SECO is a high-tech manufacturer of computer miniaturization and ready-to-use IoT integrated systems. It is not a traditional medical device company. But it is part of an emerging trend to partner with medtech companies to get more ventilators on the market quickly to help in the fight against COVID-19 .
“We don’t necessarily operate in the medical device space but it is one of our vertical markets,” says Greg Nicoloso, CEO of SECO USA.
Driven by the desperate need for ventilators during the early stages of the COVID-19 pandemic in Italy, Italian Biomedical Devices (IBD) S.r.L, led by Dr. Corrado Ghidini, quickly created a noninvasive and portable ventilator, going from concept design to first prototype build in just five weeks.
In early March, IBD approached SECO looking for embedded boards to place into a potential ventilator. This new ventilator would be a transformation of a portable dialysis device that IBD had already marketed.
“We realized fairly quickly that perhaps they didn’t have all the knowledge for what this new product needed,” he says, “and that we could put the wind behind them and help to take it to market.”
SECO and IBD forged an agreement so that SECO could help IBD with technology, industrial operations, sourcing, and marketing. The relationship evolved to include distribution of the new Biorespira ventilator worldwide.
“We did this very rapidly because of the state that Italy was in back then. Italy was really desperate for ventilators because of how quickly the pandemic was spreading,” he says.
The Biorespira is designed to help healthcare providers oxygenate adult patients without intubation in almost any location — outside of an ICU, in hospitals’ general medical wards, in nursing homes, or in private residences.
Due to the clarity and simplicity of the interface, nurses, in-home care providers, and family members require only minimal training to operate Biorespira. The device was created as a high flow system, providing an adjustable percentage of oxygen from 21 to 100 percent and a flow rate between 10 and 120 L/min. Using medical helmets or a nonvented face mask with the device ensures a closed loop system, nearly eliminating the chance of passing the SARS-CoV-2 virus that causes COVID-19 from patient to caregiver.
The Class II device is very similar to others on the market, says Nicoloso. So, while they have submitted a 510(k) for the device, they have also submitted it for FDA Emergency Use Authorization (EUA). If approved, multiple Biorespira pulmonary ventilators will be donated to hospitals in the United States, with priority given to Black communities.
“I’m eager to see Biorespira deployed and helping patients fight the effects of pneumonia and respiratory insufficiencies around the world, especially in communities that face challenges in receiving top quality healthcare,” says Dr. Ghidini.
Editor and Director of Medical Content