Comparative Effectiveness for AI MedTech

Published on: 04/09/2024

Why comparing your AI MedTech solution to the status quo isn’t enough for payer approval.

AIAI MedTechMedicareReal-World EvidenceRWEClinical UtilityPayer ExpectationsComparative EffectivenessPolicy
Comparative Effectiveness for AI MedTech

What U.S. Payers are Saying About AI MedTech

Published on: 27/08/2024

What AI MedTech founders need to know about payer expectations and evidence standards.

Clinical UtilityPayer CoverageReal-World EvidenceRWEComparative Effectiveness
What U.S. Payers are Saying About AI MedTech

The Myth of ‘Build First, Worry Later’: Why Early Reimbursement Strategy is the Key to MedTech Survival

Published on: 03/08/2024

Why U.S. reimbursement strategy should begin long before FDA approval if you want to survive.

AIAI/MLReimbursement StrategyPayerPayer EngagementProduct DevelopmentHealthcare StakeholdersClinical UtilityEvidence
The Myth of ‘Build First, Worry Later’: Why Early Reimbursement Strategy is the Key to MedTech Survival

What Do Payers Mean by “Clinical Utility”?

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.

AIArtificial IntelligenceMachine LanguageMLClinical UtilityEvidenceAI/MLInterventionPayersRegulatory ApprovalFDAFood and Drug Administration
What Do Payers Mean by “Clinical Utility”?