Medical Device Innovation Development Process

Abstract

This research contributes to developing a framework for medical device innovation (MDI) development. The scope of MDI development process is based on a government university hospital. The structure of the research process taken in this paper is based on distinguishing between three empirical case studies to build a conceptual process of MDI invention. An additional case study is used to validate and test the developed model. Specifically, this MDI development process framework is composed of five main steps which are: (i) preliminary systematic analysis, (ii) risk management, (iii) MDI conceptualized design, (iv) clinical development, and (v) production and MIP marketing management. Furthermore, contributions of effective factors for implementing MDI are technological screening, interdisciplinary blending, systematic management, value creation, and synthesis design into MDI invention process.