Senior DesignDepartment of Bioengineering University of Pittsburgh Mark Gartner, MBA, PhD Course developer and instructor September 26, 2007 Presented by Mark Redfern, PhD
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)
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
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
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”
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.