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

顶点设计“高级设计”是一个两学期的课程，在生物工程系在 匹兹堡大学，专注于基于风险的医疗产品设计过程中的食品和 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， 在第一学期开始的大约六周的课程。这些努力最终导致 确定一个顶点设计主题，适合利益，能力和未来的市场竞争力， 生物工程学生设计团队成员。从历史上看，高级设计的两个关键挑战是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，2）在确定未满足需求的过程之后， 完成并选定一个项目主题，获得基本的、快速的临床客户（临床医生、护理人员、患者） 在整个设计和开发过程中的反馈和见解。而生物医学工程 学生们一直表现出极大的意愿得到“进入诊所”，他们经常 临床环境使门外汉“走进门”变得复杂，这让他们感到沮丧。其他 复杂的因素包括不熟悉的物理环境，临床规范，如知道什么不能 触摸，偶尔恐吓临床医生的个性。为了应对这些挑战，我们建议建立 护理学院和生物工程系之间的正式本科合作伙伴关系， 匹兹堡大学高年级护理专业学生将嵌入生物工程专业学生 设计小组，在客户发现工作中最初充当临床促进者。他们的角色将 随后发展成为完整的团队成员，他们为公司带来独特和互补的视角， 生物工程专业学生的努力。第二个免费的具体目标提供这些护理学生 具有基于风险的医疗产品设计过程和相关监管的直接经验， 补偿和商业化过程。这一经验将形成一个基础的护理学生 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/创客空间。的 生物工程/护理专业学生设计团队将参与设计思维指导，并进行低， 在整个项目执行过程中，在这个新设施中进行中分辨率原型制作工作。

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.