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Effective: Summer 2014

Grade Type: Letter Grade, the student may select Pass/No Pass
Not Repeatable.
FHGE: Non-GE Transferable: CSU
5 hours lecture. (60 hours total per quarter)

Student Learning Outcomes -
  • Students who successfully complete this course should be able to define product requirements based on customer needs.
  • Students who successfully complete this course should be able to identify major requirements for sterility in clean rooms.
Description -
An introduction to the design and manufacturing of medical devices with special focus on the unique design manufacturing challenges that are necessary to achieve World Class Manufacturing excellence. Describes the fundamental systems used in the design, development, and manufacturing of medical devices and how these relate to industry regulations. Specific topics include: material and process selection considerations, aseptic processes, clean-room techniques, sterilization processes, clinical testing, lot traceability, introduction to automation and control systems, testing and instrumentation lab and manufacturing controls.

Course Objectives -
The student will be able to:
  1. Explain medical device manufacturing processes
  2. Explain the development cycle of a medical device
  3. Explain World Class Manufacturing practices
  4. Understand product requirements
  5. Perform materials selection
  6. Explain strategy development and supplier selection
  7. Explain process selection and monitoring-process validation
  8. Explain aseptic processes
  9. Understand sterility and clean rooms
  10. Understand design testing and validation
Special Facilities and/or Equipment -
None required.

Course Content (Body of knowledge) -
  1. Engineering Design
    1. Definition
    2. Learning design by doing
    3. The evolution of design
    4. Managing engineering design
  2. The design Process
    1. The design process as a process of questioning
    2. Describing and prescribing the design process
    3. Strategies, methods, and means in the design process
    4. Getting started on managing the design process
    5. Case studies
  3. Defining the client's design problem
    1. Identifying and representing the client's objectives
    2. Measuring
    3. Setting priorities
    4. Demonstrating success
    5. Constrains
  4. Functions and Requirements
    1. Identifying functions
    2. Design requirements
  5. Generating and evaluating design alternatives
  6. Design modeling, analysis and optimization
    1. Mathematical habits
    2. Mathematical tools
  7. Communicating the design outcome: building models and prototypes
    1. Prototypes, models, proofs and concept
    2. Building models and prototypes
    3. Selecting a fastener
  8. Communicating the design output: engineering drawings
    1. Design drawings
    2. Fabrication specifications
  9. Communicating the design outcome: oral and written reports
    1. Guidelines for technical communication
    2. Oral presentation
    3. The project report
    4. Final report elements
Methods of Evaluation -
  1. Midterm exams comprised of objective and/or written sections and which require critical thinking and analysis of course readings
  2. Final exam requiring knowledge and analysis of all information gathered during the course
  3. Oral presentation
  4. Written expression in evaluating course topics and which require integration of scientific principles with societal/personal views.
Representative Text(s) -
  • Dym and P. Little, Engineering Design: A Project Based Introduction, 3rd Edition, Wiley, 2008. ISBN: 0470225963. Latest edition.

  • Disciplines -
    Method of Instruction -
    Lecture, group discussion.
    Lab Content -
    Not applicable.
    Types and/or Examples of Required Reading, Writing and Outside of Class Assignments -
    1. Reading Assignments
      1. Weekly reading assignments from text and outside sources
      2. Suggested supplemental readings from articles relevant to course material
      3. Suggested supplemental reading of case studies
      4. Suggested supplemental readings from web searches relevant to course material
      5. Weekly discussions based on reading assignments and which require knowledge and integration of course material
    2. Writing Assignments
      1. Question sets based upon assigned reading on current research topics
      2. Weekly computational problem sets