MULTIDISCIPLINARY DESIGN ANALYSIS AND OPTIMIZATION FRAMEWORK FOR REGULATORY DRIVEN MEDICAL DEVICE DEVELOPMENT

Abstract

AbstractMultidisciplinary design optimization (MDO) is a technique used in the design of systems involving the integration of many disciplines. The architecture and formulation of MDO has an impact on the solution time and optimality of final designs. The process of developing medical devices requires the combination of medical and technical knowledge and abilities. Developing a medical device is done by a complicated collection of Product Development Processes that entail tremendous oversight to ensure conformity to regulatory requirements. Regulatory standards often provide stern “Go / No-Go” policies which may discretize the design variables further increasing the complexity of the optimization problem. This work proposes a novel design approach which utilizes systems engineering practices to undertake complex multidisciplinary design optimization while implementing regulatory guidelines for medical devices. The formulated model is then applied and examined in a case study towards the development of a piezoelectric respiratory sensor. It is observed that the novel framework would extensively improve the design space definition and process driven product development practices.