Design of a Heart Perfusion Device for Extending Preservation Time: A Case Study of Risk Management for a High-Risk Medical Device

An estimated 50,000 people in India need a heart transplant annually. Today, one of the biggest challenges is practical: moving organs from one hospital to another. LifeBox is a device that addresses this problem with a system that extends preservation time of the heart, specifically to allow for increased travel time and distances. It utilizes non-recirculating, intermittent perfusion of non-oxygenated, cardioplegic solution in hypothermic conditions. Preservation conditions of the donor heart directly affect heart health and patient survival. Consequently, the design of the device presents a unique set of risks that must be adequately identified and addressed. This work presents a case study, using LifeBox that captures the adopted risk management approach. Emphasis has been laid on the pathway to derive requirements that attempt to manage the identified risks. The authors hope that this study will serve as a practical guide for designers, practitioners and innovators in the medical device industry.