Case Study

Revenue Pathway for FDA Approved Medical Device

Stethoscope on keyboard of laptop

A monitoring device company had FDA approval, but a billing code was not yet available. The company’s objective was to understand the most effective and efficient approach to obtain reimbursement.

Client Pain Points

  • Needed clarity related to time-to-revenue and anticipated reimbursement for a new device in process of FDA approval prior to making material related investments.
  • Needed validation of Go-to-Market strategy and the overall economic model for the business initiative.
  • Needed market validation with Medicare Advantage payer market on reimbursement and time-to-revenue on product.

CWH Solutions

  • Performed a complete Go-to-Market assessment, providing a market-informed plan, execution recommendations, and P&L guidance.
  • Provided fee schedules timeline for Centers for Medicare & Medicaid Services and Medicare Advantage payer market.

CWH Delivering Value

  • Provided critical direct market feedback from Medicare Advantage payers on their process, timing, and requirements to accommodate new device into fee schedules.
  • Saved client a large amount of investment dollars understanding realistic time-to-revenue.
We really appreciated the insight. The analysis saved us from investing millions of dollars that we had not budgeted.”
Operating Executive Medical Device Company