EAG Biomedical Solutions

Medical devices and biomaterials frequently present challenging material issues. They must function in a range of environments that require corrosion resistance, ultra-clean manufacturing, and often surface modification to enhance biocompatibility.

Evans Analytical Group® (EAG) has a long history of developing programs that use surface, organic, and microscopic analysis to aid the research, development, and characterization of biomaterials and medical devices. We have worked with a wide range of devices, including catheters, contact lenses, pacemakers, stents, and trocars, helping customers answer a plethora of analytical questions, from the impact of a new surface treatment to the source of bonding or corrosion problems to assessing new manufacturing processes and everything in between.

Application Examples

• Failure analysis
• Contaminant analysis on biomaterials and medical devices
• Contamination testing of polymers
• Characterization of surface modified polymers
• Characterization of polymer coatings
• Ion implant depth composition profiling in metals
• Detergent residue analysis
• Qualification of incoming materials
• Particle analysis
• Causes of adhesion failure
• Molecular weight determination of polymers
• Contaminant analysis in pharmaceuticals

QA/QC Programs for Medical Devices and Biomaterials

We have developed cost-effective, specialized tests for medical devices and biomaterials that measure the quality of incoming materials, identify residues from molding and extruding processes, and inspect final products, including:

• Determining the functional groups on plastics and polymers
• Measuring the outgassing from oligomers, mold release agents, additives, and contaminants
• Evaluating the composition of ion-implanted coatings

Stainless Steel Analysis

Electropolished stainless steel materials are used increasingly in medical devices. Electropolishing provides the smooth, particle-free, corrosion-resistant surface required in this area. Properly evaluating the quality of the electropolishing process requires a combination of analytical techniques. Important parameters include chromium to iron ratios, composition and thickness of the chromium-enriched oxide layer, surface contamination, and surface finish.

Quantitative Surface Finish

You can measure surface topography (roughness) using Atomic Force Microscopy (AFM), which provides statistical parameters, such as Ra, RMS (Rq), and surface area index for quantitative comparison of surface finish.

Application Notes