The success of new product development (NPD) is impacted by a variety of factors that include characteristics of the product, development process and environment. For medical devices the problem is more complex due to its high regulated nature and the restrictions these regulations impose on the development process. The Food and Drug Administration (FDA) has been reported as the first external factor affecting companies' ability to develop new medical technology. This paper provides a review of empirical evidence literature describing the success factors for the development of medical devices. The main factors are identified and analyzed in detail through a discussion of the metrics that could be used for their assessment. Some of the factors identified include: the product’s complexity or technical challenge, the experience of the development team, the user involvement, the use of financial analysis in the development process, and the completeness of the development process.