The COVID-19 pandemic created a historic global crisis. A year after the initial outbreak in Wuhan, China, governments’ public-health response has shown that the wheels of progress grind slowly. Enter private-sector technology entrepreneurs, who are pitching in to address some of the pandemic’s most vexing clinical challenges. And many of the most original ideas are coming from innovators whose core businesses are not in health care.
Take pulmonary support. The onset of the pandemic caught the global health-care community critically short of ventilators—machines that breathe mechanically for patients whose lungs are disabled. Several tech-sector innovators are improving patient outcomes with ventilators by making them better, more effective, and more available outside of overtaxed intensive-care settings.
Project BreathEasy is an initiative that creates “digital twins” of human lungs to help doctors make more informed decisions—including choices about ventilator settings and patients’ time on ventilators, ultimately leading to more effective use of scarce intensive-care resources. The initiative was launched by OnScale, a cloud analytics company in Redwood City, CA, and LEXMA, an advanced computational fluid dynamics (CFD) solver company based in Arlington, MA.
Meanwhile, the Institute for Transformative Technologies (ITT) in Oakland, CA, is developing the iPAP, or Intelligent Positive Air Pressure Machine. Combining a BiPAP machine with an integrated oxygen concentrator, the iPAP could provide noninvasive pulmonary support for COVID-19 patients in primary-care settings. It could also be useful for places where ventilators are impractical—such as remote areas in low-income countries.
And in Toronto, Ontario’s provincial government approached ForceN, which is a member of the Autodesk Technology Centers, to meet Canada’s shortage of ventilator pressure sensors. ForcenN’s ForceFilm is a paper-thin force-sensing system that provides a “digital sense of touch” in robotics, automotive, aerospace, and other high-reliability industries. ForceN rapidly prototyped its proprietary technology to not only meet the pressure-sensor shortage but also improve the pressure sensitivity in a new generation of ventilators.
BreathEasy’s Digital Twins
Aerospace engineer Ian Campbell heads Project BreathEasy’s multidisciplinary team. “I don’t have a lot of firsthand knowledge about human lungs,” Campbell says. “What I know is how to run computational fluid dynamics simulations on massively scalable cloud supercomputers. I built a company called OnScale to do that.”
As the COVID-19 crisis developed, Campbell began looking for ways to apply that expertise. It became apparent that doctors needed to assess each patient individually, as the infection attacked each individual’s lungs in different ways. Using data principally from CT scans, OnScale and LEXMA engineers created a set of 3D simulations—a digital twin—of each patient’s lungs for individualized case assessment.
“Back in March, when we first developed the capability,” Campbell says, “doctors were asking: ‘Do I intubate this patient or not? If I do intubate the patient, what should be the pressure and the volume of air for each breath cycle? How long should I keep the patient intubated? And for different durations and settings, what are my expected outcomes?’”
Time is of the essence. If a patient arrives exhibiting COVID-19 symptoms, the doctor will order a CT scan, which provides 3D data to generate the simulations. “Our solution can then simulate air going into lungs, the lungs extracting oxygen from the air, et cetera,” Campbell says. “We can run the simulations very quickly on cloud supercomputers.” This process puts out a set of recommendations—most important, whether to intubate.
Traditionally, doctors use pulse oximetry, physical analysis, and textbook examples to decide whether to intubate a patient. There are good models for influenza, but COVID-19 models are new and constantly shifting. The digital twin provides a better analytical framework to manage outcomes, Campbell says.
Project BreathEasy intends to create an artificial-intelligence model to provide that analytical framework. Currently, a small data set comes from only several hundred patients. The model’s predictive power will increase as the data set grows. Campbell’s team is working with several ventilator manufacturers to collect more patient data.
Presumably, the digital twin will enable doctors to assess patients in finer detail, leading to better clinical outcomes, shorter intubation periods, and more effective resource management. “If facilities get swamped, patients die,” Campbell says.
ITT’s Primary-Care Pulmonary Support
ITT is a nonprofit organization set up to address macro-scale global problems such as food insecurity, wealth inequality, and human rights—often through fostering appropriate technology for low-income countries. ITT had focused on challenges such as small-scale solar-energy generation and village-level sanitation, as well as health-related projects in sub-Saharan Africa.
“And then, COVID-19 hit,” says Noha El-Ghobashy, ITT’s chief operating officer. ITT investigated the feasibility of a low-cost ventilator to deploy in Africa. The difficulty, according to El-Ghobashy, was that more than 90% of Africans have access only to primary-care facilities. “They don’t have access to tertiary hospitals with ICU beds, trained professionals, and reliable oxygen supplies,” she says.
COVID-19 patients in Africa need oxygen delivered under positive pressure to keep the alveoli in the lungs open. That’s the function of a BiPAP, a machine commonly used by first-world patients to control sleep apnea, either in a primary-care setting or at home. It doesn’t require oxygen lines or tanks, which are scarce in low-income countries.
A BiPAP may not by itself be a solution for COVID-19, El-Ghobashy says, but it could help manage COVID-19 patients’ care if combined with an oxygen concentrator. She says the trick is to precisely control the positive pressure and maximize the oxygen concentration—and to keep the cost of the entire solution under $500 to make it affordable in emerging economies.
The iPAP combines the simplicity and low cost of a BiPAP machine with key functionalities of a ventilator, integrating an oxygen concentrator and a pulse oximeter to control oxygen levels and pressure. Crucially, the unit includes an ultraviolet sterilizer for exhaled air from the mask to protect doctors and staff from aerosol infection. Either the unit or a smartphone will control oxygen concentration and pressure.
An “O2pus” unit will comprise the mask, tubing, valves, and sterilizer and will be launched and marketed separately for use with standard BiPAP machines while the iPAP is under development.
The health infrastructure in sub-Saharan Africa is extremely fragile, El-Ghobashy says. For example, maintaining a reliable oxygen supply is a significant limiting factor. ITT looked at local entrepreneurs who had developed medical-grade oxygen businesses but found that none of them were financially sustainable. So, as a separate initiative from the iPAP, to address the sub-Saharan oxygen shortage, ITT launched its own grant-funded “franchise model,” offering capital and technical assistance for local businesses to set up medium-scale oxygen plants. Philanthropic funding is used to “de-risk” the local startup, but it is expected to move to commercial sustainability in a short span of time.
ITT hopes to manufacture the iPAP systems in multiple locations—India, China, Malaysia, and Eastern Europe—to avoid the potential supply-chain disruption that ventilator marketers experienced at the start of the pandemic.
ForceN’s Pressure Sensing
ForceN started in 2015 with a focus on surgical and industrial robotics. “We make specialized force sensors for surgical robots—that way, the robot can feel the forces it applies to the human body,” ForceN’s CEO Rob Brooks says. “That’s our day job: robotics and high-reliability automation.”
ForceN manufactures a paper-thin membrane embedded with tiny force-sensing transducers that generate data to measure the forces pressing on and deforming that membrane. Where a human surgeon would feel pressure in the fingertips, ForceN’s sensors can be applied on robotic systems and medical devices to measure life-critical forces, aiding the surgeon’s procedure.
ForceN’s COVID-19–related R&D began with a Saturday-night phone call from Warren Ali, VP of innovation at Auto Parts Manufacturers’ Association (APMA), to Angad Sandhu, ForceN’s VP of business development. APMA continues to work with and support the Ontario government on ventilator production.
“Ventilators need pressure sensors,” Sandhu says. “The ones being used in many of the ventilators on the market today have been made in the US by Honeywell, primarily for the US market. There was concern that Canadian ventilator manufacturers might not be able to get those pressure sensors in time to save lives.”
ForceN quickly developed an alternative to the Honeywell sensor (with minimal funding, using makeshift development facilities during the pandemic lockdown). Honeywell eventually ramped up production to meet the market need, Brooks says, but Canadian ventilator manufacturers now have a backup source because of ForceN’s rapid prototyping and digital manufacturing.
The pressure sensor controls the flow of gases into the patient’s lungs and the pressure at which those gases are provided. Even healthy lungs can only withstand so much pressure. “You want to have a system that controls the pressure in the patient’s airways as closely as possible to prevent bruising,” Brooks says. “Just forcing air in can really damage a patient’s lungs. ICU-grade ventilators typically have four to five sensors to control pressure and the composition of the air.”
ForceN’s prior experience in medical-grade manufacturing gave it a regulatory advantage. “We’re not the final manufacturer of the ventilator, so we’re not the ones applying for regulatory approval,” Brooks says. “But we already know how the US and Canadian approval processes work.”
In many countries, government-funded teams rallied to pivot manufacturing operations to produce more ventilators, repair old or broken machines, and locate forgotten stockpiles. These are both commercial and political problems. The world’s best-prepared governments have begun to give their health-care providers some breathing space to think not only about sourcing enough ventilators but also how to achieve the best outcomes with the resources they have. That’s where entrepreneurs make their most direct contributions.