Microtest Laboratories Combines Forces for Combo Products, Testing

OUTSOURCING NEWS

Microtest Laboratories (Agawam, MA) and Texcel Medical (East Longmeadow, MA) have formed an alliance to provide medical device companies with expertise in manufacturing combination products. The goal is to help companies get their products to market faster and more efficiently.

The market for medical devices embedded with pharmaceutical or biologics components is expected to reach about $9.5 billion in 2009, but companies may still be unsure as to how to perfect the development and manufacturing processes.

“The combination products market is booming,” says Steven Richter, PhD, who is president of Microtest. “Yet many companies are struggling to manage the convergence of devices and drugs or biologics and the host of unique FDA testing guidelines, practices, and regulations that such products require.”

In trying to stay competitive in the combination products market, outsourcing could be the key.

“For such firms, outsourcing is the solution—provided that the arrangement is struck with the right partner. This is the strategy behind the Microtest-Texcel alliance,” Richter said.

Microtest Laboratories was also selected by Med-Conduit (Tyngsboro, MA) to provide bacteria testing on a cap for its central venous catheters. The devices allow skin to grow into the device, where it forms a biological seal and prevents infection at the site. The catheters are used in intensive care and long-term hospital units.

Med-Conduit's founder and president, Gerald Bousquet, MD, chose the company after working on a previous project with Richter. The project involved gaining approval for a microwave that sanitizes the catheter connection area in order to decrease the infection risk in peritoneal dialysis patients.

Microtest helps medical device companies meet challenges in product development and validation. Its areas of expertise include device sterilization validation, package validation, microbiology and cleanroom services, as well as analytical services.

Microtest is a contract manufacturer that provides testing services such as sterilization validation, package testing, stability testing, and biocompatibility testing. Texcel complements Microtest's capabilities with its own manufacturing and engineering expertise for surgical, interventional, and implantable medical devices.

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