P10023: VAD Implantation Simulator

Customer Questionnaire

Customer Questionnaire

The following set of questions were sent to our customer on Friday, Oct. 2, 2009. We are still awaiting a reply

Here at RIT, engineers have to partake in a multidisciplinary senior design project for 22 weeks. In the first 5 weeks, each group is expected to have assessed the customer needs, as well as the risks involved. From this process, the group's next step is to develop concepts, and move forward from there.

Our project (P10023) is focused on developing a VAD implantation trainer for surgeons to use. The training simulator is to provide a realistic environment for the person operating. By the end of the 22 week period our goal is to have a working model/prototype.

With that, we have developed a series of questions that we hope will enable us to pick a design concept to move forward with the design, based on your approval with our follow up on the fifteenth of October.
1.) How often are surgeons trained on the procedure of implanting a VAD?

2.) How often would you want to use this device? a. Is it going to be used 20 times a day for one training session a year, or is it used 20 times a month once a month, etc.?

3.) What are common mistakes that surgeons make (or can make) during the procedure? a. Can these be ranked in severity and frequency? b. How would they know they've made a mistake?

4.) If using this device to train, which aspects are most important to a surgeon?

Also the needs listed below are a list that our group developed through a brainstorming session. Rank the aspects you came up with along with the 12 we have developed. (1 being most important, 12 and beyond being least important)

  1. Size of test module
  2. Incorporation of lungs(fak - polymer/elastomer)
  3. Incorporation of tissue to cut through (fake - polymer/elastomer)
  4. Incorporation of cut-able diaphragm (fake - polymer/elastomer)
  5. Use of fake blood as fluid (as compared to a different fluid)
  6. Pig Heart (as opposed to artificial heart[see question 7])
  7. Quick setup and teardown
  8. Cleanable
  9. Removable parts
  10. Beating of heart
  11. Inclusion of liver, and other lower body parts
  12. Ability to cut into chest (as opposed to having the starting point at the rib spreaders

5.) What parts do you think should need to be replaced after each use?

6.) Does the whole device need to be cleaned between each session, or just before it is stored? a. What cleaning materials would be best? (i.e. saline, rubbing alcohol, etc.)

7.) Are surgeons that are training on this procedure already trained on opening a chest? a. How did they train on that procedure?

8.) How long should the trainer life be (robustness)? a. Does it need to be around for 1 year, or should all parts be changed session to session?

9.) What is the average range of people receiving the VAD implant? a. Also, which gender is more likely to receive the implant? i. From these, we are trying to find what chest size to make our model. What size do you believe is an accurate assessment? (I.e. a small male adult, or a large obese man, etc.) ii. Would it be more beneficial to make it adjustable?

10.) What is currently the most used VAD? a. Also, would it be possible to have some hardware donated to use as reference for sizing within our model (such as cannula)

11.) During the procedure, how far do the ribs need to be spread (how much working space is there in a volumetric sense?) a. Also, how much resistance is there to spreading the ribs? (Is there a measurable to this?)

12.) Is a pig heart the most beneficial option to a surgeon to use for practice, or is an artificial heart more viable?

13.) What measures of training are out there now? a. Are you happy with the current methods? i. Why or why not? b. How can these be improved?

14.) Is there anything that you believe we missed or that you may want to add to the scope of our project?

15.) Is there a better way to keep in contact, or is emailing our questions to you the best method for now?

Establish Target Specifications