The design criteria can be separated into three different sections:
Usability/Safety
-
-
-
-
- Malfunctions: How well can the device/treatment(s) handle human errors or mistakes, and how will it affect the patient?
- Waste: If the device is directly inserted/implanted into the body, how is it removed and how does it affect the body? If the above condition is met, is it biodegradable or does it need to be surgically removed?
- Difficulty to use: How hard is it to use the device and how much training does the doctor/patient need to utilize it?
-
-
-
Clinically Efficacious
-
-
-
-
- Lifetime: how long the device functions before it experiences a malfunction and needs to be replaced.
-
-
-
-
-
-
-
- Precision: how effective the device functions and fulfills its required task at hand.
- Cost Effectiveness: How expensive it is to make the device or treatment and how well it is able to perform its task.
-
-
-
Convenience
-
-
-
-
-
- Lag time: Recording lots of data can result in a time gap between the actual readings of the measurements and the data shown by the device; therefore, the device should have as little lag as possible.
- Portability: Can the device move with the patient, and how will its movement affect the results it returns?
- Proximity: How close can we get the device to the patient so that its presence does not affect the procedures that are occurring, or that others’ presence does not interfere with its readings?
-
-
-
-
Other aspects to consider:
- The software used, and the cost of that software
- Adding these new components to the pre-established design