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Stage C

Commercial strategy & market access

Finally, you’ll solidify your path to market success by completing your comprehensive strategy.

Begin your work in Stage C

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Check your work

Your work in Stage C should allow you to answer the following questions:

Regulatory strategy

  • Have you obtained the necessary regulatory authorization for market entry?
  • Is a post-market compliance plan in place to meet evolving regulatory requirements?

Reimbursement pathways

  • Have viable reimbursement models and payment pathways been identified for the DHT?
  • Is sufficient real-world evidence available to support additional reimbursement decisions?

Business priorities

  • Is the go-to-market strategy optimized for maximum adoption and market penetration?
  • Have strategic partnerships been established to accelerate commercialization?
  • Is the business model structured for long-term sustainability and scalability?

Case studies

Learn how Caption Health successfully navigated Stage C by securing NTAP designation from CMS, developing a structured reimbursement strategy and expanded commercial adoption.

View case study

Learn how AppliedVR successfully obtained FDA market authorization for RelieVRx® via the De Novo regulatory pathway, facilitating future marketing and distribution in the US.

View case study
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Help streamline the path to regulatory and commercial success to optimize health outcomes for the greatest number of patients

Join the Integrated Evidence Plans project

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