1. Senior Design Department of Bioengineering University of Pittsburgh Mark Gartner, MBA, PhD Course developer and instructor September 26, 2007 Presented by Mark Redfern, PhD

2. Course background Two semester, back-to-back course sequence for all departmental seniors Emphasizes the processes associated with design of a FDA regulated product Projects are conducted consistent with requirements of FDA Quality System Regulation (QSR) Student teams maintain design history files that include typical controlled documents Group design history files are evaluated in the spirit of FDA’s Quality System Inspection Technique (QSIT)

3. Emphasis The course sequence is centered on the unique challenges of product development within the medical environment. Computer aided engineering SolidWorks, COSMOWorks (FEA), COSMOFloWorks (CFD) Statistical design of experiments (DOX) Basic accounting and finance Balance sheets are updated regularly around group project budgets. Finance perspectives used to emphasize, “cost of change” Course content wrapped around FDA quality system regulation and reimbursement

4. Unique new facet: WISER Center Design teams are required to design, fabricate, and test prototype devices consistent with their design requirements and V&V documents Testing is complicated by students inability (generally) to test on animal or humans Senior Design partnered with the Peter M. Winter Center for Simulation, Education, and Research (WISER Center) at the University of Pittsburgh Facility allows students to test prototypes on sophisticated human simulators

5. WISER Center overview 12,000 square foot facility support by Pitt and UPMC 2nd largest simulation facility in the US 100 courses offered In 2006, 3000 students trained; 11,000 “encounters”

6. WISER Center overview

7. WISER - Senior Design Interaction

8. WISER - Senior Design Example Design team developed new inter- osseous drug delivery system Testing the prototypes was limited to bovine models etc. The WISER Center had a facility specifically to train inter-osseous injections. Testing on the models within the WISER Center would have been ideal in this application.