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Friday, June 16, 2017 3:36:57 PM
Since McNally was talking about two milestones at once and we know the three sites are in negotiations right now, the initial design freeze must also be Q2 2017.
In the normal flow of things for a medical device of this nature, it means this is the design they will bring into pre-clinical trials, with at most some very minor mods but hopefully none. Early trials will mostly validate the hardware while the software development continues. A complex system like this will need to show safety and efficacy for approval, and once the hardware design is pinned down, minor tweaks are easy.
It is initial design freeze because they are heading into about a year of much more intense (simulated)real-world utilization, from which they will be seeking feedback for more possible improvements. It is actually a fairly major milestone. Executing the plan!
I am looking forward to the AGM video.
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