Total 30 hours for academic year. 6 hours devoted to clinical and design practicum (clinical needs assessment, project proposal, R & D, patent work). 24 hours of supplemental course work as below:
- BME 890 - Summer in Residence, 8 week Clinical Practicum (full-time, tuition-free 8 week experience)
Fall Semester (15 credits):
- BME 502 – Analytic Foundations In BME (4.0 credits)
- IND 501 – Ethics & Prof Integrity (1.0 credit)
- BME 492 – Sp top:Medical Device Design (4.0 credits)
- BME 495 – Master'S Research In BME (0.0 credits)
- Graduate Biology course relevant to surgical specialty; For example: CVS 401 – Cardiovascular Bio & Disease (3.0 credits)
Spring Semester (16 credits):
- OPT 481 – Technical Entrepreneurship (4.0 credits)
- BME 495 – Master'S Research In BME (0.0 credits)
- Choice of two BME Intensive or Approved Engineering Course (4 credits each)
BME Intensives and Approved Engineering Courses can be found on the BME M.S. Curriculum page
Students will also TA during the fall or spring semester for BME Senior Design or other relevant course.
Academic year divided into discrete blocks:
Needs assessment & background research (˜2 months)
This first part of the year represents one of the most important and educational experiences for the design student. The primary goals of these two months is to gain a fundamental understanding of the mechanisms of patient care delivery, operating/procedure room technical capabilities, and disease processes commonly treated in a cardiovascular care line.
Mandatory HIPAA Training
8 weeks of clinical rotations
Clinical Needs Meeting with executive committee
The clinical immersion segment will involve the design student as an integral member of the cardiovascular care team both in and out of the operating room. Each student will rotate in each of the cardiovascular care disciplines below. The rotation schedule will be three days per week (MWF) from 7am to 5pm per day. Specific learning objectives are defined for each rotation.
Students will also be guided through observation and interview exercises to develop skills in
needs finding. Interactions with industry representatives and outside research of current technology and scientific literature will help students identify candidates for projects to receive further development.
At this meeting, students will present a list of clinical needs identified, including a general description of the clinical setting and problem as well as current alternatives and their limitations.
Project Proposal, Feasibility Assessment, & Project Vetting (˜3 weeks)
The project proposal process will require the student to synthesize his/her experiences and needs analysis from clinical immersion toward a focused solution.
Plan and design (˜3 months)
This second and third quarter of the year is when the student's engineering principles merge with their clinical needs assessment. Both clinical and engineering faculty will be available as needed for consultation. Meetings with Drs. Chandra and Lerner or other Engineering faculty will take place at 2-week intervals to discuss the progress of the project, including scheduled deliverables, obstacles, and needs.
Deliverables due every two weeks
Detailed Design Review at end of fall semester
Detailed drawings, analysis and other materials supporting the design concept will be presented in both written and oral form to a panel of engineers and clinicians. Presentation might include demonstration of an early stage prototype as well as plans for further prototyping.
Prototyping (˜3 months)
Students will develop proof-of-concept prototypes using an iterative approach to demonstrate key feasibility of their selected concept. Managing their own prototyping budget, students will coordinate manufacturing of one or more prototypes to demonstrate their concept and identify key issues for testing. Students will periodically report to Drs. Chandra and Lerner or other Engineering faculty to report on progress, demonstrate prototype and establish a plan for testing.
Testing and Draft of Patent Application (˜6 weeks)
This part of the year represents the practical testing of the project as a preparation for obtaining patent (IP) rights. In conjunction with the OTT, the student will assess the deficiencies of the designed project in regards to clinical acceptance or the marketing of licensing rights. A series of targeted experimental trials using available resources at the university will allow the student to obtain preliminary data necessary to differentiate their project from similarly existing patents.
Final Exam/Completion of Degree (May 15 – June 15)
Exit exam will consist of submission and oral defense of a written report of the design solution and proposed implementation for further development. This may include a demonstration of the prototype, reporting on test results for critical design concepts, a draft of claims for a patent application, description of regulatory hurdles, identification of the pathway towards clinical evaluation and critical elements of a business plan.
Oral Exit Exam will be on or around June 15th.
All IP and/or patent applications/approvals will be the property of the University of Rochester as delineated in IP agreement from Office of Technology Transfer (OTT).
Textbooks & Resources
Zenios, S., Makower, J., Yock, P. Biodesign: The Process of Innovating Medical Technologies. Cambridge University Press, 2010. (ISBN-13: 9780521517423)
Cronenwett, J.L., Johnston, W. Rutherford's Vascular Surgery. Elsevier, 2010. (ISBN-13: 978-1-4160-5223-4)Fundamentals of Cardiovascular Device Regulation Meeting FDA’s Mission and Making the Process Work
How to Apply
Applications will be processed through the Department of Biomedical Engineering Graduate Committee.
The Program will begin on July 1st and lasts until mid June of the following year. Applications currently for matriculation July 2013.