析心携手海创，数智化验证能否跑通器械创新闭环？

Core Viewpoint - The collaboration between Xixin Technology and Hitransmed aims to reshape the verification paradigm of medical devices through a digital verification platform, enhancing innovation in clinical settings [2][11]. Group 1: Digital Verification Transition - The medical device verification process is undergoing a systematic reconstruction, with the FDA encouraging the use of computer modeling and AI technologies, moving away from mandatory animal testing [4]. - In China, a joint initiative by seven ministries aims to accelerate the application of computer simulation and AI in medical research and device registration, reinforcing a domestic innovation support system centered on numerical verification [4]. Group 2: Platform Collaboration - Xixin Technology will provide a simulation platform based on real anatomical data, facilitating the entire process from design optimization to clinical trial assistance [5]. - Hitransmed will leverage its experience in vascular interventional devices to provide clinical application needs and product development verification scenarios [5]. Group 3: Industry Ecosystem - Xixin Technology's team consists of experts in medical imaging AI, simulation engineering, and device registration, focusing on creating a digital infrastructure that supports the entire lifecycle of medical devices [8]. - Hitransmed positions itself as an international platform for vascular interventional technology, emphasizing a triadic ecosystem of technology, investment, and transformation [10]. Group 4: Systemic Pathways - The collaboration represents a deep integration of verification methods and product chains, exploring a systematic pathway that connects medical engineering innovation, registration efficiency, and clinical accessibility [11][12]. - The essence of the partnership is to create a positive feedback loop from clinical issues to engineering design and application transformation through digital means [12]. Group 5: Trend Judgement - The verification system is becoming a starting point for the next wave of innovation, with digital simulation platforms evolving from supportive tools to integral parts of the innovation pathway [13]. - This shift implies that innovative companies need to embed verification thinking in early designs, while clinical experts gain tools for engineering expression of treatment concepts [13].