Fully Automated Urine Analyzer

1. Project & Market Opportunity
Turkey’s medical device market relies on imports for 85% of its needs, with only 30 domestically produced devices available. This dependency increases economic vulnerability to exchange-rate fluctuations and supply-chain risks. A locally manufactured, fully automated, AI-assisted urine analysis device will meet strong domestic demand and open export opportunities to the Middle East, Turkic Republics, and Europe .

2. Product Description & Technology

• Hardware: Flow-cell–based digital imaging, high-resolution camera, LED strobe illumination .

• Software: AI-driven image processing targeting >90% particle-identification accuracy .

• Integration: Seamless hospital information system (HIS) compatibility, over-the-air software updates, and standardized reporting infrastructure.

• Regulatory Compliance: Parallel CE/MDR, EMC, LVD, and ISO 13485 certification processes underway .

3. Strategic Goals & Roadmap

• Short-Term Objectives:

  • Complete a market-ready prototype and obtain CE/EMC/LVD certifications within 12 months.

  • Install at least 30 devices across three pilot hospitals by Year 2.

• Medium-Term Objectives:

  • Scale to a production line capable of 150 units and enter international markets by Years 3–5 .

4. Budget & Investment Requirements
Key cost categories include:

• Hardware procurement (camera modules, flow-cells, PCBs, enclosures)

• Software development and licensing

• Regulatory testing and certification

• Pilot deployments and field support

• Marketing, installation, and service infrastructure

Detailed cost breakdowns and cash-flow projections are provided in the financial annex.

5. Competitive Advantages & Sustainability

• Cost: 20–30% lower unit cost versus imported equivalents through local manufacturing.

• Throughput: 1–2 samples per minute (up to 80–120 tests per hour).

• Service: Nationwide rapid technical support, spare-parts logistics, and remote monitoring.

• Quality: Built-in CE/MDR and ISO 13485 compliance from project inception .

• Exportability: Modular design and multilingual interface facilitate entry into diverse overseas markets.

Call to Action
Investing now will accelerate R&D, establish production lines, and expedite regulatory approvals—critical steps for rapid market entry and export expansion. We recommend reviewing the detailed financial projections and ROI analysis in the accompanying presentation and scheduling a follow-up meeting to align on next steps.