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

项目摘要 该项目的目的是培养生物医学工程专业的高级本科生。 生物医学设备设计和开发领域。发展道路通常包括发现和 构思、发明和原型、临床前和临床测试、监管决策和 商业化。我们预计培训将带来全面发展的生物医学工程师，他们能够认识到 生物医学问题中的特定需求，并制定适当的程序来设计和实现解决方案。这个 这项拟议工作的具体目标是通过临床观察和有效地提高对问题的认识 同行和多学科交流；提高学生提出和验证解决方案的能力 发现问题；整合研究、开发、原型、临床前的多学科培训 将测试、监管决策和社会责任整合为一个完整的计划。为了实现这些目标，我们 提供链接的培训体验，以提高学生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)学生面试临床医生的临床工作， 发现问题，构思解决方案，并确定他们为期一年的项目；(2)在 模拟是设计过程中不可或缺的一部分；(3)学生参加的暑期临床沉浸 临床会议，观看手术，接受更深入的生物医学临床方面的培训 工程学；(4)顶石设计课程，学生在更大的多学科团队中详细研究 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 提交；(6)商业化培训。每年由10名学生组成的不同团体参加 课程包括临床沉浸，但这些学生将在更大的多学科团队中工作 班级项目和顶峰设计课程，从而扩大了课程的影响力。除了技术技能，我们还 也要考虑领导力、团队合作和自我导向能力的发展。到培训结束时，我们预计 学员将能够以自我指导的方式将所学知识应用到设备开发过程中。 我们还预计，培训计划将对部门和机构产生更广泛的影响，以及 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.