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Roberto Pineda replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 8 years, 2 months ago
For my Capstone Design class, my team was in charge of developing a wearable watch for autistic kids. This watch would be connected to an Android app which would be developed by us as well. The purpose of this product is to send messages to the kids while they are in class, the messages would include positive reinforcement, pay attention and negative reinforcement. This device would greatly help high functioning autistic children and adults integrate into society. These individuals tend to lack social awareness and require cues to guide them into the correct behavior. However, these individuals also tend to lack the attention to be alerted by their aide’s subtle cues (these cues tend to be small movements such as the rubbing of a chin or tapping a wrist). One possible risk of this device is that the desired frequency of the vibration of the watch calls the attention of the kid in such way that it becomes a distraction and that is not the goal of the product. The way we will make sure this problem does not occur is that we will set short and sharp set of vibrations for each command send from the app. This type of vibrations will call the attention of the user and will make him do what the command is telling me he should do. If the product fails, the possibilities won’t be as bad as other products. The worst that could happen is that the kid doesn’t feel comfortable with the watch and it is no longer used by the kid.
Let me know what you think!
Sincerely,
Roberto Pineda.