P16590: Low-Cost Fundus Camera 2
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Problem Definition

Table of Contents

Project Summary

A 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 Cases

The most common use of the Camera will be by a general practitioner in their work space.

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Some other use cases for this Camera may include:

Project Goals and Key Deliverables

The 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)

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Engineering Requirements (Metrics & Specifications)

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Constraints

Factors, 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 Requirements

The following FDA requirements must be met in order for a successful product to be produced: FDA Requirements Must conform to:

Design Review Materials

Problem Definition Presentation

Plans for next phase

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