Thank you to our R&D Series Sponsor, Ximedica.
Date and Time
Wednesday, November 30th, 2016
8:00 AM - 9:30 AM CDT
The Medical Alley Association
First Floor Training Center
4150 Olson Memorial Hwy
Golden Valley, MN 55422
Registration: 7:30 - 8:00 AM
Event: 8:00 - 9:30 AM
MEMBERS $45 / NON MEMBERS $145
Successful medical device submissions to regulatory bodies often include extensive in vitro engineering tests such as those described in the “Guidance for Industry and FDA Staff – Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” FDA document. Test requirements vary widely depending on the type of implantable device, and guidelines can often be found in regulatory guidance documents, and ASTM and ISO standards. Determining how to simulate the conditions different medical devices will experience in vivo on the benchtop is challenging and requires careful consideration of key test factors. Specific application examples will be discussed for three test configurations: durability testing of abdominal aortic aneurysm (AAA) stent grafts, multi-modal testing of peripheral stents, and materials characterization of nitinol stent coupons.
- Introduction to in vitro Mechanical Testing
- Test Standards and Guidelines
- Key Test Factors and Considerations
- Application Examples
Kent Vilendrer, CEO & President, Medical Device Testing Services
Kent Vilendrer, co-founder of Medical Device Testing Services, has been involved in materials testing applications since 1978. In 1990, he co-founded EnduraTEC Systems Corporation specializing in the development of novel material test instruments and offering contract testing services to the medical device community. In 2004, the equipment manufacturing part of EnduraTEC was sold to Bose Corporation and EnduraTEC's contract testing business was retained and renamed to Medical Device Testing Services (MDT).
MDT has been providing creative solutions for the mechanical testing of medical devices for over 26 years. Kent's efforts in the material testing industry have led to the development of new test instruments, standards and protocols. He has been a member of the stent task groups for both ISO and ASTM and is involved in instrument, controls, and fixturing research and development projects for the medical device industry on an ongoing basis.
Kristen Lipschultz, Operations Manager, Medical Device Testing Services
Kristen has been working with MDT since 2012 and is responsible for coordinating lab scheduling and customer communications, overseeing calibration and quality standards and performing in vitro mechanical testing. Kristen has expertise in materials characterization testing and biomaterial analysis. Prior to joining MDT, she worked at the Pacific Northwest Laboratory of the US Department of Energy characterizing polycrystalline optical materials.
Kristen holds a B.S. in Material Science and Engineering specializing in polymers and ceramics along with a minor in Bioengineering from Iowa State University.
Engineers and managers involved in product design and development. Consultants advising medical device manufacturers on product development and testing.