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Stage A

Market need & product benchmarking

In this stage, you will establish a clear understanding of regulatory requirements and pathways for your DHT.

Begin your work in Stage A

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Move to Stage B

Check your work

As a reminder, before you move to Stage B (Evidence Strategy and Planning), your team should be able to answer the following questions:

Regulatory strategy

  • What are the target markets and regulatory jurisdictions for this product or service?
  • How can we build a regulatory strategy that aligns with classification, pathway, and evidence requirements?

Reimbursement pathways

  • What does the purchasers’ landscape look like and what are the applicable reimbursement pathways ?
  • Which stakeholders to engage with and when to explore potential reimbursement opportunities?

Business priorities

  • What are the current market trends, policy influencers, and business drivers relevant to this effort?

If your results are not confirming your strategy, you may need to go back to Stage A to refine your value proposition and assess market needs.

Once you’re ready, move to Stage B

    Additional resources to support your success

    Stakeholder Map

    The stakeholder map categorizes decision-makers who influence the adoption of DHTs – including funders, developers, policymakers, healthcare providers, payors, patients, research institutions, standards-setting organizations, advocacy groups, and industry associations. Use this map to identify these groups and to address their specific needs to align efforts across the product lifecycle, from development and regulatory approval to market adoption and scalability.

    U.S. Payor Landscape Map

    This map outlines the diverse ecosystem of healthcare providers, including hospitals, clinics, nursing homes, pharmacies, and specialized care facilities. It will help you identify and target the right organizations for strategic engagement, reimbursement planning, and building evidence for targeted payors.

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    U.S. Provider Landscape Map

    This map outlines the diverse ecosystem of healthcare providers, including hospitals, clinics, nursing homes, pharmacies, and specialized care facilities. Use it to identify and target the right organizations for partnerships, commercialization, and strategic implementation.

    Case studies

    Explore Caption Health’s journey through Stage A highlighting the process, key decisions, and concepts that shaped their success.

    View case study

    Explore how AppliedVR identified key graphic regions, held pre-submission meetings with the FDA and prioritized payer discussions to build a reimbursement strategy.

    View case study
    Join our next project

    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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