Whether it's sales, manufacturing or research and development, the trend has been decidedly outward for U.S. medical device manufacturers.
According to a report released by the Health Industry Manufacturers Association, overseas markets for U.S. medical devices have become, and will continue to be, increasingly important to U.S. companies, with U.S. exports up 13 percent.
The Food and Drug Modernization Act of
1997 represents the first major food and medical
products reform legislation in 35 years.
|
Several forces are shaping expansion trends in this industry, according to a 1995 report prepared by The Wilkerson Group, Inc., an independent consulting firm focused exclusively on the medical products industry. These forces include a lengthy process of product review by the FDA; increased pressure to contain health care costs through managed care and other private health purchasing systems; an expansive product liability system; and more difficult access to venture capital by start-up companies.
The Wilkerson Group's survey of more than 500 medical device firms found that these companies are undergoing significant changes in order to maintain growth and profitability in response to these forces.
U.S. device manufacturers can, however, look forward to The Food and Drug Administration Modernization Act of 1997, which will speed up product reviews, accelerate the regulatory process, streamline postmarket controls and deliver new medical technology to patients faster. The new law represents the first major food and medical products reform legislation in 35 years.
Overseas markets for U.S. medical
devices have become increasingly
important to U.S. companies, with
exports up 13 percent. |
For companies interested in expanding in the U.S., a biomedical corridor has developed through the cities of Boulder and Denver, and in their surrounding counties.
In that region alone, there are 239 biomed companies, according to a survey conducted by Colorado Venture Centers (CVC) of Lakewood, Colo. Throughout the state of Colorado, CVC said there are 317 firms in the biomed industry.
In particular, Lakewood is developing into the Rocky Mountain hub for the biomedical, financial services and insurance industries. The city, just west of Denver, has recently seen the growth or relocation of industry leaders such as Kaiser Permanente, Safeco Insurance Co., and FirstBank of
Colorado.
Among Lakewood's largest employers is COBE Laboratories, Inc., which broke ground last year on a 60,000 square foot medical device sterilization facility at the Lakewood Industrial Park. COBE has three divisions, two of which are in its Lakewood campus: the blood component technology group and the renal dialysis group, which employ approximately 1,400 within Lakewood.
| "They have supported key suppliers relocating to the Lakewood area to shorten our supply chain."
-- Wes Lowe, COBE director of business services |
The new Lakewood site is designed to support these facilities as well as COBE's other manufacturing facilities worldwide.
COBE looked at other location opportunities throughout the Denver metro area, but decided its new sterilization operation should remain
in Lakewood.
"We chose to participate with the Lakewood folks because they have been very proactive with us in finding opportunities that allow us to continue to grow," said Wes Lowe, COBE director of business services. "They have supported key suppliers relocating to the Lakewood area to shorten our supply chain. ... Our sterilization process supports our
manufacturing operations, so
it's an essential part of our
manufacturing operations across the COBE companies."
The new site is expected to be operational by early 1999.
One of Lakewood's most important resources for biomedical companies is its labor force. The city's population is approximately 140,000, making it the fourth-largest city in Colorado. This population is also among the most educated in the country. Approximately 30 percent of the city's adult population have at least a bachelor's degree, which is 50 percent higher than the national average.
Lakewood is also home to the Colorado Venture Center, a biomedical business development organization that assists emerging companies, primarily in the biomed and high-tech sectors. CVC created the "Venture Guild" mentoring program that provides emerging companies with technical support to implement and refine their business plans to attract additional investment.
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