Michael Barbella, Managing Editor01.04.23
Bye bye, bacteria.
Scientists have developed a promising new weapon in the war against hospital-acquired infections. UCLA specialists are fine-tuning an anti-microbial barrier they created for implantable medical devices using zwitterionic material and ultraviolet light. Zwitterionic substances are comprised of molecules that possess an equal amount of cationic and anionic groups, thereby rendering them electrically neutral.
The UCLA team built the barrier by depositing a thin layer of zwitterionic material to a device surface and then bonding it to the underlying substrate through UV light irradiation. Early clin- ical results are encouraging—laboratory testing shows the surface treatment reduces biofilm growth by more than 80% and in some cases up to 93%, depending on the bacterial strain.
“The modified surfaces exhibited robust resistance against microorganisms and proteins, which is precisely what we sought to achieve,” Richard Kaner, a UCLA Dr. Myung Ki Hong professor of Materials Innovation, and senior research author, told the university’s news service earlier this year. “The surfaces greatly reduced or even prevented biofilm formation. Our early clinical results have been outstanding.”
Those results are based on 16 long-term urinary catheter users who switched to silicone devices containing the zwitterionic surface treatment. The modified catheter is the first product made by SILQ Technologies Corp., a UCLA spinout company Kaner founded out of his lab in April 2020. The catheter has been cleared for use by the U.S. Food and Drug Administration.
Materials science is key to medtech innovation. New and improved manufacturing materials have led to advancements such as bioprinting, skin-friendly adhesives, shape memory plastics, bioactive glass (orthopedic repair), and bioresorbable stents.
MPO’s materials feature examines the latest trends and challenges in medtech materials science, as well as the factors driving innovation in this field. Ralph Tricomi, director, market development; and Kevin Young, vice president, corporate development at Marlborough, Mass.-based contact manufacturer Web Industries Inc., were among the experts interviewed for this story; their full input is provided in the following Q&A:
Michael Barbella: What are the latest trends in medical device materials? What factors are driving these trends?
Kevin Young: There is a convergence of chemistry, electronics, and medical devices in the development of solutions to improve quality of life through early disease detection and diagnosis of maladies. We are seeing greater integration of electrical circuits and multielectrode arrays (MEA) into flexible, medical-grade materials. These materials then are used in testing devices and medical wearables with increasingly sophisticated detection capabilities and digital connectivity.
Ralph Tricomi: This connectivity provides a link between medical devices and mobile apps, electronic medical records, and digital passport solutions. Today, many people are presenting paper vaccine records to access certain airports, restaurants and other gathering places. While this exists to some degree today, look for greater proliferation and more scenarios where the individual self-administers a diagnostic test, and the results are immediately read by a mobile phone app and then easily shared with their physician, employer, airline personnel, or even a restaurant host. This convergence of electronics and medical devices is coming together quickly.
Barbella: What factors are driving innovation in medical device materials science?
Young: There is a drive to detect and diagnose diseases earlier because it’s better for human health, improves outcomes, and lowers healthcare treatment and insurance costs. Diagnostic tests must offer both affordable cost and functionality, especially for successful deployment in developing nations. These factors motivate medical device manufacturers to find cost-effective, efficient manufacturing methods.
Tricomi: The COVID-19 pandemic accelerated the medical community’s acceptance and adoption of telehealth lateral flow rapid antigen diagnostic tests. There has been substantial financial investment in connected devices and diagnostics, including the materials required to make them.
Barbella: How have adhesive medical materials evolved with the significant growth in medical wearables in recent years?
Young: The medical adhesive is crucial for multilayer laminated materials, and adhesive material suppliers are in touch with the market’s need for conformability, biocompatibility and, in some cases, transparency. For example, we work closely with OEMs to help them determine the optimal way to laminate different materials together. To help customers make multilayer products incorporating electronics, we have equipment to print on a substrate, do the multilayer lamination, and then die cutting, island placement or other converting processes. Advanced adhesives often are the method of choice to bond these layers together.
Barbella: What material challenges are associated with medical device miniaturization and how can these challenges be overcome?
Young: Manufacturing automation makes it feasible to handle smaller substrates. Automated production lines often are in clean room environments, which ensures materials remain free from debris or contamination.
Barbella: How have materials suppliers managed the supply chain challenges prompted by the pandemic, and what lessons (changes) might they implement going forward to avoid future problems/issues?
Young: The demand for materials for lateral flow immunoassay (LFI) devices has gone through the roof. These include materials for the LFI device’s sample pad, conjugate pad, nitrocellulose membrane, and backing card layer, to name just a few. Recently, the U.S. government made funding available to companies like MilliporeSigna to help them increase production of these critical elements because there haven’t been enough materials to meet demand. The supply chain is a critical component in fighting the pandemic, and this is one of many ways the government is supporting production of these critical LFI device components. To put things in perspective, consider that in Kalorama’s most recent In Vitro Diagnostics (IVD) Business Outlook, the research firm predicted the IVD market would reach $117 billion, with 26% of the business related to COVID-19—and COVID tests didn’t exist before March 2020.
Tricomi: Like others in the medical device value chain, material suppliers are looking at securitization and regionalization of their supply chains. This began in earnest in 2020 due to pandemic disruptions and continues due to follow-on problems impacting supply reliability and predictability. There are long lead times, labor shortages, and lack of infrastructure to move goods from point A to point B. Companies have learned a lot since 2020. Many see that stretched supply chains and global sourcing strategies can be a liability, especially if you’re chasing low-cost labor for materials. Businesses are rethinking their sourcing and supply chain strategies. They realize they can lose a lot of money if they can’t access their input materials. Whatever savings that were going to come from a low-cost manufacturing location could bequickly eaten up, impacting not only the bottom line but brand equity. We’ll see more North American regionalization of medical device supply chains as firms lock in predictable and secure sources.
Barbella: In what ways has the COVID-19 pandemic spurred medical materials innovation, if at all?
Young: Through the Rapid Acceleration of Diagnostics (RADx) initiative, we’ve seen all sorts of new and innovative products for COVID detection. Many will have significant impact going forward for testing and diagnosis of other maladies.
Barbella: How will medical materials science evolve over the next five years?
Young: We’re going to see a continuation of this convergence of chemistry and electronics on flexible substrates to further diagnostics and aid in patient health and safety. At a recent JP Morgan medical conference, the CEOs of Abbott, BD, and Quidel discussed how their businesses are pursuing direct-to-consumer (DTC) strategies amid a paradigm shift toward at-home care and self-testing. Materials are a critical part of making these products. All three CEOs said they see opportunities for DTC digitally connected testing for diseases beyond COVID-19. The convergence of digital technology and medtech is happening. To facilitate this, material science is going to be critical in diagnostic tests.
Tricomi: I think it says a lot that Abbott Chairman and CEO Robert Ford was one of the keynoters at the 2022 Consumer Electronics Show (CES). The entire world has changed, and telemedicine and connectivity will continue having an enormous impact on the evolution of materials science and medical device innovation.
Scientists have developed a promising new weapon in the war against hospital-acquired infections. UCLA specialists are fine-tuning an anti-microbial barrier they created for implantable medical devices using zwitterionic material and ultraviolet light. Zwitterionic substances are comprised of molecules that possess an equal amount of cationic and anionic groups, thereby rendering them electrically neutral.
The UCLA team built the barrier by depositing a thin layer of zwitterionic material to a device surface and then bonding it to the underlying substrate through UV light irradiation. Early clin- ical results are encouraging—laboratory testing shows the surface treatment reduces biofilm growth by more than 80% and in some cases up to 93%, depending on the bacterial strain.
“The modified surfaces exhibited robust resistance against microorganisms and proteins, which is precisely what we sought to achieve,” Richard Kaner, a UCLA Dr. Myung Ki Hong professor of Materials Innovation, and senior research author, told the university’s news service earlier this year. “The surfaces greatly reduced or even prevented biofilm formation. Our early clinical results have been outstanding.”
Those results are based on 16 long-term urinary catheter users who switched to silicone devices containing the zwitterionic surface treatment. The modified catheter is the first product made by SILQ Technologies Corp., a UCLA spinout company Kaner founded out of his lab in April 2020. The catheter has been cleared for use by the U.S. Food and Drug Administration.
Materials science is key to medtech innovation. New and improved manufacturing materials have led to advancements such as bioprinting, skin-friendly adhesives, shape memory plastics, bioactive glass (orthopedic repair), and bioresorbable stents.
MPO’s materials feature examines the latest trends and challenges in medtech materials science, as well as the factors driving innovation in this field. Ralph Tricomi, director, market development; and Kevin Young, vice president, corporate development at Marlborough, Mass.-based contact manufacturer Web Industries Inc., were among the experts interviewed for this story; their full input is provided in the following Q&A:
Michael Barbella: What are the latest trends in medical device materials? What factors are driving these trends?
Kevin Young: There is a convergence of chemistry, electronics, and medical devices in the development of solutions to improve quality of life through early disease detection and diagnosis of maladies. We are seeing greater integration of electrical circuits and multielectrode arrays (MEA) into flexible, medical-grade materials. These materials then are used in testing devices and medical wearables with increasingly sophisticated detection capabilities and digital connectivity.
Ralph Tricomi: This connectivity provides a link between medical devices and mobile apps, electronic medical records, and digital passport solutions. Today, many people are presenting paper vaccine records to access certain airports, restaurants and other gathering places. While this exists to some degree today, look for greater proliferation and more scenarios where the individual self-administers a diagnostic test, and the results are immediately read by a mobile phone app and then easily shared with their physician, employer, airline personnel, or even a restaurant host. This convergence of electronics and medical devices is coming together quickly.
Barbella: What factors are driving innovation in medical device materials science?
Young: There is a drive to detect and diagnose diseases earlier because it’s better for human health, improves outcomes, and lowers healthcare treatment and insurance costs. Diagnostic tests must offer both affordable cost and functionality, especially for successful deployment in developing nations. These factors motivate medical device manufacturers to find cost-effective, efficient manufacturing methods.
Tricomi: The COVID-19 pandemic accelerated the medical community’s acceptance and adoption of telehealth lateral flow rapid antigen diagnostic tests. There has been substantial financial investment in connected devices and diagnostics, including the materials required to make them.
Barbella: How have adhesive medical materials evolved with the significant growth in medical wearables in recent years?
Young: The medical adhesive is crucial for multilayer laminated materials, and adhesive material suppliers are in touch with the market’s need for conformability, biocompatibility and, in some cases, transparency. For example, we work closely with OEMs to help them determine the optimal way to laminate different materials together. To help customers make multilayer products incorporating electronics, we have equipment to print on a substrate, do the multilayer lamination, and then die cutting, island placement or other converting processes. Advanced adhesives often are the method of choice to bond these layers together.
Barbella: What material challenges are associated with medical device miniaturization and how can these challenges be overcome?
Young: Manufacturing automation makes it feasible to handle smaller substrates. Automated production lines often are in clean room environments, which ensures materials remain free from debris or contamination.
Barbella: How have materials suppliers managed the supply chain challenges prompted by the pandemic, and what lessons (changes) might they implement going forward to avoid future problems/issues?
Young: The demand for materials for lateral flow immunoassay (LFI) devices has gone through the roof. These include materials for the LFI device’s sample pad, conjugate pad, nitrocellulose membrane, and backing card layer, to name just a few. Recently, the U.S. government made funding available to companies like MilliporeSigna to help them increase production of these critical elements because there haven’t been enough materials to meet demand. The supply chain is a critical component in fighting the pandemic, and this is one of many ways the government is supporting production of these critical LFI device components. To put things in perspective, consider that in Kalorama’s most recent In Vitro Diagnostics (IVD) Business Outlook, the research firm predicted the IVD market would reach $117 billion, with 26% of the business related to COVID-19—and COVID tests didn’t exist before March 2020.
Tricomi: Like others in the medical device value chain, material suppliers are looking at securitization and regionalization of their supply chains. This began in earnest in 2020 due to pandemic disruptions and continues due to follow-on problems impacting supply reliability and predictability. There are long lead times, labor shortages, and lack of infrastructure to move goods from point A to point B. Companies have learned a lot since 2020. Many see that stretched supply chains and global sourcing strategies can be a liability, especially if you’re chasing low-cost labor for materials. Businesses are rethinking their sourcing and supply chain strategies. They realize they can lose a lot of money if they can’t access their input materials. Whatever savings that were going to come from a low-cost manufacturing location could bequickly eaten up, impacting not only the bottom line but brand equity. We’ll see more North American regionalization of medical device supply chains as firms lock in predictable and secure sources.
Barbella: In what ways has the COVID-19 pandemic spurred medical materials innovation, if at all?
Young: Through the Rapid Acceleration of Diagnostics (RADx) initiative, we’ve seen all sorts of new and innovative products for COVID detection. Many will have significant impact going forward for testing and diagnosis of other maladies.
Barbella: How will medical materials science evolve over the next five years?
Young: We’re going to see a continuation of this convergence of chemistry and electronics on flexible substrates to further diagnostics and aid in patient health and safety. At a recent JP Morgan medical conference, the CEOs of Abbott, BD, and Quidel discussed how their businesses are pursuing direct-to-consumer (DTC) strategies amid a paradigm shift toward at-home care and self-testing. Materials are a critical part of making these products. All three CEOs said they see opportunities for DTC digitally connected testing for diseases beyond COVID-19. The convergence of digital technology and medtech is happening. To facilitate this, material science is going to be critical in diagnostic tests.
Tricomi: I think it says a lot that Abbott Chairman and CEO Robert Ford was one of the keynoters at the 2022 Consumer Electronics Show (CES). The entire world has changed, and telemedicine and connectivity will continue having an enormous impact on the evolution of materials science and medical device innovation.
