Under the epidemic situation, the logistics supply chain is inevitably delayed. Domestic hospitals are cooperating with manufacturers to fully ensure the medical devices urgently needed by patients. Nevertheless, some imported products are still in short supply. The first financial reporter learned from the cardiovascular department of two large-scale third class hospitals in Beijing that the epidemic has made the already scarce large-diameter artificial blood vessel products more in short supply.
"Because the artificial blood vessel products are imported and the unit price is relatively high (10000-30000 yuan per piece), the stock of each hospital was originally very limited. Now the epidemic has exacerbated the waiting time of a series of processes such as logistics customs clearance and goods transfer. It is true that patients who need surgery have no products available." A vascular surgery expert told the first financial reporter.
Two major international manufacturers dominate artificial blood vessels
The large caliber artificial blood vessels referred to by the above experts are mainly used for patients with aortic dissection and aortic aneurysm. The commonly used caliber is 22-26mm. At present, there is no domestic substitute for this kind of artificial blood vessel products. There are only two main manufacturers, namely Terumo in Japan and MAQUET in Europe.
The cardiac surgery department of the expert's hospital is one of the largest cardiovascular departments in China, consuming more than 2000 artificial blood vessels throughout the year. "In the past, only a few hospitals could do these operations. Now many hospitals have the ability to carry out relevant operations, but the amount of artificial blood vessel products has not increased, so the shortage has become more serious." He told the first financial reporter.
According to the first financial reporter, multinational medical device manufacturers have agents, and agents need to take goods from manufacturers, but the epidemic has exacerbated the difficulty of logistics. "Many agents are beginning to fail to get the goods, and the deployment of some cross regional goods has become more difficult." The above experts told the first financial reporter.
In addition, according to the first finance and economics reporter, this kind of artificial blood vessel product is not produced in China and depends on import. "China is mainly responsible for sales, and the annual supply is not much." Relevant people told the first financial reporter.
In contrast, maikewei undertakes a larger global supply of artificial blood vessels. Statistics show that more than 70% of the world's artificial blood vessels are supplied by maikewei. In addition, mcvei also supplies products including proximal staplers for cardiac bypass surgery.
"Recently, affected by the epidemic, products such as surgical proximal staplers have also been out of stock." Another cardiovascular department ranked high in the relevant departments of Beijing hospital, the medical staff told the first financial reporter.
The first financial reporter learned from two Shanghai top three hospitals that the shortage of relevant artificial blood vessel products is not prominent because the number of cardiovascular operations has decreased significantly since the epidemic in Shanghai. However, with the gradual recovery of hospital operations after the epidemic, the stock needs to be further enriched. "Imported products will certainly be affected, and domestic substitution is the direction in the future." A director of Cardiology of a third class hospital in Shanghai told the first financial reporter.
Relevant people disclosed to the first financial reporter that the global output of artificial blood vessels of maikewei is only 100000-200000 a year, and the production capacity of artificial blood vessels has been unable to go up, mainly because the company made a decision many years ago to close the production line in the United States and transfer it to France. As a result, the French factory has not been put into operation, resulting in the tension of global supply.
"Although China has a great demand for artificial blood vessels, about 20000-30000 per year, accounting for about 10% of the global consumption, foreign manufacturers will first ensure the supply of European and American markets in principle." The above-mentioned person told the first financial reporter.
Chinese product R & D is on the way
In recent years, the investment of domestic enterprises in R & D of blood vessel related products has not increased year by year, but the chairman of the board of directors said, "the investment of domestic enterprises in R & D of blood vessel related products has not played a role in promoting the success of the disease in Beijing."
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, a former cardiac surgeon at Beijing Anzhen Hospital Affiliated to Capital Medical University, told the first financial reporter that he did not choose to invest in the research and development of large-diameter artificial blood vessels when starting a business. He mainly believed that there was little room for innovation of artificial blood vessel products, and more was to imitate foreign products. For this reason, he chose to develop a supporting artificial blood vessel for minimally invasive interventional surgery, which can now supply thousands of such products every year.
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 also see that there is a real demand for artificial blood vessels. We are ready to start the research and development of relevant products after the epidemic." Li Chao told the first financial reporter, "although to some extent, this is more like an imitation work, we still hope that the newly developed domestic products can not be inferior to the existing imported products in terms of treatment effect."
However, the research and development of medical device products is a long process, and largely depends on the supply chain and materials. Take the artificial blood vessel product as an example. It is a polyester braid and needs to use animal collagen coating. At present, domestic products are facing the shortage of medical grade polyester thread on the one hand, and are also subject to the risk of raw material supply of animal collagen coating on the other hand.
Chinese doctors hope to use a new polyurethane material to produce the artificial blood vessel. Ouyang Chenxi, chief physician of Fuwai Hospital of Chinese Academy of Medical Sciences, told the first financial reporter: "after 15 years of research and development, this product has entered the clinic. We hope it can surpass the previous generation in all aspects of performance."
It is revealed that the clinical trial is expected to be completed in 2024. "On the one hand, we are applying for the green channel of national medical innovation review. On the other hand, we also hope to apply for conditional listing." Ouyang Chenxi told the first financial reporter, "we already have relevant production equipment and standardized production plants. Once the products are approved, we can expand production on a large scale."
Sun Lizhong, a well-known cardiac surgery expert and President of Shanghai Deda hospital, told the first financial reporter: "localization is the development direction that China's medical device products must adhere to. I think we should give greater support in terms of policies. In terms of medical device evaluation, we should encourage the establishment of China's own standards to provide more development opportunities and greater space for domestic medical device manufacturers."