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Portable Breast Cancer Screening Device

Category: Diagnostic Medical Device

Client Type: Healthcare Innovation Company (Anonymized)

Geography: Emerging & Regulated Markets

Project Impact

Enabled development of a portable, cost-efficient breast cancer screening device designed for deployment in outreach programs and semi-clinical environments.

Client Challenge

The client required a portable, cost-efficient diagnostic screening device that could operate in low-resource and semi-clinical environments without compromising data reliability or regulatory readiness. Existing solutions were bulky, expensive, and not scalable for wide deployment.

369 Innovations’ Role

369 Innovations acted as the end-to-end R&D and industrialization partner, taking ownership of the device from concept development to manufacturing handover.

Scope of Work

  • Clinical need translation and product architecture
  • Hardware design and sensor integration
  • Embedded firmware development
  • Rapid prototyping and iterative design
  • Design-for-manufacturing optimization
  • Verification planning and documentation support

Execution Highlights

  • Optimized hardware architecture to reduce BOM cost
  • Designed for portability, ruggedness, and ease of use
  • Manufacturing-aligned design enabling smooth scale-up
  • Regulatory-conscious development from day one

Outcome

  • Fully functional portable diagnostic device prototype
  • Manufacturing-ready scalable architecture
  • Reduced cost per unit compared to incumbent solutions
  • Positioned for screening and outreach deployment programs

Enterprise Signal

Demonstrates capability in diagnostics-grade engineering, regulatory-aware product development, and manufacturing-ready medical device design under real-world constraints.