The USF Biomedical Engineering Capstone is a year-long, sponsor-driven design experience where student teams transform authentic clinical and industry problems into functioning solutions using the Stanford Biodesign Process. Guided by faculty, mentors, medical professionals, and industry engineers, teams deliberately combine biomedical, mechanical, electrical, and computing skill sets to navigate the full engineering journey—from early stakeholder interviews and problem framing to measurable requirements and testable specifications.
After discovery, students move quickly into concept generation, down-selection grounded
in evidence, and rapid prototyping. Bench testing informs iteration, while safety
and usability are treated as first-class constraints through early risk analysis and
human-factors checkpoints. To reflect real-world practices, teams also integrate CAPA
(Corrective and Preventive Action) approaches, adhere to design control frameworks,
and manage requirements in alignment with regulatory standards like FDA guidance and
ISO 13485.
Professional rigor anchors the work: students apply systems engineering principles
to manage budgets and schedules, conduct design reviews, document decisions, and build
verification and validation plans directly tied to requirements. Parallel to technical
work, quality-focused practices such as QA documentation ensure that outputs align
with sponsor expectations and industry norms.
The outcome is not just a working prototype but a design history package that project sponsors can carry forward in R&D. All of Capstone’s projects highlight the program’s translational focus while leveraging advanced manufacturing techniques and equipment. The sequence culminates in a public showcase where industry and clinical judges evaluate technical rigor, usability, and potential impact—followed by awards that recognize innovation, compliance rigor, and engineering execution. Many projects continue beyond the course as sponsored follow-ons, conference presentations, or early intellectual property efforts.
Graduates leave with portfolio-ready artifacts and the experience of communicating complex engineering decisions to non-technical stakeholders, while project sponsors gain de-risked prototypes and an early look at top talent. Capstone provides a powerful launchpad preparing students to join multidisciplinary teams to transform ideas into regulated, real-world solutions.