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

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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.