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CPG will have an exhibit at the upcoming annual meeting of the Orthopedic Research Society in San Francisco, CA, from February 4th to February 7th. This conference brings researchers, medical device manufacturers, surgeons, and regulatory agency representatives together to discuss the latest technologies, practices, and clinical outcomes in the area of orthopedic surgery, including hip, knee, spine, shoulder, ankle, and other joint spaces. Come visit us to learn about the latest work we are doing in this growing area.

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When marketing a new product, differentiating your product from your competition can be a nuanced activity, depending on the nature of the product. In more tightly regulated markets, customers may require side-by-side comparisons of their existing approved and validated products with your new offering, to ensure that it has the same or better properties. As they have usually gone through some time and expense to validate the product, be it a raw material or finished good, and they bear a risk in changing, you need to demonstrate that the risk is worth it in terms of cost-savings or improved performance.

At Cambridge Polymer Group, we often assemble and perform a set of standard or customized tests that helps the client highlight the key performance traits of their product, while also demonstrating that the root level performance characteristics meet or exceed what their customer is currently using. Whenever possible, we use ASTM standard tests in the relevant industries to assemble a single page of testing results that your sales group can provide to customers. We perform these tests in our ISO-certified laboratory, so you can be assured of the quality and un-biased nature of our results.

The U.S. Senate has introduced a bill that allows the FDA to require medical device companies to collect and track data on the clinical performance of their marketed devices, such as hip and knee replacements. This action is in part due to the on-going reported issues of metal-on-metal hip implants failing due to metal ion sensitivity, which some studies have shown lead to the formation of pseudo-tumors. Advocates for this data collection suggest that the information will be useful for the on-going 510(k) regulatory approval process for new devices that have similar characteristics to already marketed devices, for-going the need for clinical studies necessary in a full PMA process.

Cambridge Polymer Group is now partnered with Pulse Anatomy to produce custom anatomy models made from our patented materials for use in clinical device development and professional education. Pulse replicates the anatomy using digital data as a starting point for the process of printing of rapid prototyped parts, creating molds and producing castings. Pulse's team includes digital designers, mechanical and electrical engineers, artists, sculptors, model makers and machinists. The process of developing a model with the Pulse and Cambridge Polymer Group team is a collaborative effort with our clients to ensure the final product meets the clients criteria. Please visit Pulse Anatomy for more information on model choices, or contact CPG.

Our tissue models can be fabricated from silicone, polyurethane, or tissue-mimicking hydrogels using our patented formulations.

PEEK finds itself increasingly being used in medical device applications due to its strength, biocompatibility, resistance to radiation and degradation, and ease of processing. CPG has been providing testing services on PEEK for our clients for several years, including crystallinity assessment by DSC and FTIR, mechanical properties, surface morphology characterization, and rheological characterization. CPG now offers gel permeation chromatography assessment of molecular weight distribution of PEEK.

Cambridge Polymer Group now offers the following testing capabilities:

Variable Pressure/Environmental Scanning Electron Microscopy
Conventional scanning electron microscopy requires high vacuum and samples with a conductive surface. Polymeric materials usually have to be coated with a metal layer (gold, palladium, iridium, carbon), and wet samples must be thoroughly dried. With variable pressure SEM, wet and uncoated samples can be imaged. Cambridge Polymer Group has used this technique to examine the microstructure of hydrogels, as well as salts.

Confocal Raman Spectroscopy
A complementary technique to infrared spectroscopy, Raman spectroscopy can be conducted on wet samples without the interference of water. Raman maps can be constructed, providing compositional information as a function of position on the sample.