Hydrogel Uterus Model
Hydrogel Tissue Models
Hydrogel Uterus ModelCambridge Polymer Group designs and fabricates hydrogel-based tissue models. These models can be used for medical practioner training, imaging phantoms, and medical device testing. Using our patented hydrogel technology, we can cast hydrogels into a variety of shapes, including systems with inclusions, additives, and spatial gradients. Our models have found extensive use in […]
FDA Revisions to the 510(K) Process
The FDA has just issued a new draft document detailing if medical device manufacturers who have a product previously cleared by the 510(k) process, and have made changes to that product, have to refile another 510(k) for that product. The two main questions that a device manufacturer must ask about their revised device are as […]
Psychorheology
Psychorheology is a term that is familar to the food industry, having been used for many years. Its use in other areas, such as consumer products, is slowly starting to make its way into the common lexicon. Psychorheology is the relationship between instrumental data and sensory data. Sensory data may include ‘mouth-feel’, warmness, and richness. […]
Case Studies
Throughout our history, we have worked on a variety of interesting projects for our clients and our own internal research. Projects have included cleaning systems for ships, hydrogels for biomedical applications, psychorheology of food products, and synthetic tissue models. We have posted case studies on our web site for prospective clients to see the range […]
Workshop on Reprocessing Re-Usable Medical Devices
On June 9-8, 2011, the FDA hosted a workshop to discuss issues involved in the re-processing of re-usable medical devices, such as endoscopes and orthoscopic shavers. The purpose of the workshop was to establish what guidance documents should be established to ensure that reusable devices are being properly cleaned and disinfected/sterilized to ensure patient safety. […]
Potential Detection System for Implant Wear
Researchers at the University of Nebraska Medical center recently published their results of a study in which they developed an optical imaging agent to detect inflammation due to wear debris generated from implants. In this study, a N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer-based optical imaging contrast agent (P-IRDye) was developed and used for the detection of wear particle-induced […]
Design for Cleaning
The FDA has issued a mandate to manufacturers of re-usable medical devices to design with re-cleaning of the these devices in mind. This mandate is in response to an on-going effort to reduce the risk of infection, contamination, or disease transmission due to improperly cleaned devices. Device design should include smooth interior surface, avoidance of […]
Metal-On-Metal Hip Implants
The on-going discussion of patient response to metal-on-metal hip implants has recently increased. For the past few years, papers presented at ORS and AAOS have discussed concerns about tissue response to metal ions and debris liberated from wear in metal-on-metal hip implants. These articles allege that the metal ions can result in pseudo-tumors in some […]
The FDA Will Be Hosting a Public Workshop on the Reprocessing of Reusable Medical Devices
The FDA will be hosting a public workshop on the Reprocessing of Reusable Medical Devices on June 8th and 9th, 2011 in Silver Springs, MD. The purpose of the workshop is to discuss factors affecting reprocessing quality, device design as it relates to reprocessing reusable medical devices, reprocessing methodologies, validation methodologies, healthcare facility best practices, […]
The Next ASTM Meeting for Medical Device Development (Committee F04)
The next ASTM meeting for medical device development (Committee F04) will be meeting from May 15-17th, 2011, in Anaheim, California. This meeting will focus on ASTM standards development for the characterization of UHMWPE, PEEK, and other biomedical plastics, as well as testing protocols for medical devices and cleanliness of medical devices. Contact Cambridge Polymer Group […]