Efficient ensemble simulation methods for in silico trials of endovascular medical devices

传统的医疗器械设计始于临床前产品开发。采用体外实验和体内动物模型分别验证其合理性和有效性。如果成功，接下来将进行临床试验，以测试该设备在人体中的安全性。然而，这些试验的成功率正在下降，成本正在上升。这种失败的一个原因是，传统的试验为大多数人建立了有效性和安全性，但是它们不能根据个人的情况调整治疗。许多报告都指出了这种缓慢的创新体系及其对社会成本和次优医疗保健的影响，但对这一过程的根本变革仍有待开发。本项目将发展数值方法来解决评估血管内医疗器械性能的流体生物力学问题。该框架将以传统临床试验不可行的方式系统地探索患者与设备的相互作用和结果。集成模拟方法将允许在广泛的解剖、生理和设备设计制度中对设备进行测试，从而对医疗设备的安全性和有效性提供更大的信心。

Traditional medical device design begins with pre-clinical product development. In vitro experiments and in vivo animal models are used to establish plausibility and efficacy, respectively. If successful, this is then followed by clinical trials to test the safety of the device in humans. However, the success rates of these trials are declining and costs are rising.One reason for this failing is that traditional trials establish efficacy and safety for a majority of the population, however they are not able to adapt treatment on an individual basis. Many reports have pointed to this slow innovation system and its impact on societal costs and suboptimal healthcare, but radical changes to the process are still to be developed.This project will develop numerical methods to solve fluid-biomechanical problems assessing the performance of endovascular medical devices. The framework will systematically explore patient-device interactions and outcomes in ways that are not feasible for conventional clinical trials. Ensemble simulation methods will allow testing of devices across a wide range of anatomical, physiological and device design regimes, thus providing greater confidence in the safety and efficacy of the medical device.