Under the epidemic, the logistics supply chain is inevitably delayed, and domestic hospitals are cooperating with manufacturers to fully guarantee the medical device products that patients urgently need.
Nevertheless, some imported products are still in short supply.
The first financial reporter learned from the cardiovascular departments of two large tertiary hospitals in Beijing that the epidemic has made the large-caliber artificial blood vessel products, which are already in short supply, even more in short supply.
"Because the artificial blood vessel products are all imported, the unit price is relatively high (10,000-30,000 yuan per piece), and the stocking of each hospital is very limited. Now the epidemic has exacerbated the waiting time for a series of processes such as logistics, customs clearance, and goods adjustment. It is true that patients who need surgery do not have products available." An expert in vascular surgery told Yicai.com.
Two major international manufacturers dominate artificial blood vessels
The large-diameter artificial blood vessels referred to by the above-mentioned experts are mainly used for patients with aortic dissection and aortic aneurysm. The commonly used diameter is 22-26 mm. There are currently no domestic alternatives for such artificial blood vessels. There are only two major manufacturers, one from Japan. Terumo and Maquet in Europe.
The Cardiac Surgery Department of the hospital where the expert works is one of the largest cardiovascular departments in China, and consumes more than 2,000 artificial blood vessels throughout the year.
"In the past, only a few hospitals could perform these operations. Now many hospitals are able to carry out related operations, but the volume of artificial blood vessel products has not increased, so the shortage has become more serious." He told Yicai.com.
According to the first financial reporter, multinational medical device manufacturers all have agents, and the agents have to get goods from the manufacturers, but the epidemic has exacerbated the difficulty of logistics.
"Many agents have also begun to fail to get the goods, and the deployment of some cross-regional goods has become more difficult." The above-mentioned experts told the First Financial Reporter.
In addition, according to the first financial reporter from Terumo, this artificial blood vessel product is not produced in China, and it is imported.
"China is mainly responsible for sales, and the annual supply is not much." A relevant person told the first financial reporter.
In contrast, Maikewei undertakes a larger supply of artificial blood vessels in the world. Statistics show that more than 70% of the artificial blood vessels in the world are supplied by Maikewei.
In addition, Microvii also supplies products including proximal staplers for heart bypass surgery.
"Recently affected by the epidemic, products such as proximal staplers for surgery have also been out of stock." A medical staff member of another top-ranked Beijing hospital in the cardiovascular department told Yicai.com.
A reporter from China Business News learned from two tertiary hospitals in Shanghai that due to the significant reduction in the number of cardiovascular surgeries since the epidemic in Shanghai, the shortage of related artificial vascular products is not yet prominent. further enrichment.
"Imported products will definitely be affected to a certain extent, and domestic substitution is the direction in the future." A director of the cardiology department of a tertiary hospital in Shanghai told Yicai.com.
Relevant persons revealed to the first financial reporter that the global output of artificial blood vessels in the world is only 100,000 to 200,000 pieces, and the production capacity of artificial blood vessels has not been increased, mainly because the company made a decision many years ago. Lines were closed and moved to France, and as a result, the French factory was delayed in production, resulting in a tight global supply.
"Although China's demand for artificial blood vessels is very large, about 20,000 to 30,000 per year, accounting for about 10% of the global consumption, foreign manufacturers will in principle guarantee the supply of the European and American markets." The above person told the first financial reporter .
Chinese product development is already on the way
Li Chao, chairman of Beijing Yuhengjia Technology, told the first financial reporter: "The number of surgeries for Chinese patients has increased year by year in recent years, and the demand is increasing, but domestic artificial blood vessels have not been successfully developed. I believe this epidemic will start. To promote the role, let more companies invest in the research and development of related products."
At present, the surgical artificial blood vessel products used in the world are still the previous generation products, which have lasted for more than 50 years. Therefore, from today's point of view, artificial blood vessels are not really "high-end innovative medical device products".
Li Chao used to be a cardiac surgeon at Beijing Anzhen Hospital Affiliated to Capital Medical University. He told Yicai.com that he did not choose to invest in the research and development of large-diameter artificial blood vessels when he started his business, mainly because he believed that there was not much room for innovation in artificial blood vessels. It is to imitate foreign products.
For this reason, he chose to develop a supportive graft for minimally invasive interventional surgery, which is now available in the thousands annually.
In recent years, the shortage of artificial blood vessel products has made Li Chao see the necessity of artificial blood vessel research and development.
"Under the epidemic, we have also seen that there is indeed a demand for artificial blood vessels, and we are ready to start the research and development of related products after the epidemic." Li Chao told the first financial reporter, "Although from a certain point of view, this is more like a This kind of imitation work, but we still hope that the newly developed domestic product will at least not be inferior to the existing imported product in terms of therapeutic effect.”
But the research and development of medical device products is a long process and relies heavily on the supply chain and materials.
Take the artificial blood vessel product as an example, which is a polyester thread braid and requires the use of animal collagen coating.
At present, domestic products are faced with the shortage of medical grade polyester threads on the one hand, and on the other hand, they are also subject to the risk of raw material supply for animal collagen coatings.
Chinese doctors hope to use a new type of polyurethane material to produce the artificial blood vessels.
Ouyang Chenxi, chief physician of Fuwai Hospital, Chinese Academy of Medical Sciences, told Yicai.com: "After 15 years of research and development, this product has now entered the clinic. We hope that its performance in all aspects can surpass the previous generation's performance. product."
According to reports, the clinical trial is expected to be completed in 2024.
"On the one hand, we are applying for the national medical innovation review green channel, and on the other hand, we hope to apply for a conditional listing." Ouyang Chenxi told the first financial reporter, "We already have relevant production equipment and standardized production plants. Once the product is approved, large scale expansion is possible.”
Sun Lizhong, a well-known cardiac surgery expert and president of Shanghai Delta Hospital, told the First Financial Reporter: "Localization is the development direction that China's medical device products must adhere to. I think greater support should be given in terms of policy. In terms of evaluation, we should encourage the establishment of China's own standards to provide more development opportunities and greater space for domestic medical device manufacturers."
Author: Qian TongxinKeywords: