Paradigm Medical Industries Inc. (PDMI)

[Dubb10]

"Purpose doesn't mean a damn if you don't execute well. "
This statement can be said of the companies who submit their products to the FDA.

If you want me to go through and make create some graphs/charts from thousands of submissions, then I'm going to have to disappoint you. If I had the time to do so, maybe I would. Can you show me how it has been declining over the past 10 years? PDMI has given a very brief intro on what Paramax does and how, can you show me how it is substantially equivalent to what is currently on the market in detail with the data to back the claim? Although I am currently banning myself from posting my DD on this board for my own reason(s), I will make this one exception. The following is the detailed flow chart that the FDA uses to make decisions about all medical devices. Take notice of the single-star footnote.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081395.pdf

Nothing we have seen on PDMI's website lets us know that CSO has sufficiently addressed the questions listed on the chart. Not to say that they haven't, but how do we as investors know that they have? That is confidential information that we may never see.

Decision-making can take longer over the years because accountability is an issue if the new technology fails to do what the company says it does, or harms the people it is supposed to treat over an extended period of time. New flaws in old methodologies are found regularly. Because of this, greater scrutiny has to be conducted because quality standards have changed. Since we are dealing with a medical device company, lets look at a very basic aspect of electronics. Back in the day, a solder joint was a solder joint. As long as it made contact with 2 conductive surfaces, it was deemed OK. Current can flow from point A to B so all is good. As time elapsed and certain devices failed, we have found that certain solder joints are not acceptable under certain circumstances. We now have a set of standards and requirements for these joints. What is acceptable for a toy car is not acceptable for medical equipment used to monitor a patient's vitals in a hospital. A failed toy car means you have to fix it or go buy a new one. A failed medical device in this case means serious injury or death to a patient. Wires have to be make contact with each other and conductive posts in a certain way on a circuit board. Solder is now made of different combinations of metals which have different melting points, strength under vibration and all that jazz. That is one basic aspect of what has to be analyzed. I didn't even get into the Electrostatic discharge and counterfeit part performance aspects.