P16590: Low-Cost Fundus Camera 2/public/
Table of Contents
Project SummaryA fundus camera is used to photograph the retina to provide information about a patient's eye. Diabetic retinopathy is a complication associated with diabetes, eventually leading to blindness. With proper care, patients with retinopathy can reduce their risk of blindness by 95%. Due to the need for pupil dilation, specialized camera equipment, staff, and facilities, diabetic patients often do not receive regular screenings. By creating a low-cost, portable, and easy to use fundus camera, screening for retinopathy in diabetic patients can be performed by a general practitioner.
Use CasesThe most common use of the Camera will be by a general practitioner in their work space.
Some other use cases for this Camera may include:
- House calls
- Nursing homes
- Screenings in remote areas
Project Goals and Key DeliverablesThe goal of this project is to develop a prototype of a low-cost fundus camera. The device will be simple enough that non-specialized medical personnel will be able to use it. It will provide high quality images in a package that would not be obtrusive in a general practitioner's office. The desired outcome is to increase patient compliance with regular screenings to decrease risk of permanent blindness due to diabetic retinopathy. The design and prototype may generate significant IP potential, with several companies already investigating this type of technology due to the market potential.
Customer Requirements (Needs)
Engineering Requirements (Metrics & Specifications)
ConstraintsFactors, usually system-level, that limit your design space (e.g., cost, total weight, total footprint, total power available). Are your constraints measurable and testable, and can they be traced back to customer requirements? Have you considered economic, environmental, social, political, ethical, health and safety, manufacturability, and sustainability constraints, for example?
FDA RequirementsThe following FDA requirements must be met in order for a successful product to be produced: FDA Requirements Must conform to:
- ISO 10940: 2009 Ophthalmic instruments Fundus cameras
- IEC 606011:2005 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 6060112 Medical Electrical Equipment – Part 12: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Capability – Requirements and Tests;
- ISO 150041:2006 Ophthalmic instruments – Fundamental requirements and test methods – Part 1: General requirements applicable to all ophthalmic instruments
- ISO 150042:2007 Ophthalmic Instruments – Fundamental requirements and test methods – Part 2: Light hazard protection