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Senior Design Department of Bioengineering University of Pittsburgh

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Two semester, back-to-back course sequence for all departmental seniors ... teams are required to design, fabricate, and test prototype devices consistent ... – PowerPoint PPT presentation

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Title: Senior Design Department of Bioengineering University of Pittsburgh


1
Senior DesignDepartment 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 FDAs 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 VV 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.
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