A structured workspace for digital health teams building software as a medical device, digital therapeutics, and health AI — from clinical problem validation through regulatory clearance, privacy compliance, and market access.
Built for digital health teams navigating the full product lifecycle — from clinical insight to sustainable market access.
Validate the clinical problem through evidence review, user research, and competitive analysis before building anything.
Classify your product, map regulatory pathways, and build the clinical evidence and privacy strategy before a line of code.
Track build milestones, validation studies, interoperability standards, and security posture across the development lifecycle.
Navigate reimbursement codes, payer strategy, go-to-market execution, and post-market surveillance obligations.
Eight purpose-built modules covering the complete digital health product development lifecycle.
Structure your clinical problem using validated frameworks — Jobs to Be Done, PESTLE analysis, and the WHO Health Technology Assessment model.
Build patient and provider personas, map care journeys, and document stakeholder pain points with structured research templates.
Classify your product as SaMD, DTx, wellness, or RPM. Navigate FDA, CE Mark, and MDR pathways with guided decision trees.
Design study endpoints, enrollment criteria, and analysis plans. Compare RCT vs. real-world evidence strategies for your indication.
Map your HIPAA obligations, GDPR requirements, data governance framework, and SOC 2 readiness across your data architecture.
Design HL7 FHIR resources, API contracts, and EHR integration points. Track SMART on FHIR, CDS Hooks, and IHE profiles.
Map CPT codes, HCPCS codes, value-based care opportunities, and payer mix. Model health economics and ROI for payers.
Track adverse events, real-world performance metrics, user feedback loops, and continuous improvement obligations.
Purpose-built workflows for each category of digital health product — from FDA-regulated SaMD to consumer wellness apps.
FDA-regulated software that performs a medical purpose without being part of a hardware medical device.
Evidence-based therapeutic interventions driven by high-quality software programs to treat or manage disease.
Continuous collection and transmission of physiologic data from patients outside of conventional clinical settings.
Technology-enabled delivery of healthcare services, including synchronous video visits and asynchronous messaging.
Artificial intelligence and machine learning algorithms that support clinical decision-making or diagnosis.
General wellness applications that help users maintain or encourage a healthy lifestyle, outside FDA device definition.
Name your project, select the product type — SaMD, DTx, wellness app, RPM — and set your therapeutic area. Data autosaves to your browser with no account required.
Navigate the four phases at your own pace. Each module guides you through the decisions that matter: regulatory pathway, evidence design, privacy obligations, and reimbursement strategy.
Generate structured documents for regulatory submissions, investor decks, and compliance audits. Export your work in the format that fits your workflow.
Free to use. All data stays in your browser.
No login, no setup. Autosaved as you work.