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 and will be rewarded with a Project Option M.S. Degree.

Ph.D. Students

Ph.D. Qualifying Exam

Ph.D. students in the bioInnovate track specialization must pass the bioInnovate written qualifying exam. The purpose of the Ph.D. written qualifying exam in this track 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 their 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 particular courses are not required, the following set of courses serve as a basis for the qualifying exam. Students who complete the Ph.D. program will be rewarded with a Project Based Degree. Additional information on the Ph.D. Qualifying Exam can be found in the Department of Biomedical Engineering Ph.D. Requirements.

bioInnovate Textbooks

Textbooks and lecture materials from the program 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.

  • BIODESIGN, The Process of Innovating Medical Technologies. Zenios, Makower, Yock. 1st Ed, Cambridge University Press, 2010


For a comprehensive list of specific requirements regarding this track, please review the BME Graduate Resources page and select the Graduate Handbook that correlates to the year you started your program.




Questions regarding the bioInnovate track should be directed to Dr. Alphonsus Ng (801-581-8528).