Improving Spinal Injury Outcomes
CLIENT: The Ohio State University Spine Research Institute
INDUSTRY: Medical
SERVICES: Research, Strategy, Design, Engineering, Prototyping, Soft Goods
Back and neck pain can be debilitating, and the treatment plan needed is unique to every individual. Diagnosing conditions that cause back pain typically involves the use of large, expensive machines such as X-rays, MRIs, and CT scans. The Ohio State University Spine Research Institute (OSU SRI) received funding to develop the Conity Motion Kit, a wearable device that uses advanced motion sensors to detect spinal impairments, determine the severity of the discovered condition, and track treatment progress.
OSU SRI’s expertise was mostly in research and software development, so they chose Priority Designs to lead the development of their hard and soft goods systems. The collaboration between OSU SRI and Priority Designs’ multiple disciplines resulted in a high-quality, manufacturable, and easy to use system for OSU SRI’s motion evaluation.
Discovering User Challenges
Exploratory research of an early prototype, developed during a pilot engagement between OSU and PD, was conducted to assess and document the existing use case. Both experienced and novice OSU SRI data collectors, responsible for conducting clinical evaluations on patients with the device, were evaluated in an out-patient care environment.
User evaluations revealed several challenges with the early prototype:
- The carrying case was too heavy and bulky.
- Video instructions were lengthy and hard to follow.
- The sensors were difficult to power on and off.
- The head harness was uncomfortable and difficult to put on.
- The look and feel of the harnesses, sensors, and carrying case did not fit in the medical environment and did not appropriately reflect the cutting-edge technology within.
Brand Development
The Conity Motion Kit required a name and logo that were unique, ownable, and suitable for the targeted medical space. In parallel with the product development, our brand strategists helped OSU SRI identify their brand pillars, some of which were innovation, personalization, and expertise. The fresh brand name had to be concise, easily pronounceable, possess an available domain name, and align with brand positioning.
Our strategy team collaborated with OSU SRI’s team to grasp their brand values and generated a variety of name and logo alternatives. Following multiple rounds of name generation and surveys, “Conity” was selected, satisfying all requirements. After finalizing the name, the logo design process followed. Our team created and refined options that resonated with the MedTech industry and had a visual connection to the name “Conity”.
Additionally, we assisted OSU SRI in crafting a comprehensive brand package, encompassing color schemes and fonts to maintain consistency for their product across both physical and digital touchpoints.
Back and Head Harness Improvements
Our soft goods team utilized both user and device feedback from a previous clinical study to create system iterations with design improvements. Utilizing advanced materials and manufacturing techniques, our team developed a distinctive material blend that aligns with the unique usability requirements of the system. We used state-of-the-art heat lamination technology, laser cutting, and sew-free technology to create a custom material stack-up that was comfortable to wear, biocompatible, easy to clean, and would hold up to long-term use.
During this process, we resolved comfort issues related to the head harness by integrating the same material composition as the back harness, resulting in a user friendly system. Initial prototypes were used in the field to collect user feedback and refine further iterations.
Sensor and Clip Development
Designing a clip that securely attaches the sensor to the harness was a vital piece of the usability puzzle. It required strength to hold the sensor firmly, an intuitive interface, and simplicity with as few parts as possible. Our team of designers and engineers went through multiple iterations to create a robust and easily maintainable clip, ensuring operators face minimal challenges during use.
The existing internal sensor components were repackaged into a custom housing and the harness attachment mechanism underwent several rounds of industrial design and engineering development to enhance usability, manufacturability, and visual brand language.
Our prototype specialists used our HP Nylon 3D printer to bring each sensor, clip, and charging base iteration to life. The strength of the nylon material provided high-fidelity, low-cost prototypes to refine the feel of the interaction between the sensors and clips.
The color split and shaping of the back were chosen specifically to assist users in successfully attaching the sensor to the clip. A larger sensor housing with slightly enlarged edges was implemented to enhance grip and reduce the likelihood of accidental drops. The redesign of the sensor’s button addressed previous visibility and usability concerns by providing a larger, visually distinct button that protrudes for easy pressing.
In coordination with the industrial design team, our engineering team optimized the components to ensure they are suitable for high volume injection molding.
The LED indicator was fixed to the board, prompting our team to devise a light pipe to redirect the light to a central channel on the front of the sensor. However, during testing, it became evident that the light pipe didn’t transmit the light effectively to the user, so the design underwent several rounds of development and refinement. We adjusted the design to create a thinner housing wall over the LED, allowing light to shine through when turned on and remain invisible when turned off. This new design not only resulted in much brighter illumination and ease of use but also improved the efficiency of the production process.
Priority Designs produced several prototype kits for each design iteration. These kits were deployed in a clinical setting to collect real patient data, assess the latest designs, and gather valuable feedback.
Charging Carry Case Enhancements
To enhance the carrying and charging case, we leveraged user feedback to guide our design process. We introduced a new soft-sided shell and reduced the overall footprint. Pockets and compartments were thoughtfully incorporated to assist users in quickly storing and retrieving necessary items.
Our electrical engineering and design teams collaborated to develop an intuitive and sturdy charging base that could function independently of the case. The charging station underwent multiple rounds of iteration and testing, considering factors such as the number of sensors per station, sensor orientation, PCB variations, and the incorporation of a firmware update bay.
Visual Instructions Simplified
The placement of the harnesses on the patient is crucial for ensuring data quality, and operators must also ensure that the patient performs each exercise correctly. We supported OSU SRI by providing creative direction and graphics for various educational touchpoints, including Conity’s motion evaluation software and an instructional training video shown to operators.
FDA Compliance
In collaboration with our regulatory partner, CMD MedTech, we identified and followed appropriate FDA guidelines under our ISO 13485 compliant quality system. This assured compliance to the appropriate standards for every component of the motion kit.
Solution
Our cross-disciplinary team provided design, engineering, branding, and prototyping services to create a high-quality and easy-to-use system. The sensor casing and harnesses feature a secure interface, and the design was carefully tailored to give Conity brand presence in their physical products. The sensor, harnesses, travel case, and charging base were all engineered to meet OSU SRI’s needs and prepare their product for commercialization.
Impact
- Fewer user errors during motion evaluation.
- Smaller, lighter travel case with custom charging station.
- Increased positive feedback from users.
- Resulted in additional funding.
