| In recent years,with the development of medical materials and the increasing prevalence of cardiovascular diseases,the design of new cardiovascular balloon catheters products has gradually increased,and the market competition has been fierce.However,the research and development of cardiovascular balloon catheter is relatively late in China,and the quality management of research and development needs to be improved.As a member of the new product design enterprise for cardiovascular balloon catheters,Company H has loopholes in the design quality management of its new cardiovascular balloon catheter products,which led to low customer satisfaction after launch of the first-generation cardiovascular balloon catheter products.Based on the theory of new product design quality management and QFD technology theory,this thesis identifies the loopholes in the design quality management of H Company’s new cardiovascular balloon catheter products,and the problems of unclear design team functions,quality objectives setting,market research,inapplicable product design process and unsound design review mechanism in its management were put forward.Through the introduction of QFD technology,the design quality management of H company’s new cardiovascular balloon catheter products is optimized in four aspects:establishing QFD team and dividing rights and responsibilities;formulating quality objectives based on QFD technology;building design quality management process based on QFD technology;improving design quality management review mechanism.Under the optimized design and quality management of the new cardiovascular balloon catheter product,the QFD team successfully completed the design of the second-generation cardiovascular balloon catheter.Finally,according to the design quality management review mechanism,the design quality of the second generation of cardiovascular balloon catheter was evaluated from three aspects:personnel,achievement of quality objectives and evaluation of design quality management process.The evaluation results showed that the quality awareness and professional level of the personnel had been greatly improved.The second generation of cardiovascular balloon catheter design quality audit and customer satisfaction meet the requirements of quality objectives;The second generation of cardiovascular balloon catheter design quality management process has greatly improved the product design efficiency and design quality.Therefore,it is considered that the improved quality management of the new product design of H Company’s cardiovascular balloon catheter is applicable to the new product design of H Company’s cardiovascular balloon catheter,which has very important practical guiding significance. |