Outsourcing is Answer for Pharma, Med Device Labs Struggling to Meet Unique Testing Requirements of New Combo Products

AGAWAM, MASS. - March 23, 2007 - Outsourcing is the answer for pharmaceutical and medical device manufacturers struggling to meet the unique testing guidelines, practices, and regulations spawned by the development and production of the new breed of "combo products," said Steven Richter, Ph.D., President, Microtest, Inc. (www.microtestlabs.com).

Richter made his remarks in advance of PharmaMedDevice 2007, April 24-26 in the Jacob Javits Center in New York City. Richter's company, Microtest, will be exhibiting at the event in booth number 110.

Market demand for combination, or combo, products - medical devices embedded with a pharmaceutical or biologics component - is booming. Growing at a 10 percent compound annual growth rate, the market will reach approximately $9.5 billion in 2009 according to one analyst. Pharma companies and medicals device makers are racing participate with new product introductions.

"But most manufacturers' in-house labs are not yet ready in terms of the equipment, skills and experience needed to address the challenges of testing and validating combo products," said Richter, whose previous industry experience included a position with the U.S. Food & Drug Administration (FDA).

"Many pharma labs don't have the expertise or facilities to address the processing of a physical product through their labs - let alone the skilled personnel knowledgeable in medical device testing and succeeding such a device through the FDA maze of regulatory issues. Medical device manufacturers generally lack the drug GMP systems to handle a combo product's pharmaceutical aspects," Richter said. "And both face the costs of the training, time, and technology it would require to upgrade their in-house labs."

"Given all this, it's not unreasonable to understand why the convergence of the required resources, skill sets, and practices at in-house labs to handle combo products has been slow," Richter said. "The solution instead, for many pharma and device manufacturers, is to outsource the testing and validation needs of combination products with an outside laboratory testing partner."

For manufacturers, selecting the appropriate partner to outsource the lab testing of combo products is both critical and complex, and according to Richter, questions should include:
* Specific experience and track record relating not just with drugs or devices, but with combination products
* Specifics as to capacity, equipment and personnel
* Explanation of validated procedures and Best Practices
* Expertise with regulatory benchmarks and requirements
* Details of their technology platform: GMP, GLP, QSR, ISO, CMC
* Availability of dedicated, onsite project management, rather than relying on outside consultants, to manage the project
* Comprehensiveness of internal resources, without the need to subcontract
* Ability to deliver against the required timeline
* Cost effectiveness
* In-house manufacturing capabilities - an added "bonus" - that will not only provide valuable "real world" expertise to the partnership, but offer an additional manufacturing resource once approval is secured.

"As we anticipate the issuance of new FDA guidelines specific to the research, development, production, and validation of combo products, the selection of an outsourcing laboratory testing partner is nothing less than a critical element for any manufacturer's successful development and production process of a new combo product," Richter said.

For more information, contact Richter in the Microtest booth, number 110, at PharmaMedDevice 2007, April 24-26 in the Jacob Javits Center in New York City. Or, visit the Microtest website at www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and 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.