Microtest Laboratories (Agawam, MA) and Texcel Medical (East Longmeadow, MA) recently announced their strategic alliance to provide pharmaceutical manufacturers and biotech companies with outsourcing services for developing the latest combination products-medical devices with pharmaceutical or biologics components-a growing market that is expected to reach approximately $9.5 billion in 2009.
“The combination products market is booming. Yet many pharmaceutical 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,” says Steven Richter, PhD, president of Microtest.
“For such firms, outsourcing is the solution,” he continues, adding, “provided that the arrangement is struck with the right partner.”
Microtest is a provider of testing services and contract manufacturing for the medical device, pharmaceutical, and biotech industries. Texcel brings to the alliance manufacturing infrastructure and engineering expertise for surgical, interventional, and implantable medical devices. The companies say that together they can offer design, prototyping, development, testing, approval, and manufacturing of combination products in Texcel’s ISO 13485:2003, ISO 9001:2000, and FRD registered facility.