Biodesign-based learning platform fortified with clinical immersion and medical device commercialization pathway

摘要 在生物工程中，与医疗保健相关的重要性日益受到重视。 问题识别、思维、创造力、批判性思维、基于团队的协作和医疗 设备商业化。然而，没有系统的教育机制被纳入 生物工程课程允许生物医学工程学生识别与医疗保健相关的 问题，在临床环境施加的限制下设想解决方案，在 跨学科包容的团队环境，学习医疗器械 商业化进程。为此，我们的首要目标是准备有能力的 生物医学工程师通过创建以整体医疗需求为导向的设计和设备 从一年级扩展到大四的商业化管道。这个 整体医疗需求驱动的设计流程流水线包括10周的临床沉浸 体验(CIE)和为期5周的临床思维设计方案和创新设计- 定向课程。我们与托莱多大学医学中心和 ProMedica将有助于无缝实施CIE。创建需求驱动型设计的目标 流程管道将教授关键设计组件，包括与医疗保健相关的问题 识别、构思、设计迭代、设计约束识别和基于团队 协作。医疗器械商业化管道由知识产权组成 (保护)、专利申请、监管途径、市场分析。拟议的研究 教育计划将在五年内为近1000名学生提供机会 与临床教师和行业导师接触，从大一到大四 好几年了。而临床教员将帮助他们确定临床需求和可能的临床 在医疗器械设计中需要考虑的制约因素，行业导师将提供 设计产品的生产和商业化的前景和制约因素。 由于强制合作计划，我们与行业导师的持续关系将提供 生物医疗器械行业对拟议活动的可持续支持。

Summary In the bioengineering, there is a growing emphasis on the importance of healthcare-related problem identification, ideation, creativity, critical thinking, team-based collaboration, and medical device commercialization. Yet, no systematic education mechanisms are integrated into the bioengineering curriculum to allow biomedical engineering students to identify healthcare-related problems, envision solutions within the constraints imposed by the clinical environment, work in an interdisciplinary inclusive team-based environment, and learn medical device commercialization process. To this end, our overarching objective is to prepare competent biomedical engineers through the creation of holistic medical need-driven design and device commercialization pipelines that expand from the freshman through super-senior years. The holistic medical need-driven design process pipeline consists of 10-week clinical immersion experience (CIE) following by 5-week clinical ideation for design program and innovative design- oriented courses. Our ongoing collaboration with the University of Toledo Medical Center and ProMedica will help to implement CIE seamlessly. The aim in creating a need-driven design process pipeline is to teach crucial design components including healthcare-related problem identification, ideation, design iteration, design constraints identification, and team-based collaboration. The medical device commercialization pipeline consists of intellectual property (protection), patent application, regulatory pathways, market analysis. The proposed research education program will provide an opportunity for almost 1000 students over a five-year period to engage with clinical faculty and industry mentors starting from the freshman through super-senior years. While clinical faculty will help them to identify the clinical needs and possible clinical constraints to be considered in medical device design, the industry mentors will provide perspective and constraints for the production and commercialization of the designed product. Our ongoing relations with industry mentors due to mandatory co-op program will provide sustainable support from the biomedical device industry for the proposed activities.