Verification Results
Overall, the device was proven to be successful in immobilizing the elbow at a desired angle for appropriate healing. The angle of the elbow was held at ~90 degrees for all ten test subjects wearing the device. The device’s ability to limit the rotation in the forearm was also assessed, given the client’s suggestion to extend the device’s clinical/market usage up to forearm fractures. However, supination and pronation were not limited to the desired extent, yielding a conclusion that our device should only be used for elbow fractures unless adjustments are made prior to clinical release.
Other design specifications such as total cost, weight, and application time were met.
The device was successful in adjusting in size to fit all test subjects with forearm lengths varying from 20.5 to 31 cm, which suggests that it will be adjustable in size to fit patients of ages ranging from 18 months – 13 years old once scaled down to pediatric sizes. The group also ran into time constraints in testing the durability of the device, since no volunteer was available to wear the device for an entire week.
Validation Results
Test subjects and the client were asked to fill out the patient experience form and the client evaluation form, respectively.
Patient Rating
The patient rating form focused on assessing the device’s comfortability and ability to hold the elbow in place and adjust in size to fit patients of different arm sizes, in addition to asking for input for future improvement of the device prior to clinical release. The device’s primary ability to secure the elbow was effectively validated, with all test subjects rating the criteria highest score. The device’s potential extended usage for forearm fractures in addition to the initial target area, the elbow, was determined to not be feasible given its lacking ability to limit supination and pronation. This was determined as a result of inadequate wrist immobilization and additionally goes beyond the scope of this design project.
The additional comments provided by subjects on ways to improve the device raised some significant issues regarding the device’s functionality. 50% of the subjects reported that the velcro strap around the wrist did not secure the wrist as well the velcro secures the upper arm and the elbow. This was also visible from the verification test results where supination and pronation angles, mainly controlled by the wrist, were not limited effectively compared to those of flexion and extension, which are mainly controlled by the elbow and upper arm movement.
Other additional comments received include 80% of the subjects reporting that the device is not visually appealing. 20% of the subjects reported discomfort due to the device’s weight, and 10% of the subjects suggested substituting the current length-adjusting mechanism with a more simple one that does not require screwdrivers to secure the length extension pieces onto the device.
Client Evaluation
The client confirmed that the device effectively held the elbow in place and accommodated various arm sizes, meeting all key design specifications and receiving high scores for all criteria from the client, except for aesthetics which require further improvement. Before the product is released to the market, testing and continuous enhancements should be made to better understand consumer needs.
Details about all verification and validation tests and results can be found in the group’s final report. Future directions of the project and details about how the device will be advanced in response to the feedback are described in the Conclusion & Future Directions tab.