Updated: Jul 16
We’ve been working around the clock to ramp up our efforts to help mitigate the PPE shortage. For the sake of transparency and efficient communication (we are receiving thousands of emails a day now) I’m trying to provide updates as things evolve on this blog.
We’re official certified by the FDA to make safe and effective FDA approved PPE!
We are also working with a Quality Assurance and Regulatory Consultant who specializes in medical devices and is in direct contact with the FDA to fast track approvals on our behalf.
To make safe and effective FDA approved PPE we can only use AAMI approved PPE materials that would pass FDA inspection. We secured an order for the material and its on its way. As we tried to secure another batch of the material from the same supplier it was then seized by the Canadian government in their own PPE efforts. But due to the goodwill that we have created over the past three years as a fashion incubator and due to the amazing staff and community members we have helping us, we were able to miraculously secure some of the last remaining supply of the FDA approved fabric available at another vendor and it’s on its way to us now.
MACHINERY AND EFFICIENCY
We have been working tirelessly with the AZ Commerce Authority’s Manufacturing Extension Partnership to add efficiency and lean manufacturing techniques to our manufacturing abilities. Due to their help, we have created a lean manufacturing production line model that will allow us to produce 500 gowns a day just by adding a few more machines and sewists. We are starting production with this line immediately. However, we have had to self-fund a lot of the start-up costs needed to ramp up our abilities and get the additional equipment needed to do this. Some of this self-funded equipment is in route to FABRIC now. If we could get some financial help, this lean production line that ACA/MEP helped us figure out can be replicated multiple times to produce exponentially more items. With financial help, we feel that we can replicate this line at least three more times within our own facility to make at least 2000 items a day (more with round the clock shifts). We could then train other manufacturers in everything we now know so that we can contract them out to help fill the orders we have.
We are considering adding three shifts around the clock. Hiring for sewists and other positions will begin soon and an application will be available on our PPE web page. Sewists would need to have industrial machine experience including single needle and overlock (serger). Email us if you're interested in joining the team.
We have significant start-up costs to be able to do this. We have used personal loans/credit lines to cover these startup expenses. We have been able to raise some grant funds through Thunderbirds Charities, Tempe IDA (Industrial Development Authority) and an anonymous provider. We have also received a bunch of small donations from the community. This is not enough to really do what we need to do for all of the healthcare workers in need. Our 501(c)(3), Arizona Apparel Foundation (AAF) is seeking donations to support the purchase of some major equipment and assist in the startup costs needed to ramp up our abilities so we can get through the orders that we’ve committed to much faster. This will allow us to make more items faster and allow us to help other factories get set up so we can sub-contract them out to help fill these orders too.
Break down below:
Gerber Automatic Cutter (quote attached)=$184,000
75 industrial sewing machines to set-up 5 production lines=$161,000
Consumable supplies purchase to run machines=$3000
Building retrofit to accommodate additional machinery=$6000
CONNECTING NEEDS WITH SUPPLIERS
We have been contacted by countless healthcare facilities of every size for weeks now and have been keeping track of their needs on a spreadsheet. The items needed are in the millions at this point.
Alarmingly, there is no centralized government list where those in need can be matched with those who provide PPE. No one is being the moral compass on who gets PPE first and this is a humanitarian issue. So we’ve created our own spreadsheet and are trying to connect needs with the providers that we’ve learned of. There are a few providers who are creating 3D printed masks and other items, but we are the only ones leading the FDA approved isolation gown efforts because we pivoted our efforts so quickly. Now that we are FDA certified and understand their protocols to make safe and effective PPE, our plan is to train and contract other local apparel manufacturers to help us fill the needs on the spreadsheet we’ve created.
OPEN SOURCE PPE PROJECT
In an effort to help a smaller facility completely out of gowns who had contacted us weeks ago, we created a pattern for a semi-disposable isolation gown that could be made from a readily available fabric that can be purchased from home improvement stores and we completed and delivered an order for 30 gowns in two days before we had set up our efficient production line. This fabric can’t be laundered, but it can be wiped down with isopropyl alcohol extending the use of the gown. We are providing the pattern, technical instructions and fabric information to anyone who wants to attempt to make their own. We are currently putting together an open source kit to share with the community so that the public can start to make these. This should be available soon on our website.
In summary, at full capacity of 24/7 and 4 production lines at FABRIC we could produce 25,000 reusable gowns (which can be washed up to 300 X’s) per week. This is the equivalent of 7,500,000 disposable gowns/week. This will put a big dent in this PPE shortage of medical grade FDA approved gowns quickly. We cannot do this alone. We will do this regardless. We’ve already extended personal credit to to make this happen. We’ve done this as we see no other moral choice. We’re just hoping that more organizations from our community with the resources to do so, will step in to support our efforts. Andrew Cuomo has said the State of NY will fund manufacturer’s start-up costs so they can produce PPE. He understands that pivoting requires a capital investment.
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