the internet of medicine - just what the doctor ordered

Harshal Vora

Sales Engineer, InfoStretch

April,2016

Internet of Medicine (IoM)

Just what Doctor Ordered

©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 Innovation to 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 of Online Health 2015

² IDFT Data Breach Reports 20153 – PwC Health Research Institute, Top Health Industry Issues of 20164- CTA Industry Report


Importance of IoM

3


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


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

• Following An Integrated SDLC Approach To Merge Software Validation & Verification With Software Development

• Check Traceability Of The Software Requirements With The Design Specifications And Automated Process Compliance

• Complying With Validation Requirements For Computer Systems For Part 11 Compliance

Understanding Compliance

5


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


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


Data Comprehensiveness, Security &

Accuracy Testing

Wearable

Device

Mobile

Application Cloud/Server

Data Captured: N 1) Check for # of Records: N?

2) Check for Accuracy1) Check for # of Records: N?

2) Check for Accuracy

8

Thank You!

[email protected]

www.infostretch.com