BIOE 8600 (Biomedical Engineering Device Design Innovation) – Fall 2020 (3 Credits: Co-instructor)
BIOE 8610 (Biomedical Engineering Product Translation) – Spring 2021 (3 Credits: Co-instructor)
Course Objectives
- To apply fundamental engineering and scientific principles towards the design and commercialization of medical devices which address real world clinical needs.
- To justify design decisions using sound engineering and scientific theory / principles.
- To identify, interpret and employ critical FDA guidance documents and international standards in support of US FDA regulatory submissions for medical devices.
- To effectively communicate technical information to an audience using both oral and written forms of communication.
- To recognize design constraints imparted by manufacturing scale-up, sterilization and reprocessing considerations.
References
- Biodesign: The Process of Innovating Medical Technologies, Zenios, S., Makower, J., Yock, P., Brinton, T.J., Kumar, U.N., Denend, L., Krummel, T.M., Cambridge University Press, 2nd edition, 2015.
- Design of Biomedical Devices and Systems, 3rd Ed. King, P., Fries, R., Johnson, A., 2014.
- The Quality System Compendium: GMP Requirements & Industry Practice, 2nd Ed., Associate for the Advancement of Medical Instrumentation (AAMI).
- A Complete Guide to Quality Management Systems in the Medical Device Industry, International Standards Organization (ISO 13485).
BIOE 8470 (Transport Processes in Bioengineering) – Fall 2021 (4 Credits: Instructor)
Course Objectives
- Understand the physics in basic transport phenomena in biomedical engineering.
- Understand basic engineering principles involved in biotransport phenomena.
- Apply knowledge of mathematics and engineering principles to analyzing transport phenomena in biomedical engineering.
- Think independently, critically, and creatively.
References
- Basic Transport Phenomena in Biomedical Engineering, 2nd Ed., Fournier, R.L. Taylor & Francis, Philadelphia, PA, 2006.
- Transport Phenomena in Biological Systems, Truskey, G.A., Yuan, F., Katz, D.F. Pearson Prentice Hall, 2004.
- Human Physiology, 7th Ed., SI Fox: McGraw Hill, 2002.
BIOE 4910/H Bioengineering Research and Clinical Summer Immersion at Charleston (BEACH) – 2021 Summer I/II (6 Credits: Co-instructor)
This summer program targets students who are committed to advancing their engineering expertise in graduate schools or health professions after graduation. Hosted by the Clemson-MUSC Bioengineering Program, through hands-on work in research labs and shadowing experiences in clinics at MUSC in Charleston, students will develop a first-hand perspective about the skills necessary to succeed in graduate or health professional schools. The program will be held over 12 weeks (Summer I and Summer II per Clemson 2019-2020 Academic Calendar). For each summer session, students spend a minimum of 135 hours in total on activities including lab research, clinical shadowing and seminars. Friday mornings, all participants will meet in the classroom for seminars given by Clemson or MUSC faculty; postdoctoral scientists; PhD and medical students. Research projects will typically focus on but not limited to the following topics: orthopedics, biomaterials, bioimaging, and stem cell-based tissue engineering.
Eligibility
Rising juniors or seniors in bioengineering or any related engineering majors.
Course Credits
Participants must be enrolled for credit in BIOE 4910 or BIOE 4910H for eligibility. Students who are using this program to meet departmental honors requirements (research thesis and required seminar attendance) must enrolled for both sessions for 6 credits. Students who choose BIOE 4910 (non-honor section) can enroll either or both sessions to get 3 or 6 credits.