Total Product Life Cycle
An Example
Agenda
Post Market Surveillance
Total Product Life Cycle and Product Design
Systematic Collection of Data
Risk Assessments and Investigations (CAPA)
Final Thoughts
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May 2, 2013
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Post Market Surveillance...
 Activities carried out to gain information about the quality, safety, or
performance of products placed in the market
 Proactive collection of information
 Distinct from enforcement
 Review of post-market studies
 Clinical trials required as a condition of market approval
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May 2, 2013
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Total Product Life Cycle and Design
Identification of Risks Begins at
Design
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May 2, 2013
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Factors Important to Risk Assessment
 Device design and manufacture
 Materials
 Device users
 Human Factors
 Medical device systems
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Design Records
 Input Requirements
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Ability to deploy the implant
Ability to access the intended location
Deliver stent to lesion
 Output Requirements
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Materials
Stent Retention
Balloon Burst Pressure (Balloon Rupture)
Test Methods
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Design Records
 Design Verification
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Balloon deployment and retraction
Balloon inflation and deflation time
Deliver stent to lesion
Deploy stent at lesion
Stent dislodgment
Balloon rupture
Tensile strength
 Design Validation
 Risk Assessment
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Use FMEA
Design FMEA
Component FMEA
Process FMEA
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May 2, 2013
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Design Transfer
 Manufacturing Procedures
 Bill of Materials
 Manufacturing Process
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Crimping Process
Extrusion
 Test Methods
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Incoming Materials
In-process
Finished product
 Training
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Production and Process Controls
 Manufacturing processes procedures
 Validated processes
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Crimping
Extrusion
 Process Monitoring
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Crimping (force, mandrel diameter)
Split mold (pressure/temperature/split mold diameter)
Press parameters (force, press sheath ID)
Extrusion
 Temperature
 Pressure
 Drying of polymer granules
 Rotational speed of the screw
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May 2, 2013
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Monitoring and Analysis
Internal
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May 2, 2013
External
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Complaints &
MDRs
Service
NONCONFORMING
PRODUCT
Evaluate
Investigate
Monitor
Trend
Management
Review
Audits
Nonconforming
Product
.
Returned
Product
Supplier
Performance
CAPA
Analyze
Investigate
Identify
Verify or Validate
Implement
Disseminate
Submit to
Management Review
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May 2, 2013
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Process
Monitoring
Inspection
Monitor
Trend
COMPLAINTS
Evaluate
Investigate
Data Sources
 Complaints Types
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Difficult to deploy
Failure to deploy
Loose
Unstable
Inflation issue
Leak
Deflation time
Dislodged/Dislocated
Balloon Rupture
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May 2, 2013
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Data Sources
 Medical Device Reports
 Nonconformances
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Process Parameters
Incoming acceptance testing
In-process testing
Finished product testing
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May 2, 2013
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Post Launch Reviews
 Premarket Clinical Trials
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Comparison
 Product Launch Learnings
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Marketing and Sales
Complaints
 Postmarket Clinical Trials
 Product Performance
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Investigated Concerns
MDRs
Complaints
Design Changes
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Interlocked Concepts
CAPA and Risk Management are central to the implementation of
an effective, closed loop, continuous improvement process that
focuses on prevention and quality
Document
Control
Training
Deviations
Analysis &
Trending
Facilities &
Equipment
Audits
CAPA
Complaints
Reports
NonConformances
OOS Results
Mgmt
Review
Systems
Integration
Risk Management
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May 2, 2013
21 CFR Part 11
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Closed-loop process control
Interdependency of Post Market Surveillance, Risk and CAPA
PMS
DATA
Ris
k
CAPA
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May 2, 2013
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Final Thoughts
• Begins at design and development
• Establish a risk management process
• Identify risks early, mitigate, and monitor
• Engage in postmarket surveillance monitoring as required by
regulations
• Collect and analyze internal and external data sources
• Use leading indicators to prevent product issues
• Act on lagging indicators such as complaints, product failures, and
adverse events associated with product use
• Establish a PMS program that meets your needs
• Use a total product life cycle
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May 2, 2013
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Questions
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May 2, 2013
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Contact Information:
Monica J. Wilkins
Divisional Vice President Quality
Abbott Laboratories
(847) 937-9255
monica.wilkins@abbott.com
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May 2, 2013
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