INDUSTRY NEWS

Start-up, SpineFrontier, Benefits from ETC's Outstanding Customer Service

2007-10-15

With the goal of developing innovative medical devices for spine surgery, SpineFrontier Chief Innovations Officer, Chris Chang, began shopping for a test lab to ensure that the devices will meet FDA standards. After meetings at several facilities, Chang realized that given SpineFrontier's focus on only developing distinctly innovative devices conceived by spine surgeons, his organization needed more than a process-driven testing house that takes specs from its client, tests its device, and then mails a report. So, based on the recommendations of industry colleagues, he contacted ETC President and CEO, Dawn Lissy.

"Interacting with Dawn was a big solidifying factor for me," says Chang. SpineFrontier had a vision and an end goal, but, Chang says, We didn't know what kinds of fixtures were needed and we weren’t sure what testing was available to achieve high quality and objective results. Dawn walked SpineFrontier through all of it "from Instron machines to test set ups and now we are up to speed with the best in the business.â"

That type of support was key in Chang's decision to work with ETC. "Partnership is the main quality startups are looking for," says Chang. Since then, SpineFrontier has valued ETC's input when developing protocols, while keeping abreast of FDA regulatory and ASTM standard changes, and during SpineFrontier team meetings when making important decisions. "Our relationship with ETC is deep in trust and mutual respect so much so that it is a competitive advantage," Chang adds.

ETC Adds Value that Permits Growth

The benefits of working with ETC have allowed SpineFrontier to quickly grow beyond a single-device company.

"Like SpineFrontier, ETC is agile and nimble and adjusts well to the fickle nature of a startup," says Chang. "ETC is willing to grow with us, not just get us through the phase. ETC is acquiring more equipment to handle more of our projects and continues to keep running a quality system."

"We wouldn't be as efficient at meeting our goals for FDA submissions without Empirical Testing Corp. (ETC),"� adds SpineFrontier Innovations Manager, Todd Saunders. "ETC helps us to establish what testing we'll do. And, ETC allows us to get the most value out of our dollars spent. We make informed decisions quickly and ETC helps us to do so."

Partnering throughout the Product Development Cycle

The ETC business model is based on a foundation of outstanding customer service, bio-medical knowledge, and the highest quality testing. Each one is delivered through a stream of continuous communications throughout the product development cycle.

According to Saunders, ETC contributions include sharing insights into how one might develop test protocols during the concept phase, how to ensure that a device meets performance goals during the development phase, and, all the while, ETC keeps SpineFrontier abreast of FDA regulatory changes and the latest ASTM standards. Then, adds Saunders, “we are asked what we want to do with the information."

When SpineFrontier was preparing to go into production, ETC assisted SpineFrontier with design verification and validation of processes to ensure that all of SpineFrontier's products were of the highest quality.

"Dawn and ETC have helped us to grow our knowledge," says Saunders. "By going through the process and testing requirements, we have developed a protocol and an understanding of what processes need to run. Now we see how the feedback from Dawn, and FDA regulations, lead to successful 510k submissions. As a result of ETC's partnership, we are becoming more and more efficient at getting a device from concept to FDA clearance quickly. "