Constraints● Final design should be low-cost
● Device should be safe ○ No small parts that could be choked on, could cause harm to the patient, etc. ● The device should be comfortable and easy to use |
criteria● The device needs to measure and quantify the majority (at least 5) of the items measured by the current COWS system
● These measurements must fall below a 15% error rate in order to provide patients with accurate information ● The device must have a system to receive the data from sensors to process, and interpret it for an output |
Standards
● ISO 13485:2016
○ Medical device safety and quality assurance. This directly applies to our development process to ensure our final design can consistently meet requirements. For us, that would involve a diagnostic process run through of our final system to act as a trial run that could be repeated infinitely and not show significant deterioration over time. ● ISO 9001:2015 ○ Specifies requirements for a quality management system. Effective application of system, proof that our methods will record the data we describe with accuracy. This works in conjunction with the previously mentioned standard as it requires us to provide an exact success rate for our final design (once complete) to fulfill for this standard to be met. |
● ISO 10993-1:2018
○ Medical device safety as well as hazards. Despite the non-invasiveness of both our design options, there are still many potential safety hazards that must be considered. Small components may present potential choking hazards, or sharp edges as part of the sensors must be considered in development. ● IEC 62366-1:2015 ○ Application of usability engineering to medical devices. Describes medical device manufacturing and the risk associated with production error. As we move more towards the iPhone app approach, this is less relevant but still should be considered. Using additional sensors from other companies must be developed with their own standards already in place, but our implementation of a quality assurance test as mentioned before will satisfy this. |