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 an overall device. As medical devices become more complex and use a greater variety of materials, the potential for negative interactions increases. Therefore, 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 Analytical Services at EKG labs
EKG Labs provides medical device material and pharmaceutical compatibility testing services to support device development activities. 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.
- 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
- 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