Originally Published MPMN September 2009

MD&M MIDWEST 2009: FIRST-TIME EXHIBITORS

Testing Services Provider Has Roots in Product Design

Stephanie Steward

Prior to becoming president and CEO of Empirical Testing Corp. (ETC; Colorado Springs, CO), Dawn Lissy spent years working on spinal implant product design and development teams as an engineer. During that time, she repeatedly faced the problem of working with testing houses that demonstrated limited knowledge of the medical device industry, developed inadequate test methods for her products, and delivered unreliable results. After much frustration, Lissy finally decided she could provide a better standard of testing services for product engineers like herself.

Since Lissy launched the company 10 years ago, ETC has provided orthopedic medical device testing services for such applications as knee and hip replacement devices based on ASTM and ISO standards or customer-driven protocols. And, as orthopedics manufacturing has expanded, so have the company’s services. “Ten years ago, polyaxial screw systems were the ‘new technology;’ now, there are four different categories of nonfusion devices for spinal indications,” Lissy says. To keep up with industry changes, as well as such new and emerging technologies as small joints and dental implants, the company is involved with several ASTM subcommittees and round-robin studies.
The company prides itself on working closely with its customers to provide services that meet all of their testing needs. Because of that practice, the company listened when its customers expressed a desire for a one-stop shop for hip and knee mechanical and wear testing. It has brought a hip and knee wear testing consultant on board to meet that demand. “In order to bring the same high level of quality to each project, it made sense to hire the consultant with years of experience in testing in both the hip and knee markets,” Lissy says.
In addition to broadening its expertise, the company has grown in terms of physical space and equipment. Working out of a 10,000-sq-ft facility, the company has added eight test frames in the past year to its existing 26 frames and two wear simulators. “By adding the additional frames, [we were able to] decrease queue time for our customers from approximately six to eight weeks after receiving their components to one to three weeks, depending on the time of year and scope of test job,” Lissy says. “The two six-station wear testers allowed for ETC to be able to support the extensive testing required for nonfusion spinal devices.”
Not limited to wear testing, the company offers load-included subsidence testing, as well as analysis of screw and rod interconnection properties. The company also provides a range of testing services for a variety of discs, stabilization devices, shoulder and elbow replacement devices, and lumbar and cervical fusion and occipital cervical systems.
While the equipment is essential to its mission, the company believes that its method of partnering with customers has also helped to improve its services. The company initiates communication with its customers at least once a week and occasionally engages in site visits. These visits present opportunities for the company to suggest enhancements to customers’ processes in order to help them meet production and regulatory requirements. Additionally, the company provides what it calls “best of” technical reports that can be used as guides during R&D and when assembling regulatory submissions.

Empirical Testing Corp.
www.empiricaltesting.com
Booth #4128

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