Background
Artificial heart valves save and extend the lives of patients all around the world. Heart valve functioning is highly complex, with much variability between patients. The designs keep evolving to address the problems observed with valves implanted in patients. A significant part of the knowledge on the risk and failures of a new valve comes from field experience. Remarkably, artificial heart valve designs do not undergo rigorous design for safety and reliability processes as in aerospace engineering. This situation leads to a significant risk for the health of patients with artificial heart valves and financial risks to medical device companies.