Development of a Noninvasive Vagus Nerve Stimulation Mobile Platform with Integrated Patient Analytics

Medical

Addressing Patient Engagement and Monitoring Challenges in Neurostimulation Treatments

Patients undergoing neurostimulation therapies often lack seamless tools to track treatment sessions and monitor their wellbeing between clinical visits, resulting in fragmented data collection and reduced adherence. Clinicians require access to comprehensive, real-time patient data to optimize treatment plans.

About the Client

A mid-sized medical device company specializing in neurostimulation therapies seeks to develop a connected device ecosystem to enhance patient engagement and monitoring.

Goals for a Connected Neurostimulation and Patient Analytics Platform

Implement an intuitive mobile application interface for patients to manage and track neurostimulation sessions and wellbeing metrics.
Enable patients to easily start, stop, and control stimulation sessions remotely through connected devices.
Develop comprehensive data analytics modules to provide insights on patient symptoms, mood, activity levels, and treatment adherence.
Design notification systems to remind patients of sessions, report ongoing issues, and update on progress.
Ensure device and app security, scalability, and compliance with medical data regulations.

Core Functional Specifications for the Connected Neurostimulation System

Device Control Interface: Buttons for ON/OFF, START/STOP, and stimulation intensity adjustments.
Battery and Contact Status Indicators: Visual cues for device operation and contact integrity.
Progress and Session Timers: Display remaining session durations and real-time progress.
Locking Mechanisms: Keylock to prevent accidental changes during sessions.
User Onboarding: Step-by-step guidance and initial surveys to personalize treatment.
Home Dashboard: Summary of current progress, sessions, and notifications.
Analytics Dashboard: Visualizations of negative episodes, mood, eating habits, menstrual symptoms, activity levels, and overall wellbeing.
Event and Symptom Tracking: Easy input for symptoms, menstrual cycle data, and activity logs.
Real-time Notifications: Reminders, attack alerts, and session completion alerts.

Preferred Technologies and Architecture for the Connected Neurostimulation Platform

Mobile app development for iOS and Android platforms

Secure Bluetooth or Wi-Fi communication protocols for device connection

Cloud-based data storage and analytics infrastructure

User authentication and data encryption to ensure GDPR and HIPAA compliance

External System Integrations for Data and Device Management

Medical device APIs for real-time device control and status monitoring
User health data integration with patient record systems
Notification services for push alerts and reminders
Analytics tools for data visualization and trend analysis

Non-Functional Requirements for System Reliability and Security

Scalability to support a growing user base with minimal latency
High system availability (>99.9% uptime)
Data security compliant with medical regulations (HIPAA, GDPR)
Performance optimized for quick response times (under 2 seconds for user interactions)
Compliance with medical device software standards

Projected Business and Patient Outcomes of the Connected System

The development of this connected neurostimulation platform aims to improve patient adherence to treatment protocols, provide clinicians with rich, real-time data to refine therapy plans, and facilitate early detection of adverse events. Expected outcomes include increased treatment efficacy, higher patient engagement, and more comprehensive health tracking, supporting better clinical decision-making and enhanced patient quality of life.