Spring 2010 Newsletter

Focus on Medical Devices

We’ve been providing investigative analysis for non-routine problems in the medical device industry for many years (See our video). As industry leaders in deformulation, our scientists can characterize the composition of devices, and help investigate failure and contamination issues. Here’s a case study that illustrates our medical device testing services.

Case Study

A medical device supplier suspected that a competitor was infringing upon their patented gas sensing device. They requested that Chemir 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 (Figure 1). For confirmation, the ion corresponding to the tetraoctylammonium species was fragmented and compared with the analytical reference standard (Figure 2). 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.