An e-beam sterilization dose map simulation tool

项目摘要 因为灭菌通常只有在医疗设备经过完全设计和 在生产过程中，与未能达到监管绝育要求相关的成本是天文数字。 在最好的情况下，可以反复修改灭菌配置，直到符合法规要求 相遇了。这是一项既昂贵又耗时的工作。然而，这仍然比最糟糕的情况要好 不得不重新设计设备的部件，或者完全放弃设备。 这种“试错法”在绝育的各个方面都很普遍。作为另一个例子，当 在消毒方法之间的选择，医疗器械公司通常依赖于经验法则，这可能 导致他们的设备选择不是最优的。 因此，医疗器械行业需要一种工具，使他们能够考虑绝育 需求在产品开发过程的早期，以同样的方式考虑其他 工程问题，如热管理、应力分布和环境敏感性。这个 将这种工具结合到产品开发过程中将允许优先考虑 医疗器械安全与消毒有关，这对公众健康有积极影响。 该项目建议通过开发一个模拟工具来填补计算机辅助工程市场的这一空白 能够预测辐射灭菌的结果，而无需完全设计或制造 产品。仅从设备的计算机辅助设计(CAD)模型，建议的软件将能够 计算辐射灭菌过程中的全三维剂量分布 正在处理。通过利用图形处理单元(GPU)的大规模并行架构， 模拟将是快速和用户友好的。 开发这样的模拟工具包括设计一种对三维剂量分布进行评分的方法 在图形处理器上，以及实现辐射灭菌的物理。通过遵循增量 针对已建立的模拟库和测量的开发方法和基准测试 合同灭菌器，这个项目将产生一个准确和验证的原型模拟工具 医疗器械市场。

Project Summary Because sterilization is often only considered after a medical device has been fully engineered and manufactured, the costs associated with failing to meet regulatory sterilization requirements are astronomical. In the best case, the sterilization configuration can be iteratively modified until the regulatory requirements are met. This is an expensive and time-consuming endeavor. However, it is still preferable to the worst cases of having to redesign parts of the device or abandoning the device all together. This “trial-and-error” approach is prevalent throughout all aspects of sterilization. As another example, when choosing between sterilization methods, medical device companies often rely on rules-of-thumb which may lead to a suboptimal choice for their device. As such, the medical device industry is in need of a tool that will allow them to consider sterilization requirements early in the product development process, in the same way they would consider other engineering concerns such as thermal management, stress distributions, and environmental sensitivity. The incorporation of such a tool into the product development process will allow for a first-class consideration of medical device safety as it relates to sterilization, which has a positive impact on public health. This project proposes to fill this gap in the computer-aided engineering market by developing a simulation tool capable of predicting the outcome of radiation sterilization without having a fully engineered or manufactured product. From only the Computer Aided Design (CAD) model of the device, the proposed software will be able to calculate the full three-dimensional dose distribution that would be delivered during radiation sterilization processing. By leveraging the massively parallel architecture of Graphical Processing Units (GPUs), the simulations will be fast and user-friendly. Developing such a simulation tool involves architecting a way to score the three-dimensional dose distribution on a GPU, as well as implementing the physics of radiation sterilization. By following an incremental development approach and benchmarking against established simulation libraries and measurements at contract sterilizers, this project will result in an accurate and verified prototype of a simulation tool for the medical device market.