Showing posts tagged with partnership.
Posted March 7th, 2012 by ETC
Many companies today are challenged with the intricacies of product development, and the medical device industry is no exception. So when faced with the substantial expansion of an existing spinal product line CoreLink Engineering Manager, Mike Mueller, recently sought the advice and expertise of Empirical Testing Corp. Having already formed a partnership with ETC for testing in the past, and knowing the complexities involved in developing and testing a product in accordance with FDA standards and requirements, Mueller requested the counsel of President and CEO, Dawn Lissy.
"We contacted ETC knowing Dawn would be the person we could talk to, the person we could trust to give us advice on developing and testing this pretty sizable product line," mentions Mueller. As part of CoreLink's overall strategy, Empirical Testing Corp. was recruited to help structure a system that would provide the best return on investment. Arriving onsite to strategize with Mueller's team, Ms. Lissy's main focus was to review the current project plan and discover ways to optimize the overall approach while minimizing testing and the overall number of FDA submissions. "There were quite a few components so we wanted to break it up into multiple phases, and Dawn was able to give her input on what she thought should be in each phase and what should be tested together," states Mueller.
By all accounts the meeting was a success. When asked if there were a need for this type of support in the future and if he would recommend this particular service to colleagues, Mueller replied, "Yes, definitely. We were able to use the information gained to open up a dialogue with our regulatory consultant and lay out a path for how we're going to move forward. Dawn's expertise was instrumental in allowing us to do that."
As always, Empirical Testing Corp. is establishing itself to grow with our customers. The culture in which ETC operates is built around anticipating customer needs and structuring a set of services, even beyond testing, that offer a more complete package, helping to streamline the process when bringing a device to market. "ETC strives to implement ways to add value for our partners. Having a sound and complete strategy before engaging in a product development cycle allows everyone in the team to work in sync through the entire process. Laying out options and potential paths allows for companies to save time and money while maximizing their ROI. We are pleased to be part of that process." states Lissy.
For information regarding this unique service or any of our other services, please contact us directly at (719) 264-9937 or visit our website at www.empiricaltesting.com/services. As always we're here as part of your team so your success is our success!
Posted October 15th, 2007 by ETC
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.”
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.”
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