Case Study: Using the MDIC Patient-Centered Benefit-Risk Framework to Support an Expanded Indication

Home hemodialysis device manufacturer, NxStage, used the MDIC Patient-Centered Benefit-Risk (PCBR) Framework as a guide in developing a patient preference survey to quantify the acceptable risk of hemodialysis home alone versus at a dialysis center. Data from that survey were taken into consideration in FDA CDRH’s decision to clear an expanded indication for NxStage’s home hemodialysis device – the first 510(k) clearance in which quantitative patient preference data played a role.