Best Practices In Outsourcing Clinical Trials For Medical Device Companies

The medical device market is expected to exceed $286 billion by 2012, with 78% of that market originating in the United States.1 Today the U.S. is home to more than 6,000 medical device companies, and approximately 73% of those have fewer than 20 employees.2 This convergence of marked industry growth and development of medical devices by small companies necessitates the use of external resources to conduct product development functions including clinical trials. The outsourcing of clinical trials is attractive to device manufacturers due to both the financial and operational flexibility of various outsourcing models and the ability to access external expertise in navigating regulatory environments (U.S. and foreign) and in efficiently bringing devices to market.

Contract research organizations (CROs) are filling the need for efficient clinical trial outsourcing and providing device companies with the ability to maintain lean in-house staff and avoid incurring the costs and infrastructure associated with employment. Further, medical device CROs possess the knowledge, key relationships and regulatory acumen to efficiently execute clinical trials, saving device companies time and money.

This paper provides guidance to the aforementioned small- to mid-size medical device companies (Sponsors) planning to outsource clinical trials for the first time.