A breast screening device, built from zero
Breast cancer is far more treatable when it is found early, yet many women have limited access to regular screening. D3S Healthcare, a health-tech company based in Ahmedabad, focuses on making early breast screening more accessible and affordable through non-invasive devices, AI-based analysis and digital reporting.
Its device, BR-Scan, had to be developed from the ground up: protected, engineered, manufactured, certified and supported by software.
CADLETE Designs took on this role as D3S’s official R&D partner, and is also a stakeholder in the company.
The goal
A complete, market-ready medical screening solution that doctors can trust and use in everyday practice, combining reliable hardware, compliant manufacturing and intelligent software in one product.
Hardware, software and regulation, all at once
A medical device is only finished when the electronics, the housing, the software, the paperwork and the production line all work, and all agree with each other.
A medical device from zero
Every part of the product, from concept to electronics to software, had to be created from scratch.
Usability for clinicians
The device needed a housing that is comfortable and straightforward to use during screening.
Regulatory requirements
Medical devices must meet strict standards, so certifications such as CDSCO and ISO 13485 and their supporting documentation were essential.
One connected system, at scale
The device, its firmware and the AI-based reporting software had to work as one system, and the product had to move into consistent mass production.
From patent to certified mass production
Six stages, shown with the real boards, molds, housings and packaging from this project.
Stage 01 · Patent, concepts and market research
A protected idea, shaped by real needs
We helped the client file the patent and developed multiple product concepts.
Market surveys and a market study shaped the product around real needs before the engineering began.
- Patent filing support
- Concept development
- Market research
Stage 02 · Electronics development
Complete electronics: hardware and firmware
We handled the full electronics development, covering both hardware and firmware.
The board runs the length of the handheld device, with the LED head at one end, a small display and its battery.
- Electronics design
- Hardware
- Firmware
The board powered up in an open housing. 
Assembled boards. Stage 03 · Mechanical housing design
A housing made for the hand
We designed a user-friendly mechanical housing for the device, comfortable and straightforward to use during screening.
The housing was prepared with design for manufacturing (DFM) for injection molding.
- Mechanical housing design
- Industrial design
- DFM
BR-Scan housings. Stage 04 · Injection molding and mass production
Molds cut, housings molded, product in mass production
With the housing designed for injection molding, the product was taken into mass production.
The photos show a mold for the housing and housing shells molded from it.
- Design for injection molding
- Injection molding
- Mass production
A mold for the housing. 
Injection-molded housing shells. Stage 05 · Certification and packaging
Certified, documented and packaged
We helped D3S obtain the required certifications, including CDSCO and ISO 13485, and handled the related documentation work.
We also designed eye-catching packaging, so the device reaches doctors as a finished product.
- CDSCO
- ISO 13485
- Packaging design
Finished BR-Scan devices. 
The packaging. Stage 06 · Software and AI
Screening reports and AI-based detection software
CADLETE built the end-to-end software for screening reports and AI-based breast cancer detection.
Device, firmware and software work as one connected system. The kit shown here pairs the device with a tablet.
- Software development
- AI-based analysis
- Digital reporting
The BR-Scan kit in its carry case.
Now used by doctors across India
BR-Scan went from a patent filing to a certified, mass-produced device with its own software, and it is now successfully used by many doctors across India.
What we delivered
- Patent filing supported
- Multiple concepts developed and the product defined through market research
- Complete electronics, hardware and firmware
- A user-friendly mechanical housing designed for injection molding
- The product taken into mass production
- Certifications including CDSCO and ISO 13485 supported, with documentation handled
- Packaging and end-to-end screening and AI software delivered
- BR-Scan now successfully used by many doctors across India
Services on this project
- Medical Device Development
- Product Design
- Industrial Design
- Patent Filing Support
- Market Research
- Electronics Design
- Hardware and Firmware Development
- Mechanical Housing Design
- Design for Injection Molding
- Mass Production
- CDSCO and ISO 13485 Certification Support
- Packaging Design
- Software and AI Development
Questions about this project
What does it take to develop a medical device from scratch?
Far more than the device itself. BR-Scan needed patent support, concepts and market research, electronics and firmware, a housing, design for injection molding, mass production, certification support and documentation, packaging and software. CADLETE handled all of it as one team.
What are CDSCO and ISO 13485?
CDSCO, the Central Drugs Standard Control Organisation, is India’s national regulator for medical devices. ISO 13485 is the international standard for quality management systems in medical device design and manufacturing. CADLETE helped D3S obtain both and handled the related documentation.
Can CADLETE build the software and AI for a medical device?
Yes. For BR-Scan, CADLETE built the end-to-end software for screening reports and AI-based breast cancer detection, alongside the electronics, firmware and housing.
Can a product development company also be an R&D partner?
Yes. CADLETE is D3S Healthcare’s official R&D partner and a stakeholder in the company, and developed BR-Scan from the ground up in that role.
How is a handheld medical device housing manufactured?
BR-Scan’s housing was designed with DFM for injection molding, molds were made, and the housings are injection molded in production. Designing for the process from the start is what lets a device move from prototype to consistent mass production.
Will my product idea stay confidential?
Yes. CADLETE signs a non-disclosure agreement before any technical information is shared, so your design files and IP stay yours.
