China News Service, Wenzhou, November 14th (Zhang Yicong) Performing minimally invasive surgery in the millimeter-level surgical field that intersects the orbit, nasal cavity, and skull base is like accurately walking through the gaps of stacked overpasses. A slight deviation may touch the "safety red line" of nerves and blood vessels.
Recently, the State Food and Drug Administration approved the launch of the otolaryngology surgery navigation device of Wenzhou Qingrui Zhiyuan Technology Co., Ltd., a company settled in China Eye Valley Town. Through this Class III medical device registration certificate, we can see how, driven by China's Eye Valley Town science and technology innovation platform, clinical needs drive technology research and development, how engineering algorithms iterate product forms, and how the industrial platform undertakes the transformation of results, a full-chain innovation ecology "from the laboratory to the operating room" clearly emerges.
Technical depth: visible and accurate in the millimeter "forbidden zone"
The technical roots of this navigation device stem from real pain points on the clinical frontline. The team of Professor Wu Wencan of Wenzhou Medical University has long been engaged in the endoscopic minimally invasive diagnosis and treatment of optic nerve diseases and eye-nose-related diseases. They have always faced a core problem during surgery in the orbital apex area: the anatomical structures here are densely layered, ultrastructural structures such as the optic nerve are difficult to accurately locate, and intraoperative high-definition visualization is insufficient. It has always been a high-risk "forbidden zone" for surgical operations.
According to reports, around the need for precise positioning in minimally invasive surgery on the orbital apex optic nerve, the above-mentioned team independently developed three-dimensional skull base navigation technology dedicated to the optic nerve, improving the positioning accuracy to 0.12 mm, providing core technical support for solving this clinical problem.
The navigation equipment approved this time is the result of the industrialization of this technology. It covers surgical scenarios related to the eyes, nose, and craniofacial areas. Through optical navigation guidance and intraoperative real-time tracking, it provides surgeons with precise operating guidance and safety margin guarantees. Compared with general navigation equipment, this system has completed exclusive algorithm optimization based on the craniofacial anatomical characteristics of the Asian population and supports personalized surgical path planning. It also integrates AR augmented reality functions, which can overlay and present multiple layers of medical images, allowing doctors to obtain an almost "see-through" navigation effect under minimally invasive incisions, achieving an upgrade from "accurate pointing" to "clear vision and detailed planning".
Transformation mechanism: opening the path from clinical problems to implementation of results
Focusing on the transformation of results and undertaking the industrialization of the above-mentioned technologies, the company will settle in China Eye Valley Town, Longwan District, Wenzhou City in 2023, focusing on the research, development, production and sales of ophthalmic digital diagnosis and treatment equipment. This is not the first time that Wu Wencan's team has "hand in hand" with China Eye Valley - previously, the optic nerve biological microtubules and other achievements developed by the team have been implemented in China Eye Valley through the school's achievement transformation platform, achieving a leap from scientific research to industry.
By condensing the direction of scientific research in clinical diagnosis and treatment, and then promoting industrialization through a product matrix such as navigation equipment, endoscopic technology, and biomaterials, China Eye Valley Town is building a complete innovation link of "basic research - clinical verification - transformation of results - industrial implementation". The approval of this navigation device is a typical node on this link: the clinical team raises real questions, the engineering team transforms clinical experience into standardized products, and the industrial platform undertakes registration applications and implementation support, thereby allowing laboratory technology to truly enter clinical operating rooms.
Ecological support: industrial platform builds fertile ground for innovation and growth
The rapid approval of a Class III medical device is inseparable from the all-round support of the industrial ecosystem. China Eye Valley Town, located in the core area of the Wenzhou Daluoshan Science and Technology Innovation Corridor, was jointly built by the Longwan District People's Government and the Affiliated Eye and Optometry Hospital of Wenzhou Medical University, and has become a core industrial platform for nurturing this technology product.
Relying on the clinical, scientific research and human resources of universities, and superimposing the industrial policies and spatial supporting facilities of local governments, China Eye Valley Town focuses on ophthalmic equipment, visual optics, ophthalmic materials, new ophthalmic drugs, ophthalmic medical treatment, future visual technology and other tracks, and continues to gather enterprises and innovative projects to build a full-cycle industrial service system. Public data shows that the total number of companies settled in Eye Valley Town currently exceeds 950, forming a highly recognizable eye health industry cluster in China.
From a single technological breakthrough to a full-chain ecological formation, the implementation of this navigation device is a vivid confirmation of the innovation model of Wenzhou's eye health industry. In the future, China Eye Valley Town will be guided by technological innovation to produce more original high-end diagnostic and treatment equipment, so that more accurate, minimally invasive, and safer eye health technologies can benefit the majority of patients.
