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.
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Overcome Hardware And Software Challenges - Medical Device Case Study
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
6. 6
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
11. 11
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”
17. 17
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
18. 18
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
19. 19
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
20. 20
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
21. 21
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
22. 22
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
23. 23
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