Release date: 2016-08-19
Due to the long technology, capital and return period, subject to the overall industrial level, high-end medical equipment nine became an imported product.
[Medical devices are different from industries such as electronics and machinery. Medical devices are divided by application, the technical field is not fixed, and the scope is very broad. This means that the level of medical equipment is closely related to the overall industrial level. ]
[In the top three hospitals in China, the domestic high-end medical device products have a low occupancy rate. According to many industry insiders, more than 50% of mid-range products rely on foreign imports, and the high-end import rate is even higher than 90%. ]
[Industry reports show that the average output value of medical device manufacturers in Shenzhen is only about 40 million yuan; there are only 30 to 40 yuan in the billion yuan, and hundreds of them under 40 million yuan. ]
[In May 2015, the Health Planning Commission announced the first batch of 95 excellent domestic medical equipment lists, desktop color Doppler ultrasound diagnostic equipment, digital X-ray machine and automatic biochemical analyzer, etc., which have certain market share and competition. Appropriate equipment that meets the needs of the grassroots is selected. ]
On this hot summer day, the ice of the medical device industry seems to have begun to melt.
"In the past two years, our large-scale treatment equipment has finally begun to enter the top three hospitals in China, which was previously unimaginable." A Shenzhen-based company that produces high-end medical equipment is talking about the industry of "First Financial Daily" reporters. When you change, you are happy.
In the top three hospitals in China, the domestic high-end medical device products have a low market share. Although there is no official statistics, according to many industry insiders, more than 50% of the mid-range products rely on foreign imports, and the high-end import rate is even higher than 90%.
China's medical device industry mainly produces low-end products; high-end products are slow to develop due to problems such as long technology, capital and long payback period.
In 2015, China's medical equipment exports reached 21.17 billion US dollars, an increase of 5.73%, but the export products are still based on disposable medical supplies, medical dressings, massage equipment and low-end medical equipment. High-end products such as high-value consumables, CT machines, magnetic resonance instruments and implantable medical devices are still mainly imported.
However, in recent years, with the introduction of a series of favorable policies, a large number of medical device companies have risen vigorously and began to enter the domestic high-end market. Therefore, the industry is gradually shifting to the upstream and high-end value chain to achieve the replacement of imported products.
At the same time, the state's regulation of the medical device industry has become increasingly strict. It is foreseeable that a large number of small and medium-sized production enterprises are facing industry reshuffle, and the superior resources and market will be further concentrated in enterprises with strong financial strength.
The status of foreign brands is difficult to shake
The Pearl River Delta is one of the important concentration areas for medical device manufacturers. Compared with the enterprises that produce therapeutic equipment in the previous article, the neurological products such as transcranial Doppler (TCD) produced by Wang Yiyi's company are diagnostic equipments. The risk of human body use is not so high. It is earlier in the top three hospitals. After 2009,". He told the "First Financial Daily" reporter: "Now, the top three hospitals are our main users."
Wang Yiyi is the person in charge of Shenzhen Delikai Medical Equipment Co., Ltd. The company was jointly developed with TCD inventor Rune Aaslid and has six invention patents. In 2011, it was approved by the National Science and Technology Ministry Torch Program.
Although they had been stationed in the top three hospitals around 2009, the process was even long for the company established in 1998.
At present, their TCD has not only entered the top three hospitals in China, but also exported to the United States, Germany and South Korea. Last year, the operating income was nearly 30 million yuan. This year, due to the listing of new products, sales revenue is expected to increase by a large margin.
Even if these high-end domestic medical devices are beginning to rise, the monopoly position of foreign brands in the domestic market is difficult to shake in the short term.
Mao Weiming, the public relations director of Shenzhen Mindray Biomedical Electronics Co., Ltd., the largest medical device manufacturer in the country, told reporters that medical devices are an auxiliary tool for Western medicine, and foreign brands have great advantages in this field. From the perspective of market segments, Johnson & Johnson is a giant of implantable medical devices. GM, Philips and Siemens are the leaders in the diagnostic device industry, accounting for more than 80% of the domestic high-end market. In the field of inspection equipment, the top three foreign brands are also Occupy more than 70% of the domestic high-end market share.
He said: "It takes time to change the situation. This is a process of market accumulation, just started. In addition, the purchasers of high-end products are not short of money, there is no need to risk certain risks, and domestic products are selected for cost-effectiveness."
Many problems in the domestic medical device industry
Mao Weiming added that there are not many high-end products that can be called in China. Some of them claim that technology can be compared to foreign countries, and the quality of products may not pass.
Shanghai Securities Medical Industry analyst Du Yuyan told the "First Financial Daily" reporter that technically, there are some small sub-industries that are already quite similar to foreign countries, but there are some gaps in some large-scale imaging diagnostic equipment.
In addition to technology and quality, the entire medical device industry in China still faces the problem of too small a scale.
According to the report released by Tianxing Capital at the end of April this year, from the perspective of operating income growth rate and net profit growth rate, 103 medical device listed companies have higher growth, but the scale is generally small.
Although Shenzhen's medical device industry is developing rapidly and has a certain leading edge in China, an industry report obtained by this reporter shows that the average output value of the production enterprises here is only about 40 million yuan; Ten, as many as 40 million yuan, there are hundreds. This is hard to match the international giant's tens of billions of output.
"Chaos" is another key word in the domestic medical industry. Zhang Xiaohua, a person in charge of the Shenzhen Medical Device Industry Association, told reporters that in order to solve the problem of rents being too expensive and workers difficult to recruit, last time he led several Shenzhen business owners to visit a model industrial park and set up a factory in the local area. . At that time, they went to a company to visit, and they couldn't wait for 5 minutes. "Quality control is not good, management is chaotic."
The medical device industry is related to the overall industrial level
It’s not a cold day.
The application of medical devices is based on Western medicine, while the traditional Chinese medical theory is Chinese medicine. Since China introduced medical devices in modern times, the industrial base has been subject to foreign countries and has been weak.
In addition, medical devices are different from industries such as electronics and machinery. The latter two are divided by the technical field. For example, the radio belongs to the electronics industry, based on electronics, and the technical field is relatively fixed. Medical devices are divided by applications, and the technical field is not fixed and covers a wide range. This means that the level of medical equipment is closely related to the overall industrial level.
The level is not only reflected in the core technology, but also in various details. "We used to communicate with doctors. They said that your machine performance is very good, but the switch is not good." Zhang Xiaohua told reporters: "Doctors will feel that during my surgery, my mind should be placed in the pathological study of patients. If your equipment details are not perfect, it will disturb his attention."
A doctor told this reporter that he has no prejudice against domestic treatment equipment, but will be more cautious when using it.
He said: "The equipment is not a problem, but if there is a problem with the material itself? For example, if the temperature measuring galvanic material has impurities, will it affect the transmission data? Will it cause a chain reaction, such as poor contact?"
He added: "These are related to the manufacture of chemical materials, which is complicated, and the lack of historical experience in this field in China, but also depends on foreign experience. But surgery is about human life, and there is no need to have any concerns or omissions."
The concept of "Chongyang" in hospitals is difficult to change
The concept of this doctor is widespread in many large hospitals and it is difficult to reverse in a short time. Even if the technical level of some domestic medical devices is not much different from that of foreign brands, the price is even lower, and it is still difficult to go to the top three hospitals.
Zhang Xiaohua went to a company in Shenzhen to produce color-super equipment, and was shocked by their high demand for products. “The pillars of their (product) aluminum alloy are not only external, but also internal, which we may not see for a lifetime. They have also been processed in three processes. If not treated, although it does not affect its strength, the interior will be oxidized. Whether it is the quality of the products or the rigor of the process, they are not weaker than foreign products."
Although there are some differences in the technical specifications of the products compared with similar devices abroad, this difference has nothing to do with the conventional medical diagnosis and will not affect the patient.
However, it is not easy for this company to enter the top three hospitals. Zhang Xiaohua said: "Shenzhen many excellent medical device products have been exported to the developed countries such as the United States and Japan, but they have not been able to enter the local hospitals. Some doctors are very clear about the performance of domestically produced products, but some doctors have not used them. The first reaction is rejection. ."
He added that some hospitals have a wrong view. "If you buy equipment from a foreign company, if there is any problem with the operation, you can say that it is another reason; if you use domestic equipment, the dean will be suspected of taking a kickback."
Technical error or advancement is a problem
Technology not only keeps many latecomers who are eager to try out, but may also increase the risk of death in some companies' R&D projects.
Prokhrin is a company in Shenzhen that develops and produces non-invasive therapeutic equipment. Huang Hannian, the chief innovation officer, told this reporter that medical devices, especially therapeutic medical devices, are in the wrong direction or technically in terms of research and development, and the time to market or enter the clinic may be delayed for three or five years.
Huang Hannian added that once there are mistakes or errors in the design or direction, it needs to be redesigned or changed greatly. Animal experiments and clinical trials must be repeated from beginning to over, so that several years have passed. "It's not like developing a mobile phone. Today, I found it wrong. I can correct it tomorrow."
Provien was founded in 2003. Unlike most non-invasive therapeutic equipment manufacturers, their non-invasive treatments do not stay in superficiality, but rather seek to achieve precise treatment of visceral lesions, such as cancer, through the skin and muscle layers directly into specific parts of human tissue. . However, at present, the technology and the entire industry are in their infancy at home and abroad.
At present, in addition to uterine fibroids treatment equipment focused on gynecological treatment, they have also developed a treatment device for pancreatic cancer and a tumor for the anorectal site, which is still in clinical trials and the feedback is good.
Even if equipment and technology are ahead of the curve, how to connect the new product to the hospital in terms of technical cognition is a big challenge.
Zhao Ming (a pseudonym), a former person who worked in the medical device industry in Shenzhen, told this reporter that a company in Shenzhen had developed a dynamic ECG monitoring device, which is very early in the world. They are very early. The product can overcome the drawbacks of the previous static ECG. "In the past, the static electrocardiogram, people just sit together, the ECG is chaotic, the quality is also poor, and many abnormalities can not be seen."
Although the company was full of confidence in the quality of ECG equipment, the market quickly poured a cold water on them. "Because the doctors at the time couldn't understand, the doctors were used to seeing the ECG of people in a static state."
Long wait for clinical trials
In addition to the common problems of core technology development in various industries, it is a long clinical trial for Prometheus.
The clinical validation of the ultrasound focused treatment of uterine fibroids developed by the company began in 2008 and continued through 2011. In the meantime, they conducted two clinical trials, including uterine fibroids, adenomyosis and other gynecological oncology diseases, a total of more than 1,000 cases.
For companies in their early stages, long clinical trials are undoubtedly a torment. In addition to uneasily waiting for the test results, we must continue to invest in the money.
Huang Hannian felt that the project was super “burning money†and they spent almost 40 million yuan before and after the clinical trial of their uterine fibroids treatment system.
For many medical companies, from the screening of the disease to the clinical observation after the end of treatment, every link in the process is going out. If there is no strong financial strength, the weak shoulders of ordinary enterprises simply cannot hold back.
When the reporter visited Prokherjeen, I was confronted with two investors who went into the office of Zhang Zhi, the head of the division. Afterwards, Zhang Xie was proud to confess to reporters that "no money is lacking" - at the beginning of the founding of the company, he pulled two partners to work together, and there were new shareholders joining all the way. At most, there were 16 people. Last month, a local fund invested by 100 million yuan was also on schedule.
"If there are already similar products developed and sold in the market, then you will have a control when you go to the applicant's body test. There will be fewer cases to be done, and it is very likely that the test will be completed in half a year." Wang Yiyi explained that “However, if your product is brand new and there are no precedents on the market, it will be normal for human trials to last for two or three years.â€
Hard-won registration certificate
Wang Yiyi’s company produced diagnostic equipment, and it took a year to get the medical device registration certificate. The Medical Device Registration Certificate (hereinafter referred to as the “Registration Certificateâ€) is a “passport†for market access in the industry and cannot be sold without being listed.
In China, medical devices are classified into three categories according to the level of safety. Different drug regulatory departments conduct examination and management. The higher the category, the stricter the registration approval and management. According to the Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the “Regulationsâ€) implemented in 2014, product registration management is implemented for the second and third types of medical devices.
Globally, the medical device industry has market access issues. In the EU must pass CE certification, in the United States is the FDA; in China must obtain a registration certificate, in addition to production licenses, but the latter is relatively simple, mainly depends on the manufacturing conditions and quality management system.
Since the risk of product use of therapeutic equipment is much higher than that of diagnostic equipment, it is not enough for a company to obtain a registration certificate for one year.
Zhang Huizhi’s Pro Huiren spent eight or nine years from the founding of the certificate to the hand. According to him, only three companies that have similar products in the country have obtained registration certificates for this type of treatment equipment, even if there are no more than five in the world.
“Because the potential risks involved in medical care are too high, government authorities cannot easily approve them. Many companies have not obtained this certificate even after they have done clinical trials.†He said that the registration certificate has very high clinical requirements, including How many cases of clinical and post-treatment related indicators meet the standards and so on.
Strict management and control in the early stage is worrying and happy for these companies. Once the product has passed through the market, the quality is much less likely to be questioned by the market.
Due to the high quality of the equipment, Zhang’s enterprise has felt the power of market explosion after ten years of silence.
Since the mass production in 2014, the market has been rapidly opened. Most of the more than 30 devices produced last year have entered the top three hospitals in China, and three have been exported to South Korea. This year they expect sales to triple, and are currently working overtime to expand capacity.
Incentives and regulation are strengthening
The pace at which these companies are moving into the market is at the right time. Since 2014, the warmth of the policy has been blown in one wave.
At the end of March 2014, the newly revised Regulations were promulgated. The "Regulations" implement classified management of medical devices according to the degree of risk, and classify medical devices into one, two and three categories according to the risk from low to high. Among them, the first type of medical equipment was changed to product filing management, and the second and third types of medical equipment continued to implement product registration management.
In addition, the "Regulations" also encourage the research and innovation of medical devices, and clearly implement the new regulatory model of "first product registration, post production license".
Subsequently, the National Health and Family Planning Commission also commissioned the China Medical Equipment Association to launch the first batch of excellent domestic medical equipment product selection work, which is a major opportunity for excellent domestic medical equipment companies.
In May 2015, the Health and Family Planning Commission announced the first batch of 95 excellent domestic medical equipments. The desktop color Doppler ultrasound diagnostic apparatus, digital X-ray machine and automatic biochemical analyzer have three kinds of market share and competitiveness. Appropriate equipment that meets the needs of the grassroots is selected.
In the same month, the “Made in China 2025†strategy was issued, which required “to vigorously promote breakthrough development in key areasâ€. The top ten areas mentioned included high-performance medical devices. The strategy also proposes to improve the innovation capability and industrialization level of medical devices, focusing on the development of high-performance medical equipment such as imaging equipment and medical robots, high-value medical consumables such as fully degradable vascular stents, and mobile medical products such as wearable and remote medical treatment.
At the same time, the intensity of industry regulation is growing. In 2013, the State Food and Drug Administration was established and the organization reform was fully launched. The establishment and staffing of medical device regulatory agencies were improved and enriched. The Food and Drug Administration has established the Medical Device Registration Management Division and the Medical Device Supervision Division, which are responsible for the supervision of pre-market and post-marketing medical devices.
A prominent change is that the supervision of medical devices is expanding from the production link to the circulation, and gradually realizes the whole process. In June this year, the Food and Drug Administration issued the No. 112 Announcement of 2016, which decided to carry out centralized rectification of illegal business operations in the field of medical device circulation.
Zhang Xiaohua, who is in the industry association, has a deep understanding of this. He said that in the past, the drug supervision system had a lot of production management, especially in the product registration before production, re-registration and light supervision, and the management of the company's operation was very loose. It was only around 2000 that companies were required to have a quality management system. However, "a product must be safe and effective. If it is not controlled in the circulation, it is difficult to ensure that the product is safe and effective." "When you take the reagents that were previously assigned to medicines, you need cold chain transportation, storage and transportation conditions are very important." Zhang Xiaohua said.
In Du Fuyan's view, as the supervision becomes more and more strict, there will be a group of inferior small companies dying in the future, and the concentration of the whole industry will increase. In the future, the industry will be remodeled.
Source: First Financial Daily
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