U.S. Suppliers Step Up to Support Frontline Medical Workers, Patients, First Responders
By Mark Shortt
August 13, 2020
As a college student more than 15 years ago, Lloyd Armbrust started a mold remediation business that required workers to wear N95 face masks while putting up 6-mil plastic sheeting. During that time, Armbrust learned that those N95 masks and other medical-grade masks were made in Wuhan, China. What he didn’t know was how critical those masks would later become for millions of citizens across the globe.
Nearly 20 years later, as news of a deadly coronavirus outbreak in Wuhan spread, Armbrust remembered the city as the source of the world’s face mask supply. He was alarmed by what he was hearing.
“I was like, oh man, that’s crazy—they’re going to have to shut down all of this production, and what is the world going to do? Sure enough, that happened.”
That’s when Armbrust started looking into how he could bring that manufacturing to America. He’d seen the trends: Automation was eliminating the advantage of cheap labor, making it possible to manufacture more in the United States. He liked not having to ship the masks here on a boat, an expensive practice with significant environmental costs. Rather than buying face masks at exorbitant rates from China, he thought, why not invest in building them here?
Armbrust put together a financial model showing that automation and vertical integration would, over a period of time, enable him to manufacture masks at about the same cost or lower than they could be made in China. Now, he was ready to roll.
“I’ve been able to establish myself over the past 10 years with several investors who trust me,” Armbrust said in a phone interview. “We had a great financial model, great numbers, and a really solid business plan that I was able to leverage, plus a really good story. We were able to raise about $5 million in less than a week.”
With that, Lloyd Armbrust opened Armbrust American, an automated factory in Austin, Texas, in May. The vertically integrated facility is dedicated to producing medical-grade N95, surgical, and protective face masks to ensure that “American heroes on the front lines have proper defenses needed during this pandemic and beyond,” according to a company release. It’s part of a larger effort to bring sorely needed manufacturing back to the United States, Armbrust said, adding, “masks are just the beginning.”
After receiving more than 1.46 million orders in its first week of operation, Armbrust American is eyeing a production goal of 1.2 million masks per day, and is preparing to scale production to billions annually if needed. The company is looking to hire 60 factory workers to join a team that will include mechanical engineers, robotics engineers, machine operators, and a QA inspector, among others.
“Everyone here on the team is super excited about bringing strategic manufacturing back to the United States,” Armbrust said. “We’ve had an outpouring of support from people who say, ‘We want to invest in this manufacturing because we need this to be here.’”
The popular support comes at a time when Texas is struggling to stem the rise of new COVID-19 cases. As of August 3, the state ranked third in the number of new COVID-19 cases reported (116,647) over the previous two weeks, trailing only Florida (137,085) and California (128,597). On that date, Texas was one of 18 states and territories that had experienced a greater than 25 percent increase in COVID-19 cases over the previous two weeks, when compared to the week before, according to statistics compiled by NBC News.
The company currently sells the masks to hospitals, medical institutions, state governments, and individuals, all over the United States. “We don’t sell outside of the United States yet because the whole idea is to fulfill the need here, first,” Armbrust told D2P. In addition to these buyers, Armbrust anticipates continued demand for the masks from educational institutions, airlines, restaurants, retail establishments, and contractors, among others.
Armbrust American recently secured a $3.8 million contract to supply FDA registered, medical-grade face masks to the more than 320,000 public school teachers in the state of Texas. The masks passed the requirements for ASTM Type-II certification, achieving bacterial and particulate filtration of 99 percent. Tests were conducted by Nelson Laboratories, LLC, which also evaluated how the masks would resist fluid penetration and flammability, the company said in a release.
A key to the company’s business model is its vertical integration. Armbrust American’s factory, an ISO 7 clean room, takes raw, U.S.-made polypropylene material and performs all the steps necessary to make the fabric and manufacture the mask from that material. Armbrust said that having its own fabric machines in house to begin the process will drop the cost of mask manufacturing precipitously.
“We’ll roll it (the fabric), we’ll extrude it, we’ll cut it to size, and then we’ll put it right on the mask line, so that at one end, we’re bringing in raw polypropylene and, at the other end, we’re bringing out the mask,” he said. “The cost drops to about one cent per mask when we’re doing it all in house here, because the cost is just labor and electricity.”
Engineers Design Innovative Injection Molded Swab
When Ralph Hulseman, president of Hoowaki, LLC, challenged his team in March to think about what the company could do to help fight the spread of COVID-19, one of the first ideas proposed was to contribute protective gloves or some other form of personal protective equipment (PPE). But it wasn’t long before the company decided to use its proprietary MicroGrip® surface technology to make critically needed testing swabs.
“We settled on swabs because it’s very similar to technology we’ve been using in the work on our other devices, like stents and surgical films,” Hulseman said in an interview. “In fact, we had some discussions on swabs in a previous project, so we were kind of ready to go.”
Hoowaki, a micro surface engineering company in Greenville, South Carolina, is known for “designing friction” into products via its MicroGrip technology. The technology is based on the idea that if you change the structure of a material’s surface at the micro scale, you can greatly improve the frictional properties of that material without introducing any chemicals or new materials.
“We specialize in making things that are either highly grippy, so that they don’t move—like a stent that you don’t want to slide out of place in the body—or things that are very slippery, like an extruded tube to slide a catheter through,” Hulseman said.
Once Hoowaki decided to design a new COVID-19 swab, its engineers began working to adapt the MicroGrip technology to create a swab that feels comfortable to patients, yet has the frictional properties needed to collect a sample large enough for diagnostic testing. In a little more than two months, the team went from idea to a device—the Hoowaki® NP Collection Swab—that’s FDA registered and field tested by hospitals.
In a June release, the company reported that the Hoowaki NP Collection Swab had proven, in independent laboratory testing (qPCR Assay), to be equivalent to industry-standard flocked filament swabs in the collection of patient RNA that is critical for COVID-19 testing. Hoowaki said that it would begin mass production of the FDA registered, patent pending collection swab this summer, in volumes that are expected to reach at least several million units per month.
“The Hoowaki® NP Collection Swab is an important answer to the challenges posed by the global COVID-19 pandemic,” said Hulseman in the release. “Our design allows for production to be quickly scaled in communities around the world—rapidly addressing the rising demand for swabs, a critically important element of all COVID-19 testing.”
One of the big advantages of the Hoowaki NP Collection Swab is that it’s highly scalable. It requires no proprietary equipment and can be manufactured in high volumes on injection molding machines anywhere in the world. The other advantage is that it performs really well, Hulseman said. “It’s highly effective and meets the need.”
According to a release from Hoowaki, a recent study by Harvard University cited the need for up to 20 million COVID-19 tests per day by the end of the summer. Knowing that millions of swabs would be needed, Hoowaki’s design team set out to determine what processes could meet that scale.
The team looked at extrusion, film rolling, and different molding processes, Hulseman said. Out of those, two-shot injection molding came to be the winner. The process is readily available across the country and around the world, especially in areas where companies are making components for medical devices.
“Staying away from any proprietary, long lead time, uniquely designed equipment was one of the key criteria,” Hulseman said. “The other criterion was that it needed to work. We needed to make sure we passed every one of the tests—the safety test, the comfort test, the reliability of the actual PCR RNA testing itself.”
A Complex Design Problem
The design process required “somewhere between 20 and 30 iterations,” Hulseman estimated. A key element of those iterations was feedback from hospital staff, who let Hoowaki’s engineers know what was acceptable and what needed to be improved. South Carolina’s largest not-for-profit healthcare organization, Prisma Health, helped Hoowaki with testing and feedback.
“At the beginning of the design process, our first thought was to say, ‘Can we just have a simple extruded stick for a handle? And can we wrap a piece of film on there with the micro features?’” Hulseman recalled. “But then we quickly understood that comfort was very important. The handles have to break to fit into the vial, so they have to break at one point to eliminate contamination, but they could never, ever break in someone’s nose. So, it was kind of a complex design problem.”
Hoowaki’s engineers knew that, given those design considerations, they couldn’t use extrusion. The best option was to use an injection molded handle. “To get the comfort, as well as the collection, we’ve used two materials. It’s sort of a soft rubber tip, and that led us into injection molding,” Hulseman said.
Although the swab looks like a simple device, Hulseman said it posed some interesting engineering challenges for the tip and handle.
“You want to reach through the nasal cavity into the back of the throat, and you want it as comfortable as possible while that’s occurring,” he said. “Then you actually want to scrape off some cells and gather some cells, and you want to get the maximum volume you can.”
Hulseman said the flock on many standard swabs is electrostatically bonded to the tip and is spaced tightly, resulting in a fairly limited volume between the different flock fibers. But when Hoowaki designed the swab, it spaced out the micro pillars so that the swab could capture a larger volume of sample. “It was an interesting challenge of ‘How do you capture, how do you get the most amount?’”
After collecting a sample, the swab is introduced into somewhat viscous media, which poses another challenge. “You can’t really swish the swab; you need to wipe it off. You need to have the design as open as possible so that you can recover the maximum amount of sample,” Hulseman said. “Something like a fabric or a flock that will absorb, doesn’t readily let go. The question is, how can you grab as much sample as you can, transport it out of the body and into the vial, and then, how do you let go of it all?”
The handle of the swab has its own set of considerations. It has to be very flexible so that it doesn’t break while going into the back of the throat. But farther up the handle, it has to break cleanly, so a healthcare worker can put it into a vial, Hulseman said.
“There also has to be dimensional accuracy so that it clips in the cap. It’s like any mature product when you’re designing a new thing: There are lots of little intricacies that you don’t appreciate or think about at first.”
When designing the swab, Hoowaki’s engineers also had to pay attention to materials—specifically, medically compliant materials that would work well with the PCR test. That meant materials that were compatible with implantable medical devices and uses.
“Because the test is an RNA based test, you can’t have anything that will give any RNA contamination. And so that means no cotton, no wood, no paper, which are kind of obvious,” Hulseman said. “But it also means that you can’t have any vegetable oils, you can’t use any bio-based polymers, or anything that would give any stray RNA DNA signal.”
After all the work that went into the project, Hulseman said Hoowaki has received excellent feedback on the design.
“Everybody’s pretty pleased. We went through the user testing, the hospital testing, and at first, our early prototypes were kind of crude, but as we got to the end, I’m really pleased that the Prisma folks said they really liked the swabs, that they really appreciate the comfort and the soft tip. They don’t have any concerns about using them, and so the feedback from the hospitals has just been very rewarding.
“And, of course, it’s immensely motivating the whole team that it’s clearly a need for the nation and the world at large. It’s nice to have a real challenge for the team, and then see them really respond very well. It’s just very rewarding.”
Texas Firm Is Manufacturing NASA-JPL’s VITAL Ventilator
Much was at stake when NASA’s Jet Propulsion Laboratory (JPL), in late May, selected eight U.S. companies to manufacture a new ventilator designed for COVID-19 patients. The new ventilator, dubbed VITAL (Ventilator Intervention Technology Accessible Locally), was designed by NASA JPL engineers as a simpler, more affordable option for treating critical care patients so that traditional hospital ventilators could be reserved for patients with the most severe COVID-19 symptoms.
One of the companies selected to build the ventilator is ATron Group, LLC, a Dallas-based manufacturing services firm that specializes in building electrical wire harnesses and cable assemblies. Along with providing box builds, product assembly, and sheet metal fabrication, the company can design and fabricate programmable logic controllers (PLCs).
“This project is complex; it’s very different from a lot of things that people have built before,” said ATron Group Director of Sales and Marketing Justin Berkenstock, in a phone interview. “But we can produce pretty much anything in this realm.”
After JPL engineers created a prototype of the ventilator in just 37 days, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization on April 30. About a month later, ATron was selected from a pool of more than 100 applicants to receive a license to build the VITAL ventilator.
ATron Group Director of Engineering and Technical Services Steven Wright told D2P that the company is building its first 10 prototypes, and hopes to have thousands of them on order from different customers by the end of the third quarter. Wright said ATron was blessed to be one of the eight American companies that NASA JPL has licensed to build the VITAL ventilator.
“It’s awesome to be awarded by [an organization] as technically advanced as NASA JPL, or Caltech (which manages JPL for NASA). We’re glad that they trust us, and that they wanted to team up with us to get this product out to the market.”
One of the things that ATron has going for it, Wright said, is its versatility in the services it provides.
“We have the ability to not just be a contract manufacturer—we have a group that actually can do design and engineering if a customer needs it. Most of what we do has a wire on it of some sort, be it a cable assembly, a wire harness, a VITAL ventilator, box builds for the telecom industry, or cable harnesses for aerospace. But we also serve the alternative fuels and green effort by producing compressed natural gas, alternative fuel stations and station equipment.”
ATron is an ISO 9001 and AS9100 certified company that serves numerous sectors, including aerospace, automotive, electronics, data centers, industrial, mining, and oil and gas. In the medical arena, the company has built wire harnesses and cable assemblies for CPR equipment, and industrial gas compression systems used by hospitals. For ventilators and other medical equipment, ATron can build wire harnesses and sheet metal enclosures, integrate the harnesses into the enclosures, and develop custom PLCs.
The fact that ATron was drawn to the VITAL ventilator project, let alone selected as one of the licensees, is something that Wright credited to a culture that has flourished under ATron founder and CEO, Bob Potysman, who made his vision for ATron known from the very beginning.
“It all evolves around our CEO, who started this company in 2011 with the idea that he wanted to matter, and he wanted us to matter,” Wright said. “We spend most of our time in the industrial space, and in the aerospace and technical spaces. But when it came to the need of helping our brothers and sisters out there, in this COVID crisis that we have, we found a spot where our assembly and our ability to do some engineered value-add lent itself to what NASA JPL was putting down, so we jumped in with both feet.”
ATron has developed internal standards, processes, and tools that support its goal of responding quickly to customers’ needs. Its modular facility includes a flexible production floor that allows the firm to move equipment as needed to accommodate specific projects, and to set up new lines when the need arises.
“We don’t have barriers to how we set things up. The modularity of our floor, the way we lay out our toolsets, the way we can lay out materials, is all relevant to that,” Berkenstock said. “We can focus on changing our dynamic with the way our staff works together, to fit the task at hand, in a very efficient manner.”
Berkenstock added that ATron is an agile team that pays close attention to its customers’ needs, with an eye toward factors that drive costs. The company structures its manufacturing process to eliminate inefficiencies that may have resulted from a customer’s development of its product.
“We can get into the weeds with a lot of things, find out what their cost drivers are, and see how we can employ our efficiencies to make something better, make it faster, or, especially when it comes to medical devices and how important they are, to a top-notch quality standard,” he said.
ATron’s team is now applying that mindset to its work on the VITAL ventilator project. Not surprisingly, its goals are high.
“We aim to produce a high-quality product that will do everything that JPL and our team has set out as a set of requirements, and, ultimately, help our brothers and sisters out there to maintain a modicum of health,” Wright said. “Hopefully, we can get them on this product faster, and they’re not waiting around and getting worse before they get on an ICU type ventilator. Our goal is to help them out a little bit earlier and save lives.”
Wright’s statement that ATron was blessed to have received a license to manufacture the ventilator was echoed by Berkenstock, who said one of the company’s core values is about people.
“We believe that people are incredibly important,” Berkenstock said. “When it comes to a project like this, where we have the ability to impact not just hundreds, but, potentially, hundreds of thousands of lives, we look at it as something that we can fit into our daily activity, and it feels good for the soul. It feels good for what we do as an organization because one of the most important things here is the people that we work with, the people we interact with.
“But it also expands much further past that with our customers, our suppliers, and then the people that we serve in the greater community at large,” Berkenstock continued. “So, to have something like that on our plate—Steve said we were blessed with it and I think it really speaks to that—is the reason why a lot of people get out of bed in the morning. Because here, you can make a difference. And this project is a huge difference, especially right now.”
Berkenstock noted that the VITAL ventilator project is different from other projects in business that tend to focus heavily on the bottom line. For an American company to be awarded a project to build a ventilator in the U.S., where it will impact the lives of people during a pandemic, is a much different thing, he said. It’s different not just for a company or an organization, but for the country and the community, as well.
“Outside of everything else that we see in the world right now, we’re seeing people who are coming together in communities, people who are coming together to work for a common good and a common cause,” he said. “It’s American companies backing each other, doing the things that are necessary, in much the same way that we saw not too long ago, in other periods of challenge and turmoil.”
Precision Machining Company Is All In on Ventilator Parts
Back in mid-March, Smith & Richardson, Inc., got calls from two existing customers, saying that they needed ventilator parts fast. Although Smith & Richardson had about a six-week backlog at the time, the company was able to juggle its schedule so that it could ramp up and start producing the parts. Today, the company is still producing the ventilator parts, with no end in sight.
“We’ve made about 90,000 of each of those parts—and still counting—because we continue to get orders for ventilator components. Those are not going away yet,” said Smith & Richardson President Rich Hoster, in an interview.
The orders are for eight parts that eventually end up in ventilators manufactured by the OEMs Vyaire Medical and Nihon Kohden OrangeMed, Incorporated. Smith & Richardson does not supply the parts directly to either of the OEMs. “We supply to a ventilator valve manufacturer in Michigan—two different ones—and they supply both Vyaire and OrangeMed with a ventilator valve for their product,” Hoster said.
On some of the ventilator parts, Smith & Richardson provides Swiss CNC machining. On other parts, including some that are about two-and-a-half inches in diameter, it uses fixed headstock lathes. All of the company’s CNC Swiss lathes, as well as its fixed headstock lathes, are relatively new and enable the company to produce tight tolerance parts to very exacting tolerances, Hoster said.
For now, Hoster expects to continue supplying the ventilator parts for the foreseeable future, as long as the need exists in the United States and elsewhere.
“Right now, we’re being told it’s not going to end in the near future,” he said. “We’re still exporting a lot of ventilators to other countries, and nobody wants to give up the equipment here because if it is needed again in the future, we don’t want to be caught short-handed and scrambling again. I’m being told we’re continuing to build stockpiles of ventilators throughout the world.”
Smith & Richardson, Inc. (https://www.smithandrichardson.com/), a contract manufacturing company in Geneva, Illinois, provides precision machined parts and components for the medical, aerospace and defense, and information technology industries. For the medical industry in particular, the company has also provided machining of components for medical gauges, as well as parts for fluid and air delivery systems.
“We produce very small-diameter to large-diameter parts to very precision tolerances, and we do it in difficult-to-machine materials,” Hoster said. “We are very capable of machining exotic metals. We’re also capable of meeting very demanding needs of customers when it comes tolerances, deliveries, and turning on a dime—making what they need, when they need it.”
Hoster said Smith & Richardson has four engineers on staff to help develop manufacturing processes for customers’ parts. Its engineers also help make it easier to work with customers’ engineers to understand what they need.
“We always like to work with the customers’ engineering departments because the more you understand about how they inspect the parts, the more you can mimic how they’re going to inspect them,” Hoster said. “We can make sure we’re talking apples-to-apples, and no matter what the print says, we’re getting them exactly what they want.”
Metal Casting Company Making Parts for Diagnostic Equipment
At Graphicast, Inc., a custom metal casting company in Jaffrey, New Hampshire, customers that need parts for COVID-related production are moved to priority level in scheduling.
Since April, Graphicast has been making parts for a medical manufacturer that builds equipment used to analyze saliva-based COVID-19 tests. The components are for a pipette dispensing robot that is part of the auto-sampling diagnostic equipment. The company is also producing parts for a Massachusetts-based manufacturer of diagnostic blood analyzers, said Graphicast Sales and Operations Director Kirk Barrett, in a phone interview.
“We’re just a nice little happy company here in the southwest corner of New Hampshire, and we have this little process that not many people know about,” Barrett said. “It’s a great economic fit for people who are doing small-volume production. If they’re making 10,000 or less of something, this is certainly a process that they should look at.”
Graphicast is accustomed to meeting the challenges of manufacturing for the medical industry. According to Barrett, about 70 percent of the firm’s sales is to medical related companies. The company’s track record includes making precision cast and CNC milled parts for medical diagnostic equipment, ventilators, and hospital apparatus equipment, as well as surgical suites and trays.
Graphicast combines a zinc-aluminum alloy (ZA-12) with a low-cost graphite mold casting process to produce custom zinc parts in low to medium volumes. In addition to producing zinc castings from graphite permanent molds, the company provides CNC machining.
“In the casting industry, you have different processes, and we happen to be in this little niche—graphite permanent mold casting,” Barrett told D2P. “The real advantage of this process, in comparison to other higher volume processes, is that we can produce a graphite permanent mold pretty quickly, and produce small volume parts that are more economically sound, more economically fit.”
Barrett said that whereas a die casting tool could cost tens of thousands of dollars, Graphicast can build a graphite permanent mold for about $2,500. It wouldn’t be uncommon to see a price tag of $50,000 or up for a custom die cast tool, he said.
“With a die casting tool, you’re going to pay a lot for the mold, and you’re going to get a fairly low-dollar casting from that. We’re kind of the opposite: It’s a low-cost tool and a higher-priced part. But it does have a fit when you’re only making 2,000 of something a year.”
In addition to casting and machining, Graphicast offers in-house design and mold building. The company’s engineering staff can convert designs from other manufacturing processes to optimize the casting process. “We have a deep understanding of the requirements that the medical design community needs, and the production of their parts, and we will put a lot of processes in place to make sure their needs are met,” Barrett said.
For Barrett and the rest of the Graphicast team, it’s been rewarding to make parts that are being used to help save lives during this pandemic.
“It’s absolutely rewarding,” Barrett said. “I actually went out on the shop floor and helped with the production of some of these parts. Knowing that they’re going out there and adding to the cause is pretty nice.”