The Application of Reliability allocation methodology, from preliminary test data, to design a Definitive test plan. Application to Mechanical Heart Replacement Technology

The objective of this paper is to demonstrate the utility and relevance of the use of reliability allocation methodology in the design of reliability test plans for the qualification of new medical systems. This approach makes use of all of the information collected in the preliminary product development phases. Firstly, this methodology provides a resolution to optimizing the reliability allocation process for the design of a reliability test plan, with a view to cost containment and, secondly, demonstrates the applicability to the demanding constraints provided by the medical sector, and in particular, those in the field of Mechanical Heart Replacement Therapy. The Carmat Total Artificial Heart was the subject of this study, possibly the most demanding of reliability requirements, as it replaces the heart of patients with irreversible bi-ventricular heart failure and who are, consequently, totally reliable on the device for survival.