Rethinking the Validation Process for Medical Devices: A Cardiac Pacemaker Case Study

Existing techniques for validation of implantable medical devices such as pacemakers are heavily dependent on expensive and timeconsuming clinical trials where the sample size is small and may not represent the variance in a larger population. To address this problem, bio-engineering researchers have proposed various high fidelity models that are used for non real-time simulation. More recently, computer science (CS) researchers have developed more abstract models that are amenable for real-time (hardware-in-the loop validation), but fail to exhibit appropriate dynamic responses. In general, the challenge remains on how to develop the organ models such that they capture the appropriate behaviour while maintaining the real-time response. In this paper, we present a generic step-by-step methodology that can aid researchers who are modelling organs for the validation of medical devices. The goal of this paper is to help: (1) introduce CS researchers to the steps involved in extracting executable organ models from bio-engineering models (2) introduce bio-engineers to emulation models and available computer hardware platforms for synthesising the organ models.