Medical Device Testing Case Study: Consensus Orthopedics
Consensus Orthopedics is an innovative, large joint implant manufacturer. Since 1992, the company has implanted over 30,000 knees and 20,000 hips worldwide. The California company takes pride in its reputation for continued performance and reliability of their time-tested and proven products.
In the early stages of outsourced testing, Consensus’ design engineers would address their mechanical testing needs on a case-by-case basis, seeking out a lab through an internet search each time a need arose. This often created delays in getting implants tested due to the length of response time from individual labs when requesting a quote. Even after receiving a quote, Consensus engineers would often have extended waits because of test lab capacity issues, said Justin Creel, PhD, Consensus’ Senior Director of Research and Development. “Nothing is more frustrating as an engineer than having all the design work for a product launch complete but having to delay production because your test parts are waiting in a lab’s queue.”
Several years ago, Dr. Creel met a few Element team members at an industry event. As it happened, Consensus had hip implant testing needs at the time and the company was looking for a lab to complete the project. After their meeting, Element’s team had a quote to Consensus that same day. “We were initially drawn in by the price of the quote, which was at or below all of the other bids we received,” said Creel. “However, after that first project, it was really the responsiveness of the staff and the ability to reserve lab space in advance of parts that lead us to make the decision to begin partnering with Element and abandon our ad-hoc approach to outsourcing testing.”
Hip Wear Testing
Since that initial project, Element and Consensus have partnered on numerous successful testing endeavors, including an ISO 14242-3 hip wear testing project for which Consensus recently received 510(k) clearance. In addition to cost, responsiveness, and the ability to schedule capacity, Creel says that the structure of Element’s sales and engineering teams has helped to foster the relationship along the way. “Element’s engineers are great technical resources when we have ongoing projects. They are always available to answer questions or discuss testing solutions. On the other hand, it’s also great to have a dedicated sales rep that checks in from time to time to discuss our future initiatives and is always available at a moment’s notice to provide proposals. It’s that mix of technical knowledge and friendly personalities that make Element a great vendor to work with.”
Consensus has realized significant financial and resource benefits from this partnership with Element. Having a knowledgeable and responsive vendor to rely on has allowed the Consensus engineers to keep development projects on track. “Many of these projects are already on a tight timeline, so it’s imperative that we work with Element to schedule our testing well in advance. If we know when parts will arrive, we can notify Element’s team and they will prepare so that testing can begin almost the minute samples arrive at their front door.”
This communication has helped to streamline many of Consensus’ internal processes, which has freed up resources for other timely tasks. In addition, Consensus has been able to avoid costly manufacturing and product launch delays which could have a devastating impact on any company’s bottom line.
“When the success of our products and the generation of revenues are on the line, it’s critical to have a reliable laboratory to lean on. Overall, Element has become not only a technical resource for our team, but also a vendor we can trust to communicate throughout the testing process and deliver on their promises.”