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

> **NIH NIH R25** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2020 · $21,532

## Abstract

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.

## Key facts

- **NIH application ID:** 9917577
- **Project number:** 5R25EB025793-03
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Mark Gartner
- **Activity code:** R25 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $21,532
- **Award type:** 5
- **Project period:** 2018-07-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9917577

## Citation

> US National Institutes of Health, RePORTER application 9917577, Multidisciplinary medical product design education as a foundation to drive quality improvement through innovation in patient care (5R25EB025793-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9917577. Licensed CC0.

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