Medical Device Design and Innovation; Orthopaedic Implant Failure Analysis and Redesign

项目摘要 拟议的基于团队的医疗器械设计与创新课程将为本科三年级学生做好准备。 和高级生物医学工程专业的学生，拥有强大的工具包，成为医疗技术的创新者， 设计减少医疗错误和器械故障危险的器械所需的技能。暑期临床 浸泡，重点是识别医疗器械可预防并发症的潜在来源 不良事件和失败，将为学生提供关于安全交付的更广阔的视角， 健康护理此外，在长达一个学期的课程中， 设备故障将为学生提供负责任地开发设备的技能。 该计划将在夏季开始，最多10名学生将通过为期8周的 与耶鲁大学6个不同专业的内科医生和外科医生长期轮换。学生将与他们的工作 医生导师识别可预防的医疗/手术错误、器械用户相关危害的原因， 器械失效危险，目的是通过医疗器械设计解决这些可预防的并发症 项目此外，学生将参加教学法与结构化的夏季课程，重点是 需求确定、评估和风险管理。 在秋季，10名暑期学生将继续他们的临床沉浸阴影每周1天， 参加校园范围内的“设备设计演讲者系列”。在春季学期的课程中，每年夏天 奖学金学生将组成一个3-5人的设计团队的核心。根据需要/问题/ 在夏季和秋季临床浸泡确定可预防的医疗错误，学生，以下 生物设计创新过程中，将设计一个功能原型和商业化计划。与此同时， 在整个春季学期，学生将在一个单独的故障分析项目工作，学习如何 精确定位和模拟潜在的关键医疗器械故障机制。教学讲座将包括主题 如器械设计过程、法规事务、人因工程、负责任的行为 研究和校外医疗器械研发设施之旅。在课程结束时，开放获取内容 将作为免费的在线课程出版，学生将提交论文到PubMed索引期刊。 该应用程序的创新是将工程专业的学生嵌入临床环境中， 他们的潜在来源，可预防的医疗并发症和设备故障，以及教他们 如何识别、模拟和建模关键故障机制。这门课程旨在吸引 代表性不足的少数民族，将导致未来科学家的实际经验， 在临床环境中将有助于他们进入生物医学工程职业生涯。本课程将利用 工程、创新和医学研究资源。大学生物医学 工程生态系统也将受益于工程学院和临床医生之间的合作。

PROJECT SUMMARY The proposed team-based Medical Device Design and Innovation course will prepare undergraduate junior and senior biomedical engineering students with a robust toolkit to be innovators of medical technologies with the skills necessary to design devices that reduce medical errors and device failure hazards. A summer clinical immersion, with a focus on identifying potential sources of preventable complications from medical device adverse events and failures, will provide the students a widened perspective regarding the safe delivery of healthcare. In addition, training during the semester long course in analyses of common causes of medical device failure will provide the students the skills to develop devices responsibly. The program will start in the summer with a clinical immersion for up to 10 students rotating through an 8-week long rotation with Yale physicians and surgeons from 6 different specialties. Students will work with their physician mentors to identify causes of preventable medical/surgical errors, device user-related hazards and device failure hazards, with the goal of addressing these preventable complications with medical device design projects. In addition, students will participate in didactics with a structured summer curriculum focusing on needs identification, assessment and risk management. In the Fall, the 10 summer students will continue their clinical immersions by shadowing 1 day a week, and participate in a campus wide “device design speaker series”. Within the Spring semester course, each summer Fellowship student will form the nucleus of a design team of 3-5 members. Based on needs / problems / preventable medical errors identified within the summer and fall clinical immersion, the students, following the biodesign innovation process, will design a functioning prototype and commercialization plan. Concurrently, throughout the Spring semester, students will work on a separate failure analysis project to learn how to pinpoint and simulate potential critical medical device failure mechanisms. Didactic lectures will include topics such as the device design process, regulatory affairs, human factors engineering, responsible conduct of research, and off-campus trips to medical device R&D facilities. At the end of the course, open access content will be published as a free online curriculum, and students will submit papers to PubMed indexed journals. The innovation of this application is to embed engineering students within a clinical environment, exposing them to potential sources of preventable medical complications and device failures, as well as teaching them how to identify, simulate and model critical failure mechanisms. This course, which seeks to attract underrepresented minorities, will result in an improved pipeline of future scientists whose practical experience in a clinical environment will facilitate their entry into biomedical engineering careers. The course will utilize the engineering, innovation and medical research resources at Yale University. The University biomedical engineering ecosystem will also benefit from collaboration between engineering faculty and clinicians.