Stratos

SEATTLE MEDICAL DEVICE CONSULTING FIRM PERFECTS THE BALANCE OF INNOVATION AND CREATIVITY WITH THE STRICT REQUIREMENTS OF FDA REGULATIONS

Seattle (August 1, 2007) – Imagine if Rembrandt had stopped to write a detailed description of every brush stroke he made on the Mona Lisa. If we knew the exact angle of the stroke, precise mixture of color pigments and other key information, it might be possible to recreate the world’s most famous painting. Then again, maybe that’s why Rembrandt took four years to complete it. The U.S. Food & Drug Administration’s Quality System (FDA Register 21 CFR Part 820) can have a similar effect on new product development. It necessitates documentation that helps ensure the safety of medical devices, but if managed poorly it can constrain creativity and increase costs. It may also present unique challenges for companies working with outside consultants that must meet the same requirements. That is why Stratos Product Development, a comprehensive medical device consulting firm, developed its own FDA compliant in-house quality management system with input from many of the world’s top medical device manufacturers. Nearly three years later, the company is celebrating an unprecedented 1,000 days of compliance.

“Our system allows clients to satisfy the FDA’s regulatory requirements without sacrificing creativity during crucial phases of innovation and development,” explains Sean MacLeod, president of Stratos Product Development. “The result is a more competitive product, shorter times to market or ‘time to quality’ and a more robust solution overall. We also collaborate with our clients’ manufacturing and clinical partners early in the development process, which helps ensure a seamless, efficient transition to market deployment.”

The firm’s Quality System has become a unique distinction between the Seattle-based firm and its competitors wherever they may be. “Stratos now has a three year, documented record of compliance with FDA requirements for medical device design,” says Carl Youngman, whose firm Regulatory Affairs Associates consults with medical device manufacturers around the world. “That experience has led to the development of a staff disciplined in a defined system of good engineering practices.”

“When choosing a development partner, we look for firms that share the same design control mindset,” says Rob Weyer, vice president of Research and Development for Stratos’ client Philips Oral Healthcare. “Speaking the same language from the start leads to higher, measurable quality after your initial product launch. In the medical device market, we all know it is much more difficult to maintain compliance than it is to initially put the system in place.”

“Stratos clients also benefit from our holistic systems approach to product development,” adds MacLeod. “There is a unique convergence of skill sets when engineers, designers, scientists and business strategists who work in highly competitive and rapidly evolving fields like consumer products also apply themselves to the more tightly regulated fields of medical technology. The efficiencies and benefits are tremendous for clients trying to grow their top line.”

At a time when recent acquisitions have spawned reports of the Puget Sound area’s shrinking mindshare in the medical technology field, Stratos Product Development is enjoying unprecedented growth. “Since the majority of our clients are based outside the region,” says MacLeod, “it’s a well kept secret that some of the biggest medical companies in the world are doing their leading edge development right here in Seattle with Stratos.”

About Stratos

Stratos is a world-class company of experts in all of the disciplines required for commercializing technology and bringing products rapidly to market. We offer comprehensive systems solutions as well as individualized services ranging from product strategy and research to design and engineering to regulatory compliance. We excel in the areas of medical devices, enterprise hardware, consumer electronics, enterprise software, industrial instrumentation and life science applications. Clients benefit from our extensive background in each of these areas as well as the convergence of skill sets that fosters creativity, reduces time-to-market and offers the most compelling solution to the marketplace. Visit us online at www.stratos.com.

Medical device consulting firm perfects the balance of innovation and creativity with the strict requirements of FDA regulations.