North Carolina State
University
Biomedical
Engineering Senior Design
BME 451 & 452 is a two semester sequence of courses required of all students graduating in BME at NC State. The course uses a Design Control Process based on the FDA's Quality System Regulations to move student teams from a Needs Assessment through Product Development and Testing. Each team progresses through 5 phases, completing over 30 controlled deliverables, while maintaining a Design History File.
The course includes usual instruction in such areas as safety in design, ethics in engineering, the design process, regulatory considerations, engineering communications, teamwork, intellectual property, and project management via classroom instruction, guest speakers, small projects, and homework.
The formal design project activity commences at the beginning of the fall semester in BME 451 when the students are provided a listing of problems for potential design projects which will be provided by members of the faculty and by engineering and business professionals outside the university. We also permit student-initiated projects so long as there is a project sponsor and the project meets our general guidelines. With some guidance from the instructor, students generally form up into teams of 4-5 persons and select a problem. This selection is done through a competitive process in which preliminary and very brief proposals are generated by the teams for several of the problems.
By the middle of the fall semester, each team will have succeeded in gaining the right to develop a full engineering design proposal, normally for a unique problem. The first stage of developing that proposal is to gain directly from the sponsor(s) an in depth understanding of the problem and to negotiate the actual scope and sponsor's expectations for the project. The final deliverable for the fall semester is the formal proposal, as a written project plan and presentation.
Armed with guidance as a result of their project plans, the teams undertake the final design and implementation processes beginning in the spring semester in BME 452. The deliverable for the spring semester, as far as the project is concerned, is a final design report and formal presentation.
Throughout the process, the student teams maintain close contact with their sponsors. The course instructor provides general oversight of their activity and helps to locate information resources and stimulate thinking along the way. The course instructor also interacts with the sponsors as needed and is always available for addressing issues from the perspective of the sponsors and the students.
While the development of patentable intellectual property is not a requirement, the students are expected to conduct their work in an environment of colleagueship within the course with the BME faculty, and with the sponsor(s) while appropriately attending to practical IP measures, the need for which they are sure to experience in the real world of engineering design. They receive significant instruction in how to handle the issues of IP.
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The undergraduate program in Biomedical Engineering at NC State University is accredited by the Accreditation Board for Engineering and Technology and is provided by the faculty and staff of the Department of Biomedical Engineering. The department is a part of the College of Engineering at NC State and of the School of Medicine at UNC-Chapel Hill.