Despite advances in medical care strategies including health care delivery systems, pharmaceuticals, and devices, cardiovascular disease remains the leading cause of death and disability worldwide. This is becoming an increasingly important clinical issue worldwide, in low- and middle-income countries with changing lifestyles, and also in resource-rich countries due to the fact that patients are living longer and, in some areas, comorbid conditions such as diabetes and obesity are increasingly prevalent. To continue improving the outcome of therapy for cardiovascular disease will require multiple parallel steps and the integration of multi-stakeholder expertise. This document will focus specifically on the translational pathways for new devices but many of the key principles will also be germane for the pharmaceutical industry