Sussex IM Molds a Preventive Solution to Traumatic Brain Injury
The Q-Collar is described as the first device of its kind designed to protect athletes and military and civilian safety personnel from traumatic brain injury (TBI). Worn externally, the product developed by Q30 Innovations recently was cleared by FDA and had its commercial US launch last month. Contract injection molder Sussex IM has been involved with the project since its inception, some 7 1/2 years ago, and recently shared some insights on the evolution of the Q-Collar and how the role that Sussex IM played in bringing this product to market is shaping its future.
Helmets protect the head from the outside, but that doesn’t prevent the rapid acceleration and deceleration of the brain that leads to the twisting and tearing of neurons, which may cause traumatic brain injuries, notes Q30. Even smaller, repetitive impacts to the head can result in structural changes to the brain, adds the company. The Q-Collar helps protect the brain by applying light pressure to the jugular veins, slightly increasing blood volume inside the head and helping to reduce brain movement, according to the company. More than 25 laboratory and clinical studies reportedly back these claims. The science behind the Q-Collar fascinated Greg Gierach, Strategic Account Manager, Medical Market, at Sussex IM, as did the manufacturing challenges it presented.
“Q30 has developed a device that simulates a condition in athletes that occurs in nature,” Gierach told PlasticsToday. “The phenomenon/effect relates to anatomy similar to that of a woodpecker or bighorn sheep, as Q30 has outlined in supporting publications. While the performance and science behind the product was developed and designed by Q30 and its partners, the manufacturing challenge really came down to minimizing as many variables as possible and ensuring consistency of the end product. It was a very collaborative effort to understand the expectation and interpret the controls we needed to ensure the outcome,” said Gierach.
Material selection matters
As a “critical manufacturing partner,” Sussex IM participated in the development of part geometry and process, material selection, regulatory considerations, secondary operations, and fulfillment to commercialize the retail product in Canada, and now in the US market.
The Q-Collar is a multi-material progressively injection molded part, and selecting the appropriate materials involved several factors. “Primarily we needed to ensure that the material would adhere to all aspects of compliance, particularly biocompatibility related to skin contact, irritation, comfort, and sensitivity,” explained Gierach. The material’s durometer, surface tack, abrasion resistance, overall strength and flex modulus were all critical aspects of the material-selection process, as well, he added. “From an appearance and performance perspective, we supported development by creating sample molds that would simulate thickness, surface texture, and form to help compare material options under a common set of controls.”
Image: Sussex IM
|Sussex IM is providing Q30 with fulfillment services for the Q-Collar in Canada and the United States.|
Beyond material selection, understanding how to control all of the variables in this project as much as possible required hard work and patience in equal measure and helps to explain the 7 ½ year timeline. For Q30, that involved focus groups and test conditions; from a Sussex IM perspective, it meant strictly controlling raw materials, purchased components, and manufacturing variables, said Gierach.
Collecting data to support claims of efficacy begins with rigorously testing the product’s performance and results repeatedly with different focus groups employing a host of qualified experts to validate the results. “This, in itself, is a daunting task,” said Gierach. “Then the challenge becomes translating that data into a controlled and repeatable plan within the manufacturing process. Aligning the focus of both groups took time to develop, validate, and repeat at scale.”
US market holds promise
Q30’s diligence early on is bound to pay off as it enters the US market, according to Gierach. “With years of data and practical application experience, the outlook for larger scale acceptance in the US 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,” said Gierach.
The collaboration with Q30 led to Sussex IM achieving ISO 13485 certification and adding cleanroom molding capabilities. The certification is a formal extension of quality systems that were already in place, noted Gierach, but the commitment to the formalized standard has created industry visibility that has generated new inquiries and commercial leads, he said.
“We are currently building tooling for other medical devices, and the additional cleanroom capacity coincides with an increase in demand for domestic supply of regulated devices,” said Gierach. “Consistent with our focused corporate strategy, we are vetting opportunities that can benefit from our value-add services such as in-line decoration, unique serialization, assembly, packaging, and fulfillment.”