COVID-19 is driving patients to seek telehealth solutions, and it won’t be a short-term boom.
A look at IP litigation in 2019 and the year ahead, and some advice on how medical device companies can safeguard their intellectual property.
Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?