Total Product Life Cycle An Example

Medcon May 2, Agenda Post Market Surveillance Total Product Life Cycle and Product Design Systematic Collection of Data Risk Assessments and Investigations (CAPA) Final Thoughts

Medcon May 2, 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

Medcon May 2, Total Product Life Cycle and Design Identification of Risks Begins at Design

Medcon May 2, Factors Important to Risk Assessment  Device design and manufacture  Materials  Device users  Human Factors  Medical device systems

Medcon May 2, 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

Medcon May 2, 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

Medcon May 2, Design Transfer  Manufacturing Procedures  Bill of Materials  Manufacturing Process Crimping Process Extrusion  Test Methods Incoming Materials In-process Finished product  Training

Medcon May 2, 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

Medcon May 2, InternalInternalExternalExternal Monitoring and Analysis

Medcon May 2, NONCONFORMING PRODUCT CAPA COMPLAINTS Analyze Investigate Identify Verify or Validate Implement Disseminate Submit to Management Review Evaluate Investigate Monitor Trend Evaluate Investigate Monitor Trend

Medcon May 2, Data Sources  Complaints Types Difficult to deploy Failure to deploy Loose Unstable Inflation issue Leak Deflation time Dislodged/Dislocated Balloon Rupture

Medcon May 2, Data Sources  Medical Device Reports  Nonconformances Process Parameters Incoming acceptance testing In-process testing Finished product testing

Medcon May 2, 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

Medcon May 2, Mgmt Review Facilities & Equipment Complaints Deviations OOS Results Non- Conformances Audits CAPA Analysis & Trending Reports Closed-loop process control Document Control 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

Medcon May 2, Interdependency of Post Market Surveillance, Risk and CAPA PMS DATA Ris k CAPA

Medcon May 2, 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

Medcon May 2, Questions

Medcon May 2, Monica J. Wilkins Divisional Vice President Quality Abbott Laboratories (847) Contact Information: