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Welcome to the sDHT Adoption Navigator

The sDHT Adoption Navigator is your companion for building or adopting sensor-based digital health technologies (sDHTs) in clinical trials for medical product development.

This curated experience aggregates and organizes publicly available resources, including U.S. Food and Drug Administration (FDA) materials, to help your team navigate key decision points and technical considerations with confidence.

The Navigator does not provide regulatory advice or replace engagement with regulators; rather it has been created to support efficient access to existing resources to help teams prepare for internal planning and external discussions.

The Navigator is built to support your specific project stage, whether you need a structured roadmap or a deep-dive search.

The sDHT Adoption Roadmap

Explore the Roadmap at your own pace

The Roadmap is an interactive guide that provides structure and orientation as you navigate the selection and implementation of patient-centered endpoints.

  • Navigate common decision points and key considerations for sDHT adoption.
  • Track progress by bookmarking your journey as you go.
  • Prepare for internal planning and external discussions with key stakeholders, including regulators.

Meet NaVi

Your AI-powered research assistant

NaVi leverages a carefully curated library of publicly available resources for sDHT development and use in clinical trials, helping you find the right resources for your unique context.

  • Access FDA guidance, peer-reviewed literature, and industry standards.
  • Ask specific questions to surface relevant resources across both the Library and Roadmap.
  • Stay current with a library that evolves as new eligible materials are added.

How to get started

Sequential learning

Move through the Roadmap sections from concept to scale.

Targeted search

Jump directly to the Library or use NaVi to solve a specific challenge.

Full context

Always review linked source materials in full to apply them to your specific clinical and technical context.

who this is for

This Navigator is intended for people and teams involved in the development, evaluation, and use of sensor-based digital health technologies (sDHTs) in clinical research and medical product development. This includes, but is not limited to:

Technology developers building or refining sDHTs

Clinical trial sponsors and research teams exploring or using sDHTs

Methodologists, data scientists, and clinicians supporting study design, analysis, or implementation