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

生物医学工程设计：集成模拟、临床沉浸和监管培训

• 批准号: 10204301
• 负责人: Daniel J. Hayes
• 金额: $ 4.16万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10204301
• 关键词: Area; Biomedical Engineering; Clinical; Clinical Research; Communication; Computer Analysis; Computer Simulation; Creativeness; Data; Decision Making; Development; Device Designs; Device or Instrument Development; Devices; Education; Educational Curriculum; Educational workshop; Equipment; Fostering; Future; Goals; Guidelines; Health Technology; Healthcare; Human; Human Resources; Immersion; Institution; Interdisciplinary Communication; Interview; Knowledge; Leadership; Learning; Link; Medical Device; Motivation; Operative Surgical Procedures; Participant; Pathway interactions; Phase; Preclinical Testing; Procedures; Process; Production; Regulatory Affairs; Research Training; Self-Direction; Social Responsibility; Students; Technical Expertise; Testing; Thinking; Training; Training Programs; United States Food and Drug Administration; Validation; Work; base; career; clinical conference; commercialization; cost; design; engineering design; experience; experimental study; ideation; improved; invention; leadership development; learning strategy; lectures; multidisciplinary; peer; peer learning; preclinical trial; programs; prototype; repaired; research and development; research clinical testing; simulation; skills; student participation; technology research and development; training opportunity; undergraduate education; undergraduate student

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.

项目概要 该计划的目的是教育高年级生物医学工程本科生 生物医学设备设计和开发领域的开发路径通常包括发现和开发。 构思、发明和原型设计、临床前和临床测试、监管决策以及 我们期望培训能够培养出能够认可的全面的生物医学工程师。 生物医学问题的具体需求，并制定适当的程序来设计和实现解决方案。 这项拟议工作的具体目标是通过临床观察和有效性来加强对问题的认识 同行和多学科沟通；提高学生提出和验证解决方案的能力 发现的问题；并整合研究、开发、原型设计、临床前的多学科培训 为了实现这些目标，我们将测试、监管决策和社会责任整合为一个完整的计划。 提供链接的培训体验，以提高学生的参与度并保持培训的连续性。 一年内包括六个阶段：(1) 临床研讨会，其中学生进行访谈， (2)数值模拟课程 (3) 学生参加的暑期临床沉浸 临床会议、观看手术并接受生物医学临床方面更深入的培训 工程；（4）顶点设计课程，学生在更大的多学科团队中进行详细的工作 (5) 法规事务课程，包括 FDA 研讨会和模拟 FDA (6) 每年有十名学生参加全面的商业化培训。 计划包括临床沉浸，但这些学生将在更大的多学科团队中工作 课程项目和顶点设计课程，从而扩大了该计划除了技术技能之外的影响。 我们期望在培训结束时还考虑领导力、团队合作和自我指导技能的发展。 参与者将能够以自我指导的方式将学到的知识应用到设备开发过程中。 我们还期望培训计划将为部门和机构带来更广泛的影响，并且 希望未来的生物医学工程本科教育。