May 19, 2024  
2020-2021 Undergraduate Academic Catalog 
2020-2021 Undergraduate Academic Catalog [ARCHIVED CATALOG]

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BE 3015 - Biomedical Engineering Design I

1 lecture hours 2 lab hours 2 credits
Course Description
This course introduces students to MSOE’s biomedical engineering design process and the medical device design process in general. The connection is made between MSOE’s BME design process and the FDA QSR design control requirements and common industrial practices. While the general engineering design process is described, emphasis is placed on special medical device design requirements. Students are assigned to teams and projects. Students conduct technical, market, standards, and intellectual property research related to their team’s assignment. Fundamental project management topics and techniques are covered. (prereq: completion of all BE, BI and EE courses in the BME curriculum through winter quarter of junior year or permission of program director if up to two such courses are not completed.)
Course Learning Outcomes
Upon successful completion of this course, the student will be able to:
  • Work effectively on a team to plan a long-term, team-based project
  • Follow FDA QSR guidelines to define design inputs for a medical device design
  • Produce a written document that effectively and efficiently communicates a project proposal. 
  • Determine the FDA device classification of a proposed device
  • Research relevant standards for a proposed medical
  • Conduct intellectual property research and market analysis to describe the prior art of a proposed design

Prerequisites by Topic
  • Basics of FDA device classification and QSR guidelines

Course Topics
  • Design team formation, organization, and operation
  • Design problem definition
  • Project proposal documentation
  • Application of FDA QSR guidelines
  • Identification of customers and customer needs
  • Technical literature reviews including the systematic search of trade, medical, engineering, and intellectual property literature
  • Project budgeting and funding

Dr. Jeffrey LaMack

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