Testing the size and count of particulates shed from medical devices is a significant export opportunity for Dynatek Labs of Galena, Missouri.
Dynatek offers a range of cardiovascular testing equipment, including acute particulate testers, heart valve testers, VAD testers, silicone cardiovascular models, stent coating durability testers and stent durability testers to countries around the world.
But particulate testing as it relates to clogged arteries is its big international seller.
Cardiovascular medical devices require rigorous testing by the FDAs of the world. Its M6 Heart Valve Durability Tester provides accelerated cycling tests of 10 to 20 times normal rates before receiving approval by various international bodies.
The requirements vary by country. One of Dynatek’s largest export markets is China, where seven different FDAs and central committees run cycling tests on the company’s testers. In Europe, Dynatek must deal with some 140 certified bodies to gain entry. In India, one of its largest markets, buyers rely on US FDA certification.
Much of the company’s product development is custom work. In Europe it derives from smaller start-up medical device companies where many have varying product manufacturing specifications that require different degrees of tester customization from Dynatek Labs.
The company has its origins in its “gold standard” M6 Heart Valve Durability Tester, developed by its founder, Professor Milton Swanson in 1984. Subsequently, the company was bought by Dr. Elaine Strope, President, and Dr. James Conti, Executive VP and Senior Engineer, and it now offers several product lines.
“Intellectual property is important, but not a major concern,” said Dr. Strope. “Even in China, where many American products are reversed engineered and copied, our testers and accompanying software are extremely complex and are nearly impossible to replicate.”
In addition, the Chinese certifying bodies appreciate Dynatek Labs’ quality, durability and rapid customer service response. Some customers use Dynatek products to gain access to the US market.
While some of its steel components are imported, the products are assembled and completed in the USA. In fact, most of its components come from shops based in and around the Springfield, Missouri area, so component supplies can be provided as quickly as they are needed.
Export sales require long lead times, according to Dr. Conti. “It may take anywhere from several months to several years to complete a sale,” he said, “followed by a prolonged period to supervise assembly of the equipment.”
While the company sells through distributors in some countries, most of its sales are direct and result from previous sales and excellent customer service over several years. Its services revenue is important because devises sometimes require hundreds of millions of testing cycles, which Dynatek implements.
The company employs 18 people from its 10,000 square foot facility just south of Springfield and relies heavily on the International Office of the Missouri Department of Economic Development, for on-the ground assistance in international trade shows and other marketing and sales initiatives.