Senior Design Department of Bioengineering University of Pittsburgh

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Senior DesignDepartment of Bioengineering
University of Pittsburgh

• Mark Gartner, MBA, PhD
• Course developer and instructor
• September 26, 2007
• Presented by Mark Redfern, PhD

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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)

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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

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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

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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

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WISER Center overview
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WISER - Senior Design Interaction
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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.