Mr. Dennis Cook
CEO, Superior Felt & Filtration, USA
Mr. Dennis Cook is a passionate patient safety advocate, patent holder, who led the development of dozens of medical device products in the respiratory, anesthesia, and emergency medicine. He is committed to providing an environment for creativity for product design while balancing regulatory requirements, delivering unmet market needs, and design for manufacturing.
Mr. Cook has a dual major in Respiratory Care, and Business Management from Missouri State University. He started his career as a clinician and hospital administrator for the first 7 years of his career, then transitioned to medical device manufacturing in 1995. There he managed and developed adult, infant, and emergency medical ventilators, and oxygen delivery devices. Mr. Cook was then elevated to leadership roles as V.P of Marketing for Medline Industries, then President of the Respiratory Division. Mr. Cook then spent several years in Private Equity portfolio businesses acquiring, integrating, and divesting businesses. After that Mr. Cook co-founded a Respiratory and Anesthesia Medical Device manufacturer, D-R Burton Healthcare Products LLC and led the development of several devices that received FDA cleared followed by commercial success. Finally, Dennis is now the CEO of Superior Felt and Filtration, that has recently become a leading contract manufacture of “Industrial Non-Wovens, and Medical and Liquid filtration products”. This transformation for Superior Felt
Dec 5, 2023, 8:55AM-9:10AM EST
Medical Air Filtration Regulation Update and New Opportunities
“When Your Life Depends On It”
As the specter of COVID-19 fades and we emerge from its grip, regulatory scrutiny is intensifying to prepare for potential future respiratory pandemics. We will look at current FDA recognized standards for bacteria/viral filtrations for FDA product code, CAH . The USFDA regulations and testing standards for bacteria/viral filtration continues building on historical biocompatibility requirements. The latest revision to regulations for product code CAH was fortuitus as it relates to gas flow pathways, Volatile Organic Compounds (VOC’s) leachables in condensate, and particulate matter. Review of bacterial/viral filtration products for is underway by U.S. regulatory bodies. This is a result of increased understanding of bioburden loading of filtration media and declining efficiency over time catalyzed by the COVID-19 pandemic. In addition, and unrelated to B/V filters, N95 mask filter media and construction are getting a serious review. As a result, N95 masks will also be impacted from these regulatory body reviews and future incremental regulatory requirement changes. Such as separation of inhaled and exhaled air filtration, filter media degradation, and a decrease in non-anatomical deadspace created by N95 face masks. Lastly, we will discuss opportunities to participate in markets as we continue into the post COVID-19 era.