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What is Medical Device Material Compatibility?
Medical device material compatibility is the understanding of whether or not the different component materials in a medical device, including a drug component, can negatively interact with each other and impact the performance or safety of the overall device. Drug device compatibility is especially important as device leachables may accelerate degradation of a drug product. Another part of medical device compatibility analysis is the effect of disinfectants, sterilization, and/or cleaning.
As medical devices become more complex and use a greater variety of materials, the potential for negative interactions increases. There is a growing emphasis on investigating the interaction between individual device material components prior to performing efficacy and performance testing on a “complete” device. Material compatibility studies will likely need to be performed as part of Premarket Application (PMA) and 510(k) testing.
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Material Compatibility Testing at EKG Labs
EKG Labs provides medical device material compatibility analysis and drug device compatibility testing services to support device development. The team at EKG Labs has years of experience understanding the diverse reasons why device materials can fail and why some materials are not compatible with others. We work with clients to understand how prospective materials may interact, and we provide data to help them choose the best materials to use in their medical device or combination product. We accomplish this through a variety of analytical techniques which stress materials under controlled or accelerated conditions. Depending on the project goals, this data can be used to flag potential material incompatibility or to find material combination options that pose the least amount of risk of causing a medical device failure.
EKG Labs has worked on a wide variety of medical devices and materials for diverse therapeutic areas.
Material Expertise
- Polymers: plastic, rubber, elastomer, coatings, adhesives, etc.
- Metals: alloys, electroplated material, titanium, stainless steel, etc.
- Ceramics: alumina, aluminum oxide, zirconia compounds, etc.
- Specialty and Composite Materials
- Read more about our material expertise
Analytical Techniques
- Chromatography – HPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC
- Spectroscopy – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
- Microscopy – SEM, TEM, AFM, STM, LSCM
- Other- TGA, DSC, TOC, BET Surface Area/Pore Size Analyzer
- Learn more about our instrumentation here
Additional medical device testing at EKG Labs includes ISO 10993 chemical characterization testing and failure analysis.
