Quantification of Benefits for Medical Devices
Keywords:medical device, patient safety, FDA, quantification
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.
US Food and Drug Administration. Factors to consider when making benefit-risk determinations in
medical device premarket approval and de novo classifications. Issued March. 2012.
Chung, B., Kutty, J., Benefit-Risk Determination: A Quantitative Approach, March 2022, , RQM+, Retrieved from www.rqmplus.com
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