The Value of Scientific Publications in Surgical Device Innovation.

Abstract

Clinical trials represent a significant risk in the commercialization of surgical technologies. There is incentive for companies to mitigate their regulatory risk by targeting 510K over Premarket Approval (PMA) pathways in order to limit the scope, complexity and cost of clinical trials. As such, not all companies will publish clinical data in the scientific literature. We set out to investigate the relationship between scientific publication by surgical device companies and the impact it has on