WHITE PAPER: Implantable medical devices – a clinical approach to designing preclinical studies


Implantable medical devices are being increasingly used in both established and novel clinical applications. Given their invasive nature, such devices are subject to some of the strictest regulations and rigorous pre- and post-market controls. In vivo preclinical models represent a critical tool to study how these devices function in physiological settings and provide supporting evidence for regulatory approval processes.

However, standard experimental design and primary endpoints for preclinical studies are often limited and reductionist. Such studies can overlook common and important clinical aspects of patient condition that could have relevance to device safety and performance. We believe there is significant scope for preclinical studies to provide further insight into how implantable devices function in a range of physiological conditions. This white paper will discuss the current state of preclinical studies in this field and what could lie in the near future.