DTx Development Platform

Mahalo's DTx Development Platform is a prebuilt digital therapeutics development environment designed for pharmaceutical, medical device, and MedTech companies, as well as clinical researchers, who want to build, study, and commercialise digital therapy applications without constructing custom software infrastructure from scratch. The platform provides web and mobile app assets, tools, and integrations built on top of cloud infrastructure that meets regulatory, compliance, and security requirements, allowing teams to launch a DTx app in weeks rather than months or years.

The platform is positioned around the premise that behavior change is central to managing chronic disease, and that DTx apps represent the only scalable method for delivering behavior modification interventions at the population level. Mahalo supports the full journey from clinical research study to FDA-approved commercial product within a single application, removing the need to rebuild or re-integrate software at each stage.

Health System Problems the Platform Addresses

• Behavior change interventions
• Patient compliance and medication adherence
• Hospital readmission rate reduction
• Disease prediction and diagnosis support

Challenges Avoided by Using a Prebuilt Platform

• Unknown time to market: Custom platform development can take two or more years before accounting for integration into the broader digital health ecosystem.
• Cost overruns: Building a novel solution carries high upfront costs, and maintaining adaptability, scalability, and security can be expensive over time.
• Compliance complexity: Establishing a quality management system is resource-intensive, with added difficulty from evolving global regulatory, privacy, and security requirements.
• Lack of software development expertise: Researchers and scientists who create digital therapies are typically not software professionals, making in-house development team building a high-risk approach.

Behavior Modification Building Blocks

• Micro-learning delivered via multimedia text, image, and video content
• Personalized, data-driven behavior reinforcement
• Behavior tracking through connected devices
• Loggers for meals, weight, exercise, fluid intake, and sleep
• Personal coaching via telemedicine video or text chat
• Community features to support patient accountability

Study Launch Capabilities

• Eliminates the need for expensive custom software development
• Supports launch in weeks rather than months or years
• Allows configuration of a DTx using available tools, or commissioning of a custom digital therapy
• Collects study data on the intervention throughout the trial

From Research Study to Commercial Product

• The same app and feature set used in the clinical study carries through to the commercial product
• Study data can be used to support FDA approval submissions
• Production mode can be activated to launch apps without additional software development
• Supports doctor prescribing of the DTx via EHR systems, including EPIC and Cerner integration
• Ongoing learning from patient usage data after commercial launch

The platform operates under a compliance framework that includes HIPAA, GDPR, ISO certifications, Good Clinical Practice (GCP), and a responsible disclosure policy. Mahalo describes itself as a unified digital health platform covering both DTx development and clinical research, with deployment available across the Americas, Europe, the Middle East, Africa, and Asia-Pacific.