Overview

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 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 Department of Biomedical Engineering Ph.D. Requirements.

bioInnovate Courses

Core Courses

  • BME 6081 – Biomedical Device Innovation I
  • BME 6082 – Biomedical Device Innovation II

Competitive Admission Track Courses

  • BME 6181 – Clinical Problem Solving Through Strategic Analysis I
  • BME 6182 – Clinical Problem Solving Through Strategic Analysis II

Advanced Courses and the Program of Study

The Program of Study in Biomedical Engineering 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 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 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

  • FIN 6300 – Venture Capital
  • FIN 6881 – Managing the Venture Process
  • MGT 6810 – Entrepreneurship
  • MGT 6830 – Entrepreneurial Consulting
  • MGT 6860 – Lassonde
  • MGT 6910 – Management of Technological Innovation
  • MGT 6710 – Strategy and Technology
  • MGT 5750 – Profiles of Leadership
  • MGT 6840 – Venture Planning
  • MGT 5850 – Entrepreneurship and Poverty
  • MGT 5770 – Business Discovery
  • MGT 6820 – Venture Trends
  • MKT 6715 – Entrepreneurial Marketing
  • MKT 6860 – Marketing Research
  • MKT 6551 – Environments of Healthcare I
  • MKT 6715 – Entrepreneurial Marketing
  • MKT 6860 – Marketing Research
  • MKT 6715 – Entrepreneurial Marketing
  • MKT 6860 – Marketing Research
  • MKT 6551 – Environments of Healthcare I
  • MKT 6552 – Environments of Healthcare II
  • MBA 6860 – Technology Commercialization
  • MHA 6550 – Marketing for Health Professionals
  • MHA 6553 – Health Care Financial Management
  • MST 6020 – Effective Leadership and Management for Scientists
  • MST 6021 – Strategic Planning and Marketing for Scientists
  • MST 6022 – Production and Operations Management for Scientists
  • MST 6600 – Applied Statistical Techniques
  • FINAN 5300 – New Venture Finance
  • ACCTG 5620 – Financial Statement Analysis

Law

  • LAW 7250 – Biotech and Chemical Patents
  • LAW 7630 – New Venture Clinic
  • LAW 7773 – IP Licensing
  • LAW 7788 – New Ventures
  • LAW 7847 – Bioethics & the Law
  • LAW 7051 – Business Planning
  • LAW 7056 – Corporate Finance
  • LAW 7800 – Curr Issues Law & Biosciences
  • LAW 7360 – Health Law
  • LAW 7760 – Patent Law
  • LAW 7065 – Intellectual Property

Mechanical Engineering

  • ME EN 6050 – Fundamentals of Micromachining Processes
  • ME EN 6620 – Fundamentals of Microscale Engineering
  • ME EN 6010 – Principles of Manufacturing Processes
  • ME EN 6100 – Ergonomics
  • ME EN 6120 – Human Factors in Engineering Design
  • ME EN 6960 – Microfluidic Chip Design and Fabrication
  • ME EN 6040 – Quality Assurance Engineering
  • ME EN 6020 – Computer-Aided Manufacturing
  • ME EN 6030 – Reliability Engineering
  • ME EN 6040 – Quality Assurance Engineering
  • ME EN 6250 – Object-Oriented Programming for Interactive Systems

All of the following biomedical engineering 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.

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

Questions?

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