On December 2, 2021, the Department of Industrial Technology (DoIT), Ministry of Economic Affairs (MOEA) released the world’s first intelligent multi-vertebral surgical system, developed by the Metal Industries Research & Development Centre (MIRDC), and served as witness for the signing of a Memorandum of Understanding (MoU) with TM Robot, United Orthopedic Corp., Show Chwan Memorial Hospital, Kaohsiung Veterans General Hospital, and AIBEDA HealthTech Consulting at the Healthcare+ Expo Taiwan held in Taipei Nangang Exhibition Center. Together, they will devote efforts to develop robotic spinal surgery assistive systems domestically and build a local industrial chain for high-end, smart medical systems, thereby helping to further upgrade the medical device industry in Taiwan.
Chyou-Huey Chiou, Director General of DoIT, stated that the domestic medical device industry has proactively integrated Information and Communications Technologies (ICT) into research and development with support from national policy. The industry reached a value of NT$127 billion in 2020, chiefly thanks to the rise of home medical device (glucose meters, contact lenses, mobility scooters, etc.). Nonetheless, Taiwan fully relies on imports of robot-assisted surgical systems, such as those by brands Da Vinci Surgery, ROSA, Medtronic, etc., of which unit prices range between NT$60 million and NT$200 million. Statistics point out that Taiwan has spent NT$68 billion in imported robot-assisted surgical systems over the past five years (Globaldata). In order to take precision medicine to new heights, MIRDC integrated key technologies, such as 3D optical localization, surgical navigation systems, and surgical robotic arms. The world’s first intelligent multi-vertebral surgical system just released can achieve precise localization for surgeries on more than three spinal levels. In comparison, similar systems of overseas vendors, already applied clinically, can only be used for surgeries on less than two spinal levels due to localization limitations caused by excessive large areas. DoIT subsidized the development of relevant technologies by MIRDC with technology project resources. Eventually, the technical bottleneck was unblocked and localization with ≤1.5mm precision was achieved, offering a better solution for the ever-increasing complexity of the surgical environment, which needs to cover wide areas and even multiple targets, and clinical surgical procedures, which require high accuracy. Clinical trials of this system are planned for 2022 and 2023 in order to apply for a 510(K) with the U.S. Food and Drug Administration (USFDA) and approval with Taiwan’s Food and Drug Administration (TFDA). The future price is expected to be more competitive than that of similar products in the market, with the hope of reducing out-of-pocket expenses of Taiwanese patients down to NT$100,000.
Jason Lin, Chairperson of United Orthopedic Corp., expressed that his company had already collaborated with orthopedic surgery robot manufacturer THINK Surgical in 2019 and entered the high-end market in the U.S. and Europe by combining implant surgery and surgical robotic technology. He was delighted about MIRDC bringing together medical experts from industry and academia to develop comprehensive equipment for the system on their own, from navigation and localization systems to robotic arms, resulting in the world’s first multi-vertebral spinal surgery image-guided navigation system. In the future, United Orthopedic Corp. plans to replicate the success of its marketing strategy for the implant surgery and surgical robotic technology, helping this intelligent multi-vertebral surgical system take by storm the global high-end market.
Pei-Yuan Lee, Technology Chairperson of AIBEDA HealthTech Consulting and Honorary Superintendent of Show Chwan Memorial Hospital, indicated that minimally invasive surgery has evolved from common surgical procedures and laparoscopy to robot-assisted surgery. Particularly, the da Vinci Surgical System has helped robotic surgery gain widespread acceptance among patients, opening up plenty of opportunities. The “Key Technology for Intelligent Orthopedic Surgical System” is of great significance as it symbolizes Taiwan remains relevant to the global field of robot-assisted orthopedic surgery. Going forward, medical institutions and private enterprises will collaborate on even greater tasks. Obtainment of approvals and certification, as well as clinical applications will enable Taiwan to make a name for itself in the high-end medical devices sector.
Chih-Lung Lin, Vice President of MIRDC, talked about how the aging population has driven continuous demand for medical devices and market expansion. The current multi-vertebral spinal surgery image-guided navigation system overcomes deficiencies of its predecessors, such as how navigation software regarded visual models as continuous rigid bodies in the past. It is capable of automatic vertebral segmentation, multiple point position estimation, and image-to-physical image registration with up to 94% accuracy. This effectively reduces surgery time for physicians and delivers enhanced medical quality to patients. The surgical robotic arms incorporate products from the renowned manufacturer TM Robot. Equipped with an optical localization module and navigation software, this comprehensive, intelligent robotic arm surgical system can greatly enhance work procedures through optimal human-robot collaboration. Future efforts will continue to focus on advancing the medical device industry by providing a wider variety of smart medical solutions.