Risk cannot always be eliminated by design solutions. This is why medical devices use protective measures (i.e., – alarms) and inform users of residual risks (i.e., – warnings and contraindications in an Instructions For Use (IFU). The “ALARP” concept has a legal interpretation which implies financial considerations. Instead of claiming that the residual risks are ALARP, the company needs to show the risks are reduced AFAP with demonstrating objective evidence that the risk control options were considered and implemented. But only after applying the risk management policy to determine if additional risk controls need to be evaluated, can any residual risks be ALARP. But in general, risk control options should never be ruled out due to cost.
http://medicaldeviceacademy.com/en-iso-149712012-deviation-3-risk-reduction/