Constraints

TypeConstraintJustificationRequirement/Specification
Global and ethicalThe 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.
GlobalThe 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).
EconomicThe 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.
SocialThe 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.
PoliticalThe 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.
SafetyThe 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.
ManufacturabilityThe 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.
SustainabilityCan 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.

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