Devices – Healthcare Economist

Performance-Based Risk Sharing Agreements for Devices and Diagnostics

2022-01-03Jason ShafrinLeave a comment

Performance-based risk sharing (PBRS) have grown in importance in recent years. While most PBRS are used for expensive pharmaceutical products, PBRS also have been used with medical device and diagnostic manufacturers. Device/diagnostic PBRS may differ from those of pharmaceuticals for a number of reasons. First, while health insurers bear the burden of paying for most…

FDA to Consider Patient Preferences

2015-05-14Jason Shafrin2 Comments

Typically, the FDA evaluates drugs and devices based on whether they are safe and effective. Patient treatment preferences play little to no role in whether a drug or device is approved by the FDA. However, times are a changing. On Wednesday, the FDA released draft guidance whereby they recommend the inclusion of patient preference information…