Additional Info
For devices, approval is no longer the finish line – regulators want surveillance and follow-up evidence for the life of the product, payers want outcomes before they pay, and a registry that goes quiet is a liability. The work is thousands of small, structured conversations a year that no manufacturer wants to staff. This product is the standing capacity: it answers the complaint line at 2am and files a case-ready record, calls the registry cohort on schedule until the dataset is complete, collects the quality-of-life scores HEOR needs, and, when a field action comes, reaches every affected patient with a documented outcome. Staying on market becomes an operating capability instead of a scramble.