Characterizing medical device development

This paper first considers the full range of products that are commonly developed today. Next, a set of characteristics generally associated with medical devices is described. These characteristics are the basis for many of the policies and company-wide modes of operation that engineering managers must implement and work under. Using a traditional phased development model, a simple gap analysis between commercial and medical device activities is considered. Next, a two-dimensional mapping is used to consider the how the different factors are emphasized among different project types. The closing section considers shifting business dynamics and the impact on medical device engineering