BME272 Final Exam
November 4, 2003
20 questions, 5 points each
Honor Code
Name:______(please print)
Pledge:______
1. The program designsafe (Bruce Main) lists 5 methods for risk reduction, list and briefly elaborate on 3.
2. What is TRIZ, and how is the process used?
3. There are 6 basic characteristics of successful teams. Name 3:
4. Why are Access databases chosen over Excel spreadsheets? What added value is gained?
5. Draw and label the reliability curve for a mechanical device. What measures can be put in place to improve this curve? (Label on diagram.)
6. Define liability. Name three grounds for a lawsuit involving liability.
7. What are the required steps to become certified as a Professional Engineer? What must be done to maintain this certification?
8. Define Harmonization (in the context of this course.) Give an example.
9. What is an “Investigational Device Exemption”, how is it used, and who regulates the granting of the exemption?
10. What is the job of an “Institutional Review Board”? Why do we have such a group?
11. How is medical device software regulated? How is it classified in the US?
12. What powers does the FDA have with respect regulation of medical devices?
13. You have been retained by a company that is being sued for patent infringement for the use of a certain technology (for example, mouse-driven “point and click”) in a medical device. Your opposition holds a patent for this technology as applied to this particular device. What must you do to win your case?
14. What is a non-disclosure agreement? What may happen if one is violated?
15. What is the FDA mandated MAUDE database? How is it populated?
16. List a few techniques used (3-5) in human factors engineering.
17. What is the field of “design for failure”? Give three examples.
18. Dr. Collins discussed several ethical problems involving medical experimentation. Name one and give a brief description of the event.
19. List two early biomaterials and their uses. Who regulates biomaterials in the US?
20. For the following two problem solutions, evaluate the solution on a scale of 1 through 10, 10 being best. Then briefly discuss why you gave the grade you did and explain the basis for your answer (eg: why was A rated higher than B (or vice versa)).
A: Jim has the design task of designing a new disk carrier for students. He starts solving the problem by understanding the design of disks, and then observing how students carry their disks. He also goes to stores, and cruises the web looking for examples of disk carriers. At this point, he starts generating ideas for disk carriers, and comes up with what he thinks is a good carrier for students. The carrier is like the contemporary insulated nylon lunch boxes that are popular. His carrier can accommodate floppies and zip disks, is relatively cheap, and can fit in back packs.
B. Mary is tasked with designing the layout for her dorm room. She starts by sketching the room and cuts out scale models of the furniture oof the room. She then tries multiple versions of the room layout using her model until she is satisfied that she has arrived at the optimal solution of the layout. At that point she enlists the aid of some strong males to reorganize the actual furniture in her room.
Rating for A______Rating for B______
Explanation of ranking: