About the Projects
The design topic (i.e., the specific medical problem to be addressed and its treatment using a medical device) are determined by the students. Students work in teams of 3 people. Each team works on a separate problem. All students on the team receive the same grade for the FDA report, the final oral presentation, and the written design report.
In addition to being novel, the design needs to be realistic and well-rationalized with documented peer-reviewed references supporting the engineering basis for the design; the device needs to have a reasonable expectation of success.
The device is not to be fabricated. However, detailed drawings of the device (with all biomaterials identified), with dimensions, and showing its location in the body are required. Some teams in prior years have patented their designs, and took steps for commercialization. Professors Spector and Yannas allocate a fixed amount of “consulting” time to each group.
Collaboration among Students
Following the team’s PowerPoint presentation of the oral progress report, Professors Spector and Yannas quiz team members individually on their knowledge of their evolving design process. Students are required to answer with no input from other team members.
The FDA report, final oral presentation, and the final written design report require collaboration among members of a team.
Guidelines for Team Consulting with Instructors
Candidate projects are discussed in class until the deadline for the declaration of the membership of teams and the respective design topics; teams can be formed before that date and can begin meeting in their own group sessions.
After the deadline, teams meet separately in consulting sessions with the instructors outside of class, with the following guidelines:
- Prior to the oral progress report, teams meet with both instructors, for a total of at least 30 minutes per team per instructor. Because the two Instructors have had different experiences in the medical device area, the teams are asked to meet with each of them. Teams initiate and arrange meetings with the Instructors. Teams bring specific questions to the consulting sessions.
- After the progress reports have been submitted and 1 week before the final oral presentations, teams continue to meet with both Instructors as needed or requested by the Instructor.
Oral Progress Report/Oral Quiz
The oral PowerPoint presentation is 12 minutes in length, with all members of the team participating in the presentation. The presentation is to define the clinical problem to be addressed by the device, and the current methods of treatment. The rationale and novelty of the team’s approach for the device design needs to be presented. Alternative strategies for the design are acceptable at this stage.
Following the 12-minute presentation, Professors Spector and Yannas direct questions to each team member individually for up to 3 minutes per member, and grade their responses. The questions can be drawn from topics presented in the lectures, as they relate to the design. Questions also can deal with: the basic scientific principle/phenomenon on which the design is based, the biology of relevant wound healing/regeneration processes, the chemical formulation of the device, and/or relevant mechanics and materials science. Each student receives a separate grade.
FDA Report
One report is prepared by each team, dealing with the regulatory issues attendant to the device. The issues related to FDA regulation of medical devices are presented in 2 class lectures. The device design used for the FDA Report is not necessarily the final design. All members of the team receive the same grade. Total length is 8 pages, 1.5 line spacing and Times New Roman 12 or equivalent font; this includes text, all images and references. Here is an outline for the FDA Report (PDF).
Final Written Report
The final written report is limited to 10 pages of text; figures and references are not counted in this 10-page limit; 1.5 line spacing and Times New Roman 12 or equivalent font.
Literature references are to be provided for the sources of text and images in the report; text that has been copied and pasted into the report needs to be placed in quotation marks. This includes text that has been cut and pasted from AI sources.
Examples of Prior Design Projects
Examples of selected design projects can be found on the Supplementary Resources page, under the heading “More Resources (to be updated with time)”, Additional Course Materials.
