Using biofidelic phantom organs for design stage usability testing of endovascular delivery systems

High quality, well-designed medical devices are necessary in order to provide safe and effective clinical care to patients. Capturing the requirements of users and incorporating these requirements into the design of medical devices is an essential component of positive clinical outcome (Martin et al. 2008). Early stage usability testing provides insight into the end user and aides in the development of an optimum design. Traditionally, early stage usability design of medical devices relied on rigid, bench top, anatomical models or in some cases track models with little or no realism. Animal and cadaveric testing is costly in both time and resources, especially in the early stage of delivery system design. Advances in rapid prototyping and multi material 3D printing have paved the way for the development of biofidelic vascular systems and organs, with obvious advantages for early stage usability testing.