Finding Good Candidates for Risk-Sharing Arrangements

Continued from Part I that discusses the tools device manufacturers can use to manage risk How to find good candidates? Not all devices are created equal. But how can device manufacturers identify the low-hanging fruit for a risk-sharing arrangement? Needless to say, the more characteristics a product has that are associated with successful risk-sharing arrangements, the more such an arrangement is likely to succeed. To illustrate, in Exhibit 1, we chart a select number of risk-sharing arrangements established since 2015 along two key dimensions: product effectiveness and time needed to observe expected outcomes. The findings are based on clinical studies of the products displayed, including nine prescription drugs (13 agreements[1]) and three medical devices (four agreements[2]). Ideally, a good candidate should have a medium or large effect size and the outcomes should be observable and measurable in about a year. The dotted line rectangle in the figure captures the products that fit these characteristics. Devices that satisfy these two criteria are more likely to succeed and protect manufacturers from downside risk. Given the select nature of study populations, uncertainty always surrounds the estimated effect size in any clinical study. Thus larger effect size estimates can help guard against the possibility of downside risk associated with patient outcomes. In addition, to ensure that effect size estimates are generalizable to the target patient population, products must...
Source: MDDI - Category: Medical Devices Authors: Tags: Contract Manufacturing Design Source Type: news