Industry Overview - In 2024, China's medical device industry market size is projected to reach 1.2 trillion yuan, with medical equipment accounting for 55% of the market [2] - The first half of 2025 saw the approval of 45 innovative medical devices by the National Medical Products Administration, representing a year-on-year growth of 87% [2] Market Dynamics - The demand for innovative medical devices is driven by clinical needs, influenced by factors such as an aging population, the decentralization of medical resources, and large-scale updates of medical equipment [3] - National policies are promoting the development of high-end medical devices, accelerating innovation in domestic medical equipment [3] Technological Advancements - The integration of AI and digital technologies is transforming the medical device sector, leading to trends such as agile development and software-defined medical devices [3][4] - The release of the announcement by the National Medical Products Administration on July 3 supports the innovation of high-end medical devices through optimized approval processes and standard systems [3] Regulatory Environment - The medical device industry is characterized by strong regulatory oversight, necessitating rapid product development and innovation to meet market demands [4] - The concept of Regulated Software Lifecycle Management (RSLM) is gaining traction, emphasizing the management of software products embedded in critical medical devices [4] Company Spotlight: PTC Codebeamer - PTC Codebeamer is recognized as a leader in the ALM software space, facilitating compliance with stringent regulations while accelerating innovation in medical devices [4][6] - The platform supports agile software development and integrates with top DevOps and source code management tools, enhancing collaboration and efficiency [5][7] - PTC Codebeamer 3.0, released in April 2025, ensures comprehensive traceability across product development, helping companies mitigate compliance risks [6]