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Quantification of Benefits for Medical Devices

Authors

Bijan Elahi Eindhoven University of Technology

DOI:

https://doi.org/10.56094/jss.v58i1.217

Keywords:

medical device, patient safety, FDA, quantification

Abstract

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.

Author Biography

Bijan Elahi, Eindhoven University of Technology

Bijan Elahi has worked as a risk manager for Class II and Class III medical devices, both in the U.S. and Europe for more than 22 years. He is currently employed at Medtronic, plc and is also a lecturer at Eindhoven University of Technology in Eindhoven, Netherlands, where he teaches risk management to doctoral students in engineering.