Multidisciplinary medical product design education as a foundation to drive quality improvement through innovation in patient care

顶石设计“高级设计”是加州大学生物工程系一门为期两学期的课程。 并专注于食品和食品环境中基于风险的医疗产品设计过程 药品管理局(FDA)和医疗保险和医疗补助服务中心(CMS)的要求。未满足 临床需求识别是高级设计的基石，并在课堂外进行 在第一学期开始时大约六周的课程。这些努力最终导致 确定最重要的设计主题，以满足客户的兴趣、能力和未来的市场需求 生物工程专业学生设计团队成员。从历史上看，高级设计中的两个关键挑战是1) 促进生物工程设计学生团队与从临床医生到 家庭成员作为需求发现工作的一部分，以及2)在未得到满足的需求确定过程之后 完成并选定项目主题，获得基本、快速的临床客户(临床医生、护理员、患者) 在整个设计和开发过程中提供反馈和见解。而生物医学工程 学生们一直表现出很大的进入诊所的意愿，他们经常 对于外行来说，临床环境只是简单地“走进门”，这让他们感到气馁。其他 复杂因素包括不熟悉的物理环境、临床规范等不知道该做什么 触摸，有时还会吓坏临床医生的个性。为了应对这些挑战，我们建议创建 护理学院和生物工程系之间的正式本科生伙伴关系 匹兹堡大学。高级护理学生将嵌入到生物工程专业的学生中 设计团队最初在客户发现过程中充当临床促进者。他们的角色是 随后发展为完整的团队成员，为 生物工程专业学生的努力。第二个免费的具体目标是为这些护生提供 具有基于风险的医疗产品设计流程和相关法规的直接经验， 报销和商业化进程。这一经验将为护生的学习奠定基础。 成为未来医疗产品设计和开发活动的更有效参与者。在第三和 最终目标，我们建议在护理学院内创建一个设计工作室/创作室。这个 生物工程师/护理专业学生设计团队将参与设计思维指导，并进行低成本和 在整个项目执行过程中，在这个新设施中进行中等分辨率的原型制作工作。

Capstone design “Senior Design” is a two-semester course in the Department of Bioengineering at the University of Pittsburgh and focuses on the risk-based medical product design process in context of Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) requirements. Unmet clinical needs identification is the cornerstone of Senior Design and is conducted outside of the classroom over the course of approximately six weeks at the beginning of the first semester. These efforts ultimately result in the identification of a capstone design topic suitable to interests, capabilities, and future marketability of the bioengineering student design team members. Historically, two key challenges in Senior Design are 1) facilitating the connection of bioengineering design student teams to caregivers ranging from clinicians to family members as part of needs discovery efforts and 2) after the unmet needs identification process is complete and a project topic selected, obtaining basic, rapid clinical customer (clinician, caregiver, patient) feedback and insights throughout the design and development process. While the biomedical engineering students have consistently demonstrated a great willingness to get “into the clinic”, they are frequently discouraged by the clinical environment that complicates simply “walking in the door” to the uninitiated. Other complicating factors include the unfamiliar physical environment, clinical norms such as knowing what not to touch, and occasionally intimidating clinician personalities. To address these challenges, we propose to create a formal undergraduate partnership between the School of Nursing and the Department of Bioengineering at the University of Pittsburgh. Senior-level nursing students will be embedded into the bioengineering student design groups to initially serve as clinical facilitators during customer discovery efforts. Their roles would subsequently evolve into full team members who bring a unique and complimentary perspective to the bioengineering students efforts. The second complimentary Specific Aim provides these nursing students direct experience with the risk-based medical product design process and associated regulatory, reimbursement, and commercialization processes. This experience will form a basis for the nursing students to be more effective participants in future medical product design and development activities. In the third and final aim, we propose creation of a Design Studio/Makerspace within the School of Nursing. The bioengineer/nursing student design teams will participate in Design Thinking instruction and conduct low- and medium-resolution prototyping efforts in this new facility throughout project execution.