VisionQuest Biomedical Inc — Department of Health and Human Services SBIR Phase II: M

Description

DESCRIPTION provided by applicant The long term objective of this project is to engineer test validate and commercialize the i RxCamandquot a low priced portable and easy to use retinal camera Because of our Phase I technical accomplishments and demonstrated effectiveness we can achieve the overarching goal of this Phase II final verification and validation of the low priced non mydriatic retinal camera and repackaging of i RxCamandquot for manufacture and commercialization Our innovative approach for the i RxCamandquot is based primarily on a significant departure from current generations of desktop and handheld commercial retinal imaging devices and those cameras under development Our design strategy is based on an extensive survey analysis and consideration of the user requirements to ensure maximum ergonomic utility Existing portable retinal imagers as well as those known to be under development do not meet the requirements of a low price camera with sufficient technical capabilities field of view image quality portability battery power and ease of use to be distributed widely to the offices of medical practices where trained retinal photographers may not be available We will achieve the Phase II objectives through two specific aims to build and assemble two new cameras based on a finalized Phase I prototype camera design but with minor changes to improve usability and reduce costs and to re engineer an advanced prototype that increase the field of view from degrees to degrees Both cameras will undergo testing in a clinical environment The metrics for testing will be feedback from imagers on the usability Percentage of acceptable images for reading will be a second metric Quantitative metrics such as resolution contrast and dynamic range will be used as metrics in the bench testing of the devices In Phase II we will make design changes to improve on the following aspects larger field of view smaller pupil access auto focus ergonomics and portability We will perform extensive clinical testing in a cohort of N subjects imaged by at least two photographers of differing levels of experience in retinal imaging The testing and feedback from users will be used to prepare the i RxCamandquot for high volume manufacturing while constraining the cost of goods and manufacture to under $ and maintaining the small footprint and portability requirements We will conduct the necessary quality and safety studies needed for producing a commercial ready device that can be submitted for FDA market clearance The i RxCamandquot is a low priced alternative to expensive retinal cameras and its development is aligned with the NIH objective to reduce disparities in medical care in rural and underserved populations PUBLIC HEALTH RELEVANCE The objective of this project is to engineer test validate and commercialize the i RxCamandquot a low priced portable and easy to use retinal camera This project is relevant to public health because it addresses the lack of access to low cost retinal disease screening and diagnosis equipment in rural and underserved clinics Widespread access to retinal examinations can significantly reduce the incidence of sight threatening retinal diseases resulting in economic and societal benefits to the government and the affected populations