Insights by Coustier Advisory

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.

FundamentalsFeatured

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.

Payer CoverageEvidence 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.

Evidence PlanningCommercializationFundamentals