CATER Mask Decisions

February 3, 2021

Three Step Mask Strategy Webinar Friday Feb 5 at 10:AM CST will Address a Market Five Times Larger than the Present One

The U.S. Tight Fitting Mask Market is Five Times Higher Than the Present One

TAIJI Medical Supplies Single-Use Face Masks Designed to be Protective and Comfortable

Behind the KandyMask Micro Filter System

Mask Shortages Continue for Medical Workers

____________________________________________________________________________

Three Step Mask Strategy Webinar Friday Feb 5 at 10:AM CST will Address a Market Five Times Larger than the Present One

We need a program to insure that everyone is fitted with tight fitting efficient masks as quickly as possible. This is a new market involving  97% of the people who will need 84% of the masks Distinguished researchers have developed a three step plan which  we will be discussing on Friday.

On the 28^th we covered the background for Step 1 of the Friday webinar. Monday we covered Step 2 and Tuesday Step 3.

The three steps are (l) launching an awareness blitz, (2) advise on which masks should be worn and (3) prioritize masks for the vulnerable. View the previous Alerts at http://www.mcilvainecompany.com/CATER/subscriber/default.htm

The webinar will include a display and discussion of the three steps. We are encouraging input from all the participants and hope for a lively discussion and debate.

The U.S. Tight Fitting Mask Market is Five Times Higher Than the Present One

McIlvaine is analyzing the potential market if everyone is equipped with tight fitting efficient masks.  At this stage it can be said that this market is at least five times larger than the one being served.

The U.S. population is 331 million people. The question is how many masks will it take to insure safety for all citizens.   Nearly 20 million are less than 4 years old. Over 50 million are in kindergarten through high school.  

Over 20 million people are in healthcare and social assistance.  The number of doctors is less than 1 million. There are 2.8 million people in nursing.

Some of these people are wearing 10 surgical masks per day or several N95s.  But the maximum consumption is by people within three feet of infectious patients.  Many people are not in contact with patients on a daily basis.

DHHS estimated that 3 billion masks would be needed to fight COVID in March.  this would supply 3 million people wearing 3 masks per day for one year.

There are over 1 million firefighters but only 400,000 of them are permanent and the others are volunteer. There are 800,000 law enforcement officials.

Many in the population are not employed and spend relatively little time in public. Possibly 8 million of the 16 million people in retail are meeting with customers continually.

There are 14 million in accommodations and food service. But it is likely that only a few million would be in contact with many clients each day. 

The McIlvaine Company will be analyzing all these categories and make forecasts in terms of tight fitting and efficient masks. But the analysis is likely to show that the present market for medical workers is only 16% of the total. The most exposed group uses 15 times as many masks as the least exposed group  but only represents 3% of the population. So the challenge is supplying the other 84% of the expanded market.  This is a high efficiency market five times larger than the present one.
 

TAIJI Medical Supplies Single-Use Face Masks Designed to be Protective and Comfortable

TMS occupies a 120,000 sq ft facility in Lincolnton, NC that is already producing volumes of masks and will scale to millions. Masks can be made for nearly the same price as those made in China. TMS believes America should not have to choose between quality and price in a time of need.

·     TMS has two (2) melt-blown fabric machines in-house. Melt-blown fabric is the center layer of each mask and is what provides filtration. Many manufacturers were hindered during the height of the pandemic as they rely on sourcing from overseas. 

·     The company says it has combined automation, vertical integration and American ingenuity to solve the problem

·     Medical-grade surgical and protective face masks are designed, developed and produced end-to-end in America (Lincolnton, NC).

·     20 fully-automated assembly lines can produce thousands of masks per minute.

·     Vertically integrated factory takes raw polypropylene and transforms it into surgical and protective face masks in seconds. 

The general Consumer Series single-use face masks are designed to provide enhanced coverage with a more comfortable fit. They are wider than the average mask, reducing the gap between the edge of the mask and the ears. The nose bridge is built with higher ductility, allowing it to bend more easily and stay in place without discomfort. The ear loops on their masks are created with a thicker, more comfortable material that has been tested to stretch to two-and-a-half times the original length without losing elasticity. 

Mask Specifications

·     Engineered with three (3) layers of protection

·     Hypo-allergenic, soft, non-woven polypropylene outer layers

·     Melt-blown proprietary material inner layer for improved filtration

·     Latex free

·     Single-use

·     6.9 in ± 0.2 in (Length) x 3.5 ± 0.2 in (Width)

·     Made in Lincolnton, North Carolina  

Dan Grayson, VP Sales and Marketing agrees that there is a need for a tight fitting mask but believes there are ways to accomplish this without use of a brace. He will be traveling on Friday and unable to participate in the webinar but believes that TMS can play an important role in seeing that everyone has tight fitting efficient masks. Here are his comments.

“The pandemic has created a whole new twist on the meaning of ‘start-up’ endeavors here in the United States and globally as a whole. As the Director of Sales & Marketing for TAIJI Medical, I can speak firsthand regarding the struggles and successes of an American-based face mask manufacturer. From $0 sales, to now over 100 healthcare customers, twq massive distribution partners and a top major retailer under our umbrella, it’s been an overload of planning and strategy. But, at least in our case, the strategy is paying off.

Defining the Industry

The one word that’s beginning to look like it will define the entire face mask industry in the United States is “capacity”. As demand increases for now, it will stabilize over time when the pandemic spread slows. One then has to ask themselves, “did I position my efforts for long-term stability or did I just fill a void”. That’s a scary question that I don’t believe many new mask manufacturers have given much thought.  

The ability to continue, after the pandemic subsides will be based upon the ability to manufacture and ship large volume orders at almost import pricing. This especially rings true if the new manufacturer wants a shot at a government contract or partnering with a large distribution source, a GPO or IDN.

A National Masking Strategy?

There is simply no “national strategy” for masking and that’s the problem. The just “wear anything over one’s nose and mouth” strategy that has been disseminated, by many government officials and even doctors, has not played-out well for the past nine months. It’s simply not a strategy, rather a “hail Mary” attempt at their meaning of “mask compliance”.

I’ve seen a lot of mask manufacturers now add the manufacture of N95 or similar respirators to their capabilities. Some others have added the manufacture of cloth masks, which while having a more “stylish” appearance than that of a surgical mask or respirator, offer inefficient bacterial and particulate filtration. Some companies are even offering a “brace” for regular and surgical face masks in an attempt to make them more like a respirator.

I believe that a superior quality surgical mask offers a great level of protection as the Bacterial and Particulate Filtration Efficiencies are superior to that of a respirator or cloth mask. If one combines a face shield with the surgical mask, well, that would only serve to increase the level of protection. The concern with any traditional surgical mask is the seal around the mouth and nose areas. Our company believes that can be overcome to make the surgical mask the best overall masking choice.  

Buy American but “Economically Forced” to Buy Imports

Along with a “national strategy” has to come a reasonable price point for surgical masks and respirators being manufactured domestically. Potential buying sources and users of these masks must realize that American-made products cost slightly more. It’s a combination of superior quality, increased material and labor costs that drive-up the per piece price.

One of the biggest issues that I have seen is government entities, whether state or federal, list a Request for Pricing (bid) for millions of masks and then award the bid contract to the lowest bidder. Do they not realize in today’s world that most likely the mask that will be provided will be an inferior imported mask supplied by an entity that is not a mask manufacturer or specialist? I’ve literally seen a large (5,000,000 masks) bid opportunity awarded to “Joe’s Body Shop” at 4.5 cents per mask. There need to be established rules on these bid requests that the bidder has to be an actual mask manufacturer or long-time supplier / distributor as part of the qualifications to bid.

Another great example is that healthcare facilities want to buy from U.S. PPE manufacturers. But, because of “economics”, they are forced to buy imported masks. Their budgets have been overloaded from buying PPE and the last thing they can afford to do is to completely short-circuit their budget by purchasing masks, gowns, etc. that have a higher per piece price. In fact, some healthcare facilities are now directly sourcing their PPE from China, Thailand and Vietnam in an attempt to get the lowest price. Again, they want to “Buy American” but are forced to purchase elsewhere.

The Solutions

I can say this with great confidence. U.S. mask manufacturers will have to find a way to successfully (and quickly) increase their capacity while driving down the cost of each item of PPE to a point where they are slightly above an imported item's landed cost. The manufacturers that can do this will survive. Those that cannot will have to wait until there’s another national emergency in order to capitalize. And, in the end, we all hope that doesn’t occur again.

In the end, it's all about the mask, the comfort and the associated filtration capabilities that offer protection. At TAIJI, we have developed a more well-fitting and comfortable Class 2 surgical mask that can also be offered to the general public. We have the innovation and capacity to put the residents here in American-made masks.

Behind the KandyMask Micro Filter System

1st Layer: A high thread count microfiber which acts as a pre-filter for large particles and helps extend the life of our inner micro filter layers.

2nd Layer: A thin activated carbon material that filters out PM 2.5 particles, light gases and chemicals.

3rd Layer: 2 stacked layers of our proprietary melt blown polypropylene blend tested to filter microscopic airborne contaminants between 0.3 and 0.075 microns.

4th Layer: Is the soft microfiber inner layer making KandyMask comfortable to wear for long periods of time.

The filtration results conform with ASTM F2100 medical mask standards on these tests below.

* 99.80% Viral Filtration Efficiency

* 99.76% Bacterial Filtration Efficiency

* 97.14% Particle Filtration Efficiency @ 0.075 to 0.26 micron (yes, that is 10-25 times smaller than PM2.5)

The company uses  GB, Underwriters Laboratory and Nelson Labs for testing.

Choosing the right mask size is important for good filtration and comfort.

All the KandyMask models come in four sizes.  Height is used as a method to choose the right size mask size. In all our years of being in the protective mask space, we have found that it works for about 95% of people. The 5% usually have longer or shorter faces from nose to chin.  If you feel you are in this 5% you should potentially choose one size up or one size down.   We are also aware that everyone comes in different shapes and sizes so it's important to layout actual measurements for you to make an informed decision. 

Below is the mask size and measurement for our KandyMask 6.0 model.

1. For the height of the mask, measure from the bridge of your nose down to the right under the chin.  It is actually good to measure about 2cm / 0.7inc under your chin for a more accurate fit because the bottom of the mask tucks slightly under your chin.

2. For the width of the mask,  measure from your left cheekbone to your right cheekbone.  This measurement rarely has an effect on the wearer and is not always necessary unless you have skinnier or heavier set facial features.

Mask Shortages Continue for Medical Workers

The initial shortage has eased, but there still aren’t enough medical masks for health-care workers, let alone others. Demand for N95s is 500 to 1,000 percent higher than it was a year ago, said Megan Ranney, co-founder of Get Us PPE, which helps front-line workers obtain personal protective equipment

Even many health-care workers at well-financed hospitals wear N95s for anywhere from a day to a month, instead of changing them in between patients like they did before the pandemic. Smaller facilities are struggling even more, Ranney said. Some are relying on KN95s, a Chinese equivalent that U.S. health-care workers consider less desirable.

N95s, which once cost $1 or less each, now sell for up to $5. And for both N95s and KN95s, a surge of fraudulent or faulty products on the market has sometimes made identifying high-quality options difficult.

“Everyone is cutting corners,” Ranney said. “There is no health-care facility in the country that is using PPE the way that it did pre-pandemic.”

Why is there still a shortage?

Both the market for N95 masks and the national stockpile were small before the pandemic. The U.S. imported at least half of its PPE, including medical masks, from China, where exports shrank for months because of the outbreak, said Scott Paul, president of the Alliance for American Manufacturing, a nonprofit organization that advocates for public policies to benefit U.S. manufacturers.

Major suppliers such as 3M and Honeywell dramatically increased production last spring and summer but didn’t come close to the 3.5 billion masks that federal officials estimated were needed to fight the virus. Barriers to entry, including uncertainty about demand post-pandemic, discouraged other companies from entering the market, Paul said.

The N95 shortage America can’t seem to fix

The Trump administration took a relatively hands-off approach in encouraging the production of N95s. Federal officials arranged contracts with manufacturers, but the president mostly avoided using the Korean War-era Defense Production Act to compel companies to make masks.

“I think it’s fair to say that there were some efforts,” Paul said, “but those fell short, as well-intentioned as they may be.”

How can I tell if a medical mask is high quality?

Unlike N95 masks, KN95s are easy to find through online retailers, major chain stores and pharmacies.

If you’re going to buy KN95s, choose a type that has received emergency use authorization from the Food and Drug Administration, said Anne Miller, executive director of Project N95, a nonprofit organization that helps health-care and other essential workers access protective gear. The FDA keeps a list of approved products, which the agency refers to as “respirator models manufactured in China.”

The Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health also maintains a website focused on counterfeit N95s for reference.

Whatever face covering you choose, it should be snug and without gaps.

If I buy medical masks, am I taking them away from health-care workers?

It’s not clear whether buying N95s on the open market affects the supply available to doctors and nurses, whose contact with coronavirus patients puts them at heightened risk of infection.

Health-care facilities don’t usually get N95s from the retailers where an everyday shopper might buy them, said Tom Frieden, former director of the CDC.

Ranney cautioned that while shortages persist, there’s no way to guarantee that buying an N95 doesn’t mean one fewer mask for a doctor. Instead, she suggested choosing KN95s or KF94s, a Korean-made equivalent.

Do other countries have enough N95s?

Several countries have made N95s or their equivalents widely available to the public.

The South Korean government seized control of KF94 production and sends masks to pharmacies to sell at a set price. Singapore has offered free reusable masks in vending machines. Hong Kong residents can pick up masks at post offices.

In Europe, medical masks are now widely available at pharmacies. Austrian grocery stores distributed free masks last month after the government mandated them in stores and on public transportation.

Europe’s growing mask ask: Ditch the cloth ones for medical-grade coverings

Germany launched a $3 billion program in December to give three free medical masks to older people and those with preexisting health conditions — about one-third of the population. The southern state of Bavaria recently made N95 equivalents mandatory in some public settings.

Will the U.S. supply of these masks increase?

Although President Biden signed an executive order last month expressing a need to develop a sustainable supply chain for protective gear, his administration has not released a specific plan to increase manufacturing. White House press secretary Jen Psaki has suggested that any additional supply would be directed toward health-care workers involved in the vaccination effort. 

Biden’s stimulus proposal also requested $30 billion for “supplies and protective gear,” but Congress has yet to reach a deal.

Ensuring greater access to medical masks, for health-care workers and others, should be a critical part of the U.S. response as the more highly transmissible variants threaten to reverse declining infections, said Abraar Karan, a doctor at Brigham and Women’s Hospital and Harvard Medical School.

“As the virus gets better,” he said, “we need to get better in our response.”