Medical Devices

Medical devices and biomaterials can present challenging materials and characterization issues. They must function in a range of environments that require corrosion resistance, low leaching, involve ultra-clean manufacturing, and may be surface modified to enhance biocompatibility.

Evans Analytical Group® (EAG) has a long history of using surface, organic, and microscopic analyses to aid the research, development, and characterization of surgical tools, implantable medical devices and artificial biomaterials. We work on devices such as: orthopaedic implants, catheters, contact lenses, pacemakers, stents, and molecular diagnostic tools, helping customers address arange of analytical questions, from the impact of a new surface treatment to the source of bonding or corrosion problems, to assessing new manufacturing processes.

Application Examples

• Failure analysis
• Contaminant analysis on biomaterials and medical devices
• Contamination testing of polymers
• Phase identification of artificial bone substitutes
• Coating thickness (nm to µm scale)
• Characterization of surface modified polymers
• Characterization of polymer coatings
• Detergent residue analysis
• Qualification of incoming materials
• Particle analysis
• Causes of adhesion failure
• Extractables/Leachables analysis
• Investigation of thermal properties of polymers

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
• Quantify surface impurities on polymer devices
• Measuring the outgassing from oligomers, mold release agents, additives, and contaminants
• Evaluating the composition of ion-implanted coatings
• Surface characterization of electro-polished alloys

Metals Analysis

Electropolished stainless steel materials are used frequently 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.

Identification of Foreign Material

Medical product manufacturing has zero tolerance for foreign contaminants. Evans Analytical group has extensive experience isolating and then identifying micron and sub-micron sized organic and inorganic contaminants in products.

Extractables/Leachables

Materials subjected to harsh environments can corrode and leach unwanted impurities into the surrounding area or tissue. As part of the product development process, medical device manufacturers often subject their products to extended submersion in a simulated biological environment. The resulting solutions can then be tested to ensure that leached elements are at a minimum.

EAG conducts leaching studies for clients in the biomedical device industry to help them understand what is coming from their parts in various environments. The main technique used for this testing is ICP-MS for metallic species and GC-MS and LC-MS for molecular species.

Characterization of Surface Coatings

Ultrathin coatings are used as lubricants, antibacterial coatings and as functionalized surfaces for molecular diagnostics. Depending on the materials and coatings, EAG offers a range of surface sensitive analytical tools for determining what species are present on a surface, how thick the coating is and what impurities may also be present.

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