What is the Internet of Medicine (IoM) and should you be involved How the IoM will soon be a trillion dollar business The opportunities and pitfalls for developers and testers

1. Harshal Vora
Sales Engineer, InfoStretch
April,2016
Internet of Medicine (IoM)
Just what Doctor Ordered

2. ©2016 InfoStretch Corporation. All rights reserved.
Digital Health Landscape
2
Statistics
79% - Wearable for self directed healthcare
66%- Americans are interested in using mobile apps to
manage health-related issues
$1.3 billion revenues by end of 2016
Trigger
Insurance companies push
for Technology Innovationto
reduce claims and better
predictability
Age/Era of the Patient
Trend
Watch
Sensor Based Technologies like RFID, Optical sensors
Sensor Enhanced Imaging Systems
Telemedicine/ Virtual Doctors
Retail Medical Clinics
¹ Kelton Research/Makovsky Health, Pulse ofOnline Health 2015
² IDFT Data Breach Reports 2015
3 – PwC Health Research Institute, Top Health Industry Issues of 2016
4-CTA Industry Report

3. ©2016 InfoStretch Corporation. All rights reserved.
Importance of IoM
3

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IoM Product – Key Considerations
4
IoM Strategy IoM Development IoM QA
FDA Compliance Requirements
• Needs analysis and
business alignment
• Anticipating new use cases
• Integration of
development and test
• Design blueprinting
• Platform design
• Agile and continuous delivery
• Pre-built tools and reusable
frameworks
• Experience with the latest
platforms, sensors, devices
and OSs
• Data testing using firmware
• Simulation-based testing
• Data comprehensiveness &
accuracy testing
• Interruption testing

5. ©2016 InfoStretch Corporation. All rights reserved.
21 CFR 820.30 Compliance
1. Design Control Compliance
2. Development Planning
Compliance
3. Input & Output Compliance
4. Review Compliance
5. Validation & Verification
Compliance
6. Design Change Compliance
7. Design History File Compliance
21 CFR 820.70 (i) compliance
1. Automated Processes Compliance
2. It Validates Software Meeting
Requirements Accurately, Reliably,
And Consistently For Its Intended
Use.
21 CFR Part 11 Compliance
1. Electronic Records And Electronic
Signature Compliance
2. Ability To Generate Accurate And
Complete Copies Of Records In
Paper And Electronic Forms
3. Use Of Secure, Computer-
generated, Time-stamped Audit
Trails
4. Accurate And Ready Record
Retrieval Complying Retention Period
• FollowingAn IntegratedSDLCApproachToMerge Software Validation &VerificationWithSoftwareDevelopment
• Check Traceability OfThe SoftwareRequirementsWith The Design SpecificationsAndAutomated ProcessCompliance
• ComplyingWith ValidationRequirementsForComputerSystemsForPart 11 Compliance
Understanding Compliance
5

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OEM Wearable
Device
Backend Portal –
Server & DB
Companion
Application –
Mobile & Web
Security
Performance
Integration
Compliance
Web Services
Web Services
BLE, NFC, Wi-Fi
Device, Firmware
Functional &
Non-Functional
Testing
API &
Functional
Testing
Language,
Accessibility,
Functional &
Non-Functional
Testing
API Test
Automation
API Test Automation
IoM Ecosystem
6

7. ©2016 InfoStretch Corporation. All rights reserved.
1. Install
Firmware In
Device
2. Generate
Binary Data
3. Push Data
To Device
4. Allow To
Sync Data To
Mobile
Device/Server
5. Validate
Received Data
Firmware Based Testing Simulation Based Testing
ECG
80 bpm
Steps
Software Based Simulation
7

8. ©2016 InfoStretch Corporation. All rights reserved.
Data Comprehensiveness, Security &
Accuracy Testing
Wearable
Device
Mobile
Application Cloud/Server
Data Captured: N 1) Check for # of Records: N?
2) Check for Accuracy
1) Check for # of Records: N?
2) Check for Accuracy
8

9. Thank You!
info@infostretch.com
www.infostretch.com