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.

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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.