IEC 62304-Compliant Mobile App for Accurate Test Interpretation
Project Brief
A biotech company specializing in test kits for UTI, Pregnancy, Ferritin, and Vitamin D needed a mobile app to assist users in accurately interpreting their test results. The app required compliance with IEC 62304 standards to ensure precision and safety in diagnostics.
The objective was to empower patients to take proactive measures regarding their health by understanding their results and connecting with healthcare professionals for consultations. Additionally, the app included eCommerce functionality, enabling users to purchase test kits directly from the platform.
Period: Ongoing
Location: Australia
Engagement Model: Time and Material
Project Type: Medical Devices Mobile Application
Services Offered
- Documentations required for Safety Class B software as per IEC 62304
- Cross-Platform Mobile App Development
- Advanced Image Processing for accurate test result interpretation
- eCommerce Integration
Technologies Used
Backend: Flask (Python), Microservices Architecture
Frontend: React Native
Database: MySQL
Third-Party Services: OpenCV for image processing, Shopify Mobile Buy SDK, Shopify API for eCommerce integration, AWS S3 for storage, and Firebase for push notifications.
The Problems
User Onboarding and Experience Challenges
The company’s existing web application, built on Shopify, had an established user base. Migrating these users to the new mobile app presented challenges, as they needed to log in using their existing credentials. Managing separate databases for the web and mobile apps would create disconnects, leading to poor user experience and confusion. A seamless integration was required to allow users to log in across both platforms without issue.
Low-quality Image Capture
Users could submit poor-quality photos of their test kits, leading to incorrect results. The app needed an intuitive system to guide users in capturing high-quality images, with feedback prompts when images were unsuitable for analysis.
Manual Test Result Interpretation
Many patients were responsible for interpreting their test results manually, leading to frequent errors. Misinterpretation of complex test strips often resulted in incorrect health decisions. There was a critical need for an automated solution to provide accurate diagnostic feedback.
IEC 62304 Compliance
As the app involved medical devices, it was essential to meet IEC 62304 standards to ensure software safety and reliability. Non-compliance posed significant risks, including regulatory rejection and compromised patient safety.
The Solution We Created
To ensure a seamless user experience, we integrated the Shopify API and Mobile Buy SDK, allowing users to log in using their web credentials. This provided continuity between the website and the mobile app, eliminating the need for separate accounts.
Social login options (Google and Apple) were also added for easier registration, reducing login friction and improving user adoption.
We integrated OpenCV, a robust image processing library, to automate the interpretation of test results. OpenCV analyzes images of test kits by detecting specific markers and providing accurate diagnostics for each type of test (UTI, Pregnancy, Ferritin, and Vitamin D).
This automated process ensured reliability and reduced the risk of human error in interpreting results.
To solve the issue of low-quality images, the app provides real-time feedback to users. If an image is blurred or poorly lit, users receive prompts to retake the photo.
The app also includes tutorials and tips on capturing high-quality images. This solution drastically improved the accuracy of the analysis by ensuring that the system received clear images.
We integrated the Shopify API to allow users to purchase test kits directly within the app.
The platform includes a seamless checkout process, enabling users to browse and buy test kits without leaving the app. Shopify’s payment gateway ensures secure and efficient transactions, enhancing user engagement.
We adhered to the IEC 62304 safety standard by implementing a structured Software Development Life Cycle (SDLC) that covered Risk Management (ISO 14971), Development, Problem resolution, Configuration management, and Maintenance. Documentation was meticulously maintained at each stage, and risk management procedures were followed to ensure patient safety.
Usability engineering was incorporated following IEC 62366 to reduce human errors, and installation and acceptance procedures were in line with ISO standards. Rigorous testing and post-market monitoring further ensured ongoing compliance and reliability.
To ensure a seamless user experience, we integrated the Shopify API and Mobile Buy SDK, allowing users to log in using their web credentials. This provided continuity between the website and the mobile app, eliminating the need for separate accounts.
Social login options (Google and Apple) were also added for easier registration, reducing login friction and improving user adoption.
We integrated OpenCV, a robust image processing library, to automate the interpretation of test results. OpenCV analyzes images of test kits by detecting specific markers and providing accurate diagnostics for each type of test (UTI, Pregnancy, Ferritin, and Vitamin D). This automated process ensured reliability and reduced the risk of human error in interpreting results.
To solve the issue of low-quality images, the app provides real-time feedback to users. If an image is blurred or poorly lit, users receive prompts to retake the photo. The app also includes tutorials and tips on capturing high-quality images. This solution drastically improved the accuracy of the analysis by ensuring that the system received clear images.
We integrated the Shopify API to allow users to purchase test kits directly within the app. The platform includes a seamless checkout process, enabling users to browse and buy test kits without leaving the app. Shopify’s payment gateway ensures secure and efficient transactions, enhancing user engagement.
We adhered to the IEC 62304 safety standard by implementing a structured Software Development Life Cycle (SDLC) that covered Risk Management (ISO 14971), Development, Problem resolution, Configuration management, and Maintenance. Documentation was meticulously maintained at each stage, and risk management procedures were followed to ensure patient safety. Usability engineering was incorporated following IEC 62366 to reduce human errors, and installation and acceptance procedures were in line with ISO standards. Rigorous testing and post-market monitoring further ensured ongoing compliance and reliability.
Results
Enhanced User Onboarding Experience
The seamless login process contributed to an improved user experience, fostering greater adoption and engagement across platforms.
Improved Diagnostic Accuracy and Reliability
The integration of OpenCV for automated test result interpretation reduced manual errors, providing users with consistent and reliable diagnostics.
Increased eCommerce Engagement
The Shopify integration streamlined the purchasing process, creating a seamless user journey from test kit purchase to result interpretation, which boosted user engagement.
IEC 62304 Compliance Achieved
By adhering to IEC 62304 standards, the app met regulatory requirements, ensuring a safe and reliable diagnostic tool for patients.
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