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 a range of analytical questions, from the impact of a new surface treatment to the source of bonding or corrosion problems, to assessing new manufacturing processes.
- 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
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.
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.
Specialized Services for Medical Device Analysis
EAG also offers deformulation, consulting and litigation support services to the medical device industry through our Chemir division.
Deformulation (reverse engineering) is the separation, identification and quantitation of ingredients in a formulation. Chemir is an industry leader in providing deformulation services, assisting device manufacturers with competitive product characterization, equivalency studies and patent infringement investigations.
Chemir also has excellent expertise in medical plastics testing and polymer analysis. Our polymer experts have years of experience characterizing the full composition of plastic materials, including determining the raw materials, resins and additives present.
Chemir’s consulting and litigation support services have helped companies resolve difficult issues with product liability and intellectual property challenges. Our litigation support services include analytical testing, interpretation of technical data, critical review of data, expert opinions and deposition/trial testimony.
Related Application Notes
- Root Cause Determination of Adhesion Failure in Medical Device Packaging AN471
- Corrosion Resistance Study of Electropolished Medical Devices AN468
- FEI DualBeamTM FIB AN364
- ICP-OES and ICP-MS Detection Limit Guidance BR023
- AFM: Polymer Surface Modification BN1210
- Biomedical Applications of AFM: Imaging Hydrogel Coatings BN1424
- Characterization of Surface Contamination BN1365
- Contact Lenses: Understanding Surface Chemistry Critical to Optimizing Design BN1503
- Evaluating Polymer Cure Using Raman Spectroscopy BN1394
- Evaluation of Cleaning Efficacy BN1422
- Grain Size Analysis of Metallurgical Coatings Using FIB BN1345
- Identification of Precipitates in Biological Tissue BN1505
- Measuring the Morphological Structure of Porous Materials BN1504
- Medical Device Electronics: Improving Reliability with Auger Electron Spectroscopy BN1501
- Residual Solvents in Medical Devices BN1502
- • Stainless Steel Corrosion: Medical Device Application with Auger Electron Spectroscopy (AES) Analysis BN1500
- Thickness and Uniformity of Silver Antimicrobial Coatings BN1333
- Identifying Contaminants Using Raman: Organic Particles AN376
- EBSD Services Technique Note
- EAGLABS Bubble Chart: Analytical Resolution versus Detection Limit BR004
- Materials Characterization Brochure
- Typical Applications for Techniques / Periodic Table of Elements BR038
- Biomedical Service Brochure BR003
- Bulk Elemental Analysis BR021
- EAG Services Introduction BR011
- EAG Technique Chart BR008
- Metallurgical and Materials Analysis Brochure BR083