Estimated Cost of Developing a Therapeutic Complex Medical Device in the US.

Abstract

The US medical device market is the world's largest, but estimates of the cost to bring a medical device to market are not available to help inform policy making and regulatory efforts to enhance device safety and innovation. To estimate the mean expected capitalized cost of developing a novel therapeutic complex medical device. In this economic evaluation, an analytical model of novel therapeutic complex medical device development using data from public and proprietary sources with coverage fro