Due to COVID-19 the worldwide demand for ventilators has skyrocketed. As hospitals and other care centers are scrambling to treat critical patients, medical device manufacturers and product development companies like Nectar are working more quickly than ever, utilizing all of their resources to push out more of these devices.
Developing highly sophisticated ventilators requires extensive resources and an expert staff, but most importantly, it requires the capabilities to create a device that meets all compliance standards without delay. Nectar is well equipped with an ISO 13485 QMS, and felt confident in their ability to develop a safe, FDA cleared ventilator rapidly. Darren Saravis is Nectar’s CEO and the founder of BreathDirect. He describes “not having any other choice,” when it comes to this project, “I would never have been able to live with myself if I didn’t step up and do this because I have the ability, I have the team, we have the resources here, and I don’t want to wake up and know that I was responsible for people not living,” he says. (Reuters, 2020).
BreathDirect is a ventilator designed by Nectar to meet 90% of the needs of COVID-19 critical care patients. The ventilator was developed to utilize readily available parts to help significantly lower cost per unit. The team reached out to frequent manufacturing partner, the San Jose based firm, EVOLVE, to assist with this immense undertaking. Both Nectar and EVOLVE’s quality management expertise will contribute to BreathDirect’s timely availability.
It is because of their ISO 13485 QMS that Nectar is able to design a device quickly that meets quality standards for market clearance by the FDA. Nectar’s development process has always embodied the thorough design methodology that an ISO 13485 QMS requires. With the help of Nectar’s team of dedicated engineers and designers BreathDirect plans to be able to produce up to 40,000 devices a month, with it’s first unit coming off the line in April. For more information visit Breathdirect https://breathdirectvent.com/.
