Limited Competition: Research Project to Develop and Implement a Novel Diagnostic Tool for Early Detection of Diabetic Retinopathy

This project seeks to develop and implement a novel, non-invasive diagnostic tool for the early detection of Diabetic Retinopathy (DR). The successful proposal must demonstrate strong expertise in medical device engineering, advanced imaging, and clinical validation protocols.

Eligibility and Scope

Applications are restricted to institutions with established research infrastructure in ophthalmology and biomedical engineering. The scope requires the development of a prototype device, rigorous preclinical testing, and a comprehensive plan for multi-site clinical validation across diverse patient populations.

Key Deliverables

• A fully functional, FDA-pre-submission-ready prototype of the diagnostic tool.
• A comprehensive dataset from at least three distinct clinical validation sites.
• A detailed publication plan targeting high-impact journals (e.g., *JAMA Ophthalmology*, *Nature Medicine*).
• A final technical report detailing manufacturability and cost-effectiveness.

Review Criteria

1. Scientific Merit (40%): Novelty, technical feasibility, and potential impact on global diabetic care.
2. Approach & Methodology (30%): Rigor of the proposed validation plan and statistical power.
3. Team Capability (20%): Demonstrated expertise across engineering, clinical medicine, and regulatory affairs.
4. Budget Justification (10%): Alignment of requested funds with stated objectives.