BME Senior DesignUniversity of California, Davis

October 7, 2015

Anthony Passerini, Ph.D.

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

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

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

Novel Feature (Prototyping Lab)

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 #1Team #2Team #3

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Team #1Team #2Team #3

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Team #1Team #2Team #3

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Teams meet weekly with TAs

Monthly design reviews

Outcomes

Majority of teams achieve functional prototype

More time for verification

Direct impact on industry job search

Supplementary slides:Reporting structure

Reporting/ Review Structure

From: Design Control Guidelines for Medical Device Manufacturers (FDA)

Reporting/ Review Structure

From: Design Control Guidelines for Medical Device Manufacturers (FDA)

Prelim EDSor

Functional Reqs

Progress Report #1Design Review #1

Reporting/ Review Structure

From: Design Control Guidelines for Medical Device Manufacturers (FDA)

Mfc plan for preferred solution

Progress Report #2Design Review #2

Reporting/ Review Structure

From: Design Control Guidelines for Medical Device Manufacturers (FDA)

Prototype &

testing plan

Progress Report #3Design Review #3

Reporting/ Review Structure

From: Design Control Guidelines for Medical Device Manufacturers (FDA)

Closing the loop

Progress Report #4Design Review #4