When the COVID-19 crisis took hold worldwide, it became very clear that the supply of ventilators could dramatically change the course of the pandemic. Nectar’s CEO, Darren Saravis describes “not having any other choice,” in deciding to develop a ventilator. “I have the ability, I have the team, we have the resources here,” he said, “I don’t want to wake up and know that I was responsible for people not living,” (Reuters, 2020).
And BreathDirect was born.
Nectar engineers hit the ground running on March 22, 2020 with just an idea. Quickly the team realized that the BreathDirect ventilator could be more than an emergency ventilator for short term use, but a critical care ventilator for long term use throughout the continuum of care in the ICU, developed with the guidance of nurses and physicians. This differentiates BreathDirect from many of its peers in this emergency response space. The BDR-19 meets 90% of critical care needs, allowing it to be used for longer periods of time and for a larger variety of patient needs.
Nectar’s engineers had been involved in other ventilator projects which helped endow them with knowledge of the technical and regulatory obstacles ahead. It was Nectar’s ISO 13485 Certified QMS that first provided confidence that the team could design a device quickly. The QMS that Nectar utilizes ensures that quality standards are being upheld in every part of the development process, and records them efficiently in the method preferred by the FDA.
Nectar’s development process embodies the thorough design methodology that an ISO 13485 QMS requires. Even on a tight schedule, Nectar was able to utilize a group of 20 clinical experts to inform the device’s user needs. This exercise in design thinking makes sure that the final users of these devices directly inform the prototype iterations, and ultimately, the configuration of the final product.
Besides all the challenges of packing what is typically a 24-month magnitude project into just a few months, there was also the entirely new set of working conditions brought about by the Stay At Home Order. While laser-focused on the safety of the ventilator, the team was also dedicated to protecting each other, social distancing and donning masks for the essential hands-on work.
The device is now in more advanced stages of testing, progressing towards FDA clearance, and BreathDirect’s team is gearing up to distribute the BDR-19 internationally. For the next few weeks Nectar wants to introduce you to team members and share with you their insights from working on the BreathDirect project, and their varied areas of engineering and design expertise.