They're training an entire large team in preparation for the Daisy set so the company seems to think it's a pretty big deal and has even set aside a large income tax benefit on the balance sheet in preparation for the expected profits from it.
The needle set from my understanding reduces the currently required 38 types of needles required with the Freedom 60 (their biggest selling product) and replaces it with 1 needle set that adjusts into 38 different sizes. This makes the device far less complicated and far more "user friendly" which in turn should lead to a lot more sales. I imagine they designed this after getting much feedback from the marketplace that they would order a lot more of these if the device was much more simple for their patients -- because it's already much much cheaper. Once you combined much cheaper with much more simple it really becomes a no-brainer to go with the Freedom60 vs. the competition. Also they claim this new set will improve speed of administration and safety -- both of which are important especially in the world of super malpractice lawsuits. I think they already have a large number of orders sitting on the table waiting for the official FDA approval, hence they are already training and hiring a whole new large team to manufacture this. All of this paragraph is just my speculation as you will have to make your own conclusions from this wordking from the filing:
"We have been developing our own needle administration sets for subcutaneous immune globulin, called the Daisy Set which incorporates many enhanced features that we believe will address many of the issues faced by current offerings. The current devices are available with a number of needles from one to six, in three different lengths, and in some cases two different diameters, thus creating a logistical problem for providers to store 38 different kinds of needle sets. Our new Daisy needle sets contain an adjustable needle depth setting, and have the ability to connect to each other to create any number of joined needles, thus reducing all the offerings from 38 to only one type of needle set. In addition, since we have pioneered the fluidics for these administrations, we have designed the Daisy set for very rapid administrations with improved safety. An FDA 510(k) has been submitted for the new set and updated performance features of the Freedom60."
