When Silence is Golden in MedTech Reimbursement
Nicole Coustier Published on: 30/10/2024
In MedTech reimbursement, no news can be good news. Learn how to reduce payer confusion and build clarity into your strategy.
U.S. Healthcare Fundamentals
Nicole Coustier
The World After FDA Clearance: From HOORAY! To WAIT, WHAT?
Nicole Coustier Published on: 20/08/2024
FDA clearance is a milestone—not the finish line. Why reimbursement hurdles follow right after.
Commercialization Planning
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