Michael Barbella, Managing Editor03.04.21
There’s a very fine line between scientific discovery and fortuity.
The two are not mutually exclusive, though the latter is not always a catalyst for the former. Working in tandem, the pair have beget countless extraordinary advancements throughout history, from the discovery of gravity and radioactivity to the breakthrough creation of X-rays and penicillin.
None of these developments, however, would have been possible without the capacity for interpretation and observation. Certainly, luck has had an integral role in many modern innovations, but good fortune can only breed great progress through astute awareness and insight. As French microbiologist Louis Pasteur once noted, “...Chance favors only the prepared mind.”
For only prepared minds can recognize the opportunity generated by chance, turning unexpected or chance developments into “Eureka!” moments instead of roadblocks. The discovery of gravity, for example, exemplifies the privilege of chance observation and creative insight: Sir Isaac Newton wasn’t the first (or only) person to notice an apple falling from a tree, but he was perhaps the earliest scholar to question its trajectory and ponder its relationship to Earth’s “drawing power.”
Similarly, numerous scientists studying cathode rays in the 1890s noticed a mysterious light escaping from their Crookes tubes (a.k.a., glass bulbs) but only Wilhelm Conrad Röentgen chose to further investigate the anomaly. His curiosity (and foresight) eventually led to the discovery of X-rays.
“Not only did Röentgen get some degree of fame for this, but when he got that fame, all these other folks came out of the woodwork and said, ‘Well, I saw that too.’ And they had. But what did they do with it? Nothing. They said, ‘That was funny’ and left it,” notes Richard Gaughan, author of the 2010 book “Accidental Genius: The World’s Greatest By-Chance Discoveries.” “...people who aren’t in the scientific field say, ‘Oh, he was just lucky.’ Well, you can’t be just lucky. It takes a lot more than that. When people outside the scientific and technological fields think of the role of chance, sometimes they think of it like winning the lottery. You’re just going to win the lottery and that’s why you made this scientific discovery. No. You cannot do it unless you first put in all that groundwork to be able to understand the basics of what should happen. And when something happens that shouldn’t happen, you have to know enough to question it, and you have to have the desire to follow it up.”
All those factors were surely in place nearly two decades ago at the University of Manchester (United Kingdom) as physics professor Andre Geim pondered the ways in which carbon, the primary component of all known life on Earth, would behave under certain conditions.
A specialist in microscopically thin materials, Geim tasked a doctoral student with achieving as slim a sample as possible from a one-inch graphite crystal.
After several weeks, the student had reduced the crystal to a tiny speck but Geim was dissatisfied, hoping for an even thinner layer of carbon. At that point one of Geim’s senior fellows—by chance—noticed a ball of used Scotch tape in the garbage with a shiny film of graphite residue on its sticky side. The residue was no surprise, as graphite’s carbon layers are weakly bonded and easily removed by tape (in flake form). But the tenuity of those layers was unlike any other Geim had previously encountered.
In his quest for even slimmer graphite layers, Geim folded the piece of Scotch tape, pressed the residue together, then pulled it apart, creating a two-dimensional, atom-thick layer of carbon. That ensuing material—dubbed graphene—had long been the subject of speculation in scientific circles, but physicists assumed such a thin layer was impossible to create at room temperature.
For two years, Geim and doctorate student Konstantin Novoselov experimented with graphene to ascertain its properties. Their findings were astounding, to say the least, sounding like they were ripped from the page of a science-fiction novel: Just a single atom thick, graphene is 200 times tougher than steel; it is hard but pliable and rubber-like, able to stretch to 120 percent of its length, and it is more conductive than copper. And while it is almost completely transparent, graphene is so dense that even the smallest gas atom (helium) cannot permeate it.
Nor can viruses.
Indeed, graphene’s impenetrability has proven to be a powerful weapon against the deadly coronavirus, which has killed more than 2.4 million people globally. Numerous companies have developed graphene-enhanced textiles, inks, and coatings over the last year, incorporating the material into personal protective gear like face masks and gloves.
United Kingdom-based planarTECH, for example, created a 2AM-branded graphene-enhanced face mask with an antibacterial coating that reduces staphylococcus aureus microbes by 99.95 percent within a 24-hour period. Versarien PLC’s mask—made with its own graphene-enhance polymer, Polygrene—meets WHO guidelines as well as antibacterial and anti-viral performance criteria.
U.S. firm G-Masks LLC uses graphene oxide in its face masks to actually destroy COVID-19 and flu particles/droplets within two minutes. According to the company’s website, the masks’ mono-layered graphene oxide sheets have very sharp edges at the nano layer. These sharp edges physically sheer the lipid coating over the viruses’ encapsulated RNA strands, rendering them harmless.
G-Masks claims its MyGo2Mask is better at filtering viral/flu droplets and particulate matter than the standard N95 face coverings, trapping 99.53 percent of particles 0.3 nanometers or smaller (COVID-19 droplets measure between .07 and .09 microns). N95 masks, by comparison, filter 95 percent to 99 percent of particles larger than 0.1 microns. The MyGo2Mask is registered with the U.S. Food and Drug Administration and has earned the CE mark.
“The MyGo2Mask is different from other masks on the market simply because the secret sauce is in the graphene oxide and the quality of the graphene oxide, which comes in two layers on the mask, and the patented bonding mechanisms that we use in manufacturing the mask,” says Shep Doniger of G-Masks. “Numerous studies show that graphene oxide not only repels but likely kills viruses and prevents micro droplets from penetrating it.”
With properties that have long surprised and excited scientists, graphene was an obvious choice to help alleviate the pandemic-induced PPE shortage. Companies from nearly every industry on the planet quickly switched gears to replenish the supply, with medtech materials manufacturers and suppliers leading the charge.
Elkem Silicones, for instance, ramped up its supply of medical grade silicone rubbers used in ventilators, tubing, needleless valves, and diagnostic test kits. The company also established a KN95 silicone mask production line in China last spring that generated 900,000 masks per month. Elkem set up the line in just 35 days.
FLEXcon Company Inc. took part in the PPE replenishment effort as well, creating a single-use test hood for qualitative fit testing conducted by healthcare providers. The Spencer, Mass.-based adhesive coating and laminating innovator developed the solution to mitigate risk among hospital employees over the reusable test hoods that were typically shared among all employees.
Engineers created a disposable test-hood prototype in less than 24 hours and worked with hospital representatives to tweak the design, according to a case study written by FLEXcon North America CEO Lavon R. Winkler. Upon design finalization, engineers created special tooling for an adhesive coater to “accurately zone-coat where sealing was required.”
The test hoods are coated with pressure-sensitive adhesive along the edges and taped at the top, Winkler wrote. Shoulder pieces cut from both panels give the bottom edges a generally truncated V-shape, and part of the bottom edges rest on the test subject’s shoulders. A front panel aperture allows test substances to be introduced into the interior cavity. The hood itself is able to remain upright, thanks to the film’s thickness and pressure-sensitive adhesive strips.
“In adversity lies opportunity, and the willingness to think innovatively and work collaboratively with all stakeholders is what can mean the difference between companies that persevere and those that succumb,” Winkler said in the case study.
A culture of collaboration and quick response manufacturing enabled SEKISUI KYDEX LLC to persevere through the pandemic. The thermoplastics products manufacturer developed Premium KYDEX ION Technology that is 99 percent effective at inhibiting the growth of stain and odor-causing bacteria on KYDEX thermoplastics.
The company also reduced its material production and shipping times by two thirds (from three weeks to two to five days) for COVID-19-identified orders, including those for Ford/GE Healthcare’s and CAE Healthcare’s respective ventilator projects last spring.
SEKISUI KYDEX, FLEXcon, and Elkem were among half a dozen materials suppliers/manufacturers that detailed their COVID-19 response efforts to Medical Product Outsourcing over the last several weeks. Commentary came from Mark Denning, Medical Product Business Manager at SEKISUI KYDEX; Michael Goglia, Market Manager, Healthcare Americas, Elkem Silicones; and Jordan Smith, Business Process Improvement manager, and Lori Bitar, Market Development Manager, Medical Device and Pharma, FLEXcon.
Mark Denning: The R&D team reacted quickly to the needs of our customers at the onset of the pandemic and pivoted their efforts towards materials that held up to harsh chemicals and bacteria.
The industry had to react quickly to fulfill material needs to service equipment manufacturers. Our material lead times went from three weeks to produce and ship a normal order to two-five days for COVID-19-identified orders. As an essential manufacturer, speed was imperative to help our customers get life-saving devices to medical facilities.
We supported two major ventilator programs, including the Ford/GE Healthcare program and the CAE Healthcare CAEAir1 Mechanical Ventilator.
Backed by the power of Ford Motor Company in collaboration with GE Healthcare, the mission was clear: Produce 50,000 life-saving medical devices in response to the COVID-19 pandemic. Revere Plastics was named Ford’s supplier with assistance from SEKISUI KYDEX, manufacturer of KYDEX Thermoplastics. The goal was set. The clock was ticking. Lives were on the line and time was of the essence. What happened next is a testament to quick response manufacturing and the power of rapid prototyping.
SEKISUI KYDEX does not simply manufacture a sheet that is later cut into plastic rectangles. Fueled by 400 professionals, SEKISUI KYDEX is committed to stepping in when needed to produce fully finished, ready-to-use parts. This was a complete change from the traditional model, where a typical customer purchase is considered complete after the sale of thermoplastic sheet—a journey from extruder to integrator. This opportunity was one to try something new and help Ford and GE Healthcare meet their aggressive timelines.
Prints were developed, parts were quoted, quality documents were developed and put into place, accounts were set up with our finance team, go/no-go gauges were developed, POs were cut, material was produced, material was shipped, first articles were made and approved—all over a period of one week.
The SEKISUI KYDEX team collaborated with Revere Plastics on material requirements for both internal and external parts, first utilizing SEKISUI KYDEX’s ALLEN ABS sheet and KYDEX T-MB (antimicrobial) sheet. Later, the teams also added KYDEX T-IM injection molding resin to the mix. Along with being the first time Revere Plastics and SEKISUI KYDEX had ever worked together, this was also the first project where all three SEKISUI KYDEX materials were harmonized in a single application.
Airon’s simplified ventilator design—the pNeuton A—is responsive to the needs of most COVID-19 patients and operates on air pressure without the need for electricity, which helps speed up production times.
Michael Goglia: As a material science company, we like challenges because we love to find solutions. The pandemic has spurred a re-energized importance and momentum to innovation and material enhancements to meet the changing needs of medtech and society in general through preventative, diagnostic, and therapeutic solutions.
During the pandemic, many companies, including Elkem, increased output and even pivoted to support the increased demand for medical supplies. Elkem ramped up supply of medical grade silicone rubbers used in ventilators, tubing, needleless valves and diagnostic test kits. On the PPE front, we increased silicone gel production used in specially designed comfort face masks for the medical community. Our soft skin adhesives create a gentle and comfortable seal between the skin and the mask to prevent glass fogging. And on the vaccine side, we supplied materials to the pharmaceutical industry for tubing, siliconization of glass vials and needles used in vaccine production, packaging, and delivery, respectively.
Jordan Smith: FLEXcon was able to innovate and come up with a disposable product to aid in the pandemic. We’ve seen many companies from industries outside of healthcare pivot to see what they could do with their equipment and products to aid in the pandemic, particularly on the PPE side.
Innovating new products historically has taken a lot of time but in a crisis like COVID-19, you have to execute quickly or risk missing out on an opportunity. With the shortage of PPE in the April-May 2020 time frame, we brainstormed with a few employees and came up with a concept and prototype, and executed a fully finished product in less than 30 days. We had to move very quickly because there was an immediate need in the market.
Lori Bitar: On the pharmaceutical side, the pandemic triggered the rapid development of biologics. The pharmaceutical industry is traditionally slow—it can take up to 10 years to develop a pharmaceutical product, but with Operation Warp Speed, that timeline was expedited significantly. There were a lot of stock-out situations and the supply chain was constrained, so some materials were not available and that caused packagers to rethink what they could use. Some companies were fortunate to have longstanding relationships with suppliers, thus avoiding the shortage/delay in supply. The pandemic certainly stressed and challenged the supply chain, opening the possibilities of sourcing alternative materials.
Finding COVID-19’s Silver Lining
Well before he became president, John F. Kennedy spoke of the symbiotic relationship between crisis and opportunity. “When written in Chinese,” he noted, “the word ‘crisis’ is composed of two characters—one represents danger and one represents opportunity.”
The quote is one of Kennedy’s most memorable, even though it is factually incorrect. The Mandarin word for crisis, weiji, is written as two separate characters, with the wei syllable conveying a notion of danger, and ji signifying “incipient moment” or “crucial point.”
Nevertheless, there is some element of truth in Kennedy’s misinterpretation of weiji. Crisis does, in fact, breed opportunity: A 19th century cholera pandemic in London spurred the creation of a new scientific field, epidemiology, and the challenge of decrypting enemy messages during World War II prompted the development of computers.
Likewise, there is opportunity to be found in the current coronavirus crisis (which has been aided by both epidemiology and computers). The pandemic not only expanded telehealth services at warp speed, it also expedited the healthcare industry’s acceptance of digital medicine, data analytics, and artificial intelligence.
COVID-19 also fostered cross-industry collaboration, better communication, and turned former rivals into friends, if only for a brief period. But perhaps the most important opportunity the pandemic has provided medtech materials manufacturers and suppliers is the re-examination and possible redesign of their supply chains.
Supply continuity and nearshoring are certain to take precedence once COVID-19 is brought under control, though quick innovation will also be key going forward, several companies told MPO. Experts providing insight on medtech’s post-pandemic future included Matt Boyd, chief commercial officer, Priya George, development engineer, and Brianna Schaeffer, vice president of program management at Boyd Technologies, a Lee, Mass.-based advanced materials and technology firm; Lars Gerding, vice president of Technology at Freudenberg Medical, a contract manufacturer; and Ursula Nollenberger, product line director at Trelleborg Healthcare & Medical, a designer, developer, manufacturer, and marketer of engineered solutions for medical device, biotech, and pharmaceutical applications.
Matt Boyd: The pandemic revealed that so many materials are made outside the U.S., or if they are made domestically, the capacity is very limited. Nearshoring was already a focus of big OEMs, but it has accelerated since the pandemic began. The reason this impacts innovation is the ecosystem component. When we can source materials from neighboring states, we gain a collaborative feedback loop, so we can connect actors in the ecosystem and create innovation in a more condensed time frame. That is one of the lost opportunity costs that many players didn’t realize until the pandemic. Companies often buy materials from overseas because it’s the cheapest, but that creates an environment with less collaboration and less room for innovation as a result.
Priya George: Nearshoring is certain to become a priority moving forward. Most U.S. manufacturers and distributors are looking for sources within the states for most if not all materials. Even if companies are not engaging U.S. partners, it has become essential to have second sources domestically to be more agile in the face of future supply chain risks.
Brianna Schaeffer: Nearshoring is an excellent way to increase sustainability in the industry from a global perspective. Using domestic materials drastically reduces our carbon footprint and contributes to the growth of U.S. manufacturers.
Lars Gerding: I don’t think [the pandemic] affected our space too much. We saw more innovation in the design of devices/components like face shields, masks, ventilators, and test kits. Material innovation would be more prevalent for filter media (such as face masks), nonwovens and media to make masks more efficient (breathable vs. absorbing).
I think it is a missed opportunity that we cannot recycle material in the medical industry. But the waste that we generate can be recycled and Freudenberg is proactive about recycling. Our scrap is from a cleanroom environment, it’s clean, one polymer, and not a mix of several materials so it’s good for recycling companies. Our scrap is always from virgin material, it’s premium waste and can be recycled. Medical devices are primarily single-use but Freudenberg is supporting some initiatives to design devices that can be more easily reprocessed—enabling customers to venture down this path.
Ursula Nollenburger: The fundamental material technologies to address healthcare needs existed prior to the pandemic. The pandemic has, however, triggered healthcare providers and OEMs to take a critical look at their supply chains to mitigate risks and shortages, which many providers experienced during the first wave of the pandemic. Having a global footprint and raw material supply base helps position manufacturers to meet industry needs.
The pandemic made it clear that supply continuity in the healthcare sector is even more important than in other business areas. It’s important to be prepared for these kinds of scenarios with a high-level of flexibility, internal risk management, and a strong financial backbone.
Trelleborg Healthcare & Medical was fortunate that, when the pandemic hit, our global footprint enabled us to react quickly to market demand, shift manufacturing as needed, and ensure a continuity of supply for our customers. Redundant manufacturing on multiple continents for most of our processes, combined with a global material strategy of dual sourcing, enabled us to mitigate the risk of supply interruption in specific regions. This ability to manage pandemic-related supply chain issues simply reaffirms that our strategy is working.
The two are not mutually exclusive, though the latter is not always a catalyst for the former. Working in tandem, the pair have beget countless extraordinary advancements throughout history, from the discovery of gravity and radioactivity to the breakthrough creation of X-rays and penicillin.
None of these developments, however, would have been possible without the capacity for interpretation and observation. Certainly, luck has had an integral role in many modern innovations, but good fortune can only breed great progress through astute awareness and insight. As French microbiologist Louis Pasteur once noted, “...Chance favors only the prepared mind.”
For only prepared minds can recognize the opportunity generated by chance, turning unexpected or chance developments into “Eureka!” moments instead of roadblocks. The discovery of gravity, for example, exemplifies the privilege of chance observation and creative insight: Sir Isaac Newton wasn’t the first (or only) person to notice an apple falling from a tree, but he was perhaps the earliest scholar to question its trajectory and ponder its relationship to Earth’s “drawing power.”
Similarly, numerous scientists studying cathode rays in the 1890s noticed a mysterious light escaping from their Crookes tubes (a.k.a., glass bulbs) but only Wilhelm Conrad Röentgen chose to further investigate the anomaly. His curiosity (and foresight) eventually led to the discovery of X-rays.
“Not only did Röentgen get some degree of fame for this, but when he got that fame, all these other folks came out of the woodwork and said, ‘Well, I saw that too.’ And they had. But what did they do with it? Nothing. They said, ‘That was funny’ and left it,” notes Richard Gaughan, author of the 2010 book “Accidental Genius: The World’s Greatest By-Chance Discoveries.” “...people who aren’t in the scientific field say, ‘Oh, he was just lucky.’ Well, you can’t be just lucky. It takes a lot more than that. When people outside the scientific and technological fields think of the role of chance, sometimes they think of it like winning the lottery. You’re just going to win the lottery and that’s why you made this scientific discovery. No. You cannot do it unless you first put in all that groundwork to be able to understand the basics of what should happen. And when something happens that shouldn’t happen, you have to know enough to question it, and you have to have the desire to follow it up.”
All those factors were surely in place nearly two decades ago at the University of Manchester (United Kingdom) as physics professor Andre Geim pondered the ways in which carbon, the primary component of all known life on Earth, would behave under certain conditions.
A specialist in microscopically thin materials, Geim tasked a doctoral student with achieving as slim a sample as possible from a one-inch graphite crystal.
After several weeks, the student had reduced the crystal to a tiny speck but Geim was dissatisfied, hoping for an even thinner layer of carbon. At that point one of Geim’s senior fellows—by chance—noticed a ball of used Scotch tape in the garbage with a shiny film of graphite residue on its sticky side. The residue was no surprise, as graphite’s carbon layers are weakly bonded and easily removed by tape (in flake form). But the tenuity of those layers was unlike any other Geim had previously encountered.
In his quest for even slimmer graphite layers, Geim folded the piece of Scotch tape, pressed the residue together, then pulled it apart, creating a two-dimensional, atom-thick layer of carbon. That ensuing material—dubbed graphene—had long been the subject of speculation in scientific circles, but physicists assumed such a thin layer was impossible to create at room temperature.
For two years, Geim and doctorate student Konstantin Novoselov experimented with graphene to ascertain its properties. Their findings were astounding, to say the least, sounding like they were ripped from the page of a science-fiction novel: Just a single atom thick, graphene is 200 times tougher than steel; it is hard but pliable and rubber-like, able to stretch to 120 percent of its length, and it is more conductive than copper. And while it is almost completely transparent, graphene is so dense that even the smallest gas atom (helium) cannot permeate it.
Nor can viruses.
Indeed, graphene’s impenetrability has proven to be a powerful weapon against the deadly coronavirus, which has killed more than 2.4 million people globally. Numerous companies have developed graphene-enhanced textiles, inks, and coatings over the last year, incorporating the material into personal protective gear like face masks and gloves.
United Kingdom-based planarTECH, for example, created a 2AM-branded graphene-enhanced face mask with an antibacterial coating that reduces staphylococcus aureus microbes by 99.95 percent within a 24-hour period. Versarien PLC’s mask—made with its own graphene-enhance polymer, Polygrene—meets WHO guidelines as well as antibacterial and anti-viral performance criteria.
U.S. firm G-Masks LLC uses graphene oxide in its face masks to actually destroy COVID-19 and flu particles/droplets within two minutes. According to the company’s website, the masks’ mono-layered graphene oxide sheets have very sharp edges at the nano layer. These sharp edges physically sheer the lipid coating over the viruses’ encapsulated RNA strands, rendering them harmless.
G-Masks claims its MyGo2Mask is better at filtering viral/flu droplets and particulate matter than the standard N95 face coverings, trapping 99.53 percent of particles 0.3 nanometers or smaller (COVID-19 droplets measure between .07 and .09 microns). N95 masks, by comparison, filter 95 percent to 99 percent of particles larger than 0.1 microns. The MyGo2Mask is registered with the U.S. Food and Drug Administration and has earned the CE mark.
“The MyGo2Mask is different from other masks on the market simply because the secret sauce is in the graphene oxide and the quality of the graphene oxide, which comes in two layers on the mask, and the patented bonding mechanisms that we use in manufacturing the mask,” says Shep Doniger of G-Masks. “Numerous studies show that graphene oxide not only repels but likely kills viruses and prevents micro droplets from penetrating it.”
With properties that have long surprised and excited scientists, graphene was an obvious choice to help alleviate the pandemic-induced PPE shortage. Companies from nearly every industry on the planet quickly switched gears to replenish the supply, with medtech materials manufacturers and suppliers leading the charge.
Elkem Silicones, for instance, ramped up its supply of medical grade silicone rubbers used in ventilators, tubing, needleless valves, and diagnostic test kits. The company also established a KN95 silicone mask production line in China last spring that generated 900,000 masks per month. Elkem set up the line in just 35 days.
FLEXcon Company Inc. took part in the PPE replenishment effort as well, creating a single-use test hood for qualitative fit testing conducted by healthcare providers. The Spencer, Mass.-based adhesive coating and laminating innovator developed the solution to mitigate risk among hospital employees over the reusable test hoods that were typically shared among all employees.
Engineers created a disposable test-hood prototype in less than 24 hours and worked with hospital representatives to tweak the design, according to a case study written by FLEXcon North America CEO Lavon R. Winkler. Upon design finalization, engineers created special tooling for an adhesive coater to “accurately zone-coat where sealing was required.”
The test hoods are coated with pressure-sensitive adhesive along the edges and taped at the top, Winkler wrote. Shoulder pieces cut from both panels give the bottom edges a generally truncated V-shape, and part of the bottom edges rest on the test subject’s shoulders. A front panel aperture allows test substances to be introduced into the interior cavity. The hood itself is able to remain upright, thanks to the film’s thickness and pressure-sensitive adhesive strips.
“In adversity lies opportunity, and the willingness to think innovatively and work collaboratively with all stakeholders is what can mean the difference between companies that persevere and those that succumb,” Winkler said in the case study.
A culture of collaboration and quick response manufacturing enabled SEKISUI KYDEX LLC to persevere through the pandemic. The thermoplastics products manufacturer developed Premium KYDEX ION Technology that is 99 percent effective at inhibiting the growth of stain and odor-causing bacteria on KYDEX thermoplastics.
The company also reduced its material production and shipping times by two thirds (from three weeks to two to five days) for COVID-19-identified orders, including those for Ford/GE Healthcare’s and CAE Healthcare’s respective ventilator projects last spring.
SEKISUI KYDEX, FLEXcon, and Elkem were among half a dozen materials suppliers/manufacturers that detailed their COVID-19 response efforts to Medical Product Outsourcing over the last several weeks. Commentary came from Mark Denning, Medical Product Business Manager at SEKISUI KYDEX; Michael Goglia, Market Manager, Healthcare Americas, Elkem Silicones; and Jordan Smith, Business Process Improvement manager, and Lori Bitar, Market Development Manager, Medical Device and Pharma, FLEXcon.
Mark Denning: The R&D team reacted quickly to the needs of our customers at the onset of the pandemic and pivoted their efforts towards materials that held up to harsh chemicals and bacteria.
The industry had to react quickly to fulfill material needs to service equipment manufacturers. Our material lead times went from three weeks to produce and ship a normal order to two-five days for COVID-19-identified orders. As an essential manufacturer, speed was imperative to help our customers get life-saving devices to medical facilities.
We supported two major ventilator programs, including the Ford/GE Healthcare program and the CAE Healthcare CAEAir1 Mechanical Ventilator.
Backed by the power of Ford Motor Company in collaboration with GE Healthcare, the mission was clear: Produce 50,000 life-saving medical devices in response to the COVID-19 pandemic. Revere Plastics was named Ford’s supplier with assistance from SEKISUI KYDEX, manufacturer of KYDEX Thermoplastics. The goal was set. The clock was ticking. Lives were on the line and time was of the essence. What happened next is a testament to quick response manufacturing and the power of rapid prototyping.
SEKISUI KYDEX does not simply manufacture a sheet that is later cut into plastic rectangles. Fueled by 400 professionals, SEKISUI KYDEX is committed to stepping in when needed to produce fully finished, ready-to-use parts. This was a complete change from the traditional model, where a typical customer purchase is considered complete after the sale of thermoplastic sheet—a journey from extruder to integrator. This opportunity was one to try something new and help Ford and GE Healthcare meet their aggressive timelines.
Prints were developed, parts were quoted, quality documents were developed and put into place, accounts were set up with our finance team, go/no-go gauges were developed, POs were cut, material was produced, material was shipped, first articles were made and approved—all over a period of one week.
The SEKISUI KYDEX team collaborated with Revere Plastics on material requirements for both internal and external parts, first utilizing SEKISUI KYDEX’s ALLEN ABS sheet and KYDEX T-MB (antimicrobial) sheet. Later, the teams also added KYDEX T-IM injection molding resin to the mix. Along with being the first time Revere Plastics and SEKISUI KYDEX had ever worked together, this was also the first project where all three SEKISUI KYDEX materials were harmonized in a single application.
Airon’s simplified ventilator design—the pNeuton A—is responsive to the needs of most COVID-19 patients and operates on air pressure without the need for electricity, which helps speed up production times.
Michael Goglia: As a material science company, we like challenges because we love to find solutions. The pandemic has spurred a re-energized importance and momentum to innovation and material enhancements to meet the changing needs of medtech and society in general through preventative, diagnostic, and therapeutic solutions.
During the pandemic, many companies, including Elkem, increased output and even pivoted to support the increased demand for medical supplies. Elkem ramped up supply of medical grade silicone rubbers used in ventilators, tubing, needleless valves and diagnostic test kits. On the PPE front, we increased silicone gel production used in specially designed comfort face masks for the medical community. Our soft skin adhesives create a gentle and comfortable seal between the skin and the mask to prevent glass fogging. And on the vaccine side, we supplied materials to the pharmaceutical industry for tubing, siliconization of glass vials and needles used in vaccine production, packaging, and delivery, respectively.
Jordan Smith: FLEXcon was able to innovate and come up with a disposable product to aid in the pandemic. We’ve seen many companies from industries outside of healthcare pivot to see what they could do with their equipment and products to aid in the pandemic, particularly on the PPE side.
Innovating new products historically has taken a lot of time but in a crisis like COVID-19, you have to execute quickly or risk missing out on an opportunity. With the shortage of PPE in the April-May 2020 time frame, we brainstormed with a few employees and came up with a concept and prototype, and executed a fully finished product in less than 30 days. We had to move very quickly because there was an immediate need in the market.
Lori Bitar: On the pharmaceutical side, the pandemic triggered the rapid development of biologics. The pharmaceutical industry is traditionally slow—it can take up to 10 years to develop a pharmaceutical product, but with Operation Warp Speed, that timeline was expedited significantly. There were a lot of stock-out situations and the supply chain was constrained, so some materials were not available and that caused packagers to rethink what they could use. Some companies were fortunate to have longstanding relationships with suppliers, thus avoiding the shortage/delay in supply. The pandemic certainly stressed and challenged the supply chain, opening the possibilities of sourcing alternative materials.
Finding COVID-19’s Silver Lining
Well before he became president, John F. Kennedy spoke of the symbiotic relationship between crisis and opportunity. “When written in Chinese,” he noted, “the word ‘crisis’ is composed of two characters—one represents danger and one represents opportunity.”
The quote is one of Kennedy’s most memorable, even though it is factually incorrect. The Mandarin word for crisis, weiji, is written as two separate characters, with the wei syllable conveying a notion of danger, and ji signifying “incipient moment” or “crucial point.”
Nevertheless, there is some element of truth in Kennedy’s misinterpretation of weiji. Crisis does, in fact, breed opportunity: A 19th century cholera pandemic in London spurred the creation of a new scientific field, epidemiology, and the challenge of decrypting enemy messages during World War II prompted the development of computers.
Likewise, there is opportunity to be found in the current coronavirus crisis (which has been aided by both epidemiology and computers). The pandemic not only expanded telehealth services at warp speed, it also expedited the healthcare industry’s acceptance of digital medicine, data analytics, and artificial intelligence.
COVID-19 also fostered cross-industry collaboration, better communication, and turned former rivals into friends, if only for a brief period. But perhaps the most important opportunity the pandemic has provided medtech materials manufacturers and suppliers is the re-examination and possible redesign of their supply chains.
Supply continuity and nearshoring are certain to take precedence once COVID-19 is brought under control, though quick innovation will also be key going forward, several companies told MPO. Experts providing insight on medtech’s post-pandemic future included Matt Boyd, chief commercial officer, Priya George, development engineer, and Brianna Schaeffer, vice president of program management at Boyd Technologies, a Lee, Mass.-based advanced materials and technology firm; Lars Gerding, vice president of Technology at Freudenberg Medical, a contract manufacturer; and Ursula Nollenberger, product line director at Trelleborg Healthcare & Medical, a designer, developer, manufacturer, and marketer of engineered solutions for medical device, biotech, and pharmaceutical applications.
Matt Boyd: The pandemic revealed that so many materials are made outside the U.S., or if they are made domestically, the capacity is very limited. Nearshoring was already a focus of big OEMs, but it has accelerated since the pandemic began. The reason this impacts innovation is the ecosystem component. When we can source materials from neighboring states, we gain a collaborative feedback loop, so we can connect actors in the ecosystem and create innovation in a more condensed time frame. That is one of the lost opportunity costs that many players didn’t realize until the pandemic. Companies often buy materials from overseas because it’s the cheapest, but that creates an environment with less collaboration and less room for innovation as a result.
Priya George: Nearshoring is certain to become a priority moving forward. Most U.S. manufacturers and distributors are looking for sources within the states for most if not all materials. Even if companies are not engaging U.S. partners, it has become essential to have second sources domestically to be more agile in the face of future supply chain risks.
Brianna Schaeffer: Nearshoring is an excellent way to increase sustainability in the industry from a global perspective. Using domestic materials drastically reduces our carbon footprint and contributes to the growth of U.S. manufacturers.
Lars Gerding: I don’t think [the pandemic] affected our space too much. We saw more innovation in the design of devices/components like face shields, masks, ventilators, and test kits. Material innovation would be more prevalent for filter media (such as face masks), nonwovens and media to make masks more efficient (breathable vs. absorbing).
I think it is a missed opportunity that we cannot recycle material in the medical industry. But the waste that we generate can be recycled and Freudenberg is proactive about recycling. Our scrap is from a cleanroom environment, it’s clean, one polymer, and not a mix of several materials so it’s good for recycling companies. Our scrap is always from virgin material, it’s premium waste and can be recycled. Medical devices are primarily single-use but Freudenberg is supporting some initiatives to design devices that can be more easily reprocessed—enabling customers to venture down this path.
Ursula Nollenburger: The fundamental material technologies to address healthcare needs existed prior to the pandemic. The pandemic has, however, triggered healthcare providers and OEMs to take a critical look at their supply chains to mitigate risks and shortages, which many providers experienced during the first wave of the pandemic. Having a global footprint and raw material supply base helps position manufacturers to meet industry needs.
The pandemic made it clear that supply continuity in the healthcare sector is even more important than in other business areas. It’s important to be prepared for these kinds of scenarios with a high-level of flexibility, internal risk management, and a strong financial backbone.
Trelleborg Healthcare & Medical was fortunate that, when the pandemic hit, our global footprint enabled us to react quickly to market demand, shift manufacturing as needed, and ensure a continuity of supply for our customers. Redundant manufacturing on multiple continents for most of our processes, combined with a global material strategy of dual sourcing, enabled us to mitigate the risk of supply interruption in specific regions. This ability to manage pandemic-related supply chain issues simply reaffirms that our strategy is working.
