Stage B

Evidence strategy & planning

In Stage B, you’ll build the foundation for successful adoption and commercialization of your DHT.

Check your work

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

Regulatory strategy

Did you engage with the FDA for pre-submission meetings to validate study designs?
Have you built evidentiary packets for regulatory submissions?

Reimbursement pathways

Are you prioritizing the development of a reimbursement dossier that includes economic models and outcomes data?
Have you initiated discussions with payors to explore provisional coverage pathways?

Business priorities

Are you assessing and validating business model fit through stakeholder feedback and early partnerships?
Have you evaluated technology scalability and planned for its integration into clinical workflows?

Use the tools in this section at your own pace. Consider this process an ongoing journey rather than a one-time task, allowing you to adapt and refine your approach as needed.

Once you’re ready, move to Stage C

Additional resources to support your success

High Quality Evidence Checklist

Use this comprehensive checklist to generate high-quality evidence aligning to the evidentiary needs of downstream decision makers. It focuses on patient-centered outcomes, cost-effectiveness, and real-world usability to facilitate adoption and sustained market success for your DHT.

See full checklist

Use DiMe’s Evidence DEFINED framework to support you evidence evaluations. DiMe collaborated with healthcare stakeholders to create this framework and support give you a a harmonized, rigorous, rapid approach to assessing the clinical value of DHTs.

View framework