Startup makes ‘smarter CPR’ device to replace ‘outdated’ tool
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Three out of four patients who need emergency CPR in the hospital die, despite being surrounded by medical staff and equipment, says Dr. Jonathan Merrell. The entrepreneur, physician and engineer believes it’s a “failure of the equipment we’re using”; medical staff have relied on the same traditional bag valve mask (BVM) to deliver CPR since it was invented in 1957.
“We can do better,” says Merrell, and his Indianapolis-based startup plans to not only sell a device for “smarter CPR,” but also find higher meaning in how it’s manufactured.
Most people would recognize a traditional BVM; a mask is attached to a football shaped “bag” that medical staff squeeze by hand to help a patient breathe. BVMs are used routinely by paramedics and emergency departments, and most hospital rooms are stocked with a BVM in case it’s needed.
“If you look at cardiac arrests inside a hospital—with doctors, nurses and all the equipment you could possibly ask for around them—the mortality rate is still 75% [for people who need CPR]. It’s not fair to [medical staff]; they’ve been given equipment that was invented in the 1950s,” says Merrell, who is co-founder and CEO of Compact Medical. “We can do better. That’s our mission as a company: smarter CPR. [We’re] redefining what a BVM looks like and what it does to make it safer for everybody.”
Merrell says traditional BVMs contain more air than a patient needs to receive, and there’s no ability to prevent a lifesaver from giving a patient too much air or too much pressure.
“Human lungs are like balloons; you can pump them up so full of air that eventually they do pop, and that’s a condition known pneumothorax, or a popped lung,” says Merrell.
Merrell says giving a patient too much air can also increase chest pressure, cutting back blood return to the heart, which can cause death “by the very people who are trying to save the person’s life.”
A pediatric resident at Riley Hospital for Children at the time, Merrell first had the idea for a “smarter CPR” device while working in a local NICU (Neonatal Intensive Care Unit). Called Butterfly BVM, its name references the movement of its two sides that open and close like butterfly wings, or fireplace bellows, with an accordion-like middle. EMS World Magazine recently named the Butterfly BVM as a finalist for its 2023 Innovation Awards, which recognize new products that have the “potential to transform EMS care.”
Like traditional devices, the Butterfly BVM is operated manually by hand with no electronics, but has two dials “that are groundbreaking and aren’t found on any current offering in the BVM market.” One dial adjusts “tidal volume” to “something that’s much more reasonable than what is typically set by your standard BVM today.”
Merrell says a study with a team of ER doctors at IU Health’s Simulation Center showed the Butterfly BVM out performed the conventional BVM.
“Our dial has 13 different settings you can select, which will restrict the total amount of air the device can give to a patient; anywhere from what’s appropriate for a newborn baby, all the way up to a full-size adult—and all the pediatric ranges and everything in between,” says Merrell.
Merrell says the second dial “is a gamechanger” that sets peak pressure, giving the user seven options and a maximum pressure; if a traditional BVM is squeezed too aggressively, a lifesaver can send a spike of pressure that injures the patient’s lungs.
“The safest thing to ventilate a patient is a mechanical ventilator; a patient is intubated, and you can select what the pressure, volume and rate should be,” says Merrell. “The Butterfly BVM is getting closer to what you can do with a ventilator, but this is entirely controlled by human hands.”
Now on the doorstep of commercializing its first device, the startup has found higher meaning in manufacturing. Compact Medical is partnering with Hope Center Indy, a faith-based not-for-profit for women escaping human trafficking. Women can live on the campus, receive care and learn job skills to reintegrate into society.
“[Our assembly and manufacturing process] is…providing high-paying jobs for [Hope Center] residents, and they can learn new skills as they’re working to rebuild their lives,” says Merrell. “Hope Center’s mission is remarkable, and it’s so needed in the world today. We had other potential contract manufacturers who were interested…but the ability to do some greater good was something that really appealed to us.”
Merrell says the Butterfly BVM is helping to launch a contract manufacturing company at the Hope Center.
Merrell says the startup is submitting the device for 510(k) approval from the FDA, which is known as the “fast-tracking pathway,” and hopes to launch the Butterfly BVM next year.
“We’ve had BVMs for the last 65 years, and we think outcomes can be better,” says Merrell. “That gives us a lot of drive and a lot of motivation to see [the Butterfly BVM] get out into the real world, make a difference and save lives; that’s really what we’re all about in the end.”