bioInnovate Graduate Track
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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 should 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.

Masters Students

M.S. students within the bioInnovate track are required to successfully complete the core bioInnovate courses as well as additional elective bioInnovate courses. The acceptable elective courses are listed below (bioInnovate core and/or advanced courses).

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 bioengineering 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 bioengineering, 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 bioengineering 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 Department of Bioengineering Ph.D. Requirements.

bioInnovate Courses

Core Courses

Competitive Admission Track Courses

Advanced Courses and the Program of Study

The Program of Study in Bioengineering is a list of all courses to be completed by the student as part of the requirements for the Ph.D. The plan must be approved by the advisor and by the research supervisory committee, and submitted to the Director of Graduate Studies prior to taking the Qualifying Exam. For the students in the bioInnovate Track, the Program of Study in Bioengineering 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 five 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.

Business

Law

Mechanical Engineering

All of the following bioengineering track electives can be used as bioInnovate track electives. Students will choose electives based on their bioInnovate design projects to develop expertise in a variety of disciplines.

bioInnovate Textbooks

Textbooks and lecture materials from the above courses are appropriate study guides for the qualifying exam. In addition, the following textbooks contain relevant material for the qualifying exam and may be used as supplemental study guides.

Questions?

Questions regarding the bioInnovate track should be directed to Dr. (801-585-7741).