Validation Of Connected Health Sensors – Wearable Device

The client is a leading provider of digital health solutions to monitor patient’s activities. They have designed an IoT solution – includes a wearable gadget, mobile application & cloud application. The Objective of this product is to measure & monitor body’s vital health parameters like ECG, Heart rate, Physical activities, Body angles etc. This data is sent to the mobile device (iOS & Android) over BLE (Bluetooth Low Energy) which is further connected to the cloud.

AIM OF THE PROJECT

Our goal for this project was to implement Complete Ingestible Connected Health Solutions and QA processes for wearable product of the system & to automate testing of various software components of this system

THE CHALLENGE

Such health products have to meet stringent compliance criteria. The client wanted us to design Complete Solutions and conduct QA processes which guarantee cent percent requirement test coverage with the highest possible reliability. We were also responsible for exploring various test management & automation tools and help customers in selecting a correct automation tool. Ascertaining precision and unfailing accuracy in medical devices like this one is the foremost challenge of the project.

FEATURES
  • Product contains an ingestible tablet and a wearable fastened belt
  • Tablet / Capsule remains in body for several days
  • Monitor vital health parameters like ECG, Heart rate, Body temperature, Measure steps walked using RF frequency
  • Wearable belt communicates with mobile app over Bluetooth smart and passes the patients intake to cloud
  • Wearable product uses Cortex-M3 based SoC to interface with various sensors
  • Solution supports iOS & Android (ICS & Lollipop)
  • Cloud will generate health analysis report and both doctor and patient can view through mobile/web platforms
  • Secured hybrid cloud model by consolidating public and private cloud
  • Cloud supports a variety of databases, smart user management
  • Customer has designed a test fixture which enables engineer to access & test all important electronic signals
VOLANSYS’ ROLE

We have developed FDA compliant BSP, iOS and Android mobile application and implemented wearable product using Cortex-M3 based SoC to interface various sensors. Apart from design and development, we were largely responsible for fabricating different test cases under which the functionalities of the wearable could be challenged. Having assumed various situations, we figured out ideal ways of handling them. Verification and validation using compliant methods testing the seamless integration of the wearable
Following list shows our contribution:

  • Analyze and understand medical software product and their implementation
  • Developed FDA compliant BSP and iOS and Android mobile application
  • Implemented mechanism for the end to end communication:
  • Sensor to wearable belt to mobile app to cloud
  • Implemented wearable product using Cortex-M3 based SoC to interface various sensors
  • Designed firmware and wearable hardware using ultra low power efficient MCU and flexible analog circuits
  • Implemented Bluetooth health device profile (HDP)
  • Provided cloud integration and validation of cloud services
  • Define verification and validation requirements, test plans & test cases for medical product designs which comply US FDA design control requirements (21 CFR Part 820 – Quality System Regulation) and MDD (Medical Device Directive – European Union)
  • Use logic analyzers, Digital storage oscilloscopes, Signal generators, Source code debuggers and IDEs for testing and accurate results analysis
  • Design and implementation of a test automation framework to automate firmware testing. Uses MS Visual Studio 2013 (C#) as front end programming language and in the backend, it uses VISA SDKs (automation SDKs) from National Instruments & Agilent
  • Implement glue logic to interface various automation tools/applications in order to support end-to-end test automation (Firmware Mobile Application Cloud)
  • For embedded firmware test automation, MS Visual Studio is a perfect choice. While to automate an Android application, Appium mobile automation tool is a better choice. Hence, an interface library was developed to automate firmware & mobile application testing from a single GUI application