Biomedical Engineering Design: Integrating Simulation, Clinical Immersion, and Regulatory Training

项目摘要 该计划的目的是教育高年级生物医学工程本科生在 生物医学设备设计和开发领域。开发途径通常包括发现和 构思、发明和原型设计、临床前和临床测试、监管决策制定，以及 商业化我们希望培训将导致全面的生物医学工程师，谁可以认识到 生物医学问题的特定需求，并制定适当的程序来设计和实现解决方案。的 这项拟议工作的具体目标是通过临床观察和有效的 同行和多学科的沟通;提高学生提出和验证解决方案的能力， 确定的问题;并整合研究，开发，原型设计，临床前 测试、监管决策和社会责任整合为一个完整的项目。为了实现目标，我们 提供相关的培训体验，以提高学生的参与度并保持项目的连续性。培训 在一年的时间里包括六个阶段：（1）临床工作安排，学生采访临床医生， 发现问题，构思解决方案，并确定他们为期一年的项目;（2）数值模拟课程 其中模拟是不可或缺的设计过程;（3）夏季临床沉浸，学生参加 临床会议，查看手术，并接受更深入的生物医学临床方面的培训 工程;（4）顶点设计课程，学生在更大的多学科团队中工作， 设计、原型制作和测试;（5）法规事务课程，包括FDA研讨会和模拟FDA （6）商业化培训。每年有十名学生组成的多元化小组参加 计划，包括临床沉浸，但这些学生将在更大的多学科团队工作期间， 类项目和顶点设计课程，从而扩大该计划的影响。除了技术能力，我们 还应考虑培养领导能力、团队精神和自我指导能力。在培训结束时，我们希望 参加者将能够以自我指导的方式将所学知识应用于设备开发过程。 我们还希望培训计划将对部门和机构产生更广泛的影响， 希望对未来的生物医学工程本科教育有所帮助。

Project Summary The purpose of this program is to educate upper-division biomedical engineering undergraduate students in the area of biomedical device design and development. The development pathway typically includes discovery and ideation, invention and prototyping, pre-clinical and clinical testing, regulatory decision making, and commercialization. We expect the training will lead to well-rounded biomedical engineers, who can recognize specific needs in a biomedical problem, and develop a proper procedure to design and achieve a solution. The specific aims of this proposed work are to enhance problem recognition by clinical observations and effective peer and multi-disciplinary communications; to improve students’ ability to propose and validate solutions for identified problems; and to integrate multidisciplinary training in research, development, prototyping, pre-clinical testing, regulatory decisions, and social responsibility into one complete program. To accomplish the aims, we provide a linked training experience to enhance student engagement and maintain project continuity. The training includes six phases over the span of a year: (1) clinical workshopping in which the students interview clinicians, discover problems, ideate on solutions, and define their year-long projects; (2) a numerical simulation course in which simulation is integral to the design process; (3) summer clinical immersion in which the students attend clinical conferences, view surgeries, and receive more in depth training on clinical aspects of biomedical engineering; (4) capstone design course in which students work in larger multidisciplinary teams on detailed design, prototyping, and testing; (5) regulatory affairs course including an FDA workshop and mock FDA submission; and (6) commercialization training. A diverse group of ten students per year participates in the full program including clinical immersion, but these students will work in larger multidisciplinary teams during the class projects and capstone design course, thus broadening impact of the program. Besides technical skills, we also consider development of leadership, teamwork and self-direction skills. By the end of the training, we expect participants will be able to apply knowledge learned to a device development process in a self-directed manner. We also expect that the training program will provide a broader impact to the department and institution, and hopefully to future biomedical engineering undergraduate education.