Quantification of Benefits for Medical Devices

One of the most prominent challenges in safety risk management of medical devices is the Benefit-Risk Analysis. This paper proposes a methodology to quantify benefits, thereby creating more consistency, and explainability in the evaluation of benefits and the benefit/risk ratio. Leveraging the guidance from the FDA, we define four Dimensions for appraising benefits. The product of the rankings of a benefit in all four Dimensions is used as a quantitative measure of a benefit. The quantitative score for the overall benefit of a medical device would be the sum of the scores of the individual benefits.