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.
tct2019 San Francisco
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
Women in Science and Entrepreneurship
Dr. Elaine Strope, president of Dynatek Labs, was one of three speakers at the Women in Science and Entrepreneurship (WISE) Networking Breakfast on April 23, 2019. The WISE event was a unique opportunity for women in science and entrepreneurship in the Springfield, MO area to learn, share, and network. Dr. Strope shared her career path as well her experience in running a business in science.
MissouriCures Education Foundation (MissouriCures.org) and Rosie (Rosiesgf.com) presented the networking breakfast and the efactory (efactory.missouristate.edu) hosted the event. The Missouri Cures Education Foundation is a statewide nonprofit public education and advocacy alliance working to promote and protect medical advances to improve the health of Missourians and stimulate the economy in our state. Rosie helps support, assist, and serves as an advocate network for current and prospective female founders, business owners, and leaders in the Springfield region. The efactory is a business incubator, training center, and support network in Springfield.
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.
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
Acute medical particulate testing