Michael Barbella, Managing Editor08.06.21
Materials science has played a key role in the global battle against COVID-19.
Triiodide, salt, copper, nano-silver, polyimide, and graphene are just a few of the recruits drafted thus far in the 18-month coronavirus war. Sodium chloride, a natural anti-bacterial agent, is adept at filtering air and decontaminating surfaces, while copper “foam” can effectively capture tiny aerosol droplets carrying virus particles (diameters between 0.1 and 0.4 micrometers). Moreover, graphene has been used as a protective coating on face masks (the material’s sharp edges damage viruses), and Vyon porous plastic filters are helping a University of Cambridge (U.K.) spinout company diagnose COVID-19 infections in less than 90 minutes.
A research team at Northeastern University, meanwhile, has adopted a virus “mentality” to defeat SARS-CoV-2. The institution’s “Nano-Medicine Lab” created an injectable nano-molecular material that could prevent bacterial infection spread and also help reduce inflammation.
“What we are creating in the lab are molecules that are about 80,000 times smaller than the diameter of a strand of your hair,” Thomas Webster, the lab’s head, said in an interview posted on the school’s website. “In order to kill the viruses, you have to make a nano-meter material to disrupt their function.”
The technology Webster’s lab is researching as a potential coronavirus weapon actually was developed eight years ago as an injectable to help regenerate tissue and cartilage. The material was licensed by Concord, Mass.-based Audax Medical Inc. and has been commercialized for several regenerative medicine applications.
“We quickly hypothesized, when this COVID-19 situation came up,” Webster explained, “that these molecules are great at healing tissue, they’re great at reducing infections, exceptional at inhibiting inflammation that often comes from microbes, and perhaps it could be used to kill viruses.”
Such hypotheses were not uncommon over the last year as scientists, virologists, and medical professionals frantically searched for COVID-19’s molecular Achilles Heel. The pandemic, in fact, underscored the importance of materials science in developing tools and technologies for anti-viral research and treatment.
MPO’s March feature, Resourceful Resources, details the various pandemic response efforts of more than a half-dozen materials suppliers and manufacturers. The story also examines the challenges associated with developing wearable materials, and the impact AI and digital health has had on the space. Matt Boyd, chief commercial officer, Priya George, development engineer, and Brianna Schaeffer, vice president of Program Management at Boyd Technologies, were among the experts interviewed for the story. Their full input is provided in the following Q&A.
Michael Barbella: How is digital health and AI impacting the development of medical device materials? Has it changed the kind of materials developed/used in devices?
Matt Boyd: Regarding digital health, smart devices are the key application because they are enabled by connectivity. For example, they can have batteries built into them or electronics printed on them; they can maintain their flexibility while holding a current, storing, and exchanging power; and they can signal, whether with Bluetooth or RFID or another wireless technology. Digital health has asked for miniaturization and flexibility to be built into flexible materials. You can put any sensor you want into materials, and it will communicate the results.
Wearables aren’t only stick to skin devices, either. It can be a wrist band, implant, or garment with sensors woven to communicate with a platform. Remote patient monitoring is a better term to describe this field. It’s not just someone wearing a smartwatch but a patient with chronic medical conditions.
For example, FreMon Scientific, a partner of Boyd Technologies, developed a smart, single-use bag that senses temperature as it thaws and then communicates to the practitioner, letting them know the sample is ready. On the biotech side of things, bioreactor bags now have sensors built into the bag’s side that read through the material and monitor the temperature of the contents so that you don’t have invasive probes potentially contaminating the product.
Barbella: What material challenges are associated with developing wearable products and how can these hurdles be overcome?
Priya George: Stick to skin materials continue to evolve in popularity. Still, there are significantly more limitations on materials that go directly on human skin versus those that do not require prolonged human contact. If a medical grade material is necessary, it will increase the price. Material costs and sourcing challenges increase even more significantly when using pharmaceutical grade materials because the quality requirements are much more stringent.
Brianna Schaeffer: We have also been challenged with securing rigid devices to flexible materials. Integrating devices that monitor and communicate real-time results onto a flexible material that comes on a roll can present design challenges. It takes significant collective, creative troubleshooting to come up with a functional solution. Collaboration between companies is essential to overcome these material hurdles.
Barbella: In what ways has the global pandemic spurred material innovation?
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 timeframe. 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.
Barbella: Organizations from outside the medtech industry pitched in at the start of the pandemic to help address the shortage of ventilators and PPE. What kind of impact did that have on the kinds of materials used for those products? Was/is there more flexibility with regard to the types of materials used for ventilators and PPE?
Schaeffer: We received many calls early in the pandemic from companies looking to upgrade their quality systems. Maybe they made a meltblown fabric or geotextile layer used for another purpose initially but now wanted to increase quality and cleanliness standards to pivot and have the flexibility to provide a product that could go into a medical device. Many of these companies made very few changes to their existing lines, just some tweaks to thickness and basis weight, and had to flow materials through regulatory testing.
Boyd: On the other hand, however, I think it was a significant risk for the medical market for a couple of reasons. First, these companies were taking from the limited supply of materials needed by those already in the industry and without the expertise and quality systems in place. It’s similar to how consumers were told not to buy N95 masks because nurses and healthcare providers critically needed them early in the pandemic. Some companies purchased meltblown and other materials used for PPE, then sold their products into the consumer market because they didn’t want to deal with regulatory aspects.
Secondly, some of them used improper materials that were potentially dangerous to put on people’s faces. In one sense, it’s great that these companies had the inclination to help meet the demand for PPE, but there are many concerns about the safety and efficacy of products made when companies quickly enter into the regulated space if they don’t have the expertise to do so. The first three months of the pandemic were incredibly risky as a result. We ran in a razor-thin margin with PPE across the country, even here in Massachusetts, and there was a lot of potential for human harm. Luckily, this was minimal.
As we advance, I think we’ll see a lot of large consumer companies and tech companies coming into this space. The increased popularity of wearables and remote patient monitoring will allow these companies to operate on the fringes of regulated markets in ways that have the potential to be hazardous to patients.
Barbella: What lessons from the pandemic will materials developers/suppliers carry forward in a post-COVID-19 world?
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.
Barbella: With the growing importance of sustainability and recyclability in the industry, can medtech materials be made more sustainable? If so, how?
Boyd: Yes, materials can be made sustainably, but I think the key to becoming more sustainable has more to do with your footprint as a manufacturer and less to do with using PLA or corn-based polymers to make a single-use bag. Our industry is very focused on sustainability and recyclability of materials where it suits the application. Still, our primary focus is our manufacturing footprint, on our facility’s inputs and outputs (including waste and wastewater), and our ongoing commitment to be more sustainable.
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.
Barbella: Please discuss an instance (example) of an innovative material solution(s) your company came up with to meet challenging customer requests.
Boyd: At a high level, innovative material solutions are what we do. Clients come to us with product designs, and we come up with material and supplier solutions based on feature functionality, patient safety, and user needs. We work hard to provide innovative material solutions to our customers so they can be “best-to-market” with their product.
Schaeffer: We aided Medline with the commercialization of DriGo-HP, a multi-functional skin fold management solution. It uses patented technology to wick moisture, reduce odor, and contains encapsulated hydrogen peroxide to reduce bacterial buildup. Functionality for this product required a unique textile with inherent wicking properties to be used as the substrate material. The material is then treated with two novel coatings—one of which aids in translocating moisture outside of the skinfold; the other slowly releases hydrogen peroxide, which prevents the buildup of bacteria.
Triiodide, salt, copper, nano-silver, polyimide, and graphene are just a few of the recruits drafted thus far in the 18-month coronavirus war. Sodium chloride, a natural anti-bacterial agent, is adept at filtering air and decontaminating surfaces, while copper “foam” can effectively capture tiny aerosol droplets carrying virus particles (diameters between 0.1 and 0.4 micrometers). Moreover, graphene has been used as a protective coating on face masks (the material’s sharp edges damage viruses), and Vyon porous plastic filters are helping a University of Cambridge (U.K.) spinout company diagnose COVID-19 infections in less than 90 minutes.
A research team at Northeastern University, meanwhile, has adopted a virus “mentality” to defeat SARS-CoV-2. The institution’s “Nano-Medicine Lab” created an injectable nano-molecular material that could prevent bacterial infection spread and also help reduce inflammation.
“What we are creating in the lab are molecules that are about 80,000 times smaller than the diameter of a strand of your hair,” Thomas Webster, the lab’s head, said in an interview posted on the school’s website. “In order to kill the viruses, you have to make a nano-meter material to disrupt their function.”
The technology Webster’s lab is researching as a potential coronavirus weapon actually was developed eight years ago as an injectable to help regenerate tissue and cartilage. The material was licensed by Concord, Mass.-based Audax Medical Inc. and has been commercialized for several regenerative medicine applications.
“We quickly hypothesized, when this COVID-19 situation came up,” Webster explained, “that these molecules are great at healing tissue, they’re great at reducing infections, exceptional at inhibiting inflammation that often comes from microbes, and perhaps it could be used to kill viruses.”
Such hypotheses were not uncommon over the last year as scientists, virologists, and medical professionals frantically searched for COVID-19’s molecular Achilles Heel. The pandemic, in fact, underscored the importance of materials science in developing tools and technologies for anti-viral research and treatment.
MPO’s March feature, Resourceful Resources, details the various pandemic response efforts of more than a half-dozen materials suppliers and manufacturers. The story also examines the challenges associated with developing wearable materials, and the impact AI and digital health has had on the space. Matt Boyd, chief commercial officer, Priya George, development engineer, and Brianna Schaeffer, vice president of Program Management at Boyd Technologies, were among the experts interviewed for the story. Their full input is provided in the following Q&A.
Michael Barbella: How is digital health and AI impacting the development of medical device materials? Has it changed the kind of materials developed/used in devices?
Matt Boyd: Regarding digital health, smart devices are the key application because they are enabled by connectivity. For example, they can have batteries built into them or electronics printed on them; they can maintain their flexibility while holding a current, storing, and exchanging power; and they can signal, whether with Bluetooth or RFID or another wireless technology. Digital health has asked for miniaturization and flexibility to be built into flexible materials. You can put any sensor you want into materials, and it will communicate the results.
Wearables aren’t only stick to skin devices, either. It can be a wrist band, implant, or garment with sensors woven to communicate with a platform. Remote patient monitoring is a better term to describe this field. It’s not just someone wearing a smartwatch but a patient with chronic medical conditions.
For example, FreMon Scientific, a partner of Boyd Technologies, developed a smart, single-use bag that senses temperature as it thaws and then communicates to the practitioner, letting them know the sample is ready. On the biotech side of things, bioreactor bags now have sensors built into the bag’s side that read through the material and monitor the temperature of the contents so that you don’t have invasive probes potentially contaminating the product.
Barbella: What material challenges are associated with developing wearable products and how can these hurdles be overcome?
Priya George: Stick to skin materials continue to evolve in popularity. Still, there are significantly more limitations on materials that go directly on human skin versus those that do not require prolonged human contact. If a medical grade material is necessary, it will increase the price. Material costs and sourcing challenges increase even more significantly when using pharmaceutical grade materials because the quality requirements are much more stringent.
Brianna Schaeffer: We have also been challenged with securing rigid devices to flexible materials. Integrating devices that monitor and communicate real-time results onto a flexible material that comes on a roll can present design challenges. It takes significant collective, creative troubleshooting to come up with a functional solution. Collaboration between companies is essential to overcome these material hurdles.
Barbella: In what ways has the global pandemic spurred material innovation?
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 timeframe. 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.
Barbella: Organizations from outside the medtech industry pitched in at the start of the pandemic to help address the shortage of ventilators and PPE. What kind of impact did that have on the kinds of materials used for those products? Was/is there more flexibility with regard to the types of materials used for ventilators and PPE?
Schaeffer: We received many calls early in the pandemic from companies looking to upgrade their quality systems. Maybe they made a meltblown fabric or geotextile layer used for another purpose initially but now wanted to increase quality and cleanliness standards to pivot and have the flexibility to provide a product that could go into a medical device. Many of these companies made very few changes to their existing lines, just some tweaks to thickness and basis weight, and had to flow materials through regulatory testing.
Boyd: On the other hand, however, I think it was a significant risk for the medical market for a couple of reasons. First, these companies were taking from the limited supply of materials needed by those already in the industry and without the expertise and quality systems in place. It’s similar to how consumers were told not to buy N95 masks because nurses and healthcare providers critically needed them early in the pandemic. Some companies purchased meltblown and other materials used for PPE, then sold their products into the consumer market because they didn’t want to deal with regulatory aspects.
Secondly, some of them used improper materials that were potentially dangerous to put on people’s faces. In one sense, it’s great that these companies had the inclination to help meet the demand for PPE, but there are many concerns about the safety and efficacy of products made when companies quickly enter into the regulated space if they don’t have the expertise to do so. The first three months of the pandemic were incredibly risky as a result. We ran in a razor-thin margin with PPE across the country, even here in Massachusetts, and there was a lot of potential for human harm. Luckily, this was minimal.
As we advance, I think we’ll see a lot of large consumer companies and tech companies coming into this space. The increased popularity of wearables and remote patient monitoring will allow these companies to operate on the fringes of regulated markets in ways that have the potential to be hazardous to patients.
Barbella: What lessons from the pandemic will materials developers/suppliers carry forward in a post-COVID-19 world?
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.
Barbella: With the growing importance of sustainability and recyclability in the industry, can medtech materials be made more sustainable? If so, how?
Boyd: Yes, materials can be made sustainably, but I think the key to becoming more sustainable has more to do with your footprint as a manufacturer and less to do with using PLA or corn-based polymers to make a single-use bag. Our industry is very focused on sustainability and recyclability of materials where it suits the application. Still, our primary focus is our manufacturing footprint, on our facility’s inputs and outputs (including waste and wastewater), and our ongoing commitment to be more sustainable.
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.
Barbella: Please discuss an instance (example) of an innovative material solution(s) your company came up with to meet challenging customer requests.
Boyd: At a high level, innovative material solutions are what we do. Clients come to us with product designs, and we come up with material and supplier solutions based on feature functionality, patient safety, and user needs. We work hard to provide innovative material solutions to our customers so they can be “best-to-market” with their product.
Schaeffer: We aided Medline with the commercialization of DriGo-HP, a multi-functional skin fold management solution. It uses patented technology to wick moisture, reduce odor, and contains encapsulated hydrogen peroxide to reduce bacterial buildup. Functionality for this product required a unique textile with inherent wicking properties to be used as the substrate material. The material is then treated with two novel coatings—one of which aids in translocating moisture outside of the skinfold; the other slowly releases hydrogen peroxide, which prevents the buildup of bacteria.
