Evolving our need statement
Starting out, Jay, Andrew, and I decided to focus on bracing for patients with Cerebral Palsy, specifically ankle-foot orthotics, or AFOs. Based on all of our previous clinical observations, it seemed like there were issues with the time need to make an orthotic (~1 month) when the patient has finally outgrown the device. We learned that there were several pressure points that will experience skin irritation and redness first. This made it seem that the patient would be in pain while wearing the ill-fitting device and waiting for their new AFO. This gave us our first need statement: patients with CP need a way to monitor the fit of the orthotic as they grow. We figured sensors would be a good way to do this – the sensors would keep track of the pressures acting on the brace and when they reached a certain value this would indicate the orthotic no longer fits. So, we proposed this idea to the doctors and physical therapists. What we found out was this isn’t actually a need. Outgrowing the orthotic doesn’t cause much discomfort; some patients don’t even realize they’ve outgrown it. Not only this, sensors wouldn’t be the best way to measure the fit. They usually just check to see if there is any redness and skin irritation, or if the foot is longer than the brace.
We had a second need statement that we ran by them as well. We had noticed that orthotics can be bulky and difficult to fit into shoes. To address this we considered designing a shoe that would better fit the orthotic. We talked with a physical therapist about this and she showed us several companies which have done this same thing. Additionally, minimizing the overall bulkiness of the brace would involve focusing on manufacturing materials that would be strong enough at smaller thicknesses, something that would be out of our scope for this project.
So, taking into account all of the advice from the doctors and physical therapists, we went and looked back at all of our observations. Underlying behind all of these problems was the issue of compliance. If the device is uncomfortable from being outgrown, the patient wouldn’t want to wear it. If the device was too thick and looked weird with their shoes, the patient wouldn’t want to wear it. Compliance is an issue with almost any medical problem. A patient can be prescribed something, but it won’t actually benefit them unless they follow through. In this case, the doctor has no idea whether or not the patient has been wearing their AFO other than self-report. Measuring compliance would allow the doctor to differentiate between whether the orthotic isn’t working or if it is not being worn enough.
This entire process of shifting to a new need statement has really shown me the importance of doing research and talking with clinicians. Their perspective carries so much value, and their input is really what shapes the device to address real, current issues in the hospital.
BME Design 