Barriers to cardiovascular device innovation in Europe

Innovation has played a significant role in the dramatic reduction in mortality due to cardiovascular disease (CVD). Despite this, CVD remains the leading cause of death in Europe, claiming 4.3 million lives each year at an annual cost to the region's economy estimated at €200 billion.1 Now, two worrying trends are emerging that have profound consequences for the continuing fight against CVD: the significant increase in the very elderly population2 and a steep rise in the incidence of metabolic disorders such as obesity and diabetes. Forecasts suggest that, by 2030, CVD could affect up to 40% of the population.3 These trends are likely to translate into a dramatic increase in patient numbers, demand for more effective treatments, and increased pressure on budgets already under intense scrutiny. To respond effectively to this situation, cardiologists have recognized the urgent need for a next generation of cardiovascular treatments and devices. Innovation will have to be focused on pioneering new techniques which allow faster delivery of effective therapies to all patients in need, reduced duration of hospitalization and recovery, fewer re-admissions, improved quality of life, and overall value-for-money. Given the major challenge to cardiovascular health in Europe posed by these adverse trends—as well as the rapidly accelerating cost of healthcare—the argument to address the need is compelling. Yet the Cardiovascular Round Table (CRT) believes that a major element of the innovation process is under threat from declining investment. Device manufacturers are concerned that their ability to invest in future research and development R&D programmes will be limited by the unintentional side-effect of inefficient processes within reimbursement models. Over the …