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Guy Vinograd ☁
Guy Vinograd ☁

This document discusses quality considerations for digital health solutions. Digital health combines medical devices, mobile apps, and cloud services to monitor and manage patient treatment. It poses many challenges due to its complexity, regulations, and multiple components that must work together. The document recommends taking a life cycle approach with continuous validation of each component and system. It also advocates for an agile development process with testing at each sprint and maintaining a validated state. An end-to-end quality approach is suggested with roles covering quality management, testing, validation, and regulatory support to ensure quality across the entire integrated digital health solution.

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Quality in Digital Health Gai Anbar, Comply V&V in Agile Medical Device Development
About Comply Developer of Skyline, a novel, end to end data management platform for Biotech and Chemistry based R&D A leading provider of consulting services in Quality for Digital Health, Computerized Systems Validation and IT QA
Established in 2005 80+ Employees Partnered with Ness in 2015 Working with top tier pharma, medical device, biotech and chemical organizations
Quality, Agile Development and Digital Health
In digital health, we provide the customer with a technological solution to manage and monitor their medical treatment. Smart Device Drug Mobile device / app Cloud services Monitoring & analytics What is Digital Health ?
Only 2 FDA Approved Drug-Device Combination Products Proteus Discover Teva ProAir® Digihaler
Challenges • Very complex, innovative technology • Multiple players – internal and external • Developing regulations • Varying markets (languages, regulations, ..) • Multiple applications, multiple versions, multiple devices • On schedule, on budget, on quality  Data privacy & security  Bluetooth  Encryption  High performance  High availability  Smart devices  Firmware  Mobile: iOS, Android  Cloud storage  Cloud services Small, integrated, highly specialized team
Independent and Integrated System The Product is the integrated system Digital Health Platform Infrastructure Application Application Application Application Application External Services Mobile Apps Qualified Infrastructure Validated Platform Validated Product Validated Mobile Apps Validated
Life Cycle Approach / Continuous Validation • Each component subsystem has its own life cycle. • Standard SW & HW testing [usually Agile] • Three layers of Validation: 1) Qualification of infrastructure 2) Validation of each system 3) Validation of the submitted Product • Other official testing:  Usability & Human Factors studies  Simulated real-life testing  Cyber security
Development Phase – Agile Approach • Testing: for each Sprint • Qualification: of infrastructure and tools • Validation: before release Maintaining the Validated state • Change Management • Deviation Management • Maintenance & Support • Periodic Review • Continuous testing [automation] Life Cycle Approach / Continuous Validation
End to end testing and verification | 11 |  Automated testing platform  Nightly runs  Continuous integration  Multiple mobile phones devices  Multiple OS’s  Validated hardware-based medical device simulator  For software testing  For Automation  End-to-end testing of complete solution  Integration tested by Automation
Roles & Responsibilities Cloud Platform SDLC Docs Manual SW Testing Validation Automated Testing Apps SDLC Docs Manual SW Testing Validation Automated Testing Devices / firmware Manual Engineering & SW Testing Verification Automated Testing Continuous integration Automated Testing Governance Quality Management Quality Support SDLC Regulatory * Focus on reducing costs using highly skilled engineers at relatively low cost
End-to-End Quality Quality System SDLC Documents Testing Automated testing Validation Regulatory Support Quality Support Support of quality system and regulatory submissions Testing and validation for the complete system and it’s sub- systems in a smart approach where each has it’s own life-cycle: From the physical device to the app and cloud. Testing of development sprints, complimenting the testing done by the development groups. Validation of all the tools, platform, services, mobile apps, cloud storage, cloud . Build and maintain the automated test platform Achieve high synergy: small, integrated, highly specialized team
Gai Anbar@comply.co.il www.comply.co.il Thank You !

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Comply

  • 1. Quality in Digital Health Gai Anbar, Comply V&V in Agile Medical Device Development
  • 2. About Comply Developer of Skyline, a novel, end to end data management platform for Biotech and Chemistry based R&D A leading provider of consulting services in Quality for Digital Health, Computerized Systems Validation and IT QA
  • 3. Established in 2005 80+ Employees Partnered with Ness in 2015 Working with top tier pharma, medical device, biotech and chemical organizations
  • 4. Quality, Agile Development and Digital Health
  • 5. In digital health, we provide the customer with a technological solution to manage and monitor their medical treatment. Smart Device Drug Mobile device / app Cloud services Monitoring & analytics What is Digital Health ?
  • 6. Only 2 FDA Approved Drug-Device Combination Products Proteus Discover Teva ProAir® Digihaler
  • 7. Challenges • Very complex, innovative technology • Multiple players – internal and external • Developing regulations • Varying markets (languages, regulations, ..) • Multiple applications, multiple versions, multiple devices • On schedule, on budget, on quality  Data privacy & security  Bluetooth  Encryption  High performance  High availability  Smart devices  Firmware  Mobile: iOS, Android  Cloud storage  Cloud services Small, integrated, highly specialized team
  • 8. Independent and Integrated System The Product is the integrated system Digital Health Platform Infrastructure Application Application Application Application Application External Services Mobile Apps Qualified Infrastructure Validated Platform Validated Product Validated Mobile Apps Validated
  • 9. Life Cycle Approach / Continuous Validation • Each component subsystem has its own life cycle. • Standard SW & HW testing [usually Agile] • Three layers of Validation: 1) Qualification of infrastructure 2) Validation of each system 3) Validation of the submitted Product • Other official testing:  Usability & Human Factors studies  Simulated real-life testing  Cyber security
  • 10. Development Phase – Agile Approach • Testing: for each Sprint • Qualification: of infrastructure and tools • Validation: before release Maintaining the Validated state • Change Management • Deviation Management • Maintenance & Support • Periodic Review • Continuous testing [automation] Life Cycle Approach / Continuous Validation
  • 11. End to end testing and verification | 11 |  Automated testing platform  Nightly runs  Continuous integration  Multiple mobile phones devices  Multiple OS’s  Validated hardware-based medical device simulator  For software testing  For Automation  End-to-end testing of complete solution  Integration tested by Automation
  • 12. Roles & Responsibilities Cloud Platform SDLC Docs Manual SW Testing Validation Automated Testing Apps SDLC Docs Manual SW Testing Validation Automated Testing Devices / firmware Manual Engineering & SW Testing Verification Automated Testing Continuous integration Automated Testing Governance Quality Management Quality Support SDLC Regulatory * Focus on reducing costs using highly skilled engineers at relatively low cost
  • 13. End-to-End Quality Quality System SDLC Documents Testing Automated testing Validation Regulatory Support Quality Support Support of quality system and regulatory submissions Testing and validation for the complete system and it’s sub- systems in a smart approach where each has it’s own life-cycle: From the physical device to the app and cloud. Testing of development sprints, complimenting the testing done by the development groups. Validation of all the tools, platform, services, mobile apps, cloud storage, cloud . Build and maintain the automated test platform Achieve high synergy: small, integrated, highly specialized team