他更进一步透露公司清晰的取证路径:"今年年底可能春节前我们还可以拿到多一点，明年我们还计划要拿到两个三类证。我们一直在一步一个脚印在往前 走。" 在产业政策的宏观引领、金融活水的持续支撑与市场主体的创新实践等共同作用下，中国医疗器械行业生态正发生结构性变化。行业主旋律已从规模扩 张，转向以"创新驱动"、"国产替代"、"出海布局"为核心的全面崛起。 在这样的背景下，今海医疗作为国内微创手术领域的深耕者，其发展路径与战略思考为我们提供了一个观察行业演进的样本。根据其管理团队与合作伙伴 在近期一次专访中的阐述，我们得以勾勒出这家公司的真实轮廓。 "默然潜行"与"证"明一切，被低估的硬核壁垒 "我们一直在默默耕耘，从2021年我们转型开始，累计已取得13份中国医疗器械注册证。"在这次与今海医疗团队及其合作伙伴的线上专访中，董事长陈国 宝先生用最朴实的语言道出了公司转型以来的核心成果。 在医疗监管的深水区，这绝非简单的纸面成绩。每一张注册证的背后，都是一套完整的研发、临床、质控和生产体系，是穿越了监管丛林后获得的"技术 通行证"。今海能够在转型的短短三年内获得13份中国医疗器械注册证，足以证明公司研发体系与质量管理体系 ...

Core Viewpoint - The Chinese medical device industry is undergoing structural changes, shifting from scale expansion to a focus on "innovation-driven," "domestic substitution," and "overseas layout" as core themes for growth [2] Group 1: Company Development and Achievements - Since its transformation in 2021, the company has obtained 13 medical device registration certificates in China, demonstrating its robust R&D and quality management systems [3] - The company plans to acquire additional registration certificates by the end of this year and aims for two Class III certificates next year, indicating a steady progression in its regulatory achievements [3] - The company has made significant breakthroughs in endoscope technology, including the development of a 4K 3D naked-eye fluorescence endoscope system, positioning itself as a leader in high-end medical equipment [3][4] Group 2: Strategic Focus and Market Positioning - The company is diversifying its product offerings into areas such as spinal minimally invasive surgery and is investing in AI and surgical intelligence, aligning with future medical trends [4] - The collaboration with clinical experts is seen as a perfect match for advancing AI in surgery, particularly in spinal surgery, enhancing the company's market positioning [4][7] - The company has strategically chosen to focus on the under-served market of osteoporosis vertebral fractures, developing a bone cement infusion robot to address specific clinical needs [9] Group 3: Strategic Partnerships and Ecosystem Development - The strategic partnership with Medtronic aims to develop integrated solutions for navigation spinal endoscopy, enhancing the surgical process's visibility and safety [7][8] - This collaboration represents a shift from being a technology follower to an ecosystem builder, allowing the company to access global high-end medical markets and absorb advanced product concepts [8][11] - The company has established a dual registration mechanism for both domestic and international markets, significantly reducing the time from local launch to international expansion [11] Group 4: Market Trends and Future Outlook - The minimally invasive surgical instrument and consumables market in China is projected to reach 236 billion yuan in 2023, with a compound annual growth rate (CAGR) of 11.5% expected from 2023 to 2028 [13] - The company is well-positioned in this growing market due to its solid qualifications, forward-looking technology positioning, and top-tier ecosystem alliances [16] - The company is seen as a "silent warrior" in the market, with its strong entry barriers and clear technological pathways contributing to its value creation [17]

Core Viewpoint - The electric laparoscopic stapler market in China is experiencing growth due to increasing demand for minimally invasive surgeries, despite facing challenges from centralized procurement policies leading to a market size decline in 2024 [1][14]. Overview - Staplers are essential high-value consumables in modern surgery, replacing manual suturing with devices that use titanium staples for tissue connection [2][14]. - The demand for electric laparoscopic staplers is rising as the number of minimally invasive surgeries increases, driven by an aging population and higher expectations for medical service quality [1][14]. Market Policy - The Chinese government has implemented various policies to support the development of the medical device industry, including electric laparoscopic staplers, creating a favorable environment for market growth [6][9]. Industry Chain - The upstream of the electric laparoscopic stapler industry includes suppliers of metals like stainless steel and titanium, as well as polymer materials and components like firing mechanisms and motors [10]. - The midstream involves the research and production of electric laparoscopic staplers, while the downstream focuses on medical institutions that utilize these devices [10]. Development Status - The market for electric laparoscopic staplers is projected to decline to 3.72 billion yuan in 2024, a decrease of 7.38% year-on-year, due to the impact of centralized procurement policies [1][14]. Competitive Landscape - The market for electric laparoscopic staplers in China is relatively stable, with higher entry barriers compared to manual types, and domestic manufacturers are increasingly competing with established international brands [16][19]. - As of May 2025, a total of 210 electric laparoscopic stapler approvals have been granted by the National Medical Products Administration in China [16]. Industry Representative Companies - Jiangsu Fenghe Medical Equipment Co., Ltd. focuses on the development and production of disposable surgical consumables, contributing to advancements in minimally invasive surgery [19]. - Ningbo David Medical Devices Co., Ltd. has a comprehensive product matrix, including electric laparoscopic staplers, and reported a revenue of 5.27 billion yuan in 2024, with 1.887 billion yuan from minimally invasive surgical instruments [21]. Development Trends - Future advancements in electric laparoscopic staplers are expected to integrate sensor and artificial intelligence technologies, enhancing automation and precision in surgical procedures [23].