Slides from December 7, 2016 webinar given by Justin Noel, ICS, and Steven Dean, QNX

1. December 7, 2016
SOFTWARE PLATFORMS
EMBEDDED MEDICAL SYSTEMS FOR
GLOBAL MARKETS
Steven Dean, Global Healthcare Segment Manager,
QNX Software Systems
Justin Noel, Senior Consulting Engineer / Certified Qt Instructor,
ICS

2. Agenda
• Brief Overview of BTS/QNX
• Healthcare Trends
• Software Platform Considerations
• ICS Overview
• Qt Application Development Framework
• User Experience / Human Factors
• Conclusion

3. BLACKBERRY TECHNOLOGY SOLUTIONS (BTS)
Global,
scalable,
secure
Premier
mission-
critical
embedded
software
Elliptic curve
cryptograph
y solution
leader
Cross-functional innovation
Leader in RF
antenna
tuning
Large Pool of
Patents
BlackBerry
IoT Platform
QNX Certicom Paratek IPR
About BlackBerry:
• Established in 1985, with operations in 91
countries
• Focus on enterprise software & IP
• Security expertise trusted by world leaders,
G7 governments, top companies and law firms
About BTS:
QNX:
• Established in 1980, joined BlackBerry in 2010
• Safe, secure, reliable mission-critical software
• Used in Over 50 million cars
Certicom:
• Founded in 1985, joined Blackberry in 2009
• Global leader in Elliptic Curve Cryptography
(ECC)
• Licensed ECC to NSA and hundreds of
companies
BlackBerry IoT:
• Established in 2015
• Focused on
• Hosted and managed secure OTA
• End-to-End platform & managed services for
container/cargo asset tracking

4. Remote physicians & Clinics
• EMR
• Hemodialysis
• X-ray
• MRI
• CT
• Nitric Oxide delivery systems
• Phacoemulsifier (cataract
surgery)
• Surgical Lasers
• Cataract Extraction System
• Corneal Flap Incisor
• Sterilizer
First responders
• EMR
• AEDs
• Infusion
• Multi-parameter patient monitors
• Respiration / ventilation
• Organ Transportation device
BIO Med
• EMR
• Laboratory/Reagent
• Blood Analyzer
• Flow Cytometers
• Plasma Collection systems
Remote desktop
• EMR
• Asset Tracking
Clinical collaboration
• EMR
Transporter coordination
• EMR
• Infusion
mHealth
• EMR
• Multi-parameter patient monitors
• Medical grade gateways
• Hemodialysis
• CPAP
• Bedside Neurological Monitor
• Cardiac Monitors
• Exoskeleton
Data Center
• EMR
Operating Room
• EMR
• AED
• Ventilator
• Nitric Oxide Delivery
• Cardiac Implant
Programmer
• Xray
• Surgical Robots
• Total Artificial Heart
• Neurological Implant
Programmer
• Cardiac monitoring
ICU, Patient Rooms
• EMR
• AED
• Total Artificial Heart
• Multiparameter monitors
• Diagnostics Systems/POC
• Ventilator
• Infusion
• Bedside Neurological Monitor
• Digital X-Ray, C-Arm
AMBULATORY / CLINIC HOSPITAL HOME
QNX APPLICATION SPACE

5. A comprehensive modular software platform supporting robust, reliable, multi-core, safety-
critical embedded medical systems, with IEC 62304 compliant OS, field proven performance,
feature-rich middleware, HMI, connectivity, security, and clean IP
QNX OS – IEC 62304 Compliant Operating System
Multi-vendor Hardware Support
Connectivity
USB, Bluetooth, Wi-Fi,
3G/4G LTE, Mobile Devices
Touch Interfaces, Gestures,
Integrated Accelerated Graphics,
Video
Eclipse
Based
Developer
Tool Suite
Momentics
QNX Engineering Services
IEC 62304 Certification
Services
Security - Crypto, PKI, Trust Zone
Certificate Management Services,
FIPS …
Hypervisor
Network Connectivity Frameworks
3rd Party &
Open Source
Suites
Testing, validation, scripting,
packages and partners
Applications Environments
HMI / UI
ICS
Qt
Image
Processing
OpenCV
Open CL
Cloud EMR / EHR DDS

6. Agenda
• Brief Overview of BTS/QNX
• Healthcare Trends
• Software Platform Considerations
• ICS Overview
• Qt Application Development Framework
• User Experience / Human Factors
• Conclusion

7. • Increasing device complexity
• Enhanced scrutiny from regulatory bodies
• Move towards more intuitive user interfaces
TRENDS IMPACTING MDM’S
9
• Device connectivity and management
• Patient data integrity and security

8. Doctor’s officePortable
Clinical Imaging
Patient’s homeConnected
Cost Efficient Portable Connected
Radiology center
In the field
Consumer
67.3
54.2
42
40.9
33.7
24.6
22.3
21.5
16.5
15.8
14.4
13.5
11
10.9
9.5
0 20 40 60 80
In Vitro Diagnostics (IVD)
Cardiology
Orthopedics
Diagnostic Imaging
Ophthalmics
General & Plastic Surgery
Drug Delivery
Endoscopy
Dental
Wound Management
Diabetic Care
Nephrology
Ear, Nose & Throat (ENT)
General Hospital
Neurology
Worldwide Medtech Sales by Device Area
in 2020
CAGR
% Growth
WW Sales ($bn)
2020
HEALTHCARE MARKET MACRO TREND

9. MEDICAL DEVICE TRENDS
Source: MDDI, June 5, 2015
Smart phone & Tablet-based
solutions
What to expect -
• Awesome user experience
• Rock solid wireless connectivity
• Security improvements
a. Pump & EMR Hacking safeguards

10. MEDICAL DEVICE TRENDS
Source: Qmed, March 11, 2016
Consumerization of Medicine
• Dr. Eric Topol, Director of Scripps
Translational Science Institute speaks
of “Democratizing Medicine”
• As a consumer YOU are in charge of
your own health, while,
• Doctors focus on diagnosis and
treatment
• Punch line: March 11, 2016 Apple
files patent for Emergency Alert
System based on biometrics

11. Source: medGadget, June 24, 2015
Smart phone & Tablet-based solutions
What to expect -
• Wireless, ubiquitous connectivity
• Awesome user experience, UI
• Security improvements
a. Cloud
b. EMR Hacking safeguards
MEDICAL DEVICE TRENDS

12. Agenda
• Brief Overview of BTS/QNX
• Healthcare Trends
• Software Platform Considerations
• ICS Overview
• Qt Application Development Framework
• User Experience / Human Factors
• Conclusion

13. EVERY THING THAT CONNECTS NEEDS ROBUST SECURITY
EVERY THING THAT CONNECTS NEEDS ROBUST SECURITY
EVERY CONNECTED MEDICAL DEVICE NEEDS
ROBUST SECURITY
…with “never-been-breached” solutions covered by >450 patents
If it connects, Certicom protects

14. CERTICOMPORTFOLIO
CERTICOM SECURITY PORTFOLIO

15. GP OS vs. REAL TIME EMBEDDED OS
General Purpose Operating Systems
• Designed to do many things
• and they do them well, often extremely well
• but are not designed to offer strict guarantees of
– availability (how often the system responds to requests in a timely manner)
– reliability (how often these responses are correct)
Not necessarily good for a medical device
Real Time Embedded Operating Systems
• Engineered to guarantee:
– availability
– reliability
• this ensures that devices can meet the most stringent requirements
– technical requirements
– legislative requirements

16. Applications and Drivers
> Are processes which plug into a message bus
> Reside in their own memory-protected address space
> Cannot corrupt other software components or kernel
> Can be started, stopped and upgraded on the fly
> Failures in drivers do not require system restarts
Application
Microkernel
Application Application
Disk Graphics SerialNetworkAudio
Core OS
POSIX Memory Protection
Microkernel Instrumented Kernel
MICROKERNEL - HIGH AVAILABILITY

17. App App
AppApp
File
system
DriverNetwork
stack
Monolithic
OS
App App
Multimedia
stack
System reliability is only as
good as your worst driver
developer
TRADITIONAL MONOLITHIC ARCHITECTURE
QUESTIONABLE RELIABILITY
• Model for most OSes available today
– Windows, Linux, Android
• OS contains tremendous amount of
functionality with unrestricted CPU
privileges
• A fault in one OS component can
damage any another, leading to
system-wide corruption
– Reboot is only recovery possible

18. App App
AppApp
File
system
DriverNetwork
stack
Micro-
kernel
App App
Multimedia
stack
QNX MICROKERNEL ARCHITECTURE
MISSION-CRITICAL RELIABILITY
• All processes run in isolated process
space
– Includes drivers, file systems, stacks
– All QNX processes are “applications”
• Faults are contained so that they only
affect the faulty component
– Failed components can be dynamically
recovered while the system continues to
operate
The Medical Device Manufacturer
is now in control of system
reliability

19. Video
Compression
NXP - i.MX6
TI - AM4X/5X
Intel x86
ARM Cortex-A9
Cores
x86
ADC
Network
Hub
Video
Camera
System Power
Management
Battery Management
Memory Power
Position
Sensor
Logic
Clock
Ref
Interface
Protection
System Memory
SDRAM
FLASH /
EEPROM
Servo
Control
Master Robotic
Processor
NXP - i.MX6
TI - AM4X/5X
Intel x86
ARM Cortex-A9
Cores
x86
Robot/Comms
Processor
NXP - i.MX6
TI - AM4X/5X
Intel x86
ARM Cortex-A9
Cores
x86
System Glue
Patient
DAC
Motor(s)
/
Brakes
Safety System
…
3
2
MCU
NXP Kinetis
ARM Cortex-M4
Cores
1
ROBOTIC SURGERY - ROBOT (SLAVE)

20. Video
Decompression
Processor
NXP - i.MX6
TI - AM4X/5X
Intel x86
ARM Cortex-A9
Cores
x86
ADC
Network
Hub
Video
Monitor
System Power
Management
Battery Management
Memory Power
Position
Sensor
DAC
Logic
Clock
Ref
Interface
Protection
System Memory
SDRAM
FLASH /
EEPROM
Haptic
Device
Haptic Processor
NXP - i.MX6
TI - AM4X/5X
Intel x86
ARM Cortex-A9
Cores
x86
Master/Comms
Processor
NXP - i.MX6
TI - AM4X/5X
Intel x86
ARM Cortex-A9
Cores
x86
System Glue
Surgeon
DAC
Encoder/
Motor(s)
ROBOTIC SURGERY - CONSOLE (MASTER)

21. Agenda
• Brief Overview of BTS/QNX
• Healthcare Trends
• Software Platform Considerations
• ICS Overview
• Qt Application Development Framework
• User Experience / Human Factors
• Conclusion

22. ABOUT ICS
DELIVERING WORLD-CLASS TOUCH &
EMBEDDED DEVICES
• Founded in 1987
• Qt Certified Partner since 2002
SOFTWARE DEVELOPMENT & USER
EXPERIENCE DESIGN SERVICES
• Real-time Embedded Medical Devices
• Medical Control Systems
• Mobile Medical Applications

23. Agenda
• Brief Overview of BTS/QNX
• Healthcare Trends
• Software Platform Considerations
• ICS Overview
• Qt Application Development Framework
• User Experience / Human Factors
• Conclusion

24. Qt TOOLKIT
APPLICATION DEVELOPMENT FRAMEWORK
• More than just a GUI Toolkit
• Come for the UI. Stay for everything else!
• Kitchen Sink C++ Library
– Threads, SQL, XML, Non-Blocking
Sockets
– Over 600 Classes

25. Qt IS CROSS PLATFORM
WRITE ONCE. COMPILE ANYWHERE.
• QNX
• Windows / Linux / OSX
• Android, iOS, WinRT
• Wide usage across many industries
– Including medical devices
• Cross platform code is better code
– Compiler compliance.
– Some platforms are more forgiving than
others

26. QT MODULES AND TOOLS
IDE, BUILD SYSTEM, I18N TOOLS, UI DESIGNER

27. Qt GUI TECHNOLOGIES
QT WIDGETS
• Styleable C++ widget set
– Usual suspects of widgets
– Originally intended for desktops
• Qt handles all drawing and events
– Low integration into host platform
– Easy to make custom widgets

28. QtQuick FLUID USER INTERFACE
QT QUICK (QML)
• Scene graph driven items
– Built for embedded devices
– Written with OpenGL
• Declarative Programming Language
– Describes the UI
– Layout
– States
– Animations
– Easy integration with C++

29. HTML 5 USER INTERFACE
QT WEB ENGINE
• Google Chromium Renderer
– Standards compliant HTML5
– Rendered via separate process
• Qt Web Channel
– C++ QObject <-> JS Bridge
– Implemented with Web Sockets

30. DEVELOP FASTER WITH Qt
QT IS DESIGNED FOR EASE OF USE
• Many convivence functions
• Roughly zero boiler plate code
• API is consistent and easy to learn
– Qt’isms are easier than boost’isms + libXml’isms
• Shorten time to market

31. Qt SIGNALS AND SLOTS
COMPILE TIME TYPE SAFE CALLBACKS
• Inter-object communication
– Callbacks? Listeners? Events?
• Signals and Slots is Qt’s answer
– Observer Pattern
– Function signature is the contract
• Supports cross thread connections
– Event loop marshalling of function calls

32. Qt SIGNALS AND SLOTS
COMPILE TIME TYPE SAFE CALLBACKS

33. Qt INTERNATIONALIZATION
QT IS WORLDLY
• UNICODE strings from the ground up
• Built in utilities for internationalization
– Languages, plurals, dates, numbers
• Ships with translation tools
– For use by non-developers

34. QNX / Qt Medical Demo
QT INTEGRATES WELL WITH QNX
• Process separate HMI and control
systems
• Control systems run at real time priority
– HMI observers the system and renders
graphics
– HMI interaction causes requests to be
sent to control system
– System state changes
– HMI updates

35. COMBINING QNX AND QT FEATURES
QNX PPS DRIVES A QT HMI
• QNX PPS
– Persistent Publish Subscribe
– Kernel Level IPC
– Built for real time programming
– Solves many common real
time issues
– Priority inversion
– Qt wraps PPS in an async API
– Signals when data changes

36. Agenda
• Brief Overview of BTS/QNX
• Healthcare Trends
• Software Platform Considerations
• ICS Overview
• Qt Application Development Framework
• User Experience / Human Factors
• Conclusion

37. USER EXPERIENCE (UX) / HUMAN FACTORS (HF)
HOLISTIC APPROACH TO USING YOUR DEVICE
• Human Centered Evidence Based Design
– Know thy user
– Technical Skill
– Environment
– Weaknesses
– Psychology
– Validate your user’s experience
– Frequent user studies with actual users
– Iterative processes

38. USER EXPERIENCE (UX ) / HUMAN FACTORS (HF)
ITERATIVE PROCESS

39. HUMAN CENTERED DESIGN
UX FIRST APPROACH
• Understand the problem
• Understand the users
• Create a design concept
• Unify the design
• Test and validate the design
• Implementation support

40. USER EXPERIENCE VALUE
UX AS A VALUE PROPOSITION
• Medical is different than most industries
– UX value proposition is safety
– Better UX = Fewer User Errors
– Find HMI weaknesses during design / development
– Mitigate accordingly
– Prove your device is usable via user testing
– Less reliance on training and user manuals

41. FDA HUMAN FACTORS GUIDELINES
FDA INCREASING SCRUTINY OF HMIS
• ANSI HE75 – Human Factors Engineering of Medical Devices
• IEC 62366 – Application of usability engineering to medical devices
• ISO 14971 – Application of risk management to medical devices
• Guidance Drafts
– http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc
e/HumanFactors/ucm119190.htm#standards

42. FDA HIGH PRIORITY DEVICES
FDA HF REVIEW OF SPECIFIC PRODUCTS
• Anesthesia machines
• Automated external defibrillators
• Hemodialysis and peritoneal dialysis systems
• Infusion pumps
• Insulin delivery systems
• Ventilators

43. USER EXPERIENCE VALUE
BENEFITS OF A WELL DESIGNED UX
• Easier-to-use devices
• Safer connections between device components and accessories
(e.g., power cords, leads, tubing, cartridges)
• Easier-to-read controls and displays
• Better user understanding of the device's status and operation
• Better user understanding of a patient's current medical condition
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/

44. USER EXPERIENCE VALUE
BENEFITS OF A WELL DESIGNED UX
• More effective alarm signals
• Easier device maintenance and repair
• Reduced user reliance on user manuals
• Reduced need for user training and retraining
• Reduced risk of use error
• Reduced risk of adverse events
• Reduced risk of product recalls

45. Agenda
• Brief Overview of BTS/QNX
• Healthcare Trends
• Software Platform Considerations
• ICS Overview
• Qt Application Development Framework
• User Experience / Human Factors
• Conclusion

46. www.qnx.com | @QNX_News
www.ics.com | @ICSonQt
THANK YOU.

47. Audience Q & A
Steven Dean,
Global Healthcare Segment Manager,
BlackBerry QNX Software Systems
Justin Noel,
Senior Consulting Engineer / Certified
Qt Instructor,
Integrated Computer Solutions

48. Thanks for joining us
Event archive available at:
http://ecast.opensystemsmedia.com/
E-mail us at: jgilmore@opensystemsmedia.com