ME 128 Home

Course Syllabus [PDF]

Course Schedule

Lecture Notes

Homework

Benchmark Report

Team Case Study

Design Project - Team
Sign Up Sheet [PDF]

_____________________

ME Home

UCSB Home

Course Description:

Introductory course addresses the challenges of biomedical device design, prototyping and testing, material considerations, regulatory requirements, design control, human factors and ethics.

Course Objectives:

The course objectives are (1) to introduce students to the biomedical device industry, (2) introduction to biomedical design from concept to market, (3) design problem solving, creative thinking, design control, project planning and teamwork and (4) insight into human factors and ethical challenges.

Topics Covered:

1. Engineering Design and Medical Devices
2. Need Identification
3. Human Factors, Anatomy and Physiology
4. Design Specifications
5. Regulatory Requirements and Quality System Regulations
6. Biomaterials and Materials Selection
7. Design Control
8. Patents and Intellectual Property
9. Manufacturing and Quality Control
10. Animal Testing, Clinical Studies, and Ethical Consideration

Course Assignments:

1. Weekly reading assignments, Homework assignments (20%)
      
2. Lecture Quizzes (20%)
      
3. Team Case Study Benchmark Design Engineering Report (30%)
      
   Working in teams, the students will interact with a local medical device company regarding a commercially available product as a benchmark for review. Students should be prepared to sign a confidentiality agreement and invention assignment agreement.
      
   The students should prepare a 15 to 20 page technical engineering report. The students should review and discuss the benchmark device within the framework of the course topics including:
      
   - Need Identification and Problem Definition
   - Anatomy and Physiology
   - Patents and Intellectual Property
   - Performance Characteristics
   - Regulatory Requirements
   - Biomaterials and Materials Considerations
      
4. Team Case Study Design Review Presentation (30%)
      
   Working in teams, the students should propose the design and fabrication of a medical device with “improved” performance characteristics as compared with the benchmark design. The students should prepare and deliver a ten to fifteen minute Design Review presentation and discuss the following:
      
   - Technical Considerations
   - Design Considerations including Patents and IP
   - Proposed Efforts and Activities including Regulatory Requirements
   - Proposed schedule/critical path including Clinical Studies and Quality System Requirement

• If you are a student with a disability and would like to discuss special academic accommodations, please feel free to contact me at your convenience.
• You are expected to attend all lectures. Absences will be noted and will negatively affect your grade.
• Your grade is determined by achievement and results.
• Homework problems are expected to be completed as an individual not in collaboration with others.
• Homework is typically due on Fridays at the start of lecture class.
• Treat all exams and quizzes as work to be conducted privately
• Maintain personal academic integrity in accordance with the College of Engineering Policy on Academic Conduct.
• There will be no make-up for homework, quizzes or exams unless medical note or prior approval of the instructor.
• The last day for all students to add classes is October 14, 2009
• The last day for all students to drop classes is October 21, 2009

Professional Component:

3 units of engineering topic.

Program Outcomes:

1. The student should acquire the experience of working as part of a team to solve a practical design problem.
2. The student should be aware that an engineer often faces ethical issues and should know that the engineer has a responsibility to work within ethical principles.

Relationship to Program Objectives:

1. The student gains experience in applying principles of mathematics, science and engineering to solve problems.
2. The student is required to demonstrate the ability to understand and design a useful product in the context of solving a design problem.
3. The student is required to work effectively as part of a team.
4. The student is required to effectively communicate a design.