COMPANY NEWS

Product Development Informs ETC's 10 Years of Service to the Medical Device Industry

2009-02-17

Visit Empirical Testing Corp., in Colorado Springs, Colorado, and learn first-hand why we consistently exceed medical device testing needs. Here, you will observe a knowledgeable team of bio-medical engineers, a state-of-the-art mechanical testing facility, and an enthusiasm to ensure your medical device is efficiently tested and has every opportunity to swiftly get to market. You will also witness how pride for working in the medical device industry and experience informs an outstanding product: a test report that has been recognized throughout the industry for 10 years running.

The passion that drives ETC started well over 10 years ago with our president, Dawn Lissy. As an Acromed Corp. product development engineer, Ms. Lissy was responsible for new product design and development. She was partner of the Trauma-Tumor Team and managed the maintenance, manufacturing, testing, quality, marketing, and regulatory standards of a variety of product lines. She also faced the trials and tribulations of working with testing houses that demonstrated limited knowledge of the medical device industry, developed inadequate test blocks and methods for her products, and delivered unreliable test results. Those testing houses rarely communicated with her other than at the beginning of the project and when it was time to deliver their results at the end of testing. Additionally, she had to reverse engineer those test results to ensure that their reports were submittable for regulatory approval.

"That is how I grew to understand our clients' challenges," says Ms. Lissy. "As an engineer developing spinal implants, I had to tell test engineers what fixtures to develop and what the test blocks should look like. I only learned of product or testing issues after I received my results, so wasn't given the opportunity to maximize my resources during the test phase. Some of the issues could have been easily resolved had I received information in a timely manner. But to understand these test reports and my products' performance, I had to reverse engineer every report."

Further fine tuning her grasp of test reports and their role in achieving regulatory approval, Ms. Lissy, a member of the team responsible for the development of the Stackable Cage, participated in the initiation of a ground breaking submission pathway to FDA approval.

All of this insight converged when husband, and now-ETC Vice President, Chris Lissy, suggested that Ms. Lissy turn her frustration into the opportunity of a lifetime and a product that is known world-wide for making a difference when seeking regulatory approval. On December 22, 1998, ETC was founded as a corporation in Ohio. Within their first 5 years, ETC's facilities grew to 5,000 square feet housing 7 test frames. In 2004, the Lissy's moved ETC to Colorado and into their current 10,000 square-foot facility. In just 2 years, the number of test frames grew from 13 to 26, with 8 more added last year. The facility also is home to 2 wear simulators.

Building a burgeoning business has been gratifying, says Ms. Lissy. "But, I was especially proud to achieve A2LA accreditation," she adds. "With A2LA's ISO/IEC 17025:2005 certification (Certificate Number 2142.01), we are recognized as a mechanical test lab committed to operating in an environment that places quality first. It also says that we stand behind what we do." ETC continually expands our scope of accreditation. For a complete list of ETC A2LA certifications, visit www.empiricaltesting.com.

With increased business comes a larger staff. ETC started in Colorado with 4 employees and now employs a staff of 19. The Lissys went from being accountable for everything to cultivating an ability to quickly react to customers requirements. Along with the increase in square footage, test frames, wear simulators, and staff, ETC remains focused on delivering outstanding mechanical testing reports and services, including (a minimum of) weekly customer communications, "Next Day" services which allow clients to "jump the queue" when immediate testing is necessary, plus more customer site visits to keep in touch with clients and initiate enhancements to meet customer needs.

After 10 years of service to the medical device industry, there remains ground to break. With a devotion to exceed customer needs and to help drive medical devices to market, ETC is now originating and participating in research projects. "Whether we're making our own specimens and running tests," says Lissy, "or partnering with a research institution, we are pleased to answer questions about how parameters around a device affect the performance of the device. These are questions everyone in the medical device industry asks, but does not have the time or resources to answer."

To learn how you can benefit from working with ETC, or to schedule an onsite visit, please call 719-264-9937, email dlissy@empiricaltesting.com, or visit our website at http://www.empiricaltesting.com/visitors.php.