From valves to surgical robots: Transnational innovative medical devices seek a breakthrough in China

   Reporters learned on August 2nd from Siemens Healthineers that the Corindus system, a coronary intervention robot, has passed the special review application for innovative medical devices after expert review organized by the Medical Device Technical Review Center of the National Medical Products Administration. It also became the first foreign medical imaging equipment manufacturer to pass the special review application for innovative medical devices.Innovative MedicalDevice Review OfficeRobotThe Corindus system has passed the special review application for innovative medical devices, also becoming the first foreign medical imaging equipment manufacturing enterprise to pass the special review application for innovative medical devices.

　　Compared with traditional manual interventional surgery, interventional surgical robots have advantages such as reducing the radiation dose received by doctors and patients during surgery, improving the precision of surgical manipulation, and reducing contact between doctors and patients during surgery. In recent years, the cardiovascular intervention field has become the most promising direction for medical devices in China. From interventional cardiac valves to interventional surgical robots, foreign medical device and equipment companies are facing fierce competition from rapidly rising domestic manufacturers in China.

　　However, having good products is only the first step for innovative foreign medical device companies to enter the Chinese market. To break through in the fierce competition in China, it depends more on the company's understanding of the market, meeting patient needs, and reasonable sales and pricing strategies.

　　Rapid Growth in Demand for Interventional Surgery

　　According to reporters, the interventional surgical robot that entered the special review application channel is used for auxiliary treatment in coronary artery intervention therapy (PCI). In March this year, Professor Junbo Ge, an academician of the Chinese Academy of Sciences and from Zhongshan Hospital affiliated with Fudan University, and his team completed the first PCI surgery assisted by Corindus at Boao Super Hospital, which aroused widespread attention in China to interventional surgical robots.

　　Academician Ge Junbo told Yicai Global, "The emergence of new technologies and new medical devices has made cardiac interventional surgery safer and more effective." He predicts that the development boom of structural heart disease interventional therapy will continue for decades, and the number of interventional surgeries in China will grow rapidly.

　　Zhenrong Pu, Vice President of Clinical Therapy Systems, Siemens Healthineers Greater China, told Yicai Global, "After passing the special review application for innovative medical devices, we will submit technical documents for review, bringing Corindus closer to domestic listing."

　　After medical devices enter the special review procedure, the State Drug Administration will give priority to the review and approval of innovative medical devices on the premise that the medical devices meet the basic requirements of the review, optimize the registration and review process, and thus accelerate the listing process of innovative medical devices in China.

　　The "Special Review Procedure for Innovative Medical Devices" aims to encourage the research and development and innovation of medical devices, promote the promotion and application of new medical device technologies, and promote the high-quality development of the medical device industry. Yicai Global noted that in recent years, in the catalog of innovative medical devices approved by the National Medical Products Administration, the vast majority are Chinese medical device companies, and products approved by foreign companies are mainly concentrated in the cardiovascular field.

　　Domestic Manufacturers Benchmarking Against International Giants

　　"Price is no longer a barrier to foreign medical device products entering the Chinese market. To compete with Chinese domestic manufacturers, multinational manufacturers need a better understanding of the market and establish a more suitable strategy for China, including sales incentive mechanisms. This is still a challenge for many multinational manufacturers, especially those that entered the Chinese market later." An industry insider told Yicai Global.

　　Taking structural heart valve devices as an example, although Edwards Lifesciences has an advantage in the field of surgical aortic bioprostheses, its transcatheter aortic valve replacement system in the field of cardiac intervention still finds it difficult to occupy the Chinese market. According to Yicai Global, in the first year of Sapien3's launch, Edwards Lifesciences completed more than 200 replacement procedures. Last year, about 3,500 transcatheter aortic valve replacement procedures were performed in China.

　　China's medical device market is a huge market with a scale of nearly one trillion yuan, and its growth rate far exceeds that of other countries in the world. After high-end medical equipment has been monopolized by multinational companies for a long time, in recent years, under the impetus of national policies that strongly encourage independent research and development of innovative medical devices, China's domestic innovative medical devices are ushering in a "golden period" of development, giving birth to a large number of medical device companies that have transitioned from imitation to independent innovation.

　　The surge in interventional surgeries has also placed higher demands on the standardization of surgeries. Surgical robots can help solve the problem of standardization and are also a major trend in the development of the medical device field. Currently, many global companies, including Corindus and France's Robocath, are vying for the "Da Vinci" position in the interventional field.

　　China has also produced a number of surgical robot companies. On the same day that Siemens Healthineers' interventional surgical robot Corindus passed the special review application for innovative medical devices, Aubon Medical, a medical device manufacturer in Shanghai Zhangjiang, completed the world's first robot-assisted endovascular aortic stent grafting surgery in humans at the Changhai Hospital affiliated with the Naval Medical University.

　　In the future, Aubon will directly benchmark against Siemens Healthineers' Corindus robot system, targeting PCI coronary intervention surgery. The potential customers in the early stages of promotion are the top 500 large tertiary hospitals in China with a high volume of coronary intervention surgeries.

　　However, for this brand-new industry of surgical robots, due to the lack of standards and regulations in the market, innovative enterprises will face greater challenges. The application of the surgical robot market currently faces constraints such as insufficient scale, high Price, complex use preparation procedures, and the need for improved understanding of robot-assisted surgery among doctors and patients. It will take time for surgical robot products to gain market and user recognition; on the other hand, the equipment resource costs required for training, as well as the formulation of product standards and regulations and policies, have also become bottlenecks hindering the development of surgical robots in China.

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