Biomedical Engineering Design II

BME 49200/ 3 Cr.

This course continues the design experience from BME 49101 with verification, validation, and re-design of student projects. Regulatory and ethical design constraints will be discussed. Oral presentation and report writing are required.

• Available Online: No
• Credit by Exam: No
• Laptop Required: No

Prerequisites/Co-requisites:

P: BME 49100.

Textbooks

TBD. Both electronic and printed handouts will also be distributed throughout the semester.

Instruction Goal

This course, a continuation of BME 49100, continues the real-life experience of engineering problem solving. This semester focuses on verification and validation of the initial design through appropriate testing, followed by re-design, if appropriate. Issues of design ethics and regulatory approval will be addressed. Special attention will be given to the FDA approval process. The course culminates in an official project presentation.

Outcomes

Upon completion of the course, students will be able to:

• Use critical thinking in the testing and redesign process.  [1] 
• Make appropriate measurements necessary for testing the design, addressing the problems associated with the interaction between living and nonliving systems.  [1,2,6]
• Apply engineering principles, mathematics, and science in engineering redesign, including methods, tools and techniques. [1]
• Apply technical knowledge to testing and redesign, including methods, tools and techniques. [2,6]
• Analyze and interpret testing and verification data. [6]
• Discuss ethical issues in engineering design for biological and medical applications. [4]
• Determine ways to test a design to determine its functionality (success of the design). [6]
• Apply knowledge of regulatory constraints to engineering design. [2,4]
• Function effectively on a multi-disciplinary team through mutual support, consensus seeking, cooperation, and sharing responsibility. [5]
• Write a final report, adhering to the specified format using an appropriate writing style, grammar, and spelling. [3]
• Make an oral presentation using effective visual aids. [3]

Topics

• Verification and Validation – Test Plans
• Regulatory constraints and FDA approval
• Ethics
• Redesign
• Monthly Progress reports
• Final Reports and Documentation
• Team Assessments
• Project Presentations