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.

项目总结