PBESProceedings of Business and Economic Studies2209-26412209-265XBio-Byword Scientific Publishing Pty. Ltd.10.26689/pbes.v8i7.12832ArticleAnalysis of Key Pathways for the Technological Innovation and Clinical Translation of Medical Deviceshttps://artdesignp.com/journal/PBES/8/7/10.26689/pbes.v8i7.12832XuBo2025872025-12-09Medical devices, as the core support of the healthcare industry, are directly linked to the enhancement of healthcare service quality through their technological innovation and clinical translation efficiency. However, the field still faces a series of challenges throughout the entire value chain, including misalignment of demand, insufficient collaboration, and a lack of engineering capabilities, which hinder the clinical application of many innovative results. Based on the actual conditions of the industry, this paper provides a comprehensive analysis of key issues in various stages, such as source innovation, medical-engineering collaboration, pilot-scale translation, clinical trials, and policy support. Subsequently, targeted optimization strategies are proposed, offering references for advancing the translation of medical device innovations from the laboratory to clinical application, thus achieving a precise match between technological value and healthcare demand.

Liang H, 2025, Research on Intelligent Supervision of Medical Devices from the Perspective of Technological Integration and Regulatory Innovation. Mold Manufacturing, 25(11): 249–251.

Fan K, Cao Y, Feng B, 2025, Discussion on the Application and Innovation of Mechanical Engineering Technology in Medical Device Design. China Equipment Engineering, 2025(20): 50–52.

Li X, Zhou L, Zhang F, et al., 2024, Analysis and Research on Innovative Technologies in the Medical Device Industry from the Perspective of Big Data. China Market Regulation Research, 2024(5): 48–51.

Li J, Huang Y, Huang S, et al., 2020, Analysis and Thoughts on the Construction of High-end Medical Device Technology Standard Innovation Base. China Standardization, 2020(S1): 111–114.