Braster - Breast cancer diagnosis device

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.

Zign Innovations was contracted to design the electronics and embedded software for the device based on an existing laboratory model. We went from idea to market within one year!

Conceptual design

System design

Implementation

Industrialization

Mass manufacturing

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.

Concept 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

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.

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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

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, and together with the manufacturer, we developed the test jigs to be used during manufacturing.

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.

The advantages of
the Braster Pro

→ Possibility to perform a reliable breast examination in every doctor's office
→ Efficacy of the method has been proven in observational studies
→ The examination is painless and safe, since it does not use radiation
→ The examination takes about 15 minutes
→ The patented thermographic matrix registers even the smallest changes in the breast, starting at 3 mm in size
→Efficacy of the method is irrespective of patient’s age and breast tissue type

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Braster Pro is a telemedicine solution supported by patented technology

The Braster Care mobile app for smartphones and tablets connects wirelessly to the device, providing intuitive instructions throughout the entire examination and sending the data to the Braster Telemedical Center for analysis.

Discover our medical certified electronic projects

The development of electronic products has transformed the medical sector, advancing from basic instruments to devices that enhance patient diagnosis, treatment, and monitoring. The integration of IoT is now pivotal in reshaping healthcare. Faced with challenges like aging populations and rising healthcare costs. Connected medical devices and Medical IoT holds great promise in decentralizing and optimizing healthcare delivery.

We are specialized in medical device development, from idea to mass manufacturing. We are dedicated to help and guide you on the exciting journey of developing electronic products, accompanying you every step of the way. We use a standardized development process for medical device development. This process and our Quality Management System are certified according to ISO standard 13485:2016.

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Braster - Breast cancer screening device for home use -