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MEDICAL DEVICE PACKAGING AS TOLD THROUGH DESIGN CONTROL Jenn Goff Associate Packaging Manager, Stryker Instruments
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MEDICAL DEVICE PACKAGING
AS TOLD THROUGH DESIGN
CONTROL
Jenn Goff
Associate Packaging Manager, Stryker Instruments
Bio: Jennifer Goff
Graduated from MSU School of Packaging in Dec,
2005
Wyeth Consumer Healthcare Intern, 2004
Work History
Edwards Lifesciences, 2006-2012
Packaging Engineer I, Operations
Packaging Engineer II, R&D
Packaging Laboratory Supervisor
Sr. Packaging Engineer, R&D
Sr. Quality Engineer, Operations
Stryker Corporation, 2012 – present
Staff Engineer, R&D
Associate Packaging Manager, Instruments
Agenda
Legal
Why this presentation?
Design Control Requirements
Risk and Sample Size
Recommendations/Takeaways
Questions
Legal
The views and opinions expressed in this presentation
are those of the presenter and do not necessarily
reflect the official policy or position of Stryker
Corporation or its affiliates.
Why is this presentation important?
Packaging resource pulled in after device is mostly
designed
R&D “just put it in a pouch and a box”
Add value to the overall user experience and in
some cases, create a competitive advantage in the
marketplace.
Understand the impact proposed changes can
make.
What are Design Controls?
Design controls are in place to require manufactures
of medical devices to maintain procedures to control
the design of the device in order to ensure that
specified design requirements are met.
Design Control: FDA CFR21.8.820
Design and Development
Planning
Design Input
Design Output
Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Control: FDA CFR21.8.820
Reference: Design Control Guidance for Medical Device Manufacturers, FDA Center for Devices and Radiological Health
Design Control and Package Development Design and Development Planning
Project Plan (charter)
Cost for Packaging development
Packaging Roles and Responsibilities
Responsible/Accountable/Consulted/Informed
Understand scope of project (commodity vs innovative)
Understand regulatory strategy and potential impact to device packaging (environmental compliance, timeline strategy, clinical trials)
Design and
Development Planning
Design Input
Design Output Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design and Development
Planning
Design and Development
Planning
Design Input
Design Output Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Control and Package Development Design Input – User Needs
User Needs/Intended Use: Where to get this
information? Consider user and the patient.
VOC
Consider if package is part of the procedure
Customer complaints
Empathic Design
Design Input
Design Control and Package Development Design Input – User Needs
User Need Source
Device to remain protected through
expiration date at point of use.
Expected
Device to remain sterile through
expiration date at point of use.
Expected
Package to allow ease of aseptic
transfer.
Expected (Complaints/VOC)
Package to retain and organize used
device components during procedure.
Empathic Design
Device size needs to be clearly
identifiable with other sized devices.
Empathic Design
Package to be stored on hanging
rack.
VOC
Design and Development
Planning
Design Input
Design Output Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Control and Package Development Design Input
Design Inputs/Requirements Document
Device protection
Geometric/mass/fragility challenges
Sterilization method
Biocompatibility
Distribution plan
Countries
Storing/shipping methods
Product configuration
Labeling requirements
Design Input
Design Control and Package Development Design Input
User Need Source Design Input
Device to remain protected through
expiration date at point of use.
Expected Device to remain functional post transportation and
storage testing.
Device to remain sterile through expiration
date at point of use.
Expected
Package to allow ease of aseptic transfer by
means of picking method.
Expected
(Complaints/VOC)
Package to retain and organize used device
components during procedure.
Empathic Design
Device size needs to be clearly identifiable
with other sized devices.
Empathic Design
Package to be stored on hanging rack. VOC
Design Control and Package Development Design Input
User Need Source Design Input
Device to remain protected through
expiration date at point of use.
Expected Device to remain functional post transportation and
storage testing.
Device to remain sterile through expiration
date at point of use.
Expected Package to generate a sterile barrier around the
device for a three year shelf life.
Package to allow ease of aseptic transfer by
means of picking method.
Expected
(Complaints/VOC)
Package to retain and organize used device
components during procedure.
Empathic Design
Device size needs to be clearly identifiable
with other sized devices.
Empathic Design
Package to be stored on hanging rack. VOC
Design Control and Package Development Design Input
User Need Source Design Input
Device to remain protected through
expiration date at point of use.
Expected Device to remain functional post transportation and
storage testing.
Device to remain sterile through expiration
date at point of use.
Expected Package to generate a sterile barrier around the
device for a three year shelf life.
Package materials must allow device sterilization
by means of ETO.
Package to allow ease of aseptic transfer by
means of picking method.
Expected
(Complaints/VOC)
Package to retain and organize used device
components during procedure.
Empathic Design
Device size needs to be clearly identifiable
with other sized devices.
Empathic Design
Package to be stored on hanging rack. VOC
Design Control and Package Development Design Input
User Need Source Design Input
Device to remain protected through
expiration date at point of use.
Expected Device to remain functional post transportation and
storage testing.
Device to remain sterile through expiration
date at point of use.
Expected Package to generate a sterile barrier around the
device for a three year shelf life.
Package materials must allow device sterilization
by means of ETO.
Package to allow ease of aseptic transfer by
means of picking method.
Expected
(Complaints/VOC)
Package to have a double sterile barrier.
Package to retain and organize used device
components during procedure.
Empathic Design
Device size needs to be clearly identifiable
with other sized devices.
Empathic Design
Package to be stored on hanging rack. VOC
Design Control and Package Development Design Input
User Need Source Design Input
Device to remain protected through
expiration date at point of use.
Expected Device to remain functional post transportation and
storage testing.
Device to remain sterile through expiration
date at point of use.
Expected Package to generate a sterile barrier around the
device for a three year shelf life.
Package materials must allow device sterilization
by means of ETO.
Package to allow ease of aseptic transfer by
means of picking method.
Expected
(Complaints/VOC)
Package to have a double sterile barrier.
Inner sterile barrier to be a rigid tray with ribbed
corners.
Package to retain and organize used device
components during procedure.
Empathic Design
Device size needs to be clearly identifiable
with other sized devices.
Empathic Design
Package to be stored on hanging rack. VOC
Design Control and Package Development Design Input
User Need Source Design Input
Device to remain protected through
expiration date at point of use.
Expected Device to remain functional post transportation and
storage testing.
Device to remain sterile through expiration
date at point of use.
Expected Package to generate a sterile barrier around the
device for a three year shelf life.
Package materials must allow device sterilization
by means of ETO.
Package to allow ease of aseptic transfer by
means of picking method.
Expected
(Complaints/VOC)
Package to have a double sterile barrier.
Inner sterile barrier to be a rigid tray with ribbed
corners.
Outer sterile barrier to be a flexible pouch with a
chevron seal.
Package to retain and organize used device
components during procedure.
Empathic Design
Device size needs to be clearly identifiable
with other sized devices.
Empathic Design
Package to be stored on hanging rack. VOC
Design Control and Package Development Design Input
User Need Source Design Input
Device to remain protected through
expiration date at point of use.
Expected Device to remain functional post transportation and
storage testing.
Device to remain sterile through expiration
date at point of use.
Expected Package to generate a sterile barrier around the
device for a three year shelf life.
Package materials must allow device sterilization
by means of ETO.
Package to allow ease of aseptic transfer by
means of picking method.
Expected
(Complaints/VOC)
Package to have a double sterile barrier.
Inner sterile barrier to have ribbed corners for
ease of opening.
Outer sterile barrier to be a flexible pouch with a
chevron seal.
Package to retain and organize used device
components during procedure.
Empathic Design Package to be rigid tray design with identifiable
cavities for used devices.
Device size needs to be clearly identifiable
with other sized devices.
Empathic Design
Package to be stored on hanging rack. VOC
Design Control and Package Development Design Input
User Need Source Design Input
Device to remain protected through
expiration date at point of use.
Expected Device to remain functional post transportation and
storage testing.
Device to remain sterile through expiration
date at point of use.
Expected Package to generate a sterile barrier around the
device for a three year shelf life.
Package materials must allow device sterilization
by means of ETO.
Package to allow ease of aseptic transfer by
means of picking method.
Expected
(Complaints/VOC)
Package to have a double sterile barrier.
Inner sterile barrier to have ribbed corners for
ease of opening.
Outer sterile barrier to be a flexible pouch with a
chevron seal.
Package to retain and organize used device
components during procedure.
Empathic Design Package to be rigid tray design with identifiable
cavities for used devices.
Device size needs to be clearly identifiable
with other sized devices.
Empathic Design Package label to have color coding of compatible
sized devices used during procedure.
Package to be stored on hanging rack. VOC
Design Control and Package Development Design Input
User Need Source Design Input
Device to remain protected through
expiration date at point of use.
Expected Device to remain functional post transportation and
storage testing.
Device to remain sterile through expiration
date at point of use.
Expected Package to generate a sterile barrier around the
device for a three year shelf life.
Package materials must allow device sterilization
by means of ETO.
Package to allow ease of aseptic transfer by
means of picking method.
Expected
(Complaints/VOC)
Package to have a double sterile barrier.
Inner sterile barrier to have ribbed corners for
ease of opening.
Outer sterile barrier to be a flexible pouch with a
chevron seal.
Package to retain and organize used device
components during procedure.
Empathic Design Package to be rigid tray design with identifiable
cavities for used devices.
Device size needs to be clearly identifiable
with other sized devices.
Empathic Design Package label to have color coding of compatible
sized devices used during procedure.
Package to be stored on hanging rack. VOC Outer sterile barrier to have hang hole for
standard OR racking system.
Design and Development
Planning
Design Input
Design Output Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Control and Package Development Design Input
Initial evaluation of Risk
As the design evolves, new risks may become evident
CAUTION
Design inputs should be specific, but also need to be verified/validated therefore use caution when determining specifications or tolerances Required vs Nice to Have
Design Input
Design and Development
Planning
Design Input
Design Output Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Control and Package Development Design Output
“The results of a design effort…The finished design
output is the basis for the device master record.”1
Design Output
1Design Control Guidance for Medical Device Manufacturers, FDA
Center for Devices and Radiological Health
Design and Development
Planning
Design Input
Design Output Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Control and Package Development Design Output
Specifications
Minimum peel force
Critical quality attributes
Standards/Test results
ASTM Test Methods
Internal procedures
Drawings
Design Output
Design Control and Package Development Design Output
User Need Source Design Input Design Output
Device to remain protected through
expiration date at point of use.
Expected Device to remain functional post
transportation and storage testing. Packaging Drawing
Device to remain sterile through
expiration date at point of use.
Expected Package to generate a sterile barrier
around the device for a three year shelf
life.
BOM
Package materials must allow device
sterilization by means of ETO. Packaging Drawing/Specification
Package to allow ease of aseptic
transfer by means of picking
method.
Expected
(Complaints/V
OC)
Package to have a double sterile
barrier. BOM/Packaging Drawing
Inner sterile barrier to have ribbed
corners for ease of opening. Packaging Drawing
Outer sterile barrier to be a flexible
pouch with a chevron seal. Packaging Drawing
Package to retain and organize
used device components during
procedure.
Empathic
Design
Package to be rigid tray design with
identifiable cavities for used devices. Packaging Drawing
Device size needs to be clearly
identifiable with other sized
devices.
Empathic
Design
Package label to have color coding of
compatible sized devices used during
procedure.
Labeling Artwork
Package to be stored on hanging
rack.
VOC Outer sterile barrier to have hang hole
for standard OR racking system. Packaging Drawing
Design and Development
Planning
Design Input
Design Output Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Control and Package Development Design Review
Concept reviews
Validation strategy reviews
Which method’s were chosen and why
Sample size rationale
Manufacturing strategy reviews
Make/buy decisions
Testing anomalies/failure and root cause reviews
Design Review
Design and Development
Planning
Design Input
Design Output Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Control and Package Development Design Verification
Verification: method in which you confirm the
specified requirements can be consistently fulfilled
Which methods chose and why?
Design Verification
Design and Development
Planning
Design Input
Design Output Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Control and Package Development Design Validation
Validation: method in which you confirm the design
meets the user need/intended use.
Partner with Marketing
Ask the right questions the right way.
Avoid asking open ended questions in this stage
Design Validation
Design Control and Package Development Design Verification
User Need Source Design Input Design Output Verification/Validation
Device to remain protected
through expiration date at
point of use.
Expected Device to remain functional post
transportation and storage testing.
BOM Verification: Device functionality
protocol and report
Device to remain sterile
through expiration date at
point of use.
Expected Package to generate a sterile
barrier around the device for a
three year shelf life.
BOM Verification: Packaging protocol
and report
Package materials must allow
device sterilization by means of
ETO.
Packaging
Drawing/Specification
Verification: Sterilization
protocol and report
Package to allow ease of
aseptic transfer by means of
picking method.
Expected
(Complaints
/VOC)
Package to have a double sterile
barrier.
BOM/Packaging Drawing Verification: Packaging protocol
and report
Inner sterile barrier to have
ribbed corners for ease of
opening.
Packaging Drawing Verification: Packaging protocol
and report
Outer sterile barrier to be a
flexible pouch with a chevron seal.
Packaging Drawing Verification: Packaging protocol
and report
Package to retain and
organize used device
components during procedure.
Empathic
Design
Package to be rigid tray design
with identifiable cavities for used
devices.
Packaging Drawing Verification and Validation
Device size needs to be
clearly identifiable with other
sized devices.
Empathic
Design
Package label to have color
coding of compatible sized
devices used during procedure.
Labeling Artwork Validation: Marketing survey
Package to be stored on
hanging rack.
VOC Outer sterile barrier to have hang
hole for standard OR racking
system.
Packaging Drawing Validation: Marketing survey
Design and Development
Planning
Design Input
Design Output Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Control and Package Development Design Transfer
“Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications”2
Do packaging procedures convey exactly how to package the product?
Configuration
Photos
Clear instructions
In process specifications/monitoring
Design Transfer
2Design Control Guidance for Medical Device Manufacturers, FDA
Center for Devices and Radiological Health
Design and Development
Planning
Design Input
Design Output Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Control and Package Development Design Changes
“Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.”3
Design control documentation to be rev controlled. Tell the story.
Ensure Packaging is evaluating Device changes
Understand how proposed changes impact the overall project
Time
Cost
Resource
Design Changes
3Design Control Guidance for Medical Device Manufacturers, FDA
Center for Devices and Radiological Health
Risk and Sample Size
Considerations
Severity
Classification of the device
Implant vs disposable
Occurrence Rate
Risk Management File or FMEA
Clinical Expertise
Marketing/Sales input
Design Control Takeaways
Get involved with your project teams early
Push instead of getting pulled
Provide input/review design control documentation
Get inspired
Articles
Other industries
Team building
Design Control and Package Development
