1. BME Senior Design University of California, Davis October 7, 2015 Anthony Passerini, Ph.D.

2. Program Elements Undergraduate, 3 quarter sequence (~100 students) Receive instruction and guest lectures on topics related to the design of biomedical devices and systems Complete Machining Lab and qualification project Complete CAD Lab using SolidWorks modeling tools Participate in team-based design project (case study) Propose, design, implement and validate a unique solution to an open-ended problem that reflects a genuine clinical need

3. Program Elements Projects in recent years have focused on 3 main themes: 1.Clinical, translation, point-of-care medicine (SOM and CTSC) 2.Veterinary medicine (SVM) 3.Disabilities (Easter Seals and other non-profits) Some have been collaborative efforts with teams from MAE. Some have received special funding from pathology, the CTSC, or SVM. Some have involved partnerships with MBAs and students from the Dept. of Design

4. Novel Feature (Prototyping Lab) Learn the proper use of machining tools and demonstrate their use in fabricating a part to specification Introduction to rapid prototyping: TEAM Design, Prototyping, and Fabrication Facilities (http://bme.ucdavis.edu/team/) CNC Mill Lathe Drill Press Laser Cutter 3D Printers PCB Mill

5. Novel Feature (Prototyping Lab)

6. Best Practices (Managing large enrollments) Management structure Design review panels Electronic evaluation forms Electronic design history files Course Instructor TA #1 TA #3TA #2 Team #1 Team #2 Team #3 …. Team #1 Team #2 Team #3 …. Team #1 Team #2 Team #3 …. Teams meet weekly with TAs Monthly design reviews

7. Outcomes Majority of teams achieve functional prototype More time for verification Direct impact on industry job search

8. Supplementary slides: Reporting structure

9. Reporting/ Review Structure From: Design Control Guidelines for Medical Device Manufacturers (FDA)

10. Reporting/ Review Structure From: Design Control Guidelines for Medical Device Manufacturers (FDA) Prelim EDS or Functional Reqs Progress Report #1 Design Review #1

11. Reporting/ Review Structure From: Design Control Guidelines for Medical Device Manufacturers (FDA) Mfc plan for preferred solution Progress Report #2 Design Review #2

12. Reporting/ Review Structure From: Design Control Guidelines for Medical Device Manufacturers (FDA) Prototype & testing plan Progress Report #3 Design Review #3

13. Reporting/ Review Structure From: Design Control Guidelines for Medical Device Manufacturers (FDA) Closing the loop Progress Report #4 Design Review #4