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    Pandemic Underscores Importance of Medtech Material Innovation

    Materials must meet the changing needs of medtech and society in general through preventative, diagnostic and therapeutic solutions.

    Pandemic Underscores Importance of Medtech Material Innovation
    Michael Barbella, Managing Editor07.30.21
    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. Michael Goglia, market manager, Healthcare Americas at Elkem Silicones, was among the experts interviewed for the story. His 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?
    Michael Goglia: Digital health and AI systems are dependent upon significant amounts of data; as a result, there is an increasing need for medical technology to reliably capture and transmit data. This is driving innovation in the design and manufacturing of medical devices, as well as the innovation and selection of materials incorporated into these devices. Silicone materials are an excellent fit in this space because of their combination of biocompatibility and functional versatility. They can be custom formulated to meet a variety of needs, such as soft electrically conductive elastomers, low temperature cure encapsulants, or materials suitable for implantable devices. Elkem’s Silbione line offers a diverse range of products to solve these challenges.
     
    Barbella: What material challenges are associated with developing wearable products and how can these hurdles be overcome?
    Goglia: Developing wearable products can present some complex challenges for the designer. We break down these challenges into three distinct but complimentary problems that need to be solved – reliability, compliance, and manufacturability.
    Reliability: What materials will optimize sensor performance and reliability ensuring data integrity? To address this, we have developed new high purity conductive silicones for medical applications, which enable accurate and reliable sensor performance and signal transmission, for both electrical and thermal conductivity. Unlike other silicones that can become brittle, Elkem’s low durometer silicones remain soft even with the addition of conductive additives. This is key to the wearable product’s performance, comfort and durability.
    Compliance: How will the device comfortably adhere to the user to ensure compliance? Stretchable skin-like materials enable designers to achieve thinner and more flexible wearable devices for better comfort and integration into daily life activities. Elkem is a leader in soft, high tear, high elongation silicone elastomers. Adherence to the body is another challenge that silicones offer a wide range of solutions. Elkem’s Silbione skin adhesives allow a wearable device to gently adhere to the skin without irritation.
    Manufacturability: Designers need to consider how the material will process without damaging the critical electronic components of the device. High temperatures traditionally required to mold materials can damage the electronic component of the device or affect the drug performance in a drug delivery device. Elkem has developed unique silicone elastomers that cure at lower temperatures to maintain the functional integrity of the device.
    When looking at new innovative devices such as wearables, we encourage designers to look beyond their standard silicones and suppliers, and to take into consideration more recent silicone material innovations that can specifically address these challenges of reliability, compliance and manufacturability of wearable devices.
     
    Barbella: In what ways has the global pandemic spurred material innovation?
    Goglia: As 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 med-tech and society in general through preventative, diagnostic and therapeutic solutions.
     
    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?
    Goglia: 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 Pharma industry for tubing, siliconization of glass vials and needles used in vaccine production, packaging, and delivery respectively.
     
    Barbella: What lessons from the pandemic will materials developers/suppliers carry forward in a post-COVID-19 world?
    Goglia: The pandemic highlighted vulnerabilities in supply chains, including challenges around transportation, people power and raw material availability across all industries including medtech. The market recognizes the need for global infrastructure robustness and supplier diversity in a post-Covid-19 world, with dual sourcing on device specifications being key going forward. At Elkem, we are fully integrated and have a global production network that enabled us to continuously supply our customer needs during the course of the pandemic. We also were able to pivot to support critical supply areas.
     
    Barbella: With the growing importance of sustainability and recyclability in the industry, can medtech materials be made more sustainable? If so, how?
    Goglia: At Elkem, sustainability is a fundamental pillar of our organization. We are always looking for new and innovative ways to reduce waste and emissions, and to get more out of our raw materials. We do this to keep a sustainable competitive advantage and to secure our license to operate. We are committed to stay at the forefront of technology, advancing the production of silicon, silicones and carbon materials and to create new, innovative and green solutions and business models that promote a sustainable future.
    For medtech, silicones offer an alternative solution to oil-based plastics. Silicones are biocompatible, flexible, durable making it an ideal technology for at home medical care products and reusable applications. Silicones can easily be washed, sterilized and reused to reduce waste and the need for replacement.
     
    Barbella: Please discuss an instance (example) of an innovative material solution(s) your company came up with to meet challenging customer requests.
    Goglia: At Elkem, we work in partnership with our customers to deliver the next generation of silicones to meet the market needs. In medtech, we consistently work with our customers and partners to deliver unique solutions that solve unmet needs. In the drug delivery space for example, certain active pharmaceutical ingredients can inhibit material cure of the substrate. To address this challenge, Elkem has developed unique silicone elastomer solutions that enable silicone cure without drug interaction.
    In addition, when the pandemic hit, we also saw many customers pivot from their traditional business to support the short falls in PPE. We have helped our customers to develop unique solutions for the next generation of masks to support long term comfort and still offer the necessary protection. Some of these solutions include low density gels, silicone foams and very soft elastomers with high performing physical properties.
     
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