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.
The navigator aggregates and organizes publicly available guidance and resources, including materials published by the U.S. Food and Drug Administration, into a single easy-to-navigate experience. Content is organized into sections addressing common decision points and key considerations relevant to sDHT adoption.
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.
how to use this navigator
This Navigator is designed to be used flexibly, based on where you are in your sDHT journey. You may move through sections sequentially or jump directly to topics relevant to your current needs.
Each section focuses on specific considerations related to sDHT adoption and includes links, context, and prompts to help you assess your current program. The Navigator is intended to support planning, alignment, and preparation.
You are encouraged to review linked source materials in full and apply them to the specifics of your own clinical, technical, and regulatory contexts.
The Navigator includes two complementary components to support your needs:
sDHT Adoption Roadmap
Explore at your own pace
The Roadmap presents considerations and important references across key areas relevant to sDHT adoption. You can:
- Start wherever makes sense for your project stage
- Save information and bookmark your progress as you go
- Return anytime to pick up where you left off
sDHT Adoption Library
The sDHT Adoption Library powered by NaVi
The Library brings together publicly available resources relevant to the development and use of sDHTs in clinical trials. You can:
- Identify FDA guidance, peer-reviewed literature, and non-commercial standards identified through a predefined scoping approach
- Use NaVi, an AI-powered research assistant, to quickly locate relevant resources across the Library and Roadmap
- Revisit the Library over time as new eligible materials are added
The Library and Roadmap are supported by NaVi
NaVi is an AI-powered navigation assistant that helps you identify relevant resources based on your context and questions.
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