Medical Device Materials Failure Analysis

Medical Device materials failure analysis supports manufacturers of implantable medical devices and related healthcare products.

Intertek's material scientists are experienced in solving a wide range of material-related problems associated with the manufacture and operation of implantable medical devices, such as catheters and stents. Typical medical device material failure investigations include:

• Root cause investigations associated with FDA incidents or patient fatalities (devices /catheters / stents / delivery mechanisms)
• Cardiovascular (pre- and post-production) product contamination investigations
• Manufacturing and supply chain auditing following gastro-pulmonary device production outages
• In-process investigations aimed at improving neurovascular product manufacturing yields
• Co-working with polymer raw material suppliers to improve quality input into final production materials

Analytical approaches to medical device problem-solving include:

• Fracture and failure analysis of medical devices and associated materials
• Surface chemistry and adhesion of product bonds
• Microstructure and mechanical property relationships
• Chemical imaging and phase distribution of actives
• Materials deformulation and validation for QC