Grab a position in the CDMO track and see how Haofeng Medical plans the layout?

    As a group platform company focusing on CDMO services for interventional medical devices, Haofeng Medical has built four platforms, including equipment platform, consumable platform, material platform and energy platform, by virtue of its early-stage leading advantage, becoming the first high-end interventional medical device CDMO platform company in China. The CDMO stands for Contract Development and Manufacturing Organization. Different from mere contract manufacturing, CDMO is a contract custom R&D and manufacturing service, mainly providing innovative product process development and preparation, process optimization, registration and validation batch production, and commercial custom R&D and manufacturing services. "We can understand that CDMO is a process that combines traditional CXO, CRO, ODM, OEM, etc., from making simple medical device parts in the past to making finished products."

     "Haofeng has always been the upstream service provider of third class medical devices, and ToB is one of our advantages." "Our main customer group is medical device manufacturers, through which we serve hospitals and schools," Liu said. The products produced by Haofeng Medical include microguide wire, microcatheter, balloon catheter, various kinds of leading sheath tube and other high-value third-class medical equipment consumables used to build interventional surgical channels. For customers, it has developed refrigeration series equipment and consumables, valve delivery system, flexible bending catheter, micro guide wire, shock wave balloon and other cutting-edge medical instruments and active equipment.

    Through process exploration and refinement, the micro-guide wire product platform has built a product line with fully independent intellectual property rights. The production line will be officially launched in 2022, with the first annual output reaching 40,000 pieces, so as to challenge the localization rate of less than 5% in this market and create greater value for many partners. "We have also set up a medical device service provider innovation consortium with many upstream suppliers to build a complete industrial ecological closed loop to provide customers with comprehensive product solutions. We offer our customers a variety of services from R&D to post-market production, not just one product." Liu added.

    Ten years ago, in 2013, Liu Chunjie entered the medical device industry due to an accidental opportunity. "The three types of interventional medical devices in China mainly started to develop after 2010, especially the ones like valves and intracranial, and the market share of interventional medical devices produced in China was very low. The market share of implanted domestic medical devices is relatively high, and the market space is very huge." At the beginning of the business, Haofeng Medical positioned itself in the production of interventional medical devices and import replacement of testing equipment. The promotion of the registrant system is another development opportunity seized by Liu Chunjie. In 2017, China began to pilot the medical device registrant commissioning mode, in which a medical device registrant can entrust a licensed product to one or more enterprises with production capacity. This model brings a good opportunity for the development of interventional medical device CDMO. "With the promotion of MAH system in China, which is exactly in line with the business attributes of our company, in 2021, I will officially reintegrate the company in the direction of CDMO." Liu Chunjie said. With the continuous expansion of business, in 2020, Liu Chunjie integrated his subsidiaries and established Shanghai Haofeng Medical Co., LTD., focusing on the "global high-end interventional medical device CDMO" platform. Help enterprises save time and capital costs, accelerate product listing, improve the overall efficiency of the medical equipment industry chain.

    The CDMO field of medical devices is multi-variety, small batch, high requirements of products. This is also a big challenge faced by Haofeng. "The three types of interventional medical devices are small and complex, with many varieties and specifications. As a platform company, we serve manufacturers in all three categories of medical device segmentation fields, covering cardiovascular, peripheral blood, intracranial blood vessels and other fields. There are more than ten directions for subdivision, which leads to our inability to quickly grow bigger and stronger, and we need to continuously refine each product and each module bit by bit." In addition, Haofeng Medical has also established industry-university-research cooperation with universities. "The global interventional medical device CMDO project we deeply co-built and cooperated with Shanghai Science and Technology has become the first third-class interventional medical device CDMO platform in China." Under the promotion of both the university and the enterprise, the company has launched the micro-guide wire product with the minimum diameter of 0.010 inches, and the whole production line has its own intellectual property rights, reversing the situation that the pathway device plate in the field of neural intervention has been occupied by overseas enterprises for years, and realizing the perfect integration of platform innovation, technological innovation and product innovation.

    In the past ten years, Haofeng Medical has independently developed more than 30 kinds of production equipment, which can meet the production and testing of the whole three types of interventional medical device consumables. Among them, more than 30 kinds of processes have achieved domestic breakthrough, and 85 national authorized patents have been obtained. The production line equipment of pathway devices (interventional microguide wire, interventional catheter, balloon catheter) has completely replaced imports with domestic products. At the same time obtained CE certification, exported to overseas. "Haofeng has always dared to choose a road not taken by others to build a high-end interventional medical device CDMO platform. There is no such listed company in China." Liu Chunjie said. "In the future, my goal is to build Haofeng into a world-renowned CDMO platform company."