1 Introduction The field of interventional cardiology has seen an explosion of innovative treatments in the last 2 decades. Novel devices must meet rigorous thresholds for clinical efficacy and safety. Some innovations succeed more than others. Variations in the success trajectory of innovations cannot be explained by clinical factors, device efficacy, the experience of trialists or the amount of funding available. Many fundamental questions regarding device development have not been formally addressed. Why do some innovations dominate the cardiovascular market, while others achieve only mediocre success? Why do some innovations succeed early in their development cycle (e.g. TAVR) [1] while others (e.g. Watchman) [2] take over a decade to demonstrate safety? Why do devices that succeed in bench studies and animal experiments fail in human clinical trials? Early successes are crucial for any new device or technology. Can device developers maximize their chances of early success? When during device development should pivotal trials be performed? Can device developers use a blueprint to maximize their chances of timely success?