Good humans, businessmen, and women who want to come up with real solutions in order to return to some sense of normalcy have been asked to put their normal business ventures on hold and help develop solutions to the PPE shortage. Those business owners who happen to be engineers, doctors, and manufacturing experts have banded together on the behest of the federal government with no funding, sacrificing time from their family and employees, to serve the community. This coalition of the willing somehow developed a scalable solution to the incredible shortage of N95 masks required by hospitals only to find out there is no real sense of urgency to implement the solution. In a time when hospital insurance protocol requires N95 certified masks, the only real source is 3M who is completely beholden to the FDA manufacturing facilities located in China. While Nine Line and our unofficial task force have created a mask that seems to exceed N95 standards according to independent tests conducted earlier this week, there is no real path to accelerate the FDA approval of the mask in a time period less than 6 months from now.
I equate the situation to the Federal government calling on the private sector to build a spaceship from spare parts on their own dime, then once it proves more capable of flight than that of NASA, tell us we will have to wait this one out until our facility is up to standard. While a national disaster has the ability to showcase the best in people and organizations like the Hanes Coalition, it also showcases the worst. At a time when organizations should be focused on providing doctors and nurses like my mother the proper PPE they need to stay safe, the opportunity to make billions of dollars seems to take precedence. Individuals with connections to government officials now find themselves controlling the influence of seemingly unlimited governmental funding. Intermediaries with no experience sourcing medical supplies or managing government contracts wield their political connections to drive profits for themselves rather than help their fellow man or look for an alternative solution.
To better understand the complexities of our current predicament we must first understand the idiocracies of why everyone is craving the N95 mask. The N95 mask was the mask of choice for hospitals for years because it was the cheapest version of a mask that was required to maintain insurance coverage. According to the FDA an “N95 is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.” The N designates that the filter material is not resistant to oil and the 95 designates that 95% of all particulars that are .3 microns or greater are unable to penetrate the filter.
Now that the science lesson is complete, we must understand who makes this mask, where the materials come from, and why we can’t scale the production of masks for our nurses and doctors on the front line. The short answer is we allowed for the raw material, manufacturing equipment, and FDA certified facilities owned primarily by 3M to be controlled by China. This is not necessarily a national security issue unless a pandemic occurs and the entire world becomes fixated on the production of N95 masks. At this point, China understands the world has a demand and they control the supply. Although 3M and other large DoD contractors have been asked to scale production, they don’t control their factories and lack manufacturing capabilities to produce the N95 outside of China.
That is where we come in. The unofficial N95 task force has the ability to produce 50M filters for 5M reusable masks in the next 4 weeks. This would provide all doctors, nurses, firefighters, police officers, and military personnel with a 10 day supply of filters. However, since the filters cost approximately 50 cents per filter compared to the average $5 per N95 mask, your break even point for saving money is roughly one week. Assuming this virus lasts longer than two weeks, which we can all assume is a safe assumption, the Federal government will save billions of dollars by simply reframing the problem and developing an alternative solution. Rather than continue to entice federal, state and local governments to outbid one another on a mask that was developed in the 1950s, why not look to USA made solutions based on innovation. We have the smartest scientists, engineers, and manufacturers in the world, we just outsourced our FDA certifications to big businesses that relied on cheap labor in a foreign country. As our President has said many times, America First, China seems to be echoing a similar mantra with respect to their priorities. If we truly want to win this war, we must first relook the red tape restricting innovation based on a lack of certification and never again outsource manufacturing capabilities of PPE.
For now, while I wait for the validation of our PPE from the FDA I will encourage all those working on the front line to use any and all FDA approved respiratory devices. However, when my father who has been in and out of the ICU for underlying conditions or my mother who is a nurse asks what they should wear, I will encourage them to use the mask our coalition developed. I understand the effects of this pathogen and believe it is more effective than other PPE being advocated. However, until FDA tests validate independent tests we conducted, I have no legal claim to promote this assertion. Just that I love my parents and want them to survive the idiocracies of the current pandemic.