Dynatek Labs is a world leader in medical device testing, equipment, services and consulting with over 35 years of experience. Our core products and services are centered around stent testing, heart valve testing, acute particulate stent testing, particulates shed from catheters guide wires, implantable device delivery systems, fatigue to fracture stent testing, and coated durability device testing.
Dynatek Labs keeps hearts pumping throughout the world
IBNewsmag Frebruary 2020
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.
Lucideon and Dynatek Labs Form Strategic Partnership
Lucideon, an international development and commercialization organization (DCO) specializing in materials technologies and processes, and Dynatek Labs, a world leader in medical device testing, have formed a commercial partnership to continue to expand their collaborative support of the vascular industries.
The partnership will bring together a unique cohesion of skill sets, aligning industry leading expertise in both materials science and testing solutions. Key services include regulatory testing (e.g. coating durability testing, radial fatigue testing, and acute particulate evaluations), failure analysis, materials characterization, and materials development. This collaboration will allow both organizations’ clients to utilize a single point of contact to help support them through every stage of manufacture; from research and development, design phases, performance testing, product validation, regulatory submission, and even post-market evaluation.
Sean Borkowski, Healthcare Business Manager at Lucideon said: “Our goal is to become the first port of call for vascular companies developing new materials, testing new products, and solving business critical materials and process challenges. Together with Dynatek, we are taking another step closer towards realizing this vision.
“Both of our businesses pride ourselves in providing our clients with solutions to help them achieve product life cycle success, wherever they are in that journey. In order to do so, we will combine our decades of experience, our ever-growing industry knowledge, and our scientific ingenuity to stay ahead of the curve amidst constant regulatory pressure and change. We have confidence that together, we will continue to lead this charge as independent solutions providers.”
“With a combined presence in the United States, Europe, and Asia, Lucideon and Dynatek are prepared to support our clients across the globe.”
Kendra Conti, Global Sales Director at Dynatek said: “Dynatek has been a pioneer in durability testing for 35 years. For the past ten years, we’ve been instrumental in establishing best practices for particulate testing of medical devices. As a member of various regulatory standards committees, our team gains first-hand knowledge of current and upcoming regulatory requirements.
“We’re excited to combine our extensive industry knowledge and regulatory experience with Lucideon’s comprehensive portfolio to offer our clients a streamlined experience through the testing required for regulatory approval.”
In addition to providing solutions to end clients, the collaboration will produce informational resources to help drive the knowledge of materials science and testing excellence for medical devices.
Both companies share an agile corporate culture, offering premium services and customized approaches to testing novel medical devices.
If you would like to discuss how Lucideon and Dynatek can help with your vascular product development and testing then please contact Sean Borkowski, Lucideon on firstname.lastname@example.org or Kendra Conti, Dynatek on email@example.com
17 July, 2019
Acute medical particulate testing
Dynatek’s new Fatigue to Fracture Tester highlighted in a paper presented at a recent ASTM International Symposium.
The American Society for Testing and Materials (ASTM) International subcommittee on Endovascular Test Methods developed the new standard ASTM F3211 Standard Guide for Fatigue-to-Fracture (FTF) Methodology for Cardiovascular Medical Devices.
Dr. Matthias Frotscher of Cortronik GmbH presented a paper at ASTM’s Fourth Symposium on Fatigue and Fracture of Metallic Medical Materials and Devices in May 2018. This was the culmination of three years of research and instrument development by Dynatek and Cortronik. The paper “A New Approach for Fatigue-to-Fracture Testing of Coronary Stents” presented a test methodology taking the new ASTM standard into account, which can subject cardiovascular stents to hyperphysiological loading. In combination with FEA analysis, it can help to understand how stents fracture, e.g., to optimize device designs or evaluate the criticality of manufacturing process changes with regard to fatigue without the need to test to high numbers of cycles.
This testing was run on Dynatek’s patented FtF extreme conditions radial fatigue tester. The instrument utilizes Dynatek’s more than 30 years of experience designing and manufacturing medical device testing instruments. It provides extreme loading conditions to stents, so that they can be radially stressed to a much greater degree than previously possible.
This paper has been chosen for publication in STP 1616 of the Fourth Symposium and Fatigue of Metallic Medical Materials and Devices to be available at the ASTM STP in the near future.
Dynatek’s products are designed to fulfill current and anticipated international regulations. Learn more about how our machines satisfy the following standards:
ASTM F2394 – 07(2017)
- ASTM WK60510
- ASTM WK60511
Dynatek’s innovations list continues to grow
- First to develop fatigue to fracture testing of stents.
- First to develop technology for integrated, real-time acute particulate testing.
- First commercially available coating durability tester with in-line particulate analysis.
- First to develop precise high-speed photographic verification protocols and procedures.
- First to offer a commercially available pulsatile artificial heart tester.
- First to use 5% to 7% compliance for mock vessels.
- First in the use of precise, optically clear mock vessels.
- First to use tuned fluid oscillation in heart valve testing.
- First to create velocity flow standard.
- First to introduce Dynamic Internal Compliance of mock vessels.
- First commercially available stent/graft durability tester with single ended pressurization. Read more
Arab Health 2019 Dubai Success
Chris Conti, senior engineer, James Conti, executive vice president, and Elaine Strope, president of Dynatek Labs attended the Arab Health exhibit held at the Dubai International Convention and Exhibition Center in Dubai, UAE from January 28 to January 31, 2019. Arab Health is the largest healthcare show in the Middle East region and drew over 4000 exhibitors from 66 countries with over 84,000 attendees from across the world. Dynatek Labs exhibited in conjunction with the Missouri Department of Economic Development and our booth was located in their pavilion.