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Deffai Documentation

Roadmap & Future Vision

Building the infrastructure for 100 years of medical device innovation

Our Vision

Deffai is building the foundational infrastructure layer that will power the next century of medical device innovation. As regulations become more complex and AI transforms healthcare, we're creating the intelligence platform that makes regulatory compliance, device safety, and operational excellence achievable for every medical device company.

10 Billion

People served by 2050

100+ Countries

Regulatory frameworks supported

1 Million

Devices monitored daily

Q1-Q2 2024 Roadmap

Core Platform Launch

Three-agent AI system for FDA filing analysis, operations monitoring, and post-market surveillance.

CompletedFDA AnalysisOperationsMonitoring

Chat History & AI Memory

Persistent chat history with AI-generated naming, enabling iterative document improvement and historical tracking.

In ProgressChat ManagementVersion Tracking
Q2

Enterprise Features

On-premise deployment options, SSO integration, and advanced access controls for hospital systems.

PlannedSAML/OIDCRole-Based Access

Strategic Initiatives

Global Regulatory Intelligence

The AWS of Medical Device Compliance

Building a comprehensive regulatory intelligence platform that continuously ingests and interprets regulations across FDA, EU MDR, PMDA, and 100+ other frameworks. AI-powered guidance for pathway selection and predictive approval modeling.

Target: 2025Market: $50B+

Pediatric-First Devices

Serving the Underserved

Specialized platform for pediatric medical devices addressing the 75% off-label use crisis. Growth-adaptive device intelligence that learns as children develop, with dedicated pediatric regulatory pathways.

Target: 2025Market: $27B by 2032

AI-Native Validation

Infrastructure for Next-Gen Devices

As generative AI enters medical devices, we're building the validation and regulatory frameworks for continuous learning algorithms. Explainable AI systems specifically designed for regulatory submission and real-world monitoring.

Target: 2024 Q4First Mover Advantage

Emerging Markets Engine

4.3 Billion People Served

Value engineering platform that redesigns Western medical devices for resource-constrained environments. Ultra-low-cost, high-reliability solutions with reverse innovation pathways back to developed markets.

Target: 2025Impact: Billions

Technology Innovation Pipeline

Quantum-Ready Encryption

Preparing for post-quantum cryptography to protect sensitive medical data for decades to come.

Federated Learning Networks

Enable hospitals to collaborate on AI models without sharing sensitive patient data.

Zero-Trust Architecture

Complete zero-trust security model for on-premise deployments in critical healthcare infrastructure.

Edge AI Processing

Real-time analysis at the device level for immediate safety interventions and reduced latency.

100-Year Vision

2030: The Regulatory Brain

Deffai becomes the central nervous system for global medical device regulation, with every manufacturer relying on our intelligence to navigate the complex regulatory landscape.

2040: Predictive Safety Network

Our AI predicts device failures months before they occur, preventing adverse events through the world's largest medical device intelligence network.

2050: Universal Healthcare Access

Through our emerging markets platform, we enable affordable, high-quality medical devices for all 10 billion people on Earth, closing the global health equity gap.

2124: The Forever Company

As regulations evolve and new technologies emerge, Deffai remains the essential infrastructure layer that makes safe, effective medical devices possible for humanity.

Join Our Mission

We're building the infrastructure for the next century of medical innovation.