Today’s ventilators, little changed since the late 1980s, aren’t suitable for the demands of a pandemic for many reasons. Founded in early March, CorVent has created a new category: the cost-efficient single-use ventilator. The start-up has already gained substantial seed funding with name-brand medtech investors, and engaged with the FDA on EUA approval.
The ventilator, for decades one of the most invisible and stagnant product categories in medtech, has become a hot topic these days because the volume of patients suffering with acute respiratory distress syndrome (ARDS) as a result of COVID-19 have overwhelmed hospitals’ ventilator capacity.
In a show of solidarity, manufacturers from many industries are working on the problem. New ventilator initiatives abound: GE Healthcare, and Ford Motor Company are working together to develop and manufacture ventilators that meet the need, and surgical imaging and robotics firm Synaptive Medical Inc. is retooling its manufacturing to help fellow Canadian company O-Two Medical Technologies Inc. scale up manufacturing of its portable transport ventilators, to name only two examples among many.
Others are trying to retrofit bilevel CPAP (continuous positive airway pressure devices) designed for treating sleep apnea, to adapt them to COVID-19 patients, since the conventional face masks and machines themselves weren’t designed to prevent airborne viruses from venting into the atmosphere or to treat patients that need to be sedated and/or intubated.(See “Bilevel Respiratory Devices for COVID-19: Making the Case,” Market Pathways, April 23, 2020.)
In turn, the founders of the medical device incubator Coridea LLC (parent to many “out-of-the box” portfolio companies, including Medtronic plc’s Ardian in renal denervation, Respicardia Inc. in central sleep apnea, Reprieve Cardiovascular Inc. in acute heart failure, Axon Therapies Inc. in chronic heart failure, and many more) decided to tackle the problem.
Coridea pulled together a team that includes renowned medtech inventor Mark Gelfand, Coridea’s managing director, and chief technical officer Zoar Engelman, PhD, Coridea’s chief science officer. Bringing deep ventilation expertise, the team enlisted John O’Mahony, a medtech veteran who was once senior technical manager at the ventilator company Nellcor Puritan Bennett (which is now part of Medtronic). For the engineering support, Coridea turned to its long-standing collaborator Design Catapult in Fountain Valley, CA, an industrial design firm with a track record of rapid prototyping and launching both medical and commercial devices.
As Coridea’s inventors customarily do, they took a deep dive into the problem before designing, “We looked at many things,” says Zoar Engelman, “from difficult-to-meet blood oxygenation needs of COVID-19 patients all the way to shortages in ventilators and not enough people qualified to run the complex machines.” The analysis led the team to conclude that for many reasons, today’s ventilators, little changed since the late 1980s, aren’t at all suitable for the demands of a pandemic.
Ventilators designed for critical care are expensive, complicated to operate and service, can’t be disinfected without risk to hospital staff, and require frequent adjustments, which, again, expose hospital personnel to infected patients. Moreover, they can’t be easily stockpiled for a year or two without ongoing maintenance because they contain batteries and oxygen sensors that expire and require regular calibration.
“When you open up a new critical care ventilator today, says Engelman, “you need to bring in a service representative to get it started. It can take hours to days, not only to start it, but to train people how to use the ventilator.”
Indeed, according to a recent article in the New York Times, while the US government had stockpiled 10,000 ventilators, 2,109 were unusable because they hadn’t been properly maintained. The article also notes that the government had to enter into a $38 million service contract to maintain the devices in storage.
The next category down, sub-acute machines used in hospice or home environments are only slightly cheaper and simpler to use and still have high maintenance demands.
On the other hand, inexpensive emergency transport ventilators are relatively easy to operate, but they’re not designed to provide autonomous critical care support for unconscious or semi-conscious patients over multiple days.
Fundamentally, current ventilators are built in a way that makes them unsuitable for stockpiling and rapid deployment. At the same time, the current technology has also been built around a business model that doesn’t lend itself to the pandemic scenario. Ventilators are capital equipment, sold for $15,000-$30,000 each, according to O’Mahony, with lucrative service contracts that account for about 60% of ventilation business revenues. They’re designed for near-continuous use over many years; tubing and accessories are replaced and the machines are cleaned and reprogrammed between each use. John O’Mahony says, “The average ICU ventilator is used 4,700 hours a year. There are only 8,760 hours in an entire year!”
Current ventilators are built in a way that makes them unsuitable for stockpiling and rapid deployment.
According to O’Mahony, because of the nature of reimbursement, the ICU ventilator evolved in an environment of what he calls “specsmanship.” That is to say, innovation has centered on the continuous addition of modes, controls, and other features that require complicated software, user interfaces, and electronics.
By way of analogy, he points to the automotive industry. “A Lexus might have a host of features that you don’t need in order to drive from point A to point B: electric windows, fuel injection, air conditioning, entertainment center, etc. You can make the journey just as safely without many of these features.” The automotive industry doesn’t just make its money by selling cars, service revenues are also important, and that drives a feature set model, he says.
Similarly, a sophisticated ventilator might offer about 30 different modes of ventilation, each with dozens of different setting levels. “The ICU ventilator is the Lexus or Mercedes of ventilation,” he says, and that’s how the technology gets complicated.
The Single-Use Ventilator
CorVent Inc. was born on March 6th after the team decided to participate in a Department of Defense “hackathon” that sought designs for a low-cost ventilator made of off-the-shelf parts that could be rapidly produced, simple to use, and built for rapid deployment during a crisis. Their entry placed in the top five out of 200 applications.
Looking at ventilators used in various environments today—the ICU, home care, and in emergency transport vehicles—none were right for the situation we face now, where the large volume of patients exceeds hospital ventilator supply, which is the case during a pandemic and in emerging markets. “We believed there should be a new category: the pandemic relief or simple-support ventilator,” says Mark Gelfand.
Specifically, the company believes the CorVent Single-Use Ventilator to be the first critical care ventilator enabling rapid and affordable deployment with superior infection control for respiratory insufficiency. It was designed to complement existing hospital supply with out-of-the-box ventilation that medical personnel can depend on to properly function without expensive, on-going maintenance contracts. CorVent has an easy plug-and-play set-up and an intuitive interface that enable even untrained medical professionals to use the ventilator without extensive training.
To solve the infection control aspect, the team decided the ventilator must be a single-use, single-patient system.
To solve the infection control aspect, the team decided the ventilator must be a single-use, single-patient system. (To be clear, there is a category of disposable respiratory support devices called resuscitators, which are manually operated, but CorVent has developed a device with the sophistication of a powered ventilator that continuously supports patients autonomously over several days.) The device also has integrated filters to prevent infectious disease from aerosolizing into the environment to safeguard staff and patients.
CorVent uses off-the-shelf parts from the respiratory industry to achieve a device that addresses respiratory insufficiency at a reduced cost (at a price comparable to high-end single-use electrophysiology catheters, Gelfand notes).
Ventilation is complicated, O’Mahony says, because nobody takes the exact same breath two times in a row. “When the patient inhales, our device recognizes that. We measure their inspiratory and expiratory volume, and with that, a lot of safety is covered,” he says, further pointing out that if no flow is seen, it’s clear that the device is not connected, and if there are large variances between inspiration and expiration, signals are triggered via built-in alarms to alert staff of issues. One particular pressure sensor can detect if there is high inspiratory pressure in the circuit, a sign of occlusion or inspiratory pressure that has been set too high.
Similar to high-end ICU systems, The CorVent ventilator offers adjustments for tidal volume, inspiratory time, breath rate, and positive index for expiratory pressure. If a patient takes a breath on their own, the device recognizes the event and delivers a breath in synchrony.
That all sounds very sophisticated for a low-cost device. O’Mahony points out that ICU ventilators address three types of breath: mandatory breaths, delivered according to a set rate and volume; assist breaths, where the ventilator recognizes that the patient is initiating a breath and finishes the breath for them, and the spontaneous breath, a third, more sophisticated mode used for weaning patients off of ventilators.
“One of the compromises we’ve made for ease of use and cost is to offer only mandatory volume control ventilation and assist control mode,” says O’Mahony. “However, this type of ventilator addresses the needs of 60-70% of all respiratory insufficiency patients.” The goal is to free up the limited number of high-end ventilators for the patients that require weaning.
The pandemic landscape is shifting rapidly. For those working in medical device start-ups (or journalists reporting the news) “short-term” used to mean several months; now that time horizon is about a week. Mark Gelfand notes that founding CorVent, “totally up-ended the idea of what it takes to create a medical device. What usually takes nine months of planning and development, we did in 5-6 days.”
The FDA too, is moving with unprecedented speed to get lifesaving interventions to patients. A ventilator is a Class II medical device that sustains life, subject to a rigorous set of regulatory requirements that are lengthy to complete, but the FDA is figuring out, under its Emergency Use Authorization (EUA) authority, a way to get new ventilators to patients safely (see “The New Regulatory Normal,” Market Pathways, April 20, 2020).
The FDA authorizes such products by working with companies to develop a sub-set of standards that ensures that products are safe for patients. Engelman says, “The FDA is taking its responsibility in this pandemic very seriously. We submitted on April 8, and they got back to us over the week.” The two parties are working together on the relevant standards and on labelling, since, as the FDA outlines in its March 24, 2020 Emergency Use Authorization letter discussing ventilators, there are several respiratory product categories relevant to the pandemic, including continuous and non-continuous ventilators, gas-machines used for anesthesia, CPAP devices, resuscitators and more.
The unheard of speed with which CorVent moved from founding to funding is another sign of the times.
The unheard of speed with which CorVent moved from founding to funding is another sign of the times. A group of investors led by France’s Sofinnova Partners (which includes Redmile Group, Exor Seeds, Genesis Medtech Group, The Deerfield Foundation, the Pagliuca Family Office, and Accel founder Jim Swartz) has committed to a $4.5 million seed financing. “Their engagement and belief in the CorVent Single-Use Ventilator has allowed us to go from prototype to production in a few short weeks,” Gelfand notes.
For next steps, the company is waiting for the EUA clearance from the FDA and looking for partnerships to expand manufacturing. It also will enter uncharted territory when it comes to distribution for the pandemic setting. Gelfand says that in addition to hospital customers, “We are exploring discussions with central or local governments, nursing homes or other local supplying, distributed networks as well as talking with potential distributors.”
The COVID-19 pandemic has accelerated many changes in medical markets, from respiratory care to telemedicine. (See “COVID-19: A Pivotal Moment for Telemedicine and Remote Care Technologies,” MedTech Strategist, March 31, 2020.) It’s often said that the genie won’t go back into the bottle. Once CorVent’s single-use and cost efficient ventilator begins supporting patients during pandemic times, will it also have a role in the routine practice of medicine?
There is plenty of precedent for such transformations, says Gelfand, pointing to disposable endoscopy tools, or the advent of portable automated external defibrillators. “The end result is that we are creating a new category of ventilators,” he says.
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