Congenital heart disease (CHD),one of the main causes of infant mortality,should be screened as early as possible.However,the current screening method,auscultation,strongly depends on the doctors’ experience,and the contradiction between limited medical resource and growth of population becomes sharp.This study presents a systematic approach for the conceptual design of a novel screening system.Research and interview are carried out to determine user requirements.Quality function deployment (QFD) with consideration of related products,patent and research is implemented to find out the key user requirements of existing screening device and the order of design descriptors.With the key requirements confirmed,several concepts which focus on satisfying the key requirements are brought out.The final concept of the screening system is chosen by the application of Pugh decision matrix.The implementation of the conceptual design shows that the designed system satisfies the user requirements well.