We implemented our plan in full for the vaginal mesh case study.

Assign students into groups and one of four stakeholder roles (2/25)

  1. Device Manufacturer R&D Team
  2. Device Manufacturer Marketing Team
  3. FDA
  4. Surgeons (i.e. users)

Assign Background reading (2/25)

  1. FDA Public Health Notification on Vaginal Meshes (2008)
  2. FDA Public Health Notification on Vaginal Meshes (2011)

The students should lookup 510(k) summaries of the affected products, any marketing literature of those products, clinical studies cited in the FDA notices and any other information.

Guest Lecture: Surgeon (3/1)

Student Pre-work for discussion

  1. Draft a brief statement describing the role that your stakeholder played in the vaginal mesh failure. Prepare supporting evidence.

Student Discussion (3/3)

  1. Assemble into groups and map out the independent and interdependent roles each stakeholder played in the failure of the vaginal meshes.
  2. Submit the map as a group deliverable for the case study. (Paper copy, PPT slide or picture of board work are acceptable submissions)

Student Homework (Due 3/8)

  1. Reflection summary: Referring to your pre-discussion statement did your position with regard to the role of your stakeholder change after the group discussion? If so, how? What did you learn about medical device development from participating in this case study?



We assessed whether the case study met our teaching objective and learning goals by reviewing the concept maps and the reflection summaries. As a whole, the concept maps showed that the students were grasping the distinct yet completely interdependent roles of the various stakeholders in a medical device lifecycle. They also recognized that R&D/engineering was but a small piece, and not always the most critical one, of the overall map.

In our experience, the reflection summaries have been equally beneficial for students and instructors. The students are able to provide their individual opinion and analysis on the topic. They generally find that they learned at least something useful and applicable in their future careers. For the instructors the reflection summaries are a candid feedback mechanism on what aspects of the case studies were successful and what may need revision. We could easily map the student responses to our stated learning goals and find gaps to improve upon in future iterations.