*Recently Received FDA Approval*
Summary: Established history of successfully commercializing products in the sporting goods market, Sussex IM Inc. was contacted by Q30 Innovations, LLC, a cutting-edge research and development company that was looking for support in creating a groundbreaking new product to reduce brain injuries. After two years and thousands of hours spent researching, testing, reviewing and advising, Sussex IM and 21 other companies have helped bring to life a wearable product featuring technology to successfully limit TBIs (Traumatic Brain Injury).
Challenges: It is estimated that as many as 3.8 million concussions occur in the United States per year during competitive sports and recreational activities, according to the Clinical Journal of Sports Medicine. This elevating number does not include the concussions that go undiagnosed, which can be up as many as every five in ten. For Q30 Innovations, the question was simple – what if the best way to protect against concussions had not yet been invented?
While Sussex IM is well-versed in innovation, developing technology of this caliber does not come with a roadmap, as there is nothing else like it on the market. Instead, the process takes a lot of time, effort, patience and testing to reach the final result.
From start to finish, some of the additional challenges that Sussex IM faced when helping to create this product included:
• Material selection
• Color development
• Multi-step production process
• Customized test cell
• Material sourcing
• Packaging development
•IML development for the fit check device
Design for Manufacturing – The Planning, Testing and Reviewing Process:
To successfully create this part, our team had to do a comprehensive review process as part of our partnership planning stage. During this stage, we learned that the product included a purchased component within the assembly that is critical in the performance of the finished product. With this being an important key to a make an effective end-product, ensuring the consistency of the component and tight tolerances was vital. Our team dedicated nearly four months of review and advisement on the impact of the purchased component during the manufacturing process.
Overall, our team worked on this project for over two years, with the program broken down into three distinct phases:
Phase One – The initial phase of the project included the prototype and product concept. During this phase, our team began by researching raw material options and presenting compatibility data to the customer for review as part of a progressive multi-material manufacturing process. Our team also did our own internal testing, which included inline force testing, serialization, data recording and a dimensional inspection.
Ultimately, we developed a single cavity test strip mold to verify material compatibility. The development timeline from inception through the first molded part of the first set of tools occurred over four months. During this time, our team was also able to pursue and achieve an ISO 13485 certification.
Phase Two – The second portion of this project, which lasted a year, was the production tool development stage to fine-tune the function of the part. After verifying the material compatibility, we re-purposed the test strip mold to develop and certify a newly developed laser-etched surface finish incorporating a unique surface finish for performance, style and user comfort. This stage saw the beginning of clinical trials and studies on the comfort of the use of the product.
Phase Three – The final stage of the production of the new product included validation, IOPQ, regulatory submissions and determining the final product appearance, branding and packaging as production ramped up for commercialization, a process that took eight months.
Throughout the process, thousands of hours were devoted to the development and commercialization of the Q-Collar, based on the time the core production team, regulatory agency, and customer support team dedicated to the project. All of this hard work and the efforts of numerous test subjects, clinicians and medical professionals helped to produce the Q-Collar. Designed to exert a compressive force on the sternocleidomastoid muscles, this product causes a slight increase in blood volume in the skull, helping to reduce brain movement, which is one of the main causes of TBI.
Throughout the process, Sussex IM was pleased to offer our design support and expertise, contributing to an idea that we believe in – safer sports across the world. Today, the Q-Collar continues to be a trailblazer in the market as one of the only products designed to reduce brain injuries, where the product continues to grow its availability with a global reach.
Looking for a complete partner?
Offering more than an accomplished, custom injection molder and automated assembly manufacturer, when you work with Sussex IM, you work with a dedicated partner with more than four decades of proven success. To us, partnership means being there for your every need, from start until finish, until the job is done. Ready to get started? Contact us today at 262-246-8022 or visit us at www.sussexim.com.