Blog Tag: Class II medical devices

When using 3D modeling software everything you draw with is a curve; any line is a curve and more than one curve is a Polyline.  Sounds a bit confusing but it actually makes sense once you spend some time using the software. In addition, if you want to design an object that will eventually be saved as a .stl file so it can be 3D Printed or manufactured, it must be a closed curve. An open curve has no boundaries and therefore no solid surface from which you can build an object.

 For most people having an understanding about how something was designed and created isn’t nearly as important as how well it will work. The ability to draw and scale an object on a computer screen in three dimensions makes it easier to create the object so it has the correct amount materials in the right areas and can be easily utilized for the application for which it is intended.

When Pure Air Systems set out to build a new portable HEPA unit for a Class II Medical Device application, the project started out as a series of curves on a computer screen. The idea was to take an older design of the HEPA portable built in 2006 and modify it so it would require no tools to either change the three filters or attach it to a movable stand.

While throwing out the old design and starting over again may sound like the best idea, in reality there were many aspects of the older unit that were still viable,  it was just looking at the two end sections that required tools to access the replaceable filters from a different angle that required some major changes.

Removing the outer doors on both ends that held the prefilter and HEPA in place was a little challenge but by looking at the unit from the top rather than the ends we tried cutting slots in the top ends of the unit and looked at dropping the filters down into these slots and then capping the slot with a plastic or rubber slot cover that was easily removed by hand. Once we made this change the other modification was coming up with a better way to compress the HEPA filter gasket on the knife edge to ensure an air tight seat. This was simply done by taking a 1″ wide by 1/4″ thick x 12″ long bar and squeeze it between the top and bottom of the outer HEPA filter aluminum frame edge and the inner filter rail that supported the outer filter. This made the HEPA sit tightly against the seat and again required no tools to install.

Finally, attaching the unit to the movable stand with a bolt type process required us to place four small drop down bars from the bottom of the housing down approximately 5/16″. Then hooked end bolts would be hung from the bars dropping down into holed channel pieces and wing nuts and one washer per bolt is that is required. Again, no tools necessary.

A nice closed curve.

For more information on Pure Air Systems and their complete product line please go to our website at: https://www.pureairsystems.com. Or you can call us on our toll-free number at: 800-869-8025.

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.