Relearning English When it Comes to FDA and CMS Jargon

Nicole Coustier

Published on: 04/06/2024

MedTech teams often misunderstand what regulators mean. This article translates FDA and CMS jargon into actionable insights for reimbursement.

U.S. Healthcare Fundamentals

What Do Payers Mean by “Clinical Utility”?

Nicole Coustier

Published on: 01/06/2024

“Clinical utility” is one of the most misunderstood payer terms. This article explains what U.S. payers expect and how to prepare.

Evidence Planning

Nicole Coustier

Published on: 31/05/2024

FDA approval ensures safety and effectiveness—but CMS needs proof of clinical value. Here’s how to align your strategy with both mandates.

U.S. Healthcare Fundamentals