When Neil Ray, MD, founder and CEO of FII graduate Raydiant Oximetry and a board-certified anesthesiologist, learned about the global shortage of ventilators early in the COVID-19 crisis, he immediately considered ways that he, his colleagues and others in the Silicon Valley medtech ecosystem could help.
He first reached out to Russ DeLonzor, Raydiant Oximetry’s COO, who had previous experience working with ventilators as vice president of R&D at Nellcor Puritan-Bennett, which is now part of Medtronic’s portfolio, one of the largest medical device manufacturers of ventilators.
“Given my extensive experience using ventilators as an anesthesiologist, our experience in the industry and our network here in Silicon Valley, we were intrigued and encouraged by the idea of developing a safe, effective, low-maintenance and inexpensive ventilator that could save the lives of COVID patients with acute respiratory distress syndrome (ARDS),” said Neil.
“We were reading headlines regarding physicians in Italy having to make decisions on who would get a ventilator and who would potentially be left to die, and articles on U.S. states facing critical shortages of life-saving equipment. We knew there had to be a better way and had to do something to address this immense need,” added Russ.
Collaborating for good
Within a few days, the duo recruited a core group of founders, and within a few weeks, a cross-functional group of over 30 medical device experts joined the effort, including physicians, engineers (software, industrial design, electrical and mechanical), and quality and regulatory personnel. Some of those who volunteered were already retired, while others were still working in the industry or had been laid off due to the pandemic.
“I have never seen this type of collaboration; it’s incredible how quickly we were able to assemble a team and equally, how quickly they agreed to volunteer their time to assist patients during this crisis,” said Russ. “It really speaks to the strength of our ecosystem and willingness to step forward when it matters. These folks couldn’t go to sleep at night knowing they had the ability to develop something that would make such an impact on people’s lives.”
It took the team only four weeks to create the design and file patent applications, the latter thanks to the pro bono work of Amy Embert, counsel at Hoge Fenton Jones & Appel. The team also anticipates FDA approval under the new COVID-19 Emergency Use Authorization (EUA) for medical devices shortly.
The chosen design for commercialization came out of the early ingenious work by Russ’ son Dylan and his girlfriend Jessica Brown, both recent mechanical engineering graduates. The couple came up with a unique concept that built on the idea of a disposal resuscitator used in ambulances to keep patients ventilated. The end product is more effective, precise and durable.
Meeting more than a short-term need
Rather than just coming together to design a ventilator for a short-term need, the team decided to incorporate and head towards the path of a fully commercialized medical device company, with the aim to manufacture and distribute these life-saving devices around the globe. They named the corporation Respirana, which means to “breathe again.”
During this initial stage Neil and Russ have been serving as advisors, helping coordinate the clinical and medical input and R&D efforts. Co-founder and experienced strategy, finance and operations executive Tom Hillman is leading the company’s launch efforts as CEO and CFO. Until now, the project has been entirely self-funded.
Respirana’s ventilators will address the needs of patients with ARDS in ICU and emergency care settings during and after COVID-19. There will also be an opportunity to stockpile them for potential future pandemics, given that this device requires very little service maintenance and is a lower-cost option, compared with mechanical ventilators that can cost up to $50,000.
The ventilators will initially be made available in the most vulnerable settings, including South and Central America and Africa where they are in dire need; for example, Sierra Leone only had 18 ventilators to serve a population of 7.5 million. In the near future, the company plans to raise funds to finish commercialization, begin initial production, develop pathways for distribution and seek 510(k) approval.
“This has been a tremendously rewarding experience,” said Tom. “It showcased the deep impact that the power of collaboration, coupled with shared passion for saving human lives, can make. We are deeply appreciative of the time, dedication and enthusiasm of our entire team who kept us going, day after day and night after night, to accomplish our mission.”