6. SPECIALIZED GRADUATE TRACKS
The goal of the graduate program is to provide an educational framework that will encourage students to excel in a
chosen area of specialization with relevant technical competence. Each of the specialized graduate tracks has a track
advisor. The track advisor’s role is to guide the curricular content of the track, establish the specialized track courses,
develop track requirements for recruiting prospective graduate students and to advise the student in preparing for the
PhD written qualifying exam. Each student works with a graduate track advisor, their research advisor, and their
supervisory committee to design a program of study that meets the M.S. or Ph.D. requirements. The program of study
should reflect the specific research interests of the student and be designed to develop the highest possible level of
expertise.
The Ph.D. written qualifying exam is structured around each student’s area of specialization and therefore courses
completed as part of the program of study serve as partial preparation for the qualifying exam. The following
Specialized Track areas form the basis for Ph.D. writing qualifying exams and M.S. programs of study.
BIOINNOVATE
Dr. Robert Hitchcock, Advisor
Medical Device Design and Development
Business Plan Development
The bioInnovate track aims to provide a comprehensive biomedical device design training program through the use of
a multidisciplinary, hands-on teaching approach in classroom, clinical, and laboratory settings. The track will focus
students on clinical problem identification, medical device innovation, and commercial translation; all within the
regulatory framework of the FDA. Students will immerse themselves within clinical environments and learn to observe
procedures and medical devices to uncover unmet clinical needs. By refining these needs into feasible medical device
products with commercial potential, student teams will further develop these ideas into testable prototypes and
develop business. Upon completion of the bioInnovate track, students will be able to 1) observe and identify unmet
needs in clinical environments, 2) work effectively in multidisciplinary teams in asynchronous environments, 3)
understand and apply FDA QSR in the design and development of medical devices, 4) develop a business plan, attract
potential funding sources and start a company in the medical device industry.
Ph.D. Students
Ph.D. Qualifying Exam: Ph.D. students in the bioInnovate track are expected to have general knowledge in the field.
General knowledge includes Biomedical Engineering fundamentals, clinical needs identification, concept generation,
FDA QSR, medical device design and development, prototyping and testing, business concepts, and business plan
development. The purpose of the Ph.D. Qualifying Exam is to encourage students to revisit the fundamental principles
in Biomedical Engineering, regulatory compliance, medical device innovation, and business development. Students
should take the exam in the second year of study. Although the specific content of the exam changes each year,
approximately 25% of the exam covers material from the M.S. level Biomedical Engineering core curriculum and 75%
of the exam covers topics specific to the field of medical device development and clinical needs finding. Although
specific courses are not required, the following set of courses serve as a basis for the bioInnovate qualifying exam.
Additional information on the Ph.D. Qualifying Exam can be found in the “Examinations” section to follow.
For students in the bioInnovate Track, the Program of Study in Biomedical Engineering should include a hierarchy of
courses selected to develop expertise in a focus area. Although there are no specific requirements, knowledge in
fundamental areas noted above will be required to pass the Qualifying Exam. Additional expertise in a focus area will
be required to perform well on the research proposal.
Additional courses must be completed to meet the minimum course credit hour requirements for the Ph.D. A typical
plan of study would include approximately 5 specialized courses in addition to the bioInnovate track core courses to
reach the course credit requirement. A limited set of example courses are given below. The specific set of courses, over
and above the bioInnovate track core courses, should be selected on an individual basis to maximize expertise in the
area most closely related to the student’s area of research.