Medical device firms outsourcing clinical activities

CHAPEL HILL, NC – Medical device organizations that have expanded into emerging markets consistently report double-digit revenue, and a growing number of device companies are conducting clinical trials in these regions. Some companies have opted to use the service of contract research organizations (CROs), while others are establishing small beach-head offices and using local resources. Others have opted to invest in brick-and-mortar research facilities in countries like China and India.

This trend makes it imperative for medical device organizations to evaluate expansion of their clinical programs into emerging markets in order to cut costs and boost sales. Countries such as China and India are now requiring local clinical trials to gain regulatory approvals for market products.

A study done by Best Practices, LLC, called the Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies to Ensure Medical Device Success in a Global Marketplace, delivers hard-to-find external benchmarks on medical device clinical programs' presence in emerging markets, activities outsourced, staffing and budgets.

The study analysed factors associated with outsourcing clinical trial activities, such as cost, staffing, and quality, to help clinical leaders evaluate their organization's approach to outsourcing relative to peers. Both qualitative (including four executive interviews) and quantitative data were used in this study to enable clinical leaders to formulate strategic approaches for engaging emerging regions in clinical affairs activities.