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 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. Additional information on the Ph.D. Qualifying Exam can be found in the Department of Biomedical Engineering Ph.D. Requirements.

Life-Science Fundamentals

Students in this track must follow the standard guidelines relevant to their Life-Science Fundamental courses.

bioInnovate Track Fundamentals

Mandated: 2 of 2 required

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

Selected: 2 of 4 required

  • BME 6250 – Biomechanics II
  • BME 6302 – Biomaterials II
  • BME 6401 – Medical Imaging Systems
  • BME 6440 – Neural Engineering

Strongly recommended to take concurrently with BioInnovate:

  • 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.

David Eccles School of Business

  • ACCTG 5620 – Business Valuation and Analysis
  • ENTP 5770 – Business Discovery and Creation
  • ENTP 5774 – Funding the Social Enterprise
  • ENTP 6810 – Venture Foundations
  • ENTP 6820 – Venture Trends
  • ENTP6830 – Applied Venture Skills
  • ENTP 6840 – Venture Planning
  • ENTP 6860 – Lassonde Venture
  • FINAN 5300 – New Venture Finance
  • FINAN 5881 – Managing the Venture Process
  • FINAN 6300 – Venture Capital
  • FINAN 6881 – Venture Planning
  • MBA 6860 – Technology Commercialization
  • MHA 6550 – Marketing for Health Professionals
  • MHA 6553 – Health Care Financial Management
  • MKTG 6551 – The Environment of Healthcare I: Management and Administration
  • MKTG 6552 – The Environment of Healthcare II: Management and Administration
  • MKTG 6715 – Entrepreneurial Marketing
  • MKTG 6860 – Marketing Research
  • 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
  • STRAT 5750 – Profiles of Leadership
  • STRAT 6710 – Strategy and Technology

S.J. Quinney College of Law

  • LAW 7051 – Business Planning
  • LAW 7056 – Corporate Finance: Mergers and Acquisitions
  • LAW 7065 – Intellectual Property
  • LAW 7360 – Health Law
  • LAW 7630 – New Ventures Clinic
  • LAW 7760 – Patent Law
  • LAW 7773 – Intellectual Property Licensing
  • LAW 7788 – New Ventures
  • LAW 7847 – Bioethics and the Law
  • LAW 7889 – Colloquium in Contemporary Issues in Law and the Health Sciences

John and Marcia Price College of Engineering

  • BME 6421 – Fundamentals of Micromachining
  • BME 6701 – Microfluidic Chip Design and Fabrication
  • ME EN 6010 – Principles of Manufacturing Processes
  • ME EN 6030 – Reliability Engineering
  • ME EN 6040 – Quality Assurance Engineering
  • ME EN 6050 – Fundamentals of Micromachining Processes
  • ME EN 6100 – Ergonomics
  • ME EN 6120 – Human Factors in Engineering Design
  • ME EN 6250 – Object-Oriented Programming for Interactive Systems
  • ME EN 6620 – Fundamentals of Microscale Engineering

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).