success story

Patient Mobile App Driven Spinal Cord Simulator (SCS) for Pain Management

Our client, a leading multinational medical devices company, known for bringing cutting-edge devices and technologies to the market, envisioned a first-of-its-kind "Virtual pain management solution" for one of its devices, an implanted Spinal Cord Stimulator (SCS).

Virtusa as a strategic partner, realized this vision through its rich medical technology/device industry experience and digital transformation capability. We leveraged technologies involving IoT, Mobility, Cloud, Analytics, and AI to ensure success.

We enabled a superior patient experience driven by data analytics and intuitive UX resulting in faster pain relief and 300% more sales representative availability.

 

The Challenge

The client provides Spinal Cord Stimulator (SCS) therapy to patients with chronic pain. The SCS system consists of an implanted device, which masks pain signals traveling to the patient's brain.

The existing solution involved a physical remote control that allowed the patient to handle the device settings within a physician's pre-defined limit. It had several challenges:

  • Sub-optimal UX
    The implanted device could be re-programmed only at physician offices with the help of a programmer, coordination between parties, several days' notice, and travel time
     
  • Limited data availability
    Limited inbuilt storage on device hindered the gathering of data that could have potential usage in the research process by internal and external researchers  
     
  • Limited visibility
    Lack of real-time data on patient's pain information to generate insight into the patient profile and intervene as necessary 
     
  • Lack of personalization
    One size fits all therapy settings with little patient specific customization
The Solution

Virtusa transformed the Legacy SCS system into a smart system.

We leveraged a 10-week blueprinting process to finalize user journey, architecture, POCs, tool decisions, and implementation plan for the most critical success factor in the client's SCS therapy for patients with chronic pain. 

The final solution was a radically new Bluetooth Low Energy (BLE)-enabled mHealth app as a class III regulated Software as Medical Device (SaMD) supporting BYOD (iOS/Android) model.

The solution helped:

  • Replace the physical remote control with the mobile app
  • Connect the mobile app to SCS device via BLE and the organization's enterprise layer via REST API
  • Connect multiple parties in a secure video conferencing system and allow for remote programming of the device
  • Onboard patients, enhance operations and customer service, and generate reports on a web portal
Smart Spinal Cord Simulator

User experience

Built mHealth app on iOS and Android platforms for patients to manage surgically implanted stimulators with a phone - replacing the RFID remote

Remote Collaboration and Connectivity

Allow parties to collaborate securely and programmers to program the stimulator remotely on physician's instruction, thereby averting physical visits by the patient to the physician's office

Data gathering

Collect usage details and other metrics from the app and back it up to HIPAA and GDPR compliant cloud storage at defined intervals allowing the data to be used for advanced clinical/research and business analytics

Integration

Created APIs to extract device data and integrate with EMR and other clinical systems for an accurate representation of patient's condition

Verification & Validation (V&V)

A key component of creating Software as a Medical Device(SaMD) is the verification and validation (V&V) part, as it is one of the important qualification criterion for FDA approval. Virtusa is experienced and equipped to handle the V&V

  • API testing: Automated testing of API services for NAPI using postman tool
     
  • System testing: Testing of command protocol between the Implantable Pulse Generator(IPG) and mobile device
     
  • Web portal testing: Testing the admin portal developed for the system backend
     
  • End-to-end testing: Testing on the entire systems from end-to-end involving all the components including the admin portal, Implantable pulse generator(IPG), mobile device, and clinician programmer
     
  • Mobility testing: Pool Automated and manual testing of the mobile app for functionality, usability, and performance testing
The Benefit

Virtusa's smart SCS system helped in driving patient engagement and aid in improving SCS devices and services.

 

Benefits of smart SCS system

  • From 8% to 90%+ improvement in data collection with analytics
  • Over 300% increase in availability of representatives with less travel
  • Drive patient engagement during the trial and post-implant care through enhanced user experience
  • Reduce turnaround times by two weeks with on-demand device management
  • Create personalized therapies through enhanced data extraction and integration with EHR and clinical systems