SBIR/STTR Award attributes
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.This grant aims to improve predictability and reliability of sterilization methods of medical devices by using computer simulations. Current standard of practice is to address sterilization once the product is fully developed potentially leading to expensive changes or failure. Our approach allows to address sterilizability early in the development process thereby lowering development cost and risk and ultimately lowering cost of medical devices.
