In recent years, China has continuously improved its approval system and introduced policies to encourage hospitals to make purchases, effectively promoting the accelerated development of domestic high-end medical devices. However, many medical device enterprises in various regions still generally reflect that there are still many bottlenecks in the entire process from product research and development, clinical trials, registration review to hospital procurement. The bottleneck of long approval cycle and sluggish market sales of domestic innovative medical devices has not been fundamentally broken through, which still restricts the transformation of enterprise technological achievements and the market capture of CT tubes and imported products.
High risk, high investment, and difficulty in obtaining bank loans
A certain enterprise in the east has a 2M PET-CT molecular imaging device with complete independent intellectual property rights. One device can replace five traditional PET-CTs. The CT tube can save a lot of costs for the hospital. Research and clinical institutions from the United States, the United Kingdom, the Netherlands, Japan and other places have all expressed their hope to cooperate. The company's person in charge introduced that due to the high cost of research and development and manufacturing, mass production will bring huge financial pressure to the enterprise. The price, which is much higher than that of traditional equipment, also makes it difficult for domestic research institutions and hospitals to afford. Chongqing Yongrenxin Technology Co., Ltd. has filled the gap of artificial heart products in China by introducing technology.
Zhang Benyan, the chairman of the company, introduced that the clinical trial stage of the product is almost completed and the product is about to enter mass production and be launched on the market. The company's development investment in the first five years has exceeded 100 million yuan. Due to the lack of collateral, it is unable to obtain a loan from the bank, and there are still problems with the subsequent funds for mass production. High-end medical devices are a typical high-risk and high-investment industry. The high-end medical device enterprises in Europe and America are mainly large multinational companies. Due to the late start of the development of medical devices in China, the main innovators are mostly small and medium-sized enterprises, mainly targeting the medical niche market. They are small in scale and have weak risk resistance capabilities. The interviewed enterprises are looking forward to providing financial support for major innovation projects in medical devices through the establishment of industrial development funds, government equity investment funds and other financial innovations.

