Imagin Medical has reported continued progress toward verification of its i/Blue functional prototype product.
At the recent American Urology Association Meeting, Imagin held private focus groups with leading urologists to demonstrate the first i/Blue functional prototype product. Input from these meetings, and the overwhelmingly positive feedback from the physicians, have been used to finalize the i/Blue product’s user needs, which have been integrated into its design specification, moving the functional phase of development forward.
The Company is following the 7-step development process that the U.S. Food and Drug Administration (“FDA”) defines in its Design Control Guidance for Medical Device Manufacturers. These include: 1) user needs; 2) design input; 3) design process; 4) design output; 5) design verification; 6) device realization; and finally, 7) device validation.
Imagin is building additional i/Blue functional products which are undergoing design for the manufacturability and assembly (DFM/DFA) process. Some of these functional prototypes will be sent to an independent, external test lab to confirm compliance with electrical safety, electromagnetic emissions, human factors, user interface requirements and other key medical device regulations and standards.
Imagin will begin purchasing long-lead components for the initial pilot production manufacturing run early in the third quarter of 2019 in order to adhere to the following schedule:
Once verification testing has been completed, the Company will have achieved design verification – step 5 of the 7-step FDA development process. Imagin expects design verification will be completed during the fourth quarter of 2019.
In preparation for device realization (step 6), Imagin will then commence the manufacture of pilot production i/Blue Systems.
A portion of the aforementioned pilot production i/Blue Systems will be dedicated to device validation (step 7), which includes testing for biocompatibility, sterilization, and reprocessing. Imagin anticipates device validation will be initiated during the first quarter of 2020.
The remainder of the pilot production i/Blue Systems will be used for marketing activities in anticipation of receiving FDA clearance to sell the i/Blue System in the United States.
Jim Hutchens, President and CEO of Imagin, commented “We are pleased with the overwhelmingly positive feedback we received at our recent meetings with urologists, which confirmed that the i/Blue System would be a welcome advancement within their community. As we continue to progress the technology through the functional phase, we are looking forward to our second meeting with the FDA, currently scheduled for early September, to discuss the i/Blue System’s regulatory path.”
Source: Company Press Release.