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How to create a medical device proof-of-
concept prototype overnight
Roger Mazzella
Sr. Product Manager- Medical, TheQtCompany
Juhani Vanhala
Managing Director, Managing Director, SW Contracting, Siili Auto Oy
Bartosz Taczala
Technical Lead, Siili Auto Oy
June 10, 2020 © The Qt Company2
What do Qt Medical Customers Value?
• Capability to Create Safe, Effective, Reliable and Intuitive
User Experiences with uncompromising performance &
reliability
• Develop the best, user-adopted, efficient User Experiences
with Qt Design Tools and the ability to Rapidly Prototype on
your Target Device
• Qt is a UI/UX cross-platform development environment
• Qt is the development platform, and is embedded into,
FDA (Class I, II, and III) and EU Certified (Class I, IIa, IIb, and III)
medical devices currently on the market
• Qt provides documentation and transparency into our
development process, product performance, validation and
testing to fully support of your device compliance needs
• Get to market faster with best-in-class technology, full tooling
support and access to Qt’s industry-leading partnerships
June 10, 2020 © The Qt Company3
What’s all the interest / hype in ventilators?
SARS-CoV-2 Symptoms
• Fever or chills
• Cough
• Shortness of breath or difficulty breathing
• Fatigue
• Muscle or body aches
• Headache
• New loss of taste or smell
• Sore throat
• Congestion or runny nose
• Nausea or vomiting
• Diarrhea
SARS-CoV-2 Emergency Warning Signs
• Trouble breathing
• Persistent pain or pressure in the chest
• New confusion
• Inability to wake or stay awake
• Bluish lips or face
June 10, 2020 © The Qt Company4
Ventilator Needs: Current
Current Evolving Situation:
The Flattening of the curve throughout Asia, Europe and
Americas means that ventilators are no longer in short supply.
The demand for ventilators is decreasing
How was the need filled?
Ventilator manufacturers increased manufacturing of ventilators
already approved for market across the globe.
Additional manufacturing resources were leveraged from
industries outside of the medical device industry (i.e. Automotive)
Why? The regulatory process for new devices takes time, even in
expedited situations
June 10, 2020 © The Qt Company5
Ventilator Needs: Future
So if the curve is flattened, why are we still talking about
ventilators?
As demand for ventilators increased in response to the SARS-CoV-
2 , many of the ventilators were older technology, not very intuitive,
somewhat difficult to use.
The majority of the ventilators were not very portable.
There is a need for more modern ventilators, that are truly
portable, with intuitive UI/UX that mimics the experience on
your smartphone
June 10, 2020 © The Qt Company6
What Keeps Medical Product Developers Up at Night?
Three main areas of concern when developers of medical products select COTS software
Clinical Risk Human Factors Risk Cybersecurity Risk
Risk a product will not
work as intended
Risk a product will be
used as intended
Risk a product will
be hacked and
compromised
Qt works with our customers to support and create solutions for each
June 10, 2020 © The Qt Company7
What Keeps Medical Product Developers Up at Night?
Human Factors Risk
Risk a product will be
used as intended
June 10, 2020 © The Qt Company8
Human Factors is Critical!
What is the value of a product working as intended if
it is not USED as intended?
June 10, 2020 © The Qt Company9
• Three main goals:
Understand how the device will be
used
Drive a design that matches the
capabilities and limitations of users
Discover use errors and eliminate
them
What is Human Factors
Analysis (HFA)
June 10, 2020 © The Qt Company10
Use error and task analysis
Early prototype usability evaluation
Formal usability testing
Post-market usability studies or
surveys
Each is necessary but not sufficient.
Together they form the foundation for
the development of a safe and usable
system.
How is HFA Accomplished
June 10, 2020 © The Qt Company11
• Realize value of investment in
HFA
A development framework that facilitates
UI/UX prototyping
Tools to make it easier to implement UI
changes
Ensure the best overall user experience
HFA in Development– The
Solution
© The Qt Company
How does Qt make it easier to iteratively prototype and re-design?
• Pre-built libraries enabling Drag and Drop / WYSIWYG development
• Qt Design Tools: Qt Design Studio
• Rapid prototyping on the target device
June 10, 202012
June 10, 2020 © The Qt Company13
Rapid Prototyping on Target Device
Iterate quickly / Identify issues early and easily
Prototyping is in “Real Space” within actual environment
• Correct form factor
• Correct resolution
• Correct “look and feel”
Identify actual issues
Prioritize and Triage issues to be fixed
Fast prototyping as part of design process
Accelerating product development
Jun 10, 2020
Sudden need to vast amount of new ventilators in short
period of time created high pressure for accelerating product
development and shortening time to market.
THE NEED
High-level can’t be tested,
high-fidelity can.
Building fast prototypes early in the design phase supports innovation
by allowing the ideas to be put in front of users. This helps to get the
details right and limit amount of iterations later in the development
process. Hence reducing the total cost of innovation.
Key points:
• Incomplete experiences run the risk of highly biasing user reactions
• Rather than rapid and rough, we do rapid and right
• Amazing experiences emerge in the details
OUR CORE BELIEF
“Can Android look & feel match our brand identity?”
“What’s the best set of physical controls to operate the HMI in our device?”
“Will 3D help visualize data in my application?”
“Will a context display inside the rotary knob be usable in my device?”
“Can 3D content be streamed between different systems and displayed on
different screen?”
“Can our existing HMI technology be mixed with Qt, Android, Unity, Unreal ...”
• UX of new features
• Technical feasibility
• Performance
• Workflow
TYPES OF PROTOTYPES:
• Change of the test scenarios
• Customizing of the displayed content per test user
• Fast iterations in max. 1-week cycles
• Recording of test user and the actions made (analytics & heat maps
for eye gaze, clicks, interactions etc.)
Good prototypes should allow
A case example of fast prototyping with Qt
for MCUs
Ventilator HMI POC
Building the first HMI prototype to enable UX testing
Goal
Enable Design Teams to experience their ideas on the target platform and make quick iterations on the created concepts. Get instant feedback from the
tech (Qt for MCUs). Optimize for ability to experience the prototype quickly.
Day 1
Setting the GOALS
A Technology specialists skilled in fast prototyping
joins the design team.
The team agrees goals what needs to be prototyped
and what are the hypotheses to be verified.
Days 2 - 4
Fast prototyping
High fidelity prototype is built which can be tested on
the target platform.
Design / Dev team works together to ensure fast
iterations and tweak the prototype in real-time.
Day 5
Demo review & alignment
High-fidelity prototype review in a demo session.
Team reviews the results together and sets the
expectations for the next iteration.
Thank you!
Next – how it was done
Links to videos:
›https://www.youtube.com/watch?v=CLba2K-I8io
›https://www.youtube.com/watch?v=Wdn14pxJioI
June 10, 2020 © The Qt Company22
Qt for MCUs Training Program – Now available!
Official training course to hone your or your team's
microcontroller development skills. Learn the basics and
get your hands dirty with 'Qt for MCUs' online training
In five hours, you will learn:
• Qt for MCUs package contents
• Building and running application using command line
• Qt for MCUs application build process
• CMake API
• Qt For MCU’s specific components
• Configuring Qt Creator
• Asset management
• Styling controls
• Internationalization
• C++/QML integration
• A Technology specialists skilled in fast prototyping joins the design team
• The team agrees goals what needs to be prototyped and what are the hypotheses
to be verified.
Practice makes perfect – there will be live coding exercise included in the training.
You’ll create your very first Qt for MCUs application.
What:
1st out of three session in Qt for MCUs program
When:
24-Jun-2020
Lecturer:
Jacek Nijaki, Software Architect C++ , Siili Auto Oy as Qt Premium
Partner
How much:
€308 / $350
Read more and sign up: https://marketplace.qt.io/
June 10, 2020 © The Qt Company23
Have more questions?
Contact Qt at www.qt.io/contact-us/
Contact Siili at auto.siili.com/
Qt for MCUs: https://www.qt.io/qt-for-mcus
Qt for Medical: https://www.qt.io/medical
Follow us:
Twitter: @Qtproject
Facebook: /qt/
Linkedin: /company/theqtcompany/
Youtube: /Qtstudios/
Thank you!
June 10, 2020 © The Qt Company24

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How to create a medical device proof of-concept prototype overnight

  • 1. How to create a medical device proof-of- concept prototype overnight Roger Mazzella Sr. Product Manager- Medical, TheQtCompany Juhani Vanhala Managing Director, Managing Director, SW Contracting, Siili Auto Oy Bartosz Taczala Technical Lead, Siili Auto Oy
  • 2. June 10, 2020 © The Qt Company2 What do Qt Medical Customers Value? • Capability to Create Safe, Effective, Reliable and Intuitive User Experiences with uncompromising performance & reliability • Develop the best, user-adopted, efficient User Experiences with Qt Design Tools and the ability to Rapidly Prototype on your Target Device • Qt is a UI/UX cross-platform development environment • Qt is the development platform, and is embedded into, FDA (Class I, II, and III) and EU Certified (Class I, IIa, IIb, and III) medical devices currently on the market • Qt provides documentation and transparency into our development process, product performance, validation and testing to fully support of your device compliance needs • Get to market faster with best-in-class technology, full tooling support and access to Qt’s industry-leading partnerships
  • 3. June 10, 2020 © The Qt Company3 What’s all the interest / hype in ventilators? SARS-CoV-2 Symptoms • Fever or chills • Cough • Shortness of breath or difficulty breathing • Fatigue • Muscle or body aches • Headache • New loss of taste or smell • Sore throat • Congestion or runny nose • Nausea or vomiting • Diarrhea SARS-CoV-2 Emergency Warning Signs • Trouble breathing • Persistent pain or pressure in the chest • New confusion • Inability to wake or stay awake • Bluish lips or face
  • 4. June 10, 2020 © The Qt Company4 Ventilator Needs: Current Current Evolving Situation: The Flattening of the curve throughout Asia, Europe and Americas means that ventilators are no longer in short supply. The demand for ventilators is decreasing How was the need filled? Ventilator manufacturers increased manufacturing of ventilators already approved for market across the globe. Additional manufacturing resources were leveraged from industries outside of the medical device industry (i.e. Automotive) Why? The regulatory process for new devices takes time, even in expedited situations
  • 5. June 10, 2020 © The Qt Company5 Ventilator Needs: Future So if the curve is flattened, why are we still talking about ventilators? As demand for ventilators increased in response to the SARS-CoV- 2 , many of the ventilators were older technology, not very intuitive, somewhat difficult to use. The majority of the ventilators were not very portable. There is a need for more modern ventilators, that are truly portable, with intuitive UI/UX that mimics the experience on your smartphone
  • 6. June 10, 2020 © The Qt Company6 What Keeps Medical Product Developers Up at Night? Three main areas of concern when developers of medical products select COTS software Clinical Risk Human Factors Risk Cybersecurity Risk Risk a product will not work as intended Risk a product will be used as intended Risk a product will be hacked and compromised Qt works with our customers to support and create solutions for each
  • 7. June 10, 2020 © The Qt Company7 What Keeps Medical Product Developers Up at Night? Human Factors Risk Risk a product will be used as intended
  • 8. June 10, 2020 © The Qt Company8 Human Factors is Critical! What is the value of a product working as intended if it is not USED as intended?
  • 9. June 10, 2020 © The Qt Company9 • Three main goals: Understand how the device will be used Drive a design that matches the capabilities and limitations of users Discover use errors and eliminate them What is Human Factors Analysis (HFA)
  • 10. June 10, 2020 © The Qt Company10 Use error and task analysis Early prototype usability evaluation Formal usability testing Post-market usability studies or surveys Each is necessary but not sufficient. Together they form the foundation for the development of a safe and usable system. How is HFA Accomplished
  • 11. June 10, 2020 © The Qt Company11 • Realize value of investment in HFA A development framework that facilitates UI/UX prototyping Tools to make it easier to implement UI changes Ensure the best overall user experience HFA in Development– The Solution
  • 12. © The Qt Company How does Qt make it easier to iteratively prototype and re-design? • Pre-built libraries enabling Drag and Drop / WYSIWYG development • Qt Design Tools: Qt Design Studio • Rapid prototyping on the target device June 10, 202012
  • 13. June 10, 2020 © The Qt Company13 Rapid Prototyping on Target Device Iterate quickly / Identify issues early and easily Prototyping is in “Real Space” within actual environment • Correct form factor • Correct resolution • Correct “look and feel” Identify actual issues Prioritize and Triage issues to be fixed
  • 14. Fast prototyping as part of design process Accelerating product development Jun 10, 2020
  • 15. Sudden need to vast amount of new ventilators in short period of time created high pressure for accelerating product development and shortening time to market. THE NEED
  • 16. High-level can’t be tested, high-fidelity can. Building fast prototypes early in the design phase supports innovation by allowing the ideas to be put in front of users. This helps to get the details right and limit amount of iterations later in the development process. Hence reducing the total cost of innovation. Key points: • Incomplete experiences run the risk of highly biasing user reactions • Rather than rapid and rough, we do rapid and right • Amazing experiences emerge in the details OUR CORE BELIEF
  • 17. “Can Android look & feel match our brand identity?” “What’s the best set of physical controls to operate the HMI in our device?” “Will 3D help visualize data in my application?” “Will a context display inside the rotary knob be usable in my device?” “Can 3D content be streamed between different systems and displayed on different screen?” “Can our existing HMI technology be mixed with Qt, Android, Unity, Unreal ...” • UX of new features • Technical feasibility • Performance • Workflow TYPES OF PROTOTYPES:
  • 18. • Change of the test scenarios • Customizing of the displayed content per test user • Fast iterations in max. 1-week cycles • Recording of test user and the actions made (analytics & heat maps for eye gaze, clicks, interactions etc.) Good prototypes should allow
  • 19. A case example of fast prototyping with Qt for MCUs Ventilator HMI POC
  • 20. Building the first HMI prototype to enable UX testing Goal Enable Design Teams to experience their ideas on the target platform and make quick iterations on the created concepts. Get instant feedback from the tech (Qt for MCUs). Optimize for ability to experience the prototype quickly. Day 1 Setting the GOALS A Technology specialists skilled in fast prototyping joins the design team. The team agrees goals what needs to be prototyped and what are the hypotheses to be verified. Days 2 - 4 Fast prototyping High fidelity prototype is built which can be tested on the target platform. Design / Dev team works together to ensure fast iterations and tweak the prototype in real-time. Day 5 Demo review & alignment High-fidelity prototype review in a demo session. Team reviews the results together and sets the expectations for the next iteration.
  • 21. Thank you! Next – how it was done
  • 23. Qt for MCUs Training Program – Now available! Official training course to hone your or your team's microcontroller development skills. Learn the basics and get your hands dirty with 'Qt for MCUs' online training In five hours, you will learn: • Qt for MCUs package contents • Building and running application using command line • Qt for MCUs application build process • CMake API • Qt For MCU’s specific components • Configuring Qt Creator • Asset management • Styling controls • Internationalization • C++/QML integration • A Technology specialists skilled in fast prototyping joins the design team • The team agrees goals what needs to be prototyped and what are the hypotheses to be verified. Practice makes perfect – there will be live coding exercise included in the training. You’ll create your very first Qt for MCUs application. What: 1st out of three session in Qt for MCUs program When: 24-Jun-2020 Lecturer: Jacek Nijaki, Software Architect C++ , Siili Auto Oy as Qt Premium Partner How much: €308 / $350 Read more and sign up: https://marketplace.qt.io/ June 10, 2020 © The Qt Company23
  • 24. Have more questions? Contact Qt at www.qt.io/contact-us/ Contact Siili at auto.siili.com/ Qt for MCUs: https://www.qt.io/qt-for-mcus Qt for Medical: https://www.qt.io/medical Follow us: Twitter: @Qtproject Facebook: /qt/ Linkedin: /company/theqtcompany/ Youtube: /Qtstudios/ Thank you! June 10, 2020 © The Qt Company24