Automated Safety Systems Engineering for Focused Ultrasound Medical Devices

聚焦超声是一种革命性的非侵入性手术方法，它利用超声能量精确地破坏身体深处的组织，而不会对周围组织造成切口或损伤。它可用于治疗多种疾病，与传统手术方法相比，有可能提供更快的恢复，更少的副作用和更低的护理成本。聚焦超声医疗设备复杂且软件密集；此外，它们对安全至关重要，必须采取重大措施确保它们的可靠性、稳健性和安全性。该项目旨在开发新的软件和安全工程技术，以提高聚焦超声医疗设备软件开发人员的生产力，并帮助确保最终产品是安全的，并且可以根据相关医疗标准进行认证。通过解决认证的技术挑战和非常巨大的成本，该项目将开发技术，不仅能够大大提高软件密集型医疗设备的安全性，而且还将使加拿大医疗设备行业受益，特别是中小型公司，对他们来说，认证成本是一项巨大的财务负担和风险。

Focused ultrasound is a revolutionary non-invasive surgical approach that uses ultrasound energy to precisely destroy tissue deep in the body without incisions or damage to surrounding tissues. It can be used to treat a broad range of medical conditions, with the potential to offer faster recovery, decreased side effects and reduced cost-of-care compared to traditional surgical methods. Focused ultrasound medical devices are complex and software intensive; moreover, they are safety critical, and significant steps must be taken to ensure their reliability, robustness and safety. This project aims to develop new software and safety engineering techniques to both improve the productivity of software developers of focused ultrasound medical devices and help ensure that the ultimate product is safe and can be certified as such in compliance with relevant medical standards. By addressing the technical challenges and very significant costs of certification, this project will develop techniques that will not only enable substantial improvements in the safety of software-intensive medical devices, but will also benefit the Canadian medical device industry, and in particular small-to-medium sized companies, for whom the cost of certification is a tremendous financial burden and risk.