The Boston Globe’s weekly Ocean State Innovators column features a Q&A with Rhode Island innovators who are starting new businesses and nonprofits, conducting groundbreaking research, and reshaping the state’s economy. Send tips and suggestions to reporter Edward Fitzpatrick at firstname.lastname@example.org.
This week’s Ocean State Innovators conversation is with Michael Lombardi, founder and president of Lombardi Undersea, a diving contractor and consultant based in Middletown, R.I.
Question: Where did you get the idea to make oxygen treatment hoods in response to the COVID-19 outbreak?
Answer: I had my eye on the oxygen treatment hoods after seeing some media from Italy where helmet-based ventilation has been used for several decades. It dawned on me that these same hoods were used here in the United States for hyperbaric oxygen treatment of decompression sickness. After several discussions with colleagues, and after receiving a serious inquiry to manufacture 10,000 of these to meet a US supply deficiency, the opportunity presented itself as real.
I teamed up with Subsalve USA, a Quonset-based manufacturer of performance inflatable products for underwater, defense, and other markets. It is really their manufacturing capacity with 40 years in the business that is driving the success of the hood itself. Within a week, we had a functional prototype, and within two weeks we had several dozen sample units in the hands of key US physicians for evaluation. We launched a site, www.oxygentreatmenthoods.com, to facilitate early sales and to provide additional product information.
Q: How many hoods have you made, how much do they cost, and where have you shipped them?
A: More than 2,000 hoods have been produced and shipped within the last six weeks, since starting the project, and we have several open orders. To date, units have shipped to the United States, Canada, Costa Rica, Brazil, Spain, Dubai, Nigeria, Philippines, South Africa, Ukraine, and Lithuania. Unit cost ranges from $125 to $145 depending on some features.
All indications are that the global COVID-19 market could be in excess of 500,000 of these devices. Presently, there is no single hood manufacturer with that capacity, so we hope to capture as much of that as possible. But most importantly, we hope to play an important role in ensuring the medical community does not have a shortage. It is important for all of the companies involved to find some success in the interest of humanitarian relief.
Q: How are the hoods being used in the United States? Do you need government approval?
A: The hoods are being used in the United States for investigational purposes, as well as medical staff training on this technology. We have requested emergency use authorization from the US Food and Drug Administration, and that process is in review. Multiple hospitals are coordinating various clinical studies, and all are sitting tight awaiting the emergency use authorization to go through.
Q: Can they be used in place of ventilators? What advantages do they offer as opposed to ventilators?
A: The oxygen hoods are the key patient interface for a treatment called noninvasive positive-pressure ventilation (NIPPV). This treatment is recognized as a proactive step to treat acute respiratory distress syndrome. A 2016 clinical trial conducted at the University of Chicago Medical Center revealed that NIPPV reduces the need for patients to be intubated (and placed on a ventilator), and also reduces patient mortality. This is a big, big deal. In the United States, the treatment protocol has been to quickly jump to intubation when respiratory distress becomes severe. In Italy, they go to NIPPV via these hoods to avoid the need to intubate, and it has proven successful.
Q: How do the hoods work?
A: The process is actually quite simple, and directly analogous to modes of diving I use in normal times. The hoods are supplied with a constant high flow of air with pure oxygen titrated in to elevate the oxygen fraction. The high flow creates a very slight pressure. This inflates the lungs and promotes oxygenation, which is therapeutic. The flow itself can come from wall air found in hospitals, a Bilevel Positive Airway Pressure (BiPAP) machine, or even a Continuous Positive Airway Pressure (CPAP) machine. Each source is substantially less expensive than the ventilators that have been in short supply.
Another added benefit is that a viral filter can be fitted on the expiratory side of the hood, so if patients exhale virus it does not spread into the health care worker’s space. That adds protection for the clinicians, which is equally important.
Q: What have your and your company manufactured in the past?
A: I have designed and built all sorts of interesting things over the years. I build my own life support for diving, partly out of necessity and partly because I trust myself explicitly and feel the need to understand the equipment at an intimate level to have this trust. I’ve been involved in systems, components, and instruments for rebreather systems, atmospheric diving systems, surface air systems, and other inflatable structures (for underwater).
In 2012, I was funded by the National Geographic Society to design and build an underwater inflatable tent to support very deep diving for science. I went on to patent the technology in partnership with New York University, and have significantly advanced the habitat’s life support over the last few years. This technology has direct implications in future Mars habitation. It has been very exciting to see the commonality in life system requirements among and between industry sectors.