Promotion of Clinical Application Evaluation for Research & Development and Design of
Domestic Laparoscopic Stapler
XIONG Wei1, SUN Jing1, SUN Fei1, FENG Jingy1,2
1. Department of Clinical Engineering and Material Supplies, The First Affiliated Hospital, Zhejiang University School of Medicine,
Hangzhou Zhejiang 310003, China; 2. Key Laboratory of Clinical Evaluation Technology for Medical Device of Zhejiang Province,
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou Zhejiang 310003, China
Abstract：Objective Through the clinical simulation application evaluation of domestic laparoscopic stapler prototype, to quickly
found the shortcomings and improvements of the stapler prototype, to promote its research & development (R&D) and design process
to better meet the needs of clinical practical application. Methods A simulation platform for the clinical real application scenario of
domestic laparoscopic stapler prototype was established. Clinical experts were selected, and expert evaluation methods were adopted
to carry out application evaluation of manual and electric laparoscopic stapler prototypes from the dimensions of performance,
usability, effectiveness, ease of use, ease of learning and satisfaction. Results The proportion of all performance indicators of the
two stapler prototypes as “excellent” or “good” could reach more than 80%, but there was a lot of space for improvement in the
indicators such as trocar matching, gun barrel rotation, jaw bend, grasping operation and safety switch. The system usability scale
evaluation results showed that the manual laparoscopic stapler prototype had better usability than 60.43% of similar products on the
market, and the electric laparoscopic stapler prototype had better usability than 76.45% of similar products on the market. The results
of usefulness, satisfaction, and ease of use scale showed that the manual laparoscopic stapler prototype was inferior to the electric
model in terms of effectiveness, ease of use, ease of learning and satisfaction. Conclusion The application evaluation of domestic
laparoscopic stapler prototype carried out in this paper directly feeds the device experience of clinical staff, actual needs, device
defects, device optimization and improvement plans to the R&D team, and it can avoid unnecessary R&D resource consumption,
improve R&D efficiency and process, and provide experience reference for the development of domestic laparoscopic stapler
industry.
熊伟1，孙静1，孙斐1，冯靖祎1,2. 临床应用评价促进国产腔镜吻合器研发设计[J]. 中国医疗设备, 2023, 38(11): 116-121.
XIONG Wei1, SUN Jing1, SUN Fei1, FENG Jingy1,2. Promotion of Clinical Application Evaluation for Research & Development and Design of
Domestic Laparoscopic Stapler. China Medical Devices, 2023, 38(11): 116-121.
