In the book Atlas Shrugged, Ayn Rand wrote; “Every man builds his world in his own image. He has the power to choose, but no power to escape the necessity of choice.” This is basically a true statement. It also follows that making no choice is, in essence, a choice you make.
While this may seem a little philosophical the reality is that there is enough information and access to information about the direction the business world is moving to completely understand the choices you need to make to exist in this world. Companies are now recognizing the painful fact that they can no longer opt in or opt out of a new technology as the world can now work around them, through them and not with them and still grow. Sometimes the choices are made for you and you just have to accept the baton and run with it.
When Pure Air Systems opened their doors in 1985, they had to make a decision to market HEPA based air filtration systems to the residential market place when these systems were only used primarily in the commercial and institutional markets. The decision to take that jump paid off as PAS is now celebrating its 28th year in business. Now, Pure Air Systems is taking another leap of faith with its new entry into the very challenging medical products market.
Building a product for the medical market requires you to file a form with the FDA. The amount of information and data that is required is enormous and it is not unusual to have 500 to 700 pages of documentation and performance and operational protocol produced to satisfy the FDA. In addition, the performance of the product has to meet or exceed base line requirements as tested against similar approved products or processes. This process can take from 4 months to a year to complete. The real issue is the completion of all the paper work and then the testing of the prototype medical product.
PAS began the process of developing the new APPAIS unit ( a variation of their HPS 500 portable HEPA unit ) in March of 2013. The FDA has indicated the approval of the unit as a Class II medical device will take place the last week of December, 2013. That is almost 10 months to the date of which the process was started. The upside is the product will have FDA approval and a patent that will preclude any other company from jumping in to this product application and offer an opportunity for Pure Air Systems to capture a market that here to for they could not touch.
The choice to build a product specifically for the medical market was made with the understanding that there would be significant costs associated with the process. Developing and building prototypes is not easy or inexpensive and the time and labor to complete the forms and data required by the FDA requires hundreds of hours and countless re-writes to ensure the materials are up to the demands of the FDA. It is the necessity of choice.
For more information on the complete line of HEPA and Carbon based air filtration systems please go to our website at: https://www.pureairsystems.com. You can also follow us on Twitter @pureairsystems or call us anytime on our toll-free number at: 800-869-8025.