• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Optimize EP Launches CaRM Cardiac Device Data Management Platform

    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

    Moon Surgical Expands Leadership Team
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    PTI Engineered Plastics Inc.

    FUTEK Advanced Sensor Technology Inc.

    Creganna Medical, part of TE Connectivity

    Unicep

    Element
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    MW Life Sciences

    Concise Engineering

    Unicep

    maxon

    K-Tube Technologies
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    Addressing the COVID-19 Crisis: Best Practices in PPE Development and FDA Review

    How a supply partner can help a non-traditional medtech manufacturer navigate the regulatory process successfully.

    Addressing the COVID-19 Crisis: Best Practices in PPE Development and FDA Review
    With tested filtration performance equivalent to an N99 (meaning 99 percent of contaminants are trapped in the filter and do not penetrate the mask), the SpectraShield 9900 mask exceeds the United States Center for Disease Control and World Health Organization guidelines for protection against infectious microbial threats such as Avian Influenza, SARS and Tuberculosis. Image courtesy of Sciessent.
    Addressing the COVID-19 Crisis: Best Practices in PPE Development and FDA Review
    Agion treated central venous catheter from Vygon. Image courtesy of Sciessent.
    Lise H. Moloney, Director of Business Development—Healthcare, Sciessent05.18.20
    The COVID-19 pandemic has drained the existing supply chain for personal protective equipment (PPE) desperately needed to safeguard both healthcare workers and patients. Because current medical device manufacturers are struggling to keep up with the demand, companies in other industries have been called upon to allocate manufacturing lines to the production of masks and other PPE.

    With extensive knowledge and experience in the medical device industry, including the U.S. Food and Drug Administration (FDA) review process, Sciessent has partnered with both healthcare and non-healthcare manufacturers to develop and gain regulatory clearance for masks containing our Agion Antimicrobial for use in healthcare settings.

    In this article, we share two stories of mask development—one with a traditional medical device manufacturer following the severe acute respiratory syndrome (SARS) outbreak in the early 2000s, and another this year with a manufacturer from outside of the medtech industry—comparing and contrasting the two from an FDA regulatory process perspective. We also offer thoughts on where product opportunities will expand given the care needs of patients who have contracted COVID-19, and tips for finding a supply partner when developing PPE and other medical supplies and devices.

    The 2003 SARS Outbreak
    Following the 2003 SARS outbreak, medical device manufacturer Nexera made the decision to develop a N95 respirator mask constructed from Foss Performance Materials’ Agion Antimicrobial treated polyester fiber. As a medtech company, Nexera had experience with FDA review for its devices so it understood what the process entailed. The company looked to us as its supply partner to help with regulatory considerations related to our antimicrobial.

    Because Nexera had developed the mask in response to SARS, as a product that could help in future respiratory virus outbreaks, the Nexera and Sciessent teams had ample time for pre-planning prior to FDA submission. This included the opportunity to develop data to support the mask’s antimicrobial claims. Working together, the teams successfully obtained FDA clearance for Nexera’s SpectraShield 9500 N95 respirator mask, and later leveraged additional data to secure an updated 510(k) with cleared claims to inactivate viruses by 99.99 percent in five minutes.

    The 2020 COVID-19 Crisis
    While the 2003 SARS outbreak impacted patient lives, the healthcare industry, and the medical product supply chain, it came nowhere near the disruption we are experiencing with today’s COVID-19 pandemic. Healthcare organizations are desperate for PPE to protect their workers and patients from this rapidly spreading respiratory illness, and there are simply not enough masks available.

    The U.S. government, the FDA, and manufacturers are collaborating to boost mask production. Since current medical device manufacturers are struggling to keep up with COVID-19-related product demand, the U.S. Department of Health and Human Services has asked companies in other industries to allocate manufacturing lines to the production of masks and other PPE. One group called to action is a cooperative consortium of major apparel manufacturers, including Hanesbrands.

    The development of FDA-cleared medical supplies and devices is far different from product development in the retail sector. Under regular circumstances, it can take years for a medical company to design, manufacture, and gain regulatory clearance for a healthcare product. With the U.S. government requesting Hanesbrands manufacture and deliver millions of masks to address the current pandemic, the company didn’t have years to invest in its regulatory submission—it had days.

    Selecting a Supply Partner
    Developing a product for healthcare and securing FDA approval or clearance is a daunting task for a medical device manufacturer, let alone a company from outside the industry. An educated and experienced antimicrobial supply partner can serve as a valuable resource to help overcome challenges and expedite processes for an efficient time to market. When evaluating a potential supplier, look for the following attributes:
    • Medical Industry and FDA Experience: Ensure your supplier has worked with other manufacturers to successfully develop medical products cleared or approved by the FDA for use in healthcare. A supplier that understands medical device design controls and regulatory review can help you decide on the best way to present your product to the agency.
    • Serves as an Extended Team Member: A supplier should do more than supply its product; it should partner with you through the development and regulatory review process, being available to help when needed.
    • Willingness to Get Hands On: Beyond offering support from a consulting standpoint, a supplier should be willing to take an active role, whether it is writing the antimicrobial sections of the FDA 510(k) or generating performance data needed to back up claims.
    • Flexible, Nimble, and Quick to Act: At any time, a company requires a supplier to be responsive to meeting its needs, but even more so during the current COVID-19 crisis as manufacturers work to quickly develop and deliver PPE and other critical supplies. Look for a supplier that has resources aimed at expediting processes, such as an in-house laboratory for rapid testing of formulations and prototypes, and related data generation.
    While the FDA is leveraging its Emergency Use Authorization (EUA) to accelerate the timeframe for clearance of products to address the COVID-19 crisis, and this is certainly a benefit to companies producing PPE, Hanesbrands still had to meet the agency’s requirements. We served as a collaborative partner in these efforts with medical device expertise, a wealth of data, and extensive experience in navigating the FDA’s regulatory review pathway.

    Leveraging Past Knowledge
    Unlike our premeditated work with Nexera to develop a mask following the SARS outbreak nearly two decades ago, our work with Hanesbrands required that we leverage existing knowledge and experience to quickly fill-in various information gaps. Instead of developing a product from the ground up, Hanesbrands was repurposing its knitted cotton fabrics treated with Agion Antimicrobial to develop its masks.

    We supported Hanesbrands in their interactions with FDA. Given the urgent need to address the PPE shortage, it appeared communication was far more open and frequent with the agency under the EUA directive. The correspondence and exchange of information between Hanesbrands and FDA moved quickly. In this circumstance, the FDA did not clear specific efficacy claims; in fact, the agency said no efficacy claims could be made.

    Having worked closely with the FDA with Nexera for its N95 mask and with other medical device manufacturers for their products, we were able to pivot quickly and apply our understanding of the regulatory process to the Hanesbrands situation. We were also able to leverage the data on safety and efficacy, including viruses from the Nexera mask’s second 510(k) clearance, to help fast track the Hanesbrands mask clearance. As a result, FDA cleared Hanesbrands’ mask in a matter of days, enabling the company to quickly transition its operations to relieving the PPE shortage.

    Where the COVID-19 Crisis Might Take Us
    Due to its enormous impact on the healthcare industry, the COVID-19 pandemic is driving innovation in PPE and beyond. We have been approached by other companies, both traditional medtech manufacturers and others from outside of the industry, with ideas for new products featuring the Agion Antimicrobial. Certainly products used in respiratory care hold promise for antimicrobial treatment since COVID-19 is a respiratory illness. These include endotracheal tubes, laryngoscope blades, and airway circuit filters designed to combat the virus.

    Another area for consideration during the current pandemic relates to products used on COVID-19 patients in the intensive care unit who are susceptible to healthcare acquired infections. The effectiveness of the Agion Antimicrobial against bacteria is a key feature in this product category. For example, Agion has been incorporated into central venous catheters in the fight against central line–associated bloodstream infections (CLABSI). Clinical data shows a 90 percent reduction in CLABSI with the use of Agion treated catheters.1,2

    Conclusion
    Based on experience working with manufacturers and FDA, we recommend any company considering the development of a medical product containing an antimicrobial first do its homework to understand its intended market. While the EUA allows FDA to quickly review the use of specific medical devices during a public health crisis, for continued use beyond the EUA, the device manufacturer must meet all regulatory requirements. The manufacturer must first prove there is a true clinical need, then demonstrate how its product meets that need. There is no compromise.

    References
    1 Strategies to Prevent Central Line-Associated Bloodstream Infections in Acute Care Hospitals: 2014 Update” published in Infection Control and Hospital Epidemiology (ICHE), July 2014, vol. 35, no. 7.
    2 Bertini G, Elia S, Ceciarini F, Dani C. Reduction of catheter-related bloodstream infections in preterm infants by the use of catheters with the AgION antimicrobial system. Early Hum Dev 2013;89(1):21–25.


    Lise H. Moloney has over 20 years of experience in the antimicrobial additive and medical device fields in both R&D and business development. Her experience includes market development, product development, technology assessment, and regulatory strategy. At Sciessent, Moloney plays a key role in strategic planning and execution of marketing the company’s Agion antimicrobial technology to the healthcare industry. Prior to joining Sciessent, she was with Covidien, where she was group leader in Advanced Research, vetting new technologies and establishing Clinical Advisory Boards to guide and support advanced research programs.
    Related Searches
    • Materials
    Related Knowledge Center
    • Materials

    Related Online Exclusives

    • Materials
      Setting the Standard: Protective Nanocoatings for Today

      Setting the Standard: Protective Nanocoatings for Today's Medtech

      Ensuring medical products are safe from the outside environment is a significant challenge that nanocoatings can help resolve.
      Zsolt Pulai, EVP, Technology & Development, HZO Inc. 12.02.20

    • Materials
      Stock vs. Custom Springs for Medtech

      Stock vs. Custom Springs for Medtech

      A review of the pros and cons for medical equipment designers.
      Edward Jones, Marketing Manager, John Evans’ Sons 10.08.20

    • Materials
      New Materials Impact the Medical Technology Outsourcing Market

      New Materials Impact the Medical Technology Outsourcing Market

      How UHMWPE fiber is driving innovation in a quickly expanding sector.
      Abey Paul, Global Business Leader for Honeywell 06.02.20


    • Materials
      Plastics and Medtech: Annual Industry Survey Results

      Plastics and Medtech: Annual Industry Survey Results

      Medical device manufacturers prefer domestic plastics manufacturing and many use thermoforming on a project.
      Jason Middleton, Vice President of Sales & Development, Ray Products 04.24.20

    • Electronics | Materials
      Ultra-Thin Base Materials Take PCB Miniaturization to the Next Level

      Ultra-Thin Base Materials Take PCB Miniaturization to the Next Level

      Flexible and rigid ultra-thin base materials enable highly reliable, thinner PCBs.
      Daniel Schulze, Engineering Manager at Dyconex 02.07.20

    • Materials
      Advancing Infection Prevention Tools

      Advancing Infection Prevention Tools

      The applications and benefits of porous polymer materials and components.
      Jack Chan, Global Marketing Director, Porex 01.17.20


    • Materials
      Avoiding Problems While Collaborating in the Medical Textile Industry

      Avoiding Problems While Collaborating in the Medical Textile Industry

      When to include or exclude an inventor from a patent application.
      Mareesa Frederick and Courtney Bolin, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 12.19.19

    • Materials
      Understanding Key Processes for Mixing APIs with Silicone

      Understanding Key Processes for Mixing APIs with Silicone

      The pros and cons of drug delivery and device enhancement.
      Andrew Gaillard, Healthcare & Medical Segment Manager, Trelleborg Sealing Solutions 12.05.19

    • Materials
      Novel Polymers for Sustained Release: Trends Impacting the Drug Delivery Market

      Novel Polymers for Sustained Release: Trends Impacting the Drug Delivery Market

      An interview with ProMed Pharma's director of pharma services James Arps analyzes the diverse drug delivery/combination products market.
      Sam Brusco, Associate Editor 11.15.19


    • Materials
      5 Questions for Scapa Healthcare at Medica/CompaMed 2019

      5 Questions for Scapa Healthcare at Medica/CompaMed 2019

      Formulation development, adhesive coating, filling, converting, printing, and packaging for skin-contact adhesive and skin care topical solutions.
      Sean Fenske, Editor-in-Chief 11.15.19

    • Materials
      5 Questions for NuSil Technology at Medica/CompaMed 2019

      5 Questions for NuSil Technology at Medica/CompaMed 2019

      Celebrating 40 years of high purity materials for medical devices.
      Sean Fenske, Editor-in-Chief 11.15.19

    • Materials
      5 Questions for Elkem Silicones at Medica/CompaMed 2019

      5 Questions for Elkem Silicones at Medica/CompaMed 2019

      Range of implant-grade silicones, comprised of injectable and extrudable silicone rubbers, as well as adhesives.
      Sean Fenske, Editor-in-Chief 11.15.19


    • Materials
      5 Questions for DSM at Medica/CompaMed 2019

      5 Questions for DSM at Medica/CompaMed 2019

      Material solutions for cardiology, soft tissue repair, wound care, diabetes, cellular therapies, and orthopedics applications.
      Sean Fenske, Editor-in-Chief 11.15.19

    • Materials
      5 Questions for Saint-Gobain Life Sciences at Medica/CompaMed 2019

      5 Questions for Saint-Gobain Life Sciences at Medica/CompaMed 2019

      Filtration technologies and custom-developed, purpose-built, filtration-based solutions.
      Sean Fenske, Editor-in-Chief 11.15.19

    • Materials | Molding | Packaging & Sterilization
      5 Questions for Colorite at Medica/CompaMed 2019

      5 Questions for Colorite at Medica/CompaMed 2019

      Thermoplastic elastomer compound line for a wide variety of uses in medical devices and packaging.
      Sean Fenske, Editor-in-Chief 11.15.19


    Trending
    • STERIS To Buy Cantel Medical For $4.6B
    • Meeting Critical Ventilator Product Requirements Amid Pandemic
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Medtech Matters: Talking Robotic Surgery With Zimmer Biomet
    Breaking News
    • Optimize EP Launches CaRM Cardiac Device Data Management Platform
    • U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    • FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    • Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    • Moon Surgical Expands Leadership Team
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Brown Fat Associated with Reductions in Chronic Disease Risk
    NIH Study Identifies Antibacterial Properties in Taurine
    NSF Begins New Certification Program
    Coatings World

    Latest Breaking News From Coatings World

    Zeppelin Acquires MTI Mischtechnik
    Ezio Braggio Joins ChemQuest Europe
    IFS Coatings Announce Carbon Offset Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Optimize EP Launches CaRM Cardiac Device Data Management Platform
    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    Frontage Bolsters Clinical Services Capabilities
    Sanofi Unveils EUROAPI as Name of New European API Company
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Neenah to Host Packaging Webinar for Printers
    W.S. Badger is Named a ‘150 Top Impact Company’
    Mana Products, Meiyume and RPG Form The Vertical Beauty Alliance
    Happi

    Latest Breaking News From Happi

    Amyris Named a Top Social & Environmental Impact Company
    L'Oréal Bans Animal Hair in Brushes
    Ashland Launches Antaron ECo Gel
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Shemesh Adds U.S. Headquarters
    TZMO USA, Special Needs Group Form Partnership
    BAHP Announces 2021 Officers, Board of Directors
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    New Chief Clinical Officer on Board at IncludeHealth
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Toppan Announces 2050 Environmental Vision
    SOI Industry Consortium Joins SEMI as Strategic Association Partner

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login