"I base it on the fact that the POC diagnostic market is 75% made up of glycose and infectious disease tests." this is where it becomes disruptive and you are imo not seeing what Minicare can/will do if it indeed is successful with this technology.. it will create a whole new range of tests for the POC market that are currently not able to be done.. so what happens here is that overtime that 75% reduces while the new markets made possible by the Minicare system now being able to do laboratory tests and creating new areas within the POC market.. now it may be hard for you to fathom that in the future the POC market will not be dominated by only these few areas .. but the POC landscape will change and it will grow outside of these areas.. and this is where Philips are aiming .. they are not aiming to take on the glucose and infectious disease players .. they are creating new areas in POC where they will be the only one's playing initially (yes they will also take on the existing markets but imo they want to forge into new markets where they will lead the way).. so while i get you point.. its a narrow view that the POC market will remain stagnant and only exist within these few markets and players you mentioned, forever, when in fact its about to become a hole lot more in the years ahead.. be that with Philips or Alere or whoever else gets HHPOC devices to function as well as benchtop lab equipment and across as many tests .. KINDA LIKE KODAK and the small time photo labs and digital age that killed them as they did not adapt to new technologies.. imo ..
BTW.. 2018 for FDA approval.. mate you are way off imo..
FDA APPROVAL TIMEFRAMES.. for medical devices
"Emergo conducted a review of public data on medical devices cleared by the US Food and Drug Administration between January 1, 2010 and December 31, 2014.
Key takeaways from this year’s analysis:
- A company submitting a 510(k) today has a 22% chance of getting it cleared within 3 months, and a 61% chance of getting it cleared within 6 months.
Exhibit A shows cardiovascular below.. 159-174 days on average.... pretty sure philips will be all over the requirements and unless something major goes wrong .. lets say 6 months instead of 3.. that puts us approval in 2016 not 2018...
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