From concept through FDA approval and into manufacturing.
In early 2008, we were approached by Dr. Marc Ellman, an ophthalmic surgeon, who owned and operated the Southwest Eye Center in El Paso, Texas. He had an idea for a digital ophthalmoscope and wondered why such an instrument was not already readily available on the market. Even in our digital age, the manual handheld ophthalmoscope, invented over 100 years ago, is still prevalent in medical circles. Dr. Ellman needed a company to help him take his idea and turn it into a real product, so he came to us.
The scope of the project included the entire medical device lifecycle from concept to manufacturing release. D2 Realization was able to not only develop a working prototype, but helped Dr. Ellman’s newly formed company, Eyequick, bring the product successfully through FDA, European and worldwide approval and then into FDA certified manufacturing. In 2012, after an extended design effort, the Eyequick digital ophthalmoscope rolled off a production line in Michigan and into eager customer hands.
D2 Realization was nominated as a finalist for the San Diego Business Journal Innovation Awards for our work on this device. The D2’s work also led to Dr. Ellman patenting his device in patent number USD635257S1. The device also won Vision Choice Awards Best New Product International Vision Expo West 2011.