Colorado Springs

Founded: 1988

Privately owned

Employees: 105 U.S.; 205 Dominican Republic

President and COO Steven Burdorf is leading the contract manufacturer to new heights in the massive medical device market.

CEA Medical Manufacturing –- like many of America’s most successful companies –- does much of its work as a behind the scenes contributor to the $125 billion U.S. medical device industry, the world’s largest.
CEA’s Colorado Springs-based operation includes new product design, development and engineering, accompanied by partly or fully assembled products which are packaged in a sterile environment and shipped — all from a single source.

“We pride ourselves on delivering best-in-class products and services to some of the world’s largest medical companies,” says Burdorf, noting that CEA is a contract manufacturer, not an OEM. “What sets us apart is our turnkey system. Materials flow seamlessly, enabling us to stay ahead of the market.”

CEA designs and manufactures disposable, plastic, and reusable electromechanical devices used in critical care applications as well as guide wire delivery devices to the heart. End users include cardiologists, gastroenterologists, neurologists, hospitals, and medical practices.

“An expanding global marketplace demands smart supply chain logistics and careful production cost management. Fortunately these have long been two of our core competencies,” Burdorf says.

Unlike other industries, medical device makers frequently depend on “nearshore” rather than “offshore” facilities for high volume mass production. CEA’s Dominican Republic manufacturing plant, for example, is located along with 25 other medical device companies — many of which purchase the company’s equipment and components and utilize its “flow manufacturing” practices. In contrast, the Colorado Springs headquarters houses batch-production and new product design as well as CEA’s sales, engineering and administrative functions.

“Colorado is more accessible to those looking for product engineering and design assistance — one of our specialties,” Burdorf explains, adding that the Rocky Mountain headquarters helps attract engineers and technical talent. And there’s room to grow — a good thing based on current forecasts for a 25 percent staff increase in 2015.

Already FDA-registered and ISO-certified, Burdorf expects CEA to add an additional ISO environmental certification (14003) next year. The move comes in response to green initiatives in the medical industry — particularly among hospitals — and will enable company to qualify as a preferred supplier and bolster ROI.

Sales are handled by a small but highly skilled in-house business development team, but the bulk of business is generated through word of mouth and long-term client relationships. The company’s design team includes mechanical and electrical engineers, though CEA doesn’t hold its own intellectual property. Its U.S. staff also includes dozens people working in supply chain logistics, assembly, quality control, and technical support.

Supply chain partners include some raw materials providers (mostly metals and plastics) as well as subcomponent makers. About one-third of the company’s production involves components that have been shipped in. Organized for growth, Burdorf says in the next 12 months, the company will invest in four key areas: engineering, quality, supply chain, and capital improvements, including a second plant in the Dominican Republic.

Burdorf emphasizes that leading-edge technology will not only support CEA’s core competencies in complex assembly, electrical and mechanical engineering, plastics, and guidewires, but it will also drive new product development. “There’s been tremendous change these past few years. We’re more focused than ever on product accuracy, smaller-size equipment and increased speed of execution,” he says.

That strategy seems to be paying big dividends. Even through the last recession, the company prospered. That uptrend is likely to continue, based on CEA Medical’s aggressive growth strategy and consistent double-digit annual growth rates — both revenue and profit. Today its products are shipped throughout North America, Europe, and worldwide.

“The future is very bright for CEA,” touts Burdorf.

Challenges: “Our biggest challenge is staying ahead of changes in regulations within the FDA. It’s a very fluid environment. We may have to rethink some of our manufacturing processes,” says Burdorf.

Opportunities: Growth and job creation. “U.S. medical device manufacturing as a whole continues to be a growing industry –- and we help bring high-value employment to Colorado Springs. What we’re focused on is continuing to add value in our community and state,” Burdorf notes. We now have an opportunity to make a real impact, to help develop a stronger economy through partnerships with higher education institutions in our area, as well as will the Colorado Springs Regional Business Alliance and the Colorado Bioscience Association.”

Needs: Skilled workforce. “We’re looking for talented people who share technical expertise, a willingness to embrace our corporate emphasis on exceptional service, quality, and to help us manage costs for our customers,” explains Burdorf.