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.

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
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 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

14. Gai Anbar@comply.co.il
www.comply.co.il
Thank You !