Medical Device Materials Failure Analysis

Understanding a medical device failure requires far more than a simple inspection, it demands deep materials-science expertise capable of uncovering subtle degradation mechanisms, contamination pathways, and structural weaknesses that can compromise patient safety. 

Modern implantable and invasive devices, from catheters to stents, operate in complex biological and manufacturing environments where polymers, metals, coatings, and adhesives must perform flawlessly. Yet challenges such as micro-fractures, surface chemistry failures, surface degradation, material Degradation, wear, Fatigue Failure, corrosion, material incompatibility, supply-chain variability, and unexpected contamination can arise at any stage, from raw-material selection to final clinical use.

Effective medical device failure analysis therefore integrates advanced analytical techniques, microstructure evaluation, surface adhesion studies, chemical imaging, and materials deformulation, with a systems-level understanding of manufacturing processes, regulatory expectations, and real-world device performance. This comprehensive, materials-driven approach enables accurate root-cause determination, supports authority incident investigations, improves production yields, and ultimately ensures safer, more reliable medical devices.

Medical Device Materials Failure Investigation and Problem Solving

Our medical device failure analysis experts support manufacturers of both non-invasive and implantable medical devices, including catheters, stents, and delivery systems. Using advanced materials-science methodologies, our experienced scientists work closely with clients to identify root causes of device failure, resolve production issues, and implement effective remediation strategies. Our multidisciplinary approach can be used to 

• Fracture and failure analysis of devices and associated materials
• Optical microscopy and scanning electron microscopy (SEM) to examine fracture surfaces, wear patterns, and microstructural features
• Surface chemistry and adhesion studies to evaluate bond integrity and interface performance
• Microstructure and mechanical property correlation to assess material behavior and reliability
• Chemical imaging and phase-distribution analysis of active and inactive components
• Particulate contamination and surface-residue analysis to identify sources of foreign materials
• Materials deformulation and QC validation to verify composition and ensure consistency
• Metallurgical testing for metals, alloys, and structural components

Examples of Analytical Techniques Used to Study Medical Device Failure

Impurity or unknown identification (particles, fibers, surface defects): 

• Fourier-transform infrared (FTIR) microscopy
• Confocal Raman spectroscopy
• Scanning electron microscopy - energy dispersive X-ray spectroscopy (SEM-EDS)

Polymorph identification with aging or conditioning

• Polarized light microscopy
• Raman spectroscopy
• Differential scanning calorimetry
• Powder X-ray diffraction
• Solid state nuclear magnetic resonance (NMR)

Reverse engineering (liquids, solids, polymers)

• FTIR
• NMR
• Thermal testing
• Gel permeation chromatography

Glass and polymeric packaging performance (USP<1660>, flexible packaging, failure evaluation)

• FTIR microscopy
• SEM-EDS
• Inductively coupled plasma (ICP)
• Raman mapping
• Oxygen transmission rate (OTR) and Water vapor transmission rate (MVTR)

Polymer composition, mechanical properties, and compatibility

• NMR
• FTIR
• Dynamic mechanical analysis
• Thermal analysis

By integrating deep materials understanding with state-of-the-art analytical techniques, we provide definitive insights into medical device materials failure. Our experts are ready to help you strengthen product performance, compliance, and manufacturing robustness.

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