AGAWAM, MASS. - June 4, 2007 - Med-Conduit, an innovative developer and marketer of central venus catheters (CVCs) has teamed with Microtest Laboratories of Agawam, Mass., a leading provider of testing services to the medical device industry.
CVCs are found in use at intensive care and long term units in hospitals. When inserted into a patient, it enables that patient's skin to grow into the device and form a biological seal that has a significant impact on preventing infection at the site of insertion, explained Dr. Gerald Bousquet, M.D., President, Med-Conduit.
Microtest is conducting bacteria testing on a new cap that Med-Conduit is implementing for its CVCs, said Dr. Bousquet.
Dr. Bousquet turned to Microtest for its current testing needs after working with the company and its founder, Steve Richter, Ph.D., on a previous project.
Dr. Richter had assisted Dr. Bousquet to navigate the stringent US Food and Drug Administration (FDA) application process and successfully obtain the critical FDA approvals he required to manufacture and sell a product at his previous company, Microwave Medical Systems. The product, the Microwave Sanitizer, is a microwave designed to sanitize the catheter connection area to decrease the risk of infection for patients in peritoneal dialysis.
"Dr. Richter's prior experience working at the FDA, combined with his deep expertise and background in medical device development, and his personal passion to succeed, made all the difference in securing the approvals we required," Dr. Bousquet said. "Dr. Richter even traveled with our company principles to meet with the FDA in Washington, DC."
Microtest offers a host of single-source solutions that assist medical device manufacturers facing a rising volume and complexity of challenges in product development and validation, including:
o Medical device sterilization validations
o Package validations
o Microbiology and clean room services, and
o Analytical services.
A new free white paper written for medical device manufacturers discusses sterility testing as well as reviews different testing methodologies Titled "Sterility Testing: Essential Things You Must Know," it's authored by Dr. Richter, and is available for download at: microtestlabs.com/sterilitypaper.
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption.
For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.