Type | Constraint | Justification | Requirement/Specification |
Global and ethical | The device must work with skin tones from all over the world. This is also an ethical constraint. | Skin tone ranges can vary between countries this device must work just as well for all ranges to be used anywhere. | Add specification, which states that the device can perform just as well (within 5% deviation) on all skin tones from around the world. |
Global | The device must present the information using different measurement systems from all over the world. | Not doing so might lead to conversion errors and a harm to the patient. | Add Specification the device must have a UI that allows users to adjust the measuring system.(Metric and Imperial systems are enough). |
Economic | The device must be affordable. | Current DVT treatments can be expensive and can exclude individuals from getting the care they need. | The ability to diagnose early should be cheaper than the current treatments. |
Environmental | The device must be rechargeable. | One time usage battery manufacturing produces way more green gases than rechargeable ones. | Add Specification for the device’s battery must be able to function for at least 500 recharge cycles. |
Social | The device does not have any social constraints. | Intended use in the hospital only, doesn’t affect the patient’s quality of life. | Does not Exist. |
Political | The device can be manufactured using common parts that are widely available around the world. | This is in order to surpass sanctions that can be imposed on other countries. | Add Specification parts used for imaging and compatible oximeters must be available to all major countries. |
Safety | The device is electrically secure. | Electrical surges might be lethal or harm the patient. | Has to comply with the relevant parts of IEC 60601-1-11:2015. This is a specification for a new requirement for electrical safety. |
Manufacturability | The design has to be valid for mass manufacturing. | Mass manufacturing is essential to benefit as many people as possible. | Easily repeatable parts that do not require very specific machinery to make. This is a new requirement. |
Sustainability | Can be used with multiple patients. | The device shouldn’t be one time use as that can cause a large waste in materials and manufacturing efforts. | Add Requirement the device electrical components should be built protected so the device can be sterilized and reused. |