With the advancement of new technologies and diverse customer-centered design requirements, the medical device design decision making becomes challenge. Incorporating multiple stakeholders’ requirements into the medical device design will significantly affect the market competitiveness and performance. The classic design decision making approaches mainly focused on design criteria priority determination and conceptual schemes evaluation, which lack the capacity of reflecting the interdependence of interest among stakeholders and capturing the ambiguous influence on the overall design expectations, leading to the unreliable decision making results. In order to relax these constraints in the medical device design, this paper incorporates rough set theory with cooperative game theory model to develop a novel user-centered design decision making framework. The proposed approach is composed of three components: 1) end/professional user needs identification and classification, 2) evaluation criteria correlation diagram and scheme value matrix establishment using rough set theory; and 3) fuzzy coalition utility model development to obtain optimal desirability considering users’ conflict interests. We used a blood pressure meter case study to demonstrate and validate the proposed approach. Compared with the traditional Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) approach, the proposed approach is more robust.

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