Failure Analyses...Medical Devices

Service Detail from ANALYZE Inc.

Failure Analyses...Medical Devices-Image

ANALYZE has implemented a time-tested approach to failure and root causes analyses. While the causes of product failure are varied, the problem solving process by which they are identified and understood is a series of well-defined steps:

  • Discovery or Information Gathering
  • Define Problem
  • Establish Hypotheses to Explain Real Life Observations
  • Design an Experimental Approach to Acquire Missing Information
  • Test Hypotheses to Narrow Focus on Most Likely Cause(s)
  • Communication and Feedback
  • Develop Actions to Solve Problem

Examples of failure analysis projects include the following:

  • Thermoplastic Urethane Bond Failure
  • Medical Device Cleaning
  • Composite/Adhesive/Al Panel Bond Failure
  • Implantable Medical Device Issues
  • Corrosion Products in Failed A/C Compressor Unit
  • Printed Circuit Board and Flexible Circuit Problems
  • Stress Cracking in Molded Plastic Parts
  • Surface Appearance of Consumer Electronic Housings
  • Warping of Plastic Parts
  • Environmental Degradation of Plastic Articles
  • Loss of Paint and Coating Adhesion to Substrates
  • Aerospace O-Ring/Gasket Environment Compatibility
  • Consumer Packaging Film Surface Treatments
  • Plastic Food Container Seals

The ability to respond quickly to client needs is important as there are often significant business and risk management issues associated with root cause/failure analysis investigations.