In this webinar presented with leading System-on-Module designer and ICS partner Variscite, we will present a real example of a medical device featuring the DART-MX8M-PLUS, i.MX8 Plus-based System on Module. Walking through this case study will allow us to showcase specific challenges that characterize the medical field as well as common software challenges. As a webinar attendee, you will: Gain tools that will help you choose the hardware that best suits your project needs. Receive useful software tips that will help you get your project off the ground.

1. Overcome Hardware & Software Challenges
Medical Device Case Study
Speakers:
• Lisandro Pérez Meyer - Software Engineer, ICS
• Tal Semo - Managing Director Sales and Marketing - The Americas, Variscite

2. 2
 About Variscite
 Case Study: about the project
 Case Study: hardware
 About ICS
 Case Study: software
 Questions?
Webinar
Agenda

3. 3
 19 years in the SoM market with an extensive customer base and pipeline
 Stable supply using internal production facilities ensuring complete control over the manufacturing process
 Direct support by the R&D team within 24 hours
 The only SoM vendor in NXP's Platinum membership
 Providing the most diversified i.MX based product portfolio
 Highest quality standards meeting strictest regulatory requirements, including the medical standard
 Ecosystem of partners for a complete end-to-end solution
About Variscite

4. 4
Variscite System on Module Provides
 Two pin-compatible product families enable seamless migration to future technologies
 The Ultimate SoM customization
 100% yield – All the time
 Production-ready hardware and software
 Tested and used by hundreds of customers – proven high reliability and low risk!
 Free support for customers: Customer Portal, GitHub, VariWiki, CAD
 Robust longevity up to 15 years for hardware and software

5. 5
Variscite Pin2Pin product families
Two highly scalable product families based on NXP processors
Note:
Pin2Pin compatibility depends on pinmux options
VAR-SOM Pin2Pin Family
NXP i.MX8M Plus
4x 1.8GHz Cortex-A53
VAR-SOM-MX8M-PLUS VAR-SOM-MX8X
NXP i.MX8X
4x 1.2GHz Cortex-A35
Pin2Pin Compatible
VAR-SOM-6UL
VAR-SOM-MX6
NXP i.MX6
4x 1.2GHz Cortex-A9
VAR-SOM-SOLO/DUAL
NXP i.MX6
2x 1GHz Cortex-A9
VAR-SOM-MX8M-NANO
NXP i.MX8M Nano
4x 1.5GHz Cortex-A53
VAR-SOM-MX8M-MINI
NXP i.MX8M Mini
4x 1.8GHz Cortex-A53
NXP i.MX8 2x 1.8GHz Cortex-A72
+ 4x 1.2GHz Cortex-A53
VAR-SOM-MX8
DART-MX8M
NXP i.MX8M
4x 1.5GHz Cortex-A53
DART-MX8M-PLUS
NXP i.MX8M Plus
4x 1.8GHz Cortex-A53
Pin2Pin Compatible
DART Pin2Pin Family
DART-MX8M-MINI
NXP i.MX8M Mini
4x 1.8GHz Cortex-A53
NXP i.MX6 UL/ULL/ULZ
900MHz Cortex-A7

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Why use a System on Module?
 Faster time to market
 Reduced R&D cost
 Proven solution
 Easy development and integration
 Access to the latest technology

7. 7
 About Variscite
 Case Study: about the project
 Case Study: hardware
 About ICS
 Case Study: software
 Questions?
Webinar
Agenda

8. 8
Case Study: about the Customer / project
 Medical Devices company
 Laser-based device
 Subject to FDA approval
 Looking for a partner which complies with the Medical ISO 13485
 Looking for extended Longevity

9. 9
 About Variscite
 Case Study: about the project
 Case Study: Hardware
 About ICS
 Case Study: Software
 Questions?
Webinar
Agenda

10. 10
Case Study: Hardware
 Multicore solution for high processing needs
 NPU for AI.
 Product has size constraint
 Requires two displays HDMI and LVDS
 Strong GPUs for intense graphic / GUI
 Requires MIPI CSI camera input
 Requires USB 3.0
 Dual Ethernet, 2x Gbe
 Real time processor to manage several peripherals
 Longevity – minimum 10 years

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11
i.MX8M Plus System on Module
 Up to Quad 1.8GHz i.MX 8M Plus Cortex-A53
 with 800MHz Cortex-M7 co-processor.
 AI/ML NPU acceleration 2.3 TOPS
 Display: HDMI 2.0, LVDS, DSI
 Vivante GC7000UL/ GC520L 2D/3D accelerator
 1080p video encode/decode and HQ audio
 Dual GbE with TSN, USB3, CAN/CAN-FD
 Dual MIPI CSI camera inputs
 Built-in certified single-band 802.11 b/g/n or
 dual-band 802.11 ac/a/b/g/n + BT5.2/BLE
 Up to 4GB LPDDR4, 64GB eMMC
 -40 to 85°C Industrial temperature range
 15 years of longevity

12. 12
 About Variscite
 Case Study: about the project
 Case Study: hardware
 About ICS
 Case Study: software
 Questions?
Webinar
Agenda

13. 13
 Founded in 1987
 Largest source of independent Qt expertise in North America Provides:
• Integrated custom software development for embedded, touchscreen, mobile and desktop applications
• User experience (UX) design with Boston UX design studio
• Platform services
• Device cybersecurity
• Cloud & Web services
 Dedicated Medtech Practice but our portfolio includes everything from professional restaurant equipment
to autonomous vehicles.
 HQ in Waltham, MA with offices in California, Canada, Europe
About ICS

14. 14
 About Variscite
 Case Study: about the project
 Case Study: hardware
 About ICS
 Case Study: software
 Questions?
Webinar
Agenda

15. 15
Now that we have a great board to work with it’s time to kick off the development.
Let’s see some challenges that we face:
 The need of a development process that complies with IEC 62304 “medical device software -
software life cycle processes” and IEC 62366 “medical devices”
 Creating an OS image using Yocto which has the necessary changes for the product and only
the required software set
 Setting up and putting into action an SDK with the development team
 The user experience
Customer challenges

16. 16
IEC 62366 - Application of usability engineering to medical devices
 PROCESS for a MANUFACTURER to analyze, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates
to SAFETY
 Assess and mitigate RISKS associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE
 It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE
We will call this “THE PROCESS”

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IEC 62366 - medical device software - software life cycle processes
 Specifies life cycle requirements for the development of medical devices
 Harmonized by the EU and the United States - can be used to comply with
regulatory requirements from both these markets
Contents:
 General requirements
 Software development process
 Effect of safety classification on required development process documentation
 Software maintenance process
 Software risk management process
 Software configuration management process
 Software problem resolution process

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What makes it medical related is the process
 The difference between any device and a medical device is the process.
Be sure to:
 Document all the processes. Yes, even the first prototype tests
 Start the risk analysis process as soon as possible

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What makes it medical related is the process
 Things that help the process to meet the IEC 62366 and IEC 62304 criteria
 Common development methodology
 Common architecture
 Validated tools and dependencies
 Common code library
 Have cybersecurity requirements in mind
 If you work with external contractors be sure to have a methodology to produce the appropriate knowledge transference.
 Incorporate the usability team throughout the development process

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 A Yocto setup adapted to the product
 Projects normally require other peripherals like sensors
 Not only enable the peripherals the project needs… also disable the ones it doesn’t
 Specific bootloader/kernel configuration
Tip: try to prepare a test for each of the above, specially the sensors. They will not only help you to understand their capabilities
sooner, they will also help you provide proper QA during manufacturing.
The embedded OS

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Things that you will need to do:
 Enable/disable the features the project requires
 Customize the experience
 Set up the desired building tools, like Qt 6
 Integrate your peripherals with Qt 6
 Do it in your own layer!
 Have a powerful build server
Again, be sure to create documentation.
The embedded OS - software

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 It’s not only development, think on factory set-up
 Integrate your device with the cloud: fleet management
 Be able to upgrade your device with Over The Air (OTA) updates and/or by having some specific access to the board
Did I mention documentation?
The embedded OS - software

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 Developers normally do not work with the full Yocto setup at hand
 Provide developers with a dedicated, fine tuned SDK which can allow them to build code in their stations without the full Yocto
setup
 Try to use a common IDE, better yet if your team’s preferred one
 And again… documentation!
The Software Development Kit

24. 24
From a proof of concept…
 Test the hardware
 Add support for the required protocols
…to a full-blown application
AWESOME user experience
The main application

25. 25
Did I mention documentation?

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27. 27
Customer Portal
Variscite Portal
Website
www.variscite.com
Email
sales@variscite.com
Variscite wiki
variwiki.com
Please contact us - Variscite
GitHub
github.com/varigit

28. 28
Website
www.ics.com
Email
info@ics.com
Please contact us - ICS

29. THANK YOU!