Name:______

Final Exam

BME 272

October 21, 2010

20 questions, 5 points each

Honor Code:______

  1. Define reliability, give an example. Define failure, give several causes. Define MTBF.
  1. List, and define, three of the five common claims involving product liability.
  1. We discussed 5 levels of design for safety in the coke machine part of the safety engineering lecture. List and define at least 3 of the 5 levels of the safety hierarchy.
  1. What is a concept map and what are they used for? Draw an example for “design of medical devices.”
  1. What are the three FDA medical device classifications? Give an example of each.
  1. What is the Delphi method and what is it generally used for? What are its drawbacks?
  1. In the discussions of TRIZ and of the program Innovation Workbench, the term contradiction (map and/or interaction) was used. What is a contradiction (in terms of design?). Draw an example contradiction map.
  1. What was the stated usefulness of Access, according to our lecturer Dr. Paul Harris? What is a query? What is a key? Give an example of each with respect to a medical database.
  1. Why should you consider licensure (MD or PE)? What are the steps required for the PE? How do you maintain the PE?
  1. Name 5 of the 8 elements of the Business Proposal.
  1. What is the purpose of the group calling itself “Closing the gap”? Give an example.
  1. What is the definition of a medical device (in the US)? What powers does the FDA have with respect to these devices?
  1. Dr. King had a total knee prosthesis installed last July. Draw and label a 3 (or more) function 3 (or more) quality QFD diagram for the design of this prosthesis.
  1. What are a few of the elements listed in the topic “Universal Design for Learning” Where might this “design” be applied?
  1. What are the basic rules of ethics as publicized by such groups as NSPE, IEEE, and BMES? (Name 3 or more …)
  1. What are “typical” uses for Excel versus Access Programs in design work? When and why do you typically go toward Access?
  1. What is involved in the application of “human factors?” Give an example.
  1. What is a Pareto diagram? Give a simple example and discus its use.
  1. Draw an objectives tree for the process of taking a design class.
  1. Dr. King’s wife teaches 4th grade. One of her students has Cerebral Palsy. He needs to use a fairly clumsy walker to move about. He cannot write normally, he can enter responses to homework and classroom exercises into his laptop with difficulty. Outline the steps you would attempt to take to make this student’s life better. (Outline your design plan.) …(continue over side as necessary.)