Braster
Breast cancer screening device for home use
Braster is an innovative e-health medical product which allows women to perform regular self-examination for breast cancer from the comfort of their homes. The most common method for breast cancer examination is mammography. This method is painful and requires women to visit the hospital. With Braster, women can perform the examination themselves at home. The collected data is communicated automatically to a back-end where the data is analyzed by AI and doctors. The feedback is provided through the Braster mobile app.
Zign Innovations was contracted to design the electronics and embedded software for the device based on an existing laboratory model. In this project, we worked closely together with the customer, the mechanical design company and the app development partner to fulfill the requirements and realize the integrated proposition.
From idea to market within one year!
Project Scope
- Clarification and conceptual design
- System design
- Implementation
- Industrialization
- Mass manufacturing
Clarification and conceptual design
Clarification and conceptual design
The Braster device collects multiple images through a camera which are sent to the backend over Wi-Fi, leveraging the internet connection of a nearby phone. The main challenge was to create a cost-effective design based on a microcontroller which could perform these data intensive functions simultaneously.
System design
System design
During the System design phase, we have designed a cost-efficient electronics hardware design. Based on the use cases and requirements we selected and verified the critical hardware components. In this phase we also defined the software architecture including interfaces with mobile app and back-end system including remote secure firmware update feature.
Implementation
Implementation
The core of the device is an STM32 microcontroller which manages all peripherals, such as the WiFi chip, camera and battery management system. The recorded images are stored in a local flash memory and communicated with the back-end through the controller. The camera was carefully selected to meet the specific requirements for angle, distance and output quality.
Industrialization
Industrialization
In the industrialization phase, the product was prepared for mass production with a target production volume of 10.000 pieces per year. This phase includes DFM, DFA and DFT for the electronics, where the designs are being analyzed for manufacturability, assembly and testing. All test engineering for electronics (FCT) was done by Zign Innovations, and together with the manufacturer, we developed the test jigs to be used during manufacturing.
Mass manufacturing
Mass manufacturing
As designer of the device, Zign supervised the manufacturing of all electronic parts in the selected factories in Asia on behalf of the customer. During production we verified that the critical-to-quality criteria were met. And after production we provided lifecycle management services.
- Project scope
- Main challenges
- What we did
- Sectors
Project scope
Project Scope
- Clarification and conceptual design
- System design
- Implementation
- Industrialization
- Mass manufacturing
Main challenges
Main challenges
- Medical device class IIa (60601 compliant)
- Time to market within one year after start project
- Efficient image acquisition and data communication
What we did
What we did
- Electronics engineering
- Embedded Software
- DFM/DFA/DFT
- Test design and engineering (FCT & EOL)
- Sourcing
- Certification (Medical Class Ila)
- Manufacturing supervision
Sectors
Sectors
- Medical devices
- Consumer electronics
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