Biomedical Engineering Design and the Promotion of High Value

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					Biomedical Engineering Design
  and the Promotion of High
   Value Relationships with
      Clinical Medicine

       Robert Hitchcock
                   Background

A highly regulated industry


Collaborative development
      environment

                                Utah BioDesign

   University resources
   and vision
              Course Highlights

   Projects are initiated by clinicians

   Students interact with clinicians

   Focus on FDA Quality System Regulation –
    Design Controls

   Projects required to follow Standard
    Operating Procedures
  Regulatory Environment
               USPTO    FDA
  CSA
                              ASTM


IEC
                                EC

JCAHO

                              GHTF

        ISTA           ISO
           Why Design Control?
   Systematic
    • Allows organizations to develop design processes that meet
      their needs.

   Team based
    • Multidisciplinary teams are empowered to make decisions.

   Customer focused
    • Requirements play a key role in driving specifications and
      validation.

   Robust
    • Verification and validation ensure a higher quality design.

   Required by law
         Design Control SOPs
   Approach used by all medical device and
    pharmaceutical companies
   Interprets FDA QSR for design course
   Creates common ground for students
   Provides consistent guidelines for
    assessment
   “Audit" students as part of their
    assessment
                      Design Control SOPs
Document Name                          Doc. #     Description                                                Regulatory
                                                                                                             Fulfillment
Design Control Policy                  DC 04 01   Outline the procedures to follow to develop new, or        21 CFR
                                                  modify existing products.                                  820.30 (a)
Design Input – Marketing Brief,        DC 04 04   Provides a procedure to develop the items that must be     21 CFR
Product Specification Considerations              considered and documented in the design input phase of     820.30 (c)
                                                  device development.
Design and Development Planning        DC 04 12   To indicate the factors that may be considered in the      21 CFR
                                                  generation of a design and development plan (the Plan)     820.30 (b)
                                                  for a new product, product improvement, or product
                                                  modification, or components of products
Design Changes                         DC 04 20   To indicate the process to be followed when changing, or   21 CFR
                                                  making additions to, approved documents that are           820.30 (i)
                                                  included as part of Design History Files.
Design Review                          DC 04 16   to indicate the process to be followed to conduct Design   21 CFR
                                                  Reviews.                                                   820.30 (i)
Design Validation                      DC 04 28   To indicate the general process to follow and the          21 CFR
                                                  documentation required to establish a Design Validation    820.30 (g)
                                                  Plan and perform Design Validations of new and revised
                                                  designs (products).
Design Verification                    DC 04 24   To indicate the general process to follow and the          21 CFR
                                                  documentation required to establish a Design               820.30 (f)
                                                  Verification Plan and perform Design Verifications of
                                                  new and revised designs (products).
Device Master Record                   DC 04 16   to indicate the contents of a Device Master Record         21 CFR
                                                  (DMR).                                                     820.121
Course Timeline – Spring / Fall
Projects
   Bone marrow
    aspiration device

   Heart patch for
    stem cell delivery

   Third heart sound
    monitor

   Optically guided
    feeding tube

   Fiber optic
    respirometer

				
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posted:2/29/2012
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