Stage C

Commercial strategy & market access

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

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.