Regulatory requirements and optimization of multiple criteria decision analysis to quantify the benefit-risk assessment of medical devices.

Introduction: Worldwide medical device regulatory authorities increasingly rely on the benefit-risk ratio for decision-making. However, current benefit-risk assessment (BRA) methods are mostly descriptive, not quantitative.

Areas covered: We aimed to summarize the regulatory requirements of BRA, discuss the feasibility of adopting multiple criteria decision analysis (MCDA), and explore factors for optimizing the MCDA for quantitative BRA of devices.

Expert opinion: Regulatory organizations emphasize BRA in their guidance, and some recommend user-friendly worksheets to conduct qualitative/descriptive BRA. The MCDA is considered one of the most useful and relevant quantitative BRA methods by pharmaceutical regulatory agencies and the industry; the International Society for Pharmacoeconomics and Outcomes Research summarized the principles and good practice guidance of MCDA. We recommend optimizing the MCDA by considering the following unique characteristics of the device BRA: using data from state of the art as a control and clinical data from post-market surveillance and literature; considering the device's diverse characteristics when selecting controls; assigning weight according to type, magnitude/severity, and duration of benefits and risks; and including physician and patient opinions in the MCDA. This article is the first to explore using MCDA for device BRA and might lead to a novel quantitative BRA method for devices.