Breaking through the "non-technical obstacles" in medical device innovation

After decades of efforts in the medical equipment industry in Shanghai, the high-end and independent layout of the industrial chain has emerged, and the independent leading brands represented by Lian Ying, Wei Chuang, Tou Jing, and Yi Rui have emerged.But overall, the industry's R & D investment level, core technology accumulation, talent reserve thickness, industrial competitiveness, etc., still have a clear gap with the global leader.

How to solve the problems of “difficulties in growing up” in the independent industry of medical devices and “difficulties in promoting independent products”?Since the beginning of last year, the Shanghai Municipal Party Committee of the Agricultural and Industrial Party has formed a detailed report after a year of research, and made recommendations on strengthening and expanding the medical device industry in this city during the two sessions of the Shanghai Conference.

The medical device industry has encountered four "no"

From simple imitation, introduction and digestion and absorption, to the fact that the industry's independent innovation has made great strides, the products have formed a certain international influence, and the achievements of the Shanghai medical device industry are obvious to all.However, behind the achievements, there are still many shortcomings in the industry and society that are not conducive to the development of the medical device industry.According to the survey conducted by the Shanghai Municipal Committee of the Agricultural Workers' Party, the main performance is “four noes”: insufficient R&D investment, insufficient collaborative innovation, poor market access, and weak customer purchasing intention.

The R&D investment gap is not really a problem unique to Shanghai companies.According to statistics, according to the main business income, the top 20 medical device companies in China currently have less than 1/6 of the total investment in the medtronic inc.

The synergy of production, learning, research and medicine is the basis for the innovation and development of the medical device industry.However, because of the information asymmetry or ability mismatch, enterprises and colleges in this city are difficult to form in-depth collaboration, which greatly affects product independent innovation and transformation of results.

What is even more regrettable is that even if medical device companies have made innovations, the products are still struggling in the process of going to the market.The survey found that due to the shortage of approval personnel and many approvals, the listing of new medical devices has not been accelerated.Even after passing the approval, getting the license and entering the procurement bidding process, many innovative medical devices have not been included in the medical service charge list.Every time it enter a hospital, it have to go through the process, and each process takes at least half a year. If you want to enter the medical insurance payment catalog, it will take several years.

From the user's point of view, because imported medical device products have long been in a monopoly position, many medical institutions have “brand inertia” and “use inertia”, and they are reluctant to buy or reluctant to use domestically-innovated medical devices.Although the relevant departments set up medical device localization assessment indicators for hospitals, hospitals often pay for assessments by purchasing low-end domestically produced equipment, while independent innovation products are blocked from the high-end market.

Cultivate and improve the innovation chain

Some people say that China's medical device industry is welcoming the "Golden Decade", and opportunities cannot be missed.In the face of the challenges faced by the medical device industry, the Shanghai Municipal Party Committee of the Peasant Workers Party gave policy recommendations one by one in the proposal. The core is to break through the missing links in the industry chain, cultivate and improve the innovation chain, and break through the various non-technical obstacles that innovative products land. "

In order to strengthen the collaborative innovation of “production, study and research” and empower the industry to upgrade, the Shanghai Municipal Committee of the Agricultural Workers’ Party believes that Shanghai needs innovative mechanisms.Establish a “Medical Device R&D and Transformation Technology Service Platform” and plan a “Medical Device Professional Park”.And with the help of the Yangtze River Delta integration national strategy to expand the development space.

The "service platform" will become the basis for the joint research of production, learning, research and medicine in this city. All parties should aim at the common links of the industry and break through a number of key technologies of "bottlenecks".At the same time, the "platform" should provide assistance to small and medium-sized medical device companies in terms of after-sales service and doctor training, and reduce their research and development costs.

The establishment of a "professional park" requires the guidance of relevant departments to make room for it, and ultimately attract more medical device innovations to be transformed locally in Shanghai.

Clearing up unnecessary obstacles in the process of listing innovative products is also a problem that the Agricultural Party Committee of Shanghai Municipality is trying to solve.The proposal believes that Shanghai needs to develop innovative policies that facilitate the timely entry of high-end medical devices into the market.It includes the establishment of scientific and reasonable connection policies in the medical insurance catalog application, bidding and admission at all levels, and rationalizes and simplifies the corresponding registration and approval procedures.

At present, the first class of new drugs in the country can be included in the medical insurance product catalogue through the fast track.The Shanghai Municipal Committee of the Agricultural and Labor Party believes that innovative medical device products should also refer to this policy and be included in the medical insurance catalogue of this city.In addition, in order to simplify the process of entering medical equipment into hospitals, it is recommended to change the current “applications to each hospital one by one” to “one hospital application, general hospitals in the city”. (The chief reporter of the newspaper Zhang Yi)