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Pia Gyselen's avatar

My answer is C. You clearly want more benefit with a new device. But all depends on the magnitude of the benefit and of the risk. You would like to ensure your overall benefits outweigh the overall (residual) risks, and depending on the medical field and the type of innovation, one would accept a higher risk if the benefit is clearly above those of current existing devices. With the EU MDR, manufacturers are now required to quantitatively analyse the benefit/risk ratio of their medical device, and to compare this to the benchmark of the standard of care/state of the art, providing a clinical evaluation report with all information and supporting clinical data. In the end, you want to be able to help the patient.

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Juan Daccach's avatar

Same to equivalent could be considered as no innovation but if you have a novel device that compares in BR ratio to a well standing comparator then great. Other two options show direct proportion of movement of both R and B so question becomes do you want more of one or less than one and since they move together I’ll take more benefit and same amount of risk increase. We all strive to have these two variables move in different direction (more benefit and less risk) - but that’s not an option since it would be a no brainer answer

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