The document discusses key considerations for selecting drug delivery technology, including defining the intended purpose and benefits, creating a mission statement, identifying essential needs and functions, establishing critical processes, ensuring design control traceability, developing risk management confidence, managing the software life cycle, utilizing quality agreements, and consulting tools. It emphasizes getting the right things right the first time through a proactive approach focused on mission essentials.
3. Our Mission
Advance medical product safety engineering by
providing the industry best practice-based
software solutions and expert consulting.
Mar-23 3
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5. 5
Mission
To integrate, and streamline
medical product design
controls, risk management
based on the industry best
practices
make product safety,
effectiveness, time to market,
cost of maintenance, and
compliance a competitive
advantage
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8. Be clear on the purpose of
your drug delivery system
Intended use, intended benefits and
context of use at combination product
end to end system level
• Intended use, indication for use,
user and patient population, use
and environment conditions,
operational conditions
• Intended benefits (clinical
benefits, economic benefits,
competitive advantage etc.)
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9. Create a
mission
statement for
the product
Simple statement about what the
product must do and what results the
product must achieve
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10. Identify the
mission
essential
needs
Effectiveness – does what is
supposed to do
Safety – does it safely,
securely
Usability – ease of use
Cost – affordable
Competitiveness –
competitive advantage
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12. Establish
Critical
Processes
• Design Control Process and
Traceability
• Risk Management Process and
Traceability
• Manufacturing Process and
Traceability
• Software Life Cycle Process and
Traceability (if applicable)
• Cybersecurity Process and
Traceability (if applicable)
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13. Ensure
Design Controls
Traceability
• Intended use & User needs & Product
Standards
• Risk Analysis
• Design input requirements
• Design out
• Design Verification
• Design Validation
• Design Transfer
• Control Strategy
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14. Develop Risk
Management
Confidence
• Compliance with standards / FDA
guidance
• Methods – risk assessment, hazard
analysis, URRA, FMEAs
• Personnel – Medical / clinical
• Review of relevant safety
information e.g., MAUDE database
• Risk Traceability!
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15. Manage
Software Life
Cycle
• Life Cycle Process – IEC 62304
• Software Hazard Analysis and Software Safety Classification
• Software Requirement Management
• Test case management
• Traceability Management
• Configuration and Change Management
• Defect Management
• Source Code and Version Control
• Code coverage
• Software Verification Testing
• Software System Testing (interfaces with hardware, network etc.)
• Software Traceability Matrix – Design Input SRS VT
• Software Maintenance Plan
• Cybersecurity (if applicable)
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18. Get the right things
right the first time
– the biggest saving
for schedule and
cost
Right Things:
• Mission Essentials
• Most Important Ones
• Not Everything
• …
Right Way
• Proactive
• Right Experience
• Right tools for traceability
• …
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20. Drug Delivery System is
adequately safe for its
intended use
Evidence
(data)
Evidence
(data)
Evidence
(data)
Rationale /
Argument
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Safety Assurance Case per FDA
Infusion Pump Guidance
The safety assurance case (or safety case) consists
of a structured argument, supported by a body of
valid scientific evidence that provides an
organized case that the infusion pump adequately
addresses hazards associated with its intended
use within its environment of use.
