CH Biomedical occupies a significant position in China’s artificial heart and VAD landscape. Its magnetically levitated ventricular assist system has been implanted in multiple leading hospitals, supporting end-stage heart failure patients through complex long-term clinical courses. Clinical studies in this domain involve heterogeneous data sources, variable follow-up patterns, and stringent regulatory expectations. To ensure that this critical information could effectively support scientific reasoning, internal decision-making, and future international submissions, the company required a rigorous and reproducible analytical framework.

Our collaboration began with reorganizing and standardizing the underlying clinical data structure, allowing datasets from different hospitals, devices, and time periods to be integrated into a unified analytical environment. Based on this foundation, we developed robust survival analysis models to examine long-term postoperative outcomes, device dependency, and the interactions among multiple risk factors. Key endpoints were further evaluated through sensitivity and stability assessments to ensure interpretability and statistical defensibility.

As part of the modeling process, we also refined methods for multicenter harmonization, addressing common challenges such as missing follow-up, event-time irregularities, and baseline imbalance. This allowed the resulting evidence to more accurately reflect real-world patient trajectories rather than artifacts of inconsistent data collection.

To support communication across clinical, engineering, and managerial teams, we designed clear and intuitive visualization tools capable of presenting complex statistical trends in a format suited for medical decision-making. Some analytical components were further prepared in alignment with expectations for international regulatory submissions, including FDA-style documentation emphasizing traceability, model explanation, and reproducibility.

Through this ongoing partnership, CH Biomedical has strengthened its capabilities in clinical data science, enabling faster and more confident evaluation of clinical strategies and supporting its broader vision of global regulatory advancement.