The authors recommend changes to the paradigm employed in the current ISO Heart Valve Standard (ISO 5840) so that future patients who receive a heart valve prosthesis are assured of a device that will function with minimal complications for at least 25 years. Based on valve failures of the past decade, it is clear that current standards are inadequate because present-day Standards and Regulatory Agencies operate in a manner which inhibits innovation and creativity. Thus, engineers and scientists in this field react to problems, rather than proact. As we approach the new millennium, the authors consider it time to rethink the ground rules.