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

Agenda

• Brief Overview of BTS/QNX

• Healthcare Trends

• Software Platform Considerations

• ICS Overview

• Qt Application Development Framework

• User Experience / Human Factors

• Conclusion

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 PlatformQNX 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

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

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

ConnectivityUSB, Bluetooth, Wi-Fi,

3G/4G LTE, Mobile Devices

Touch Interfaces, Gestures, Integrated Accelerated Graphics,

Video

EclipseBased

Developer Tool Suite

Momentics

QNX Engineering Services

IEC 62304 Certification Services

Security - Crypto, PKI, Trust ZoneCertificate Management Services,

FIPS …

Hypervisor

Network Connectivity Frameworks

3rd Party & Open Source

Suites

Testing, validation, scripting, packages and partners

Applications Environments

HMI / UI

ICS

Qt

ImageProcessing

OpenCV

Open CL

Cloud EMR / EHR DDS

Agenda

• Brief Overview of BTS/QNX

• Healthcare Trends

• Software Platform Considerations

• ICS Overview

• Qt Application Development Framework

• User Experience / Human Factors

• Conclusion

• 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

Doctor’s officePortable

Clinical Imaging

Patient’s homeConnected

Cost Efficient Portable Connected

Radiology center

In the field

Consumer

67.354.2

4240.9

33.724.6

22.321.5

16.515.8

14.413.5

1110.9

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

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

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

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

Agenda

• Brief Overview of BTS/QNX

• Healthcare Trends

• Software Platform Considerations

• ICS Overview

• Qt Application Development Framework

• User Experience / Human Factors

• Conclusion

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

CERTICOM PORTFOLIOCERTICOM SECURITY PORTFOLIO

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

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

App App

AppApp

File system

DriverNetwork stack

Monolithic OS

App App

Multimediastack

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

App App

AppApp

File system

DriverNetwork stack

Micro-kernel

App App

Multimediastack

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

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)

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

DACLogic

Clock

Ref

Interface

Protection

System Memory

SDRAM

FLASH /

EEPROM

Haptic

DeviceHaptic 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)

Agenda

• Brief Overview of BTS/QNX

• Healthcare Trends

• Software Platform Considerations

• ICS Overview

• Qt Application Development Framework

• User Experience / Human Factors

• Conclusion

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

Agenda

• Brief Overview of BTS/QNX

• Healthcare Trends

• Software Platform Considerations

• ICS Overview

• Qt Application Development Framework

• User Experience / Human Factors

• Conclusion

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

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

QT MODULES AND TOOLS

IDE, BUILD SYSTEM, I18N TOOLS, UI DESIGNER

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

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++

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

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

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

Qt SIGNALS AND SLOTS

COMPILE TIME TYPE SAFE CALLBACKS

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

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

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

Agenda

• Brief Overview of BTS/QNX

• Healthcare Trends

• Software Platform Considerations

• ICS Overview

• Qt Application Development Framework

• User Experience / Human Factors

• Conclusion

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

USER EXPERIENCE (UX ) / HUMAN FACTORS (HF)

ITERATIVE PROCESS

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

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

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/DeviceRegulationandGuidance/HumanFactors/ucm119190.htm#standards

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

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/

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

Agenda

• Brief Overview of BTS/QNX

• Healthcare Trends

• Software Platform Considerations

• ICS Overview

• Qt Application Development Framework

• User Experience / Human Factors

• Conclusion

www.qnx.com | @QNX_News

www.ics.com | @ICSonQt

THANK YOU.

Audience Q & A

Steven Dean,

Global Healthcare Segment Manager,

BlackBerry QNX Software Systems

Justin Noel,

Senior Consulting Engineer / Certified Qt Instructor,

Integrated Computer Solutions

Thanks for joining us

Event archive available at:

http://ecast.opensystemsmedia.com/

E-mail us at: jgilmore@opensystemsmedia.com