With the continuous improvement of medical testing and instrumentation engineering technologies, the design, testing and development methods of in vitro diagnostic instruments are developing rapidly. In vitro diagnostic instruments are also gradually developing into a class of typical high-end medical equipment. The design of in vitro diagnostic instruments involves a variety of medical diagnostic methods and biochemical, physical and other related technologies, and its development process involves complex system engineering. This paper systematically organizes and summarizes the design, testing and development methods of in vitro diagnostic instruments and their development in recent years, focusing on summarizing the related technologies and core aspects of the R&D process, and analyzes the development trend of the in vitro diagnostic instrument market.