Total Product Life Cycle An Example. Medcon May 2, 2013 2 Agenda Post Market Surveillance Total Product Life Cycle and Product Design Systematic Collection.

Total Product Life CycleAn Example

MedconMay 2, 2013

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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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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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Total Product Life Cycle and Design

Identification of Risks Begins at Design

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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

• Ability to deploy the implant

• Ability to access the intended location

• Deliver stent to lesion

Output Requirements

• Materials

• Stent Retention

• Balloon Burst Pressure (Balloon Rupture)

• Test Methods

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Design Records

Design Verification• 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

• Use FMEA

• Design FMEA

• Component FMEA

• Process FMEA

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Design Transfer

Manufacturing Procedures

Bill of Materials

Manufacturing Process

• Crimping Process

• Extrusion

Test Methods

• Incoming Materials

• In-process

• Finished product

Training

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Production and Process Controls

Manufacturing processes procedures

Validated processes

• Crimping

• Extrusion

Process Monitoring

• 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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InternalInternalInternalInternal ExternalExternal ExternalExternal

Monitoring and Analysis

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NONCONFORMING PRODUCT

CAPA COMPLAINTS

Analyze

Investigate

Identify

Verify or Validate

Implement

Disseminate

Submit to Management Review

Evaluate

Investigate

MonitorTrend

Evaluate

Investigate

MonitorTrend

Complaints & MDRs

Management Review

Nonconforming Product

Returned Product

Service

Audits

Supplier Performance

Inspection

Process Monitoring

.

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Data Sources

Complaints Types

• Difficult to deploy

• Failure to deploy

• Loose

• Unstable

• Inflation issue

• Leak

• Deflation time

• Dislodged/Dislocated

• Balloon Rupture

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Data Sources

Medical Device Reports

Nonconformances

• Process Parameters

• Incoming acceptance testing

• In-process testing

• Finished product testing

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Post Launch Reviews

Premarket Clinical Trials

• Comparison

Product Launch Learnings

• Marketing and Sales

• Complaints

Postmarket Clinical Trials

Product Performance

• Investigated Concerns

• MDRs

• Complaints

• Design Changes

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MgmtReview

Facilities & Equipment

Complaints

Deviations

OOS Results

Non-Conformances

Audits

CAPA

Analysis & Trending

Reports

Closed-loop process control

DocumentControl

Systems Integration

21 CFR Part 11

Training

CAPA and Risk Management are central to the implementation of an effective, closed loop, continuous improvement process that focuses on prevention and quality

Risk Management

Interlocked Concepts

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Interdependency of Post Market Surveillance, Risk and CAPA

PMSDATA Ris

k

CAPA

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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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Questions

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Monica J. WilkinsDivisional Vice President QualityAbbott Laboratories(847) [email protected]

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