Overview

The bioInnovate track aims to provide a comprehensive biomedical device design training program using a multidisciplinary, hands-on teaching approach in classroom, clinical, and laboratory settings. The track focuses students on clinical problem identification, medical device innovation, and commercial translation; all within the regulatory framework of the FDA. Students immerse themselves within clinical environments and learn to evaluate observed procedures and medical devices to uncover unmet clinical needs. Student teams further develop these ideas into testable prototypes and potential businesses by refining these needs into feasible medical device products with commercial potential. Upon completion of the bioInnovate track, students will be able to:

  • Understand and apply 21 CFR 820.30 (Design Control) and ISO 13485 7.3 (Design and Development) in the design and development of medical devices
  • Develop a business strategy, identify potential funding sources, and outline a business model for a medical device startup company
  • Understand how medical devices interact with complex biological systems
  • Develop a medical device using various design tools and methods
  • Develop and implement a regulatory strategy for FDA submission

Masters Students

M.S. students in the bioInnovate track must successfully complete the bioInnovate course requirements, as well as those required for the M.S. degree program.

Ph.D. Students

Ph.D. students in the bioInnovate track must successfully complete the bioInnovate course requirements, as well as those required for the Ph.D. degree program. This includes passing the bioInnovate written qualifying exam. The purpose of the qualifying exam in this track is to verify students’ proficiency in the fundamental principles of Biomedical Engineering, regulatory compliance, medical device innovation, and translational strategy development. Students should take the exam in their second year of study. Although the specific content of the exam changes each year, approximately 50% of the exam covers material from the Bioinnovate track fundamentals courses, and the remaining 50% from student elective classes.

Please refer to the latest Graduate handbook for more information on requirements for bioInnovate courses and graduate degree programs.

Bioinnovate Study Materials

Lecture materials from the program courses are appropriate study guides for the qualifying exam. In addition, the following textbook contains relevant material for the qualifying exam and may be used as supplemental study guides:

Biodesign: The Process of Innovating Medical Technologies. Zenios, Makower, Yock. 2nd Ed, Cambridge University Press, 2015

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

Questions regarding the bioInnovate track should be directed to Dr. Alphonsus Ng