Advances in medical technology have improved patient care for millions of Americans by giving physicians tools for life-saving therapies. However, patient and physician demand for access to breakthrough medical technology often comes in conflict with the urgent need for payors and providers to reduce costs. Consequently, the FDA is beginning to scrutinize the value for the dollar created by new technologies and is raising the clinical bar for approvals. These factors are contributing to a more challenging environment in the U.S. for medical innovation.