Dawn Health develops regulated digital health products, including software as a medical device (SaMD) and digital therapeutics (DTx), to enhance chronic care management through patient empowerment and remote monitoring. Their platform accelerates the development and market entry of these solutions, improving patient adherence and outcomes while ensuring compliance with medical device regulations.
Funding
$11.5M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Developing regulated digital health products, such as Software as a Medical Device (SaMD) and Digital Therapeutics (DTx), is a complex and time-consuming process, particularly for chronic care management solutions. Traditional development cycles can be lengthy, hindering the rapid deployment of patient-empowering and remote monitoring tools.
Solution
Dawn Health offers a platform designed to accelerate the development and market entry of regulated digital health products, specifically SaMD and DTx solutions. The platform provides pre-built, medical-grade foundational building blocks, leveraging fully automated regulatory documentation and rapid testing to reduce time-to-market. By offering a comprehensive medical device eQMS, cybersecurity, and quality processes, the platform enables the creation of bespoke solutions that empower patients, improve adherence, and enhance chronic care management. The platform's capabilities facilitate increased market activation, improved patient adherence, and efficient data collection, ultimately driving commercial opportunities in digital health.
Target Audience
The primary target audience includes global pharmaceutical partners seeking to develop and deploy regulated digital health products for chronic care management.
Features
- Medical-grade platform with ISO 13485:2016 certified QMS
- Automated regulatory documentation and rapid testing capabilities
- Pre-built foundational building blocks for SaMD and DTx development
- Human-centric design approach for exceptional product usability
- Support for side-effect tracking, progress tracking, and medication reminders
- Dose logging and escalation features
- Electronic patient-reported outcomes and digital biomarkers
- Remote patient management and virtual clinic capabilities
- Cognitive behavioral therapy integration