The novel coronavirus is having a significant economic impact on most sectors, including the healthcare industry. Government all over the world are responding to the threat of COVID-19 with all essential measures, such as nationwide lockdowns, social distancing, and large-scale quarantine to reduce the spread of the virus.
According to the CDC, there were over 2,208,486 confirmed cases and over 119,133 deaths in the U.S. due to COVID 19, as of 17th June 2020. As the COVID-19 outbreak has presented hospitals with a large number of patients requiring assistance from respiratory ventilators, there is an increasing demand for respiratory assisted devices. Currently, it is a challenge to predict the exact Coronavirus pandemic curve in the world. However, looking at the grim situation in the U.S., the peak demand for critical care equipment along with the mechanical ventilators and other respiratory assist devices is anticipated to rise significantly over the next few months.
Hospitals are overburdened with patients due to the COVID-19 pandemic and the scarcity of medical equipment in critical care units has been the biggest challenge for the healthcare sector. To cope up with the situation, on 24th March 2020 FDA issued Emergency Use Authorization (EUA) for some respiratory assist devices such as certain ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, sleep apnea devices, anesthesia gas machines for use as ventilators and others. The agency also confirmed that the manufacturers need not submit510(k) for the modified use of the products. Previously FDA also issued various EUA for special purposes such as for H7N9 Influenza in 2013, Ebola Virus in 2014, Zika Virus in 2016, etc.
The respiratory assist devices can be segmented into ventilators and ventilator accessories and others. The others include respiratory muscle stimulator, diaphragmatic pacing therapy system, and COVID-19 airway management isolation chamber (CAMIC). More than 50 players received EUA approval for their ventilators during this emergency which includes BioMedInnovations, LLC, Nanotronics Imaging, Inc, Guangzhou Hypnus Healthcare Co., Ltd, CMI Health, Lanick Med Systems LLC, AutoMedX, Inc. etc. The companies which got approval for ventilator tubing connectors include Bloom Energy, Stryker Instruments, Covidien LLC, Safe Flight Instrument Corporation, MakeMedical, etc.
According to the Intensive Care Med 2019 report, patients more than four days on mechanical ventilation develop respiratory muscle atrophy which causes delayed extubation and weaning failure. In May 2020, FDA issued EUA for VentFree Respiratory Muscle Stimulator from Liberate Medical, LLC to reduce disuse atrophy during prolonged ventilation. in February 2020 EUA has been issued for Hemolung Respiratory Assist System from ALung Technologies, Inc. to treat lung failure from COVID 19. It can also be used as an adjunct to invasive or non-invasive mechanical ventilation to reduce the chances of hypercapnia and alike symptoms.
On May 2020 FDA issued EUA for the emergency use of COVID-19 Airway Management Isolation Chamber (CAMIC) within the Military Health System by the healthcare providers and U.S. Army as extra protection along with PPE (personal protective equipment) to prevent contamination during transport of COVID-19 confirmed or suspected patients. CAMIC consists of plastic bags, perforated PVC piping, wall-mounted vacuum pump, or portable vacuum pump with HEPA filter.
COVID-19 has already caused major social and economic impacts globally. This public health emergency can be a critical time for the growth of medical devices especially respiratory device manufacturers. Companies have a major opportunity to demonstrate the effectiveness and efficacy of their products during the pandemic. On the contrary, there are some limiting factors such as scarcity of labor and closed manufacturing plants, supply chain hurdles, traveling difficulties which can impact the production. On a brighter side, the lengthy approval procedures by regulatory authorities are expected to be resolved post-pandemic, if the products can show proven efficacy during this emergency. New companies possess a major opportunity to launch products during this emergency and show their efficacy to ease up regulatory approval procedures and gain market share.
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