Critical Success Factors for the Fuzzy Front End of Innovation in the Medical Device Industry

The purpose of this study is to identify industry-level new product development (NPD) critical success factors (CSFs) that influence the idea screening and project selection processes used by small-to-medium (SMB) medical device manufacturers. Understanding CSFs may assist business executives and NPD managers in improving their processes so as to reduce the high cost of project failure associated with medical device development. Starting with a list of potential CSFs drawn from NPD literature and industry experience, a pilot survey identified 16 CSFs that may prove to be significant in the final research. These CSFs fall into the following three candidate CSF (cCSF) affinity groups: (1) developing a business case prior to project approval, (2) producing an executive-level new product development strategy for the innovation team, and (3) establishing a culture of innovation. This research should contribute to an improved understanding of front end CSFs, help NPD managers develop better criteria for selecting the right project mix, and help those managers achieve higher levels of consistency in meeting project objectives.