American countries put forward the return of manufacturing industry, which has brought the threat of supply chain disruption to Chinese enterprises.

In the manufacturing end, open the whole industry chain or solution. Cui Jinhai said that it is important to open up the whole industrial chain in the manufacturing end, especially to strengthen the research and development of raw materials“ Because Ogilvy is a whole industry chain layout, Southeast Asian countries can not replace our products, and our product quality has exceeded international standards, which is the advantage of our products. "

For an excellent leading enterprise, a long-term sustainable and stable supply chain is the basic condition for its survival. Fang Xiaoliang, general manager of Zhejiang Dongfang gene biological products Co., Ltd., said that in addition to focusing on core technology and production capacity, Dongfang gene is also striving to extend the industrial chain to prevent related risks“ In order to maintain stable supply, we need to tap and import technology. In addition, the layout of the whole industrial chain is also our dream. Although this is very difficult for enterprises, as Chinese enterprises, we must break through this bottleneck. "

To control the risks of supply chain and industrial chain, Xu Chao, deputy general manager of global marketing of Shenzhen Mindray Medical Co., Ltd., said frankly that the national level should support the relevant key parts manufacturing enterprises, gather the strength of the industry and concentrate the advantages of the industry, so as to highlight the international competitiveness of the industry“ In fact, the chain of medical device industry is very long. As a complete machine manufacturer, it is impossible to produce everything. Take the ventilator as an example, there are two or three parts that need to be imported. Although there are enterprises in other industries in China that can produce them, only when the number reaches 140000 sets, can the suppliers achieve profit and loss balance, and 400000 sets can make profits. But our current output is about 40000 units a year. I suggest that the state can subsidize the enterprises of parts and components, so that they can first achieve break even, and gradually realize the goal of controlling the safety of key parts by the Chinese themselves. "

Meng Dongping pointed out that whether extending the industrial chain to cover all links, or focusing on its core production technology, and forming a benign interactive relationship with partners, are actually the positioning and selection of enterprises in the market“ Over the years, trade frictions have been growing. I think that trade frictions are actually the adjustment of interests. Only by mastering the initiative of core technology, can enterprises win the first place in the competition of interests. "

We should not only start from the core product service and supply chain control, but also support the industrial atmosphere with enterprise strength. Cao Lin, chairman of the board of Nanjing novozan Biotechnology Co., Ltd., said that it is important to find and train domestic suppliers in advance“ Although it is still unqualified, we should support it and give time for improvement and iteration, otherwise it may be stuck in the future. "

"In fact, for a long time, efficiency and cost have always been the core elements in the global supply chain and industrial chain. However, with the change of global development pattern and the impact of epidemic situation, we should pay attention to the security controllability and risk control ability of supply chain and industrial chain." Meng Dongping said.

What are the difficulties in innovation and high quality development?

Meng Dongping said that due to the impact of the epidemic, the demand for medical materials such as masks and protective clothing surged, leading to many enterprises switching to production, which also brought great pressure to the supervision. In fact, no matter for the enterprises that are in urgent transition to production or those who have been deeply engaged in the industry for a long time, if they want to achieve long-term and high-quality development, the fundamental way is to have core technology and professional strength, as well as the ability to control products and allocate resources.

"The first addition of the new regulation on the regulation of medical devices is to" promote industrial development. " Li Qingyun, deputy director of Shanghai Drug Administration, said, "this change embodies the main spirit of the legislation. Therefore, from this point of view, the registrant system and Articles 8, 9 and 12 are all around innovation, which are reflected in industrial policy support, tax collection, science and technology project approval, financing and credit."

Cui Jinhai said that both innovation and quality should be reflected in the source, including R & D, design, manufacturing, transportation and comprehensive capabilities. In fact, they come down in one continuous line“ Whether in the high-tech medical field or in the medical field of basic consumables, innovation is an eternal topic. The industrial chain includes product R & D, technology implementation, manufacturing management and testing, which needs to be really connected. In addition, with the development of intelligent and digital technology, it is a great opportunity for China's manufacturing industry to innovate. "

There is still a gap between China's IVD industry and the international leading level, but the epidemic situation has given it a rare opportunity for development. Fang Xiaoliang said that there is a gap, but it is not insurmountable, and even can win in some aspects“ In terms of new crown anti epidemic, we have surpassed some international brands, and our quality reliability has been proved after clinical practice. "

Fang Xiaoliang said frankly that compared with foreign companies, there are gaps in R & D strength, evaluation system, clinical program and regulatory system of Chinese enterprises.

Behind a certain profit is actually a considerable scale of industrial strength. In addition to industrial level design, regulatory level should also provide institutional design guarantee for enterprises to release more innovative vitality“ Chinese enterprises are good at driving with cost leadership, but innovation can not be cost led. Innovation is to support enterprise R & D expenses with high gross profit. For example, in strategic sourcing, the most important thing is to look at quality rather than price. Therefore, when supporting innovative core parts enterprises, the state should make strategic distribution. " Cao Lin said.

But Xu Chao believes that enterprises without high gross profit are not necessarily "difficult to do R & D". With the help of capital, enterprises can achieve breakthrough development. However, in the process of pursuing innovation and high-quality development, enterprises need to balance the industrial development direction and development space“ First of all, the gross profit comes from the difference between the selling price and the cost. Now the purchasing tends to be centralized, and the cost will naturally decrease when the quantity is large. However, it is more important to do a good job in supply chain management, control raw material procurement and improve production efficiency. For example, the gross profit of Mindray medical is 65%, and 10% of the annual turnover is invested in R & D. however, our gross profit is actually due to the large volume. Second, in fact, many enterprises engaged in R & D have no profit, and their R & D funds actually come from capital. However, many truly original technologies come from small start-ups. "

Meng Dongping said that in fact, any enterprise needs to measure and position its development according to the principles of the market, rather than simply imitate it.

How to establish international standard system?

Cui Jinhai said that it is not an obstacle, but a habit, that standards are really achieved or not. In fact, China's standards are almost the same as those of Europe and the United States, but in the process of implementing standards, there are differences in supervision and implementation“ I think the regulatory authorities should re integrate the international standards to form a habit at home and make them more similar. "

Products are for the ultimate market services, only with consumer demand first, can we really produce, manufacture and develop suitable products. Xu Chao pointed out that globalization can be divided into three stages: the primary stage is production in China and sales in China; The intermediate stage is made in China and sold in the United States; The ultimate stage is us production and US sales“ We are now in the second stage, producing in China, establishing our own sales market and regulatory teams in the United States and Europe, but we still have to set up factories abroad in the end. "

Fang Xiaoliang believes that in the formulation of standards, the most important thing is to introduce foreign standards. Domestic standards pay more attention to hardware or procedures, while foreign standards pay more attention to products and post event monitoring“ Many enterprises mistakenly think that they can sell overseas after entering the white list. In fact, it is easy to enter foreign countries, but the supervision after entering the market is very strict. " Standards and rules are the only way to achieve high-quality development, and effective measures must be taken. Li Qingyun said frankly that the differences between China's and foreign standards are not small in some aspects, but most of them are interlinked, because the purpose of establishing standards is to ensure safety and effectiveness. The new and old regulations clearly stipulate that medical devices should meet the national compulsory standards, and those without national compulsory standards should comply with the industry standards. In fact, it is not only stipulated in administrative regulations, but also in criminal law. The most noteworthy crime is the crime of illegal operation of medical devices. Therefore, we must not go beyond the minefield.

Meng Dongping said that whether it is epidemic prevention materials, medical equipment, or traditional Chinese medicine, they have encountered many standard barriers in the process of going international, but in fact, behind the standard differences are differences in cognition and ideas“ In the process of integration, how to seek common ground while reserving differences and win-win cooperation is a serious and urgent topic that we need to think about. "

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