外骨骼机器人作为医疗康复设备在中国迎来发展机遇。2025年该领域市场规模超过16亿元，出货量约2.6万台，其中医疗康复领域占据主要市场份额1。这类机器人通过感知、决策、执行三个模块的协同工作，帮助脊髓损伤、脑卒中等神经系统疾病患者恢复行走功能1。在我国康复治疗师短缺的背景下——每10万人口仅配备3.57名治疗师，而每年术后康复、慢性病康复等人群规模达上亿人次1——外骨骼机器人能将原需2—3个治疗师参与的步行训练减少至1名治疗师，从而缓解从业压力1。
然而，这一技术在发展过程中仍面临多重挑战。设备重量普遍在1.8千克以上，续航时间一般为2—4小时，续航能力提升与重量控制存在内在矛盾1。成本方面，面向医院的产品定价基本在七八十万或上百万元，使许多医疗机构未能真正购买1。不同患者的适用性存在差异，盲目使用可能带来损伤1。在监管层面，外骨骼机器人属二类医疗器械，但各地审评标准不统一，临床疗效参差不齐，部分产品存在超适应证使用的现象1。国家相关标准体系正在制定中，聚焦功能安全、电器安全、机械安全等方面，预计明年发布1。业界正在探索与脑机接口的协同应用，以期实现从"机器带动人"的被动训练向"人带动机器"的主动训练模式的转变1。
China's exoskeleton robot market for medical rehabilitation reached over 1.6 billion yuan in 2025, with approximately 26,000 units shipped, establishing the healthcare and recovery sector as the dominant market segment.1 These devices operate through three core modules—sensing, decision-making, and execution—to help patients with spinal cord injuries and stroke recover walking function.1
The technology addresses a critical healthcare gap, as China experiences approximately 100 million annual rehabilitation cases following surgery and for chronic disease management, while the country is severely understaffed with only 3.57 rehabilitation therapists per 100,000 people.1 By deploying exoskeleton robots, hospitals can reduce the number of therapists needed for gait training from two to three down to just one.1 However, the devices come with substantial barriers to adoption. Hospital-grade exoskeletons typically cost between 700,000 to over 1 million yuan, pricing that has prevented many medical institutions from making purchases.1 The technology also carries inherent limitations: most units weigh over 1.8 kilograms with battery life between two to four hours, creating a trade-off between extending endurance and reducing weight.1
Beyond cost and technical constraints, regulatory inconsistencies pose challenges to the industry's development. As Class II medical devices, exoskeletons face non-uniform approval standards across regions, with clinical efficacy varying significantly and some products being used beyond their approved applications.1 National standards addressing functional safety, electrical safety, and mechanical safety are currently under development and expected to be released next year.1 Looking forward, researchers envision integrating brain-computer interfaces to transition from passive, machine-driven training to active, patient-initiated movement modes.1
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