Hunan Huaxiang Medical Technology湖南华翔医疗科技

Hunan Huaxiang Medical Technology Co., Ltd.

Hunan Huaxiang Medical Technology Co., Ltd. (formerly known as Hunan Huaxiang Incremental Manufacturing Co., Ltd.) is a high-tech enterprise focusing on the research and development of medical 3D printing technology, product transformation, and providing industrial-grade digital solutions to hospitals and research institutions. The company is dedicated to replacing imports and developing personalized medical devices for precise treatment, providing customized and patient-matched medical devices. The main products include surgical navigation instruments and surgical implant devices, using raw materials such as polymer materials, titanium alloys, tantalum metal materials, and zinc alloy materials. The company has established a comprehensive industrial chain including material research and development, software processing, 3D printing, and surface modification, providing comprehensive, precise, and efficient surgical solutions to doctors and patients. The company has accumulated rich and instructive operational experience and application cases in provincial top-tier hospitals, technological education, and regional medical service areas (such as 3D printing centers and medical rehabilitation centers), making it a pioneer in the comprehensive promotion of 3D printing technology in China and a leading enterprise in the orthopedic medical device field in Hunan Province.

After years of in-depth development, the company has achieved remarkable results in the field of medical 3D printing. It has completed over 20,000 cases of medical-industrial interactive design, production, and clinical application of 3D-printed polymer medical models, rehabilitation aids, and surgical planning guides; and conducted more than 2,000 cases of 3D-printed titanium alloy spinal fusion surgeries. Currently, the company's products are widely used in various clinical disciplines including orthopedics, craniomaxillofacial surgery, neurosurgery, vascular surgery, urology, plastic surgery, dentistry, oral surgery, general surgery, thoracic surgery, and cardiac surgery.

The company has been recognized as a national high-tech enterprise, an innovative enterprise by Sci-Tech China, a specialized and new small and medium-sized enterprise in Hunan Province, a notable contributor to 3D printing medical device group standards, a pilot intelligent manufacturing enterprise in Changsha, a science and technology type small and medium-sized enterprise, a model enterprise in the "two-type" demonstration project, an AAA credit enterprise, and an advanced unit in technological innovation. It has obtained production and operating licenses for Class I, II, and III medical devices and has passed certifications for medical device quality management systems, ISO9000 quality management systems, two-type integration management systems, and intellectual property management systems.

Technical Achievements

The company has been granted 23 authorized invention patents, 100 utility model patents, 45 design patents, and 10 software copyrights. It has participated in the development of 2 national standards, 1 industry standard, led the development of 2 industry standards, and contributed to the development of 10 industry standards. It has obtained 35 Class I medical device record certificates, 6 Class II medical device registration certificates, and 9 Class III medical device registration certificates. The company has undertaken 11 provincial and ministerial-level science and technology projects, including leading 1 national key research and development program and undertaking 2 municipal (county) level major science and technology projects.

The company has received several honors, including:

9 innovation platforms, including centers for polymer additive manufacturing, implantable medical devices, 3D printing oral medical devices, and more

Collaborations with Peking University, Tsinghua University, Zhejiang University, Xi'an Jiaotong University, Central South University, Chinese Academy of Sciences, Shanghai Jiao Tong University, and over 50 universities, research institutions, and hundreds of hospitals

Areas of collaboration: biometallic materials, laser additive manufacturing, AI and software, surface modification, testing, biological evaluation, and clinical trials.

The company has an R&D center of 14,000 m², including a 5,600 m² GMP cleanroom. The R&D and testing center is equipped with 6 dedicated medical 3D printers and over 200 digital R&D, testing, and production devices. These include selective laser sintering and melting equipment, high-speed centrifuge, stent compression machine, inductively coupled plasma spectrometer, electronic universal material testing machine, SL451 laser rapid prototyping machine, precision automatic lathe, radial force tester, three-roll mill, Haas five-axis rotary table, precision rotary forging machine, surgical vacuum pump, bone screw performance tester, organic carbon analyzer, and various other devices. The total equipment value exceeds 25 million RMB. Additionally, the company has over 10 auxiliary software systems for industrial internet, product design and simulation, and product lifecycle management.

The company's overall technology level is leading domestically, with 4 core products/technologies. Among these, the porous vertebral/interbody fusion device has received 100 key industrial new product certifications from Hunan Province, Hunan Province Biomedicine Industry Chain key product certification, and was included in the Ministry of Industry and Information Technology's first batch of typical additive manufacturing application scenarios. This product fills a gap in both domestic and international laser additive manufacturing medical applications and has been reported by People's Daily Online. It is the first domestic product to apply laser 3D printing technology in the medical field and achieve NMPA certification for commercialization.

The additive manufacturing interbody fusion device is the first internationally to be produced using laser 3D printing and obtain NMPA certification for clinical application, breaking foreign technology monopolies, and has been covered by media such as Changsha Evening News and Xiangjiang New Area official channels.

The company’s biodegradable zinc alloy material design and medical product creation project has been evaluated by Academician Wang Yingjun and Academician Jiang Baoguo as filling an international gap. It has received technical achievement registration from the Hunan Provincial Department of Science and Technology, completed the world’s first clinical application in 2020, and has been reported by Shaanxi TV and Hunan Red Net.

The company’s biodegradable zinc alloy vascular stent project has been evaluated by a third party as filling a domestic technological gap.

The company uses advanced IT such as digital medical imaging, artificial intelligence, industrial internet, simulation, and big data technologies for comprehensive digital transformation across R&D, design, production, traceability, logistics, operations management, and finance. Product 3D modeling is done with E3D and CAD software; mechanical performance is analyzed and simulated with Abaqus and Ansys; product lifecycle management is handled with Kingdee PLM; smart manufacturing production management is managed with Farsoon Buildstar and Makestar; production quality traceability is managed with UDI software; product circulation management is done with Qianfang Yiji software; operations management is facilitated by Kingdee Cloud OA; and financial and supply chain management is handled with Kingdee KIS software.

Due to its strong IT and intelligent foundation, the company’s “Big Data in Medical 3D Printing Demonstration Project” was recognized as a key project by the Hunan Provincial Department of Industry and Information Technology. The “3D Printing Medical Device STL Visualization Interactive System” received the Changsha City Outstanding Industrial APP Award. In 2021, the company achieved integration management system certification and was recognized as a pilot unit for integration by the Hunan Provincial Department of Industry and Information Technology. The company’s digital transformation and innovation project was listed as a key project for digital transformation in Hunan's manufacturing industry, and in 2023, it was recognized as a smart manufacturing pilot enterprise in Changsha.