Case Studies
Medical Device Case Studies
A Sticky Situation
A long time client had developed a novel adhesive for use in wound care products. They approached Cyanta to investigate the optimum bandage and gauze material for the adhesive. Cyanta's mission was to determine which prototype maintained its adhesive properties the best after being stored in an accelerated aging environment.
Once the prototypes were shipped to Cyanta, they were stored in the facility's cGMP stability chambers at various conditions including 40°/75% RH. Prototypes were removed at time points 0, 1, 2, 3 and 6 months and underwent peel tests (tensile, 180° Peel and Shear). Data was compiled and a detailed report generated with the optimum prototype identified. This data was used by the client to perform more in depth development testing with Cyanta which ultimately resulted in a new product launch.
Medical Device Patent Infringement
A medical device supplier suspected that a competitor was infringing upon their patented gas sensing device. They requested that Cyanta deformulate (reverse engineer) the competitor's product to investigate the possibility of patent infringement.
The patented technology claimed the device required a specific polymer matrix, a gas transport enhancer, pH adjusting component, a hygroscopic agent, and a reactive element. Of all the components in the assembly, identification of the gas transport enhancer was critical. After a thorough review of the technology, the gas transport enhancer was claimed to consist of a variety of chemistries, one example being a quaternary ammonium species.
The sample was extracted with an appropriate solvent and analyzed by direct infusion Ion Trap/Mass Spectrometry using Electrospray Ionization. The molecular ion suggested the species may be tetraoctylammonium, and an analytical reference standard was analyzed for comparison. For confirmation, the ion corresponding to the tetraoctylammonium species was fragmented and compared with the analytical reference standard. The results demonstrated the device contained tetraoctylammonium as the gas transport enhancer.
Our client was able to use these results to support their case of patent infringement.
