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

Plain Language SummaryWorldwide regulatory organizations for medical devices emphasize benefit-risk assessment (BRA) in their guidance and recommend qualitative or descriptive BRA approaches. However, no guidance has described any quantitative BRA method for medical devices. The multiple criteria decision analysis (MCDA) method is considered the most useful and relevant quantitative BRA method for drugs by pharmaceutical regulatory agencies and industries. The principles of MCDA are described by the International Society for Pharmacoeconomics and Outcomes Research and lead to emerging good practice guidance on the implementation of MCDA to support healthcare decision-making. To optimize the MCDA method for the quantitative BRA of medical devices, we recommend considering the unique characteristics thereof; including using data from SOTA as a control; using additional clinical data from post-market surveillance and literature; considering the device's diverse characteristics when selecting a control; assigning weight according to the type, magnitude/severity, and duration of benefits and risks; and including both physician and patient opinions in the MCDA method. The medical device industry and device regulatory organizations could benefit from this article. A quantitative BRA tool can be developed based on our findings and can be used by agencies and companies to monitor the safety and effectiveness of medical devices throughout their life cycle. Future research should focus on developing these theoretical considerations into a user-friendly tool for the quantitative BRA of devices and the validation of such tools using different types of devices. IntroductionWorldwide 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 CoveredWe 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 OpinionRegulatory 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.