FDA Approved Q-Collar is designed to help limit Traumatic Brain Injury (TBI) in military personnel and athletes.
Sussex, Wis (Sept. 14, 2021) — Sussex IM, a long-standing leader in custom injection molding and advanced automation, is the trusted contract manufacturer for Q30 Innovations. A company whose mission is to protect athletes and military / public safety personnel from Traumatic Brain Injury (TBI) with an externally worn Q-Collar.
The Q-Collar, which is a multi- material progressively injection molded part, is the first of its kind for effective TBI protection. After years of development and testing, it has recently been cleared by the FDA to release in the US market. September 2021 marked the commercial launch of the Q-collar, which is now available for pre-order in the US.
“Sussex IM is proud to be a critical manufacturing partner of the Q30 Science Q-Collar. The history behind the science is intriguing,” says Greg Gierach, the Strategic Account Manager in the medical market for Sussex IM. “It is very satisfying to witness the evolution of cutting-edge product design, support the strategic marriage of select materials and associated processes to generate the outcome.”
Q30’s decision to choose Sussex IM as their partner was predicated on a long history of collaboration as well as Sussex IM’s reputation for industry-leading injection molding, automation, innovation initiatives and relentless support of design perspective for manufacturability.
“The capability of our team has supported the entire evolution of this product. Sussex IM has been a critical partner in the development of part geometry, materials, process development, regulatory considerations, secondary operations and fulfillment to commercialize the retail product in Canada and now in the US Market,” says Gierach.
The combination of Q30’s scientific research and Sussex IM’s manufacturing capabilities has led the Q-Collar development towards a device ideal for reducing the risk of TBI. “We have been involved in this for 7 1/2 years. We were brought in as a manufacturer at the very inception of this program,” says Keith Everson, CEO of Sussex IM.
The FDA process for clearance created an opportunity for Sussex IM, as they worked with Q30 to make sure all the requirements were supported for the project. “This program also opened the door for us to receive the ISO 13485 Certification and expand into medical/clean room molding,” says Everson. This internationally accepted manufacturing standard positioned Sussex IM for a quality management system that would support future medical applications. The Q-Collar has been in trial for professional athletic teams, military personnel, and other non-sport related groups highlighting the Q-Collar’s application flexibilities.
“As outlined in numerous case studies published by Q30 science, the Q-Collar’s impact is beginning to get noticed in a variety of applications,” says Gierach. “With years of data and practical application experience, the outlook for larger scale acceptance in the U.S. market appears very promising. Q30 has done an exemplary job of providing data and research to support the effectiveness, addressing concerns of new product innovation, market findings of the emerging technology and positioning in the appropriate arenas to draw awareness of the benefits of the product.”
The upcoming months will be an exciting time for Sussex IM and for Q30 in their continued effort to help mitigate, and eventually eliminate, the effects of TBI.