Transcript Biomedical Engineering Design and the Promotion of High Value Relationships with Clinical Medicine Robert Hitchcock.

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
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Students interact with clinicians
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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.
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Team based
• Multidisciplinary teams are empowered to make decisions.
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Customer focused
• Requirements play a key role in driving specifications and
validation.
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Robust
• Verification and validation ensure a higher quality design.
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Required by law
Design Control SOPs
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Approach used by all medical device and
pharmaceutical companies
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Interprets FDA QSR for design course
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Creates common ground for students
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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
modify existing products.
21 CFR
820.30 (a)
Design Input – Marketing Brief,
Product Specification Considerations
DC 04 04
Provides a procedure to develop the items that must be
considered and documented in the design input phase of
device development.
21 CFR
820.30 (c)
Design and Development Planning
DC 04 12
To indicate the factors that may be considered in the
generation of a design and development plan (the Plan)
for a new product, product improvement, or product
modification, or components of products
21 CFR
820.30 (b)
Design Changes
DC 04 20
To indicate the process to be followed when changing, or
making additions to, approved documents that are
included as part of Design History Files.
21 CFR
820.30 (i)
Design Review
DC 04 16
to indicate the process to be followed to conduct Design
Reviews.
21 CFR
820.30 (i)
Design Validation
DC 04 28
To indicate the general process to follow and the
documentation required to establish a Design Validation
Plan and perform Design Validations of new and revised
designs (products).
21 CFR
820.30 (g)
Design Verification
DC 04 24
To indicate the general process to follow and the
documentation required to establish a Design
Verification Plan and perform Design Verifications of
new and revised designs (products).
21 CFR
820.30 (f)
Device Master Record
DC 04 16
to indicate the contents of a Device Master Record
(DMR).
21 CFR
820.121
Course Timeline – Spring / Fall
Projects
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Bone marrow
aspiration device
Heart patch for
stem cell delivery
Third heart sound
monitor
Optically guided
feeding tube
Fiber optic
respirometer