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

摘要: 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 may not represent variance in a larger population. To address this problem, bio-engineering researchers have proposed various high fidelity models that used non real-time simulation. More recently, computer science (CS) developed more abstract amenable (hardware-in-theloop validation), but fail to exhibit appropriate dynamic responses. In general, challenge remains how develop organ they capture behaviour while maintaining response. paper, we present generic step-by-step methodology can aid who modelling organs devices. The goal paper help: (1) introduce CS steps involved extracting executable from (2) bio-engineers emulation available hardware platforms synthesising models.