Syllabus

Homer Stryker MD School of Medicine – Medical Engineering Department

Spring 2021

Lead Faculty: Peter A. Gustafson, PhD

In Collaboration with the Western Michigan University College of Engineering and Applied Sciences

Last update: Mon Mar 15 10:59:17 AM 2021

Schedule

  1. Weekly status report about project progress (~5 minutes per student on average)
    • Typically Monday 1-1:20PM
  2. Lecture
    • Monday 1-2:30PM
    • Wednesday 1-2:30PM
  3. Major assessments
    • One mid term exam – (tentatively March 1st 1PM)
    • Final report OR final exam – (TBD)
  4. Mid-Session Presentation
    • March 1st 1PM (tentative)
  5. Final Presentation
    • Monday April 26th 1PM

Virtual office hours will be held on Google Meet

The calendar is also available full screeen in any browser.

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Course Description

In this course, students will use an integrated interdisciplinary approach to engineering design, concurrent engineering, design for manufacturing, and industrial design for new product development. Topics include design methods, philosophy and practice, the role of modeling and prototyping, decision making, ethics, risk, cost, materials, manufacturing process selection, platform and modular design, quality, planning and scheduling, and creativity and innovation. The course emphasizes entrepreneurial product development.

Prerequisites

  • MedE6330 (Medical Engineering Innovation and Concept Generation)

Textbook/Suggested Resources

  • Creative Design of Products and Systems
  • Saeed B. Niku. Wiley Press 2009
  • Approximately Chapters 7-13

Course outline/topics

  1. Introduction/expectations/purpose of the course
  2. Design considerations, decisions, and consequences
  3. Project planning (Agile, etc)
  4. Human factors in design
  5. Aesthetics of design
  6. Material properties, selection, and processing
  7. Design of experiments
  8. Power Analysis
  9. Economics of design
  10. Quality and design
  11. Design and product liability
    1. Recalls
    2. Reducing product liability risk
    3. Failure mode effect analysis
    4. Design review

Course Objectives

  • To understand and gain experience in modeling and testing medical devices and other associated hardware
  • To develop prototypes that may be useful in a likely thesis or significant project that will be conducted over the remaining time to degree

Learning Outcomes

By the end of the course, the student should be able to:

  • Describe a rational process for bringing a medical device to market
  • Describe a product and its development plan to a variety of audiences
  • Discuss the professional and ethical responsibilities associated with medical product development

Assignments and approximate due dates

There multiple types of assignments in this course. The authoritative due dates are listed on the course calendar.

  • Case study reports [5 required, typically 2-3 pages, estimated 2-3 hours of work per case study]
    • Vioxx recall and its implications
    • Lack of ventilators during the early stages of the Covid-19 pandemic
    • Origins and implications of the opiod crisis of 2019
    • Implications of Theranos on medical device entrepreneurship
    • Implications/priorities of the Covid-19 vaccine roll out
    • Ethics of single use devices
    • Ethics of unlicensed e-textbooks
  • Prototypes
    1. Sketch models (Alpha 0) [Estimated a few hours work per model]
      • At least one per concept, at least 5 concepts (Approximately two per week for weeks 3-5)
    2. Alpha prototypes
      • Alpha 1 - Approximately one per week for weeks 6-9 (One to two of the down-selected concepts)
    3. Beta prototypes
      • Approximately one to two in the remaining weeks
  • Validation plan
    1. Customer survey, etc
    2. Physical experimentation planned (bonus points if executed)
      • Design of experiments
      • Build of jigs/etc
      • Data analysis
    3. Computational models planned (bonus points if executed): Examples include
      • Finite element
      • Computational fluid dynamics
      • Multibody dynamic
      • Matlab/octave
      • Etc… whatever is appropriate
  • Business plan
    • Funding
    • Etc
  • Public Presentations (A subset of these will be selected)
    • Elevator pitch
    • Academic lecture
    • Venture pitch (The week before finals)
    • Academic presentation (AKA final presentation)
    • Grant application (Coordinate with Springstead HSIRB)
  • Other assessment of learning
    • Mid Term Exam
    • Final Presentation/Report

Gradescope.com will be used for most homework distribution, collection, and grading.

Grading System

Percentage Grade
>= 90 A
>= 85 BA
>= 80 B
>= 75 CB
>= 70 C
>= 65 DC
>= 60 D
<60 E
Task Percent
Case Studies 15%
Prototypes 20%
Product Validation Plan/Business Plan 15%
Exams 20%
Public Presentations/Report 30%

Course Policies/Attendance Policy

  • Students are required to attend all lecture and activity sessions unless there is an urgent need to miss them.

Assessment and Evaluation

  • Students will work together extensively on the product development process in this course.
  • Assessment will be done with ongoing feedback
  • Grading will be conducted for each of the major milestones

Locations

  • WMU College of Engineering and Applied Sciences
  • WMU Homer Stryker M.D School of Medicine
  • WMU Homer Stryker M.D School of Medicine Innovation Center