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This year, it could all come together for Annamarie and Paul Saarinen, the wife-and-husband team behind Minneapolis-based medtech startup Bloom Standard.
Officially launched in 2020 by Annamarie, who’s CEO of the company, Bloom Standard is developing a portable ultrasound device for scanning newborns’ hearts and lungs for potentially fatal conditions. If successfully brought to market, the company estimates its device could save an estimated 1.3 million young lives annually worldwide.
As of early March, Bloom Standard has raised $2.1 million in funding. Approximately 50% of that is from investors (two-thirds from Minnesota), and the remainder from R&D grants and non-dilutive funding. The company also completed a second pre-seed venture round in early December, which capped a very busy year. That same month, Bloom Standard announced that the U.S. Food and Drug Administration (FDA) granted a “Breakthrough Device Designation” for its flagship product, the EVA RAPIDscan ultrasound system.
Before that, in October, the startup received a utility patent for its device, with more patents expected to follow. The company is moving through the FDA approvals process and intends to begin commercial manufacturing early next year.
This year, Annamarie will be meeting with physicians and infant-health professionals in Wales, Mexico, India, Mongolia, and Bolivia as well as in the U.S. “They’re co-development partners on our device,” she says. “They’ve given us lots of support.” The company currently has eight clinical study sites across four continents, with seven more sites waiting for prototypes. In between her travels, she and Paul juggle video calls and time zones with their far-flung researchers and executives. “We’ve both been learning how this works, and how our personalities fit into these roles,” says Paul, who is Bloom Standard’s CMO. Adding to the challenge: The Saarinens are a two-entrepreneur family. Besides his “day job” for Bloom Standard, Paul co-owns Starcade, a St. Paul arcade featuring classic 1980s games that he co-launched a few years ago.
Plus, the Saarinens are parents to two teenage daughters, and they’re devoted to maintaining a supportive family. What keeps them persevering? Above all, it’s Bloom Standard’s mission, which is very close to their hearts—as close, in fact, as their younger daughter.
Birth of an Idea
Neither Annamarie nor Paul Saarinen is an engineer. Nor did they have long medical device resumes before Bloom Standard. Annamarie worked as a TV producer in Iowa and Kansas, covering health and policy before shifting to public affairs, government relations, and health economics. Paul built a career in online marketing and advertising; he’d also conducted product development and marketing work for several medtech companies.
Fifteen years ago, everything changed for the Saarinens.
That’s when their daughter Eve was born, a couple of years after her sister, Elle. Just before the hospital was ready to send mother and daughter home, the family’s pediatrician discovered that Eve had a heart murmur. Heart murmurs in newborns aren’t necessarily worrisome. Still, the Saarinens’ pediatrician suggested checking it out via an echocardiogram, an ultrasound image of the heart. Fairview Southdale didn’t have its own pediatric “echo” equipment, but the Edina hospital just happened to have available a rolling mobile echo cart and a pediatric echocardiographer from the University of Minnesota’s Children’s Hospital, who was visiting that day to evaluate a different baby. The pediatrician jumped at the chance to get baby Eve evaluated on the spot, telling Annamarie and Paul that she didn’t want them to worry. “And I wasn’t worried about it, to be honest,” Annamarie recalls. “Eve looked totally fine.”
An hour later, “there’s a cardiologist standing in the doorway of my room saying that Eve was in heart failure.”
Eve was rushed to U of M Children’s (now M Health Fairview Masonic Children’s Hospital), which could provide the cardiac care she suddenly needed. Doctors there discovered that she had rare and critical defects in her heart, problems that had been missed during previous prenatal ultrasounds. Besides having a rare mitral valve defect, Eve had an extra electrical pathway in her heart causing it to sporadically beat excessively fast. Each condition on its own would be extremely difficult to treat in a tiny baby. Together, they were so complex that only two hospitals in the country were willing to even try to ablate (surgically freeze) the node in Eve’s heart, then try to repair or replace the heart valve.
As Annamarie had discovered, a child with heart defects like Eve’s may look perfectly healthy. But once at home, the baby can go into cardiogenic shock. Even if the parents get their child to the ER in time, rapid surgical intervention “is never, never—repeat, never—optimal,” Annamarie says. “These kids have more surgeries, longer lengths of stay, poor outcomes, neurological compromise, and on and on.”
Eve had to undergo numerous surgeries in her very young life, but she was lucky. She’s now 15, thriving in school, and demonstrating a talent for art and illustration. Her mother knew that early diagnosis was crucial to Eve’s survival. “But where this becomes a problem is in Hibbing or Wyoming or North Dakota where the kids aren’t near the intervention that’s required,” Annamarie says. Even large hospitals often don’t have the necessary technology. In researching the problem, she discovered that only about 5% to 10% of children in the U.S. have immediate or near-immediate access to pediatric echocardiography.
“That felt like a problem needing solving,” Annamarie says. “I wasn’t sure I was the one to solve it. But I knew it needed solving.”
At the time of Eve’s birth, Annamarie was a partner at St. Paul-based communications and public affairs agency Ainsley Shea, where she specialized in health policy and the medtech industry. With her employer’s encouragement, she launched the Newborn Foundation in 2010 as a side project to advocate for policies and technologies to reduce infant mortality through early detection and intervention.
The foundation’s first achievement was establishing the country’s first multi-hospital pilot study, conducted in conjunction with the Minnesota Department of Health, to assess the efficacy and feasibility of pulse oximetry testing, which measures blood oxygen levels, on newborns before discharge from the hospital nursery. This study alongside a federal advocacy effort drove the addition of newborn heart screening to the U.S. Department of Health and Human Services’ Routine Uniform Screening Panel.
“Once we got newborn pulse oximetry screening added to the panel in the United States, there were other countries and ministries of health and other clinicians reaching out to us, asking about our process for doing that,” Annamarie says. She learned that “the newborn screening community—and I mean the actual public health people who work on the conditions on the newborn screening panel in our country and others—is quite small internationally. Almost everybody knows one another.” Since its launch, the Newborn Foundation has implemented large-scale programs for screening medically fragile babies in 15 countries, and it has helped establish screening policies in six of those nations.
There still remained the problem of access to the needed imaging technology to augment newborn screening. Where pediatric ultrasound or echocardiography equipment isn’t readily available, Annamarie wondered whether automation, artificial intelligence, and telemedicine solutions might be possible.
In undertaking such a project, Annamarie had powerful allies. One was Lazaros Kochilas, the pediatric cardiologist who led Eve’s medical team in Minnesota. The other was Pedro del Nido, a Boston-based, internationally renowned pediatric cardiothoracic surgeon who performed Eve’s surgeries. Del Nido brought together PhD-level technologists from the medtech industry, Boston Children’s Hospital, and Harvard University to explore how AI could determine the difference between a healthy heart and a sick heart. “That was a proof of concept that validated pretty early on,” Annamarie says.
But there was yet another hurdle: How would these ultrasound images be captured, even before they were interpreted? “You can have all the fancy equipment in the world, but unless you solve the image-gathering problem, there’s a bottleneck,” Paul says. If pediatric cardiologists receive images from technicians not trained in that equipment, the resulting images often can be “of almost no value.” What was needed was a portable, reliable imaging device that health care workers on the front line of care could use. This device would acquire the necessary images, then identify any problems that would require the baby to be moved to a facility offering more specialized equipment and care.
The beginnings of a solution to the challenge turned out to be inside the Saarinens’ own home.
A Company Comes to Life
“Paul, in his infinite nerdery, started playing around with drones as an early adopter,” Annamarie recalls. He found he could use software to “stitch” drone images together—of the Saarinens’ neighborhood, for instance. The drones available around 2013 cost around $600, but “the technology they packed into them was fantastic,” Paul says. Could a similar approach be used for capturing ultrasound images? “As far as we had seen, no one had ever attempted to do it,” he says. There were good reasons why. For one thing, the software available at the time wasn’t quite up to the job.
By 2015, “we finally thought, ‘Hey, maybe the technology has finally caught up with the idea,’” Annamarie says. A proof-of-concept grant from the University of Minnesota Pediatric Device Innovation Consortium allowed the Newborn Foundation to work with research specialists in areas including pediatric cardiology, engineering, and nuclear medicine to develop automated ultrasound for pediatric patients. The proof-of-concept research validated the idea that “we could ultimately build a version of automated newborn and pediatric ultrasound that wouldn’t require a skilled user to operate it,” Annamarie says.
The Newborn Foundation had previously launched an “innovation incubator” to support pediatric screening research. But the Saarinens saw that the portable screening technology they envisioned had “a commercialization pathway—we could actually build it—and that it could be purchased for deployment,” Annamarie says. That meant the device couldn’t be developed under the aegis of the nonprofit Newborn Foundation. “That’s how Bloom Standard became a thing,” she says.
Annamarie’s husband says that the company “felt real to me” in 2019, when the Saarinens lured Jacob Colvin to serve as Bloom Standard’s chief operating officer. Colvin was a cofounder of Utah-based Owlet Baby Care, which makes infant-monitoring devices for the consumer market. Colvin’s hiring “meant Bloom Standard was outside of just the family and Eve’s medical teams,” Paul says. “That’s when the momentum started rolling.”
By September 2021, “we had MacGyvered a prototype,” Annamarie says, and tested it using ballistics gel, “which is common for ultrasound testing when you’re not using human tissue.” The prototype delivered images that had depth and resolution comparable to a commercial probe. From there, Bloom Standard refined the prototype so that it would be suitable for imaging validation trials on actual patients. With clinical trials under way, Bloom Standard is gathering more data for its AI machine-learning team to optimize the algorithms of the device’s image interpretation software.
In January 2022, Bloom Standard received more validation: Its first venture capital funding, in the form of a $240,000 check written by Minneapolis-based Groove Capital. “They have a really good mix of experience,” says Groove founder and partner Reed Robinson. “Annamarie has a unique global view on pediatric care. Her network is vast. Her understanding of the space is very strong. Her relationships will be incredibly helpful to help this team move fast. She’s also incredibly versed in device development, pediatric care, and the regulatory pathway—areas that are usually some of the hardest parts about medical device businesses.”
Robinson also appreciates Bloom Standard’s growing market opportunity. “What they’ve discovered is that this [device] is not something that just fits in well in underdeveloped health care markets,” he says. Even in more developed markets, such as rural parts of the U.S., should find it appealing “because of the cost, efficiency, and portability.” Plus, “the team is doing the things we thought they were going to do. And the opportunity in front of them continues to expand.”
Bloom Standard currently has 10 employees, all of whom work remotely. CTO Lewis McFayden oversees a team of five biomedical engineers in Bloom Standard’s offices inside the Hong Kong Science and Technology Park, where the company was awarded funding. In 2021, Bloom Standard received a European Union grant that allowed the company to maintain an office inside the Institute of Life Sciences and School of Medicine at Swansea University in Wales. The team also runs a small lab at the Center for Device Innovation at the Texas Medical Center in Houston, which it opened after completing a six-month incubator program there last June. The company expects to add six more employees this year.
A Family Project
As if scaling a medtech device startup weren’t enough, the Saarinens have another startup. Paul Saarinen always loved classic 1980s arcade games such as Donkey Kong, Frogger, and Pac-Man. A few years back, he began buying and refurbishing these earlier versions, which soon led to the idea of opening a retro-game arcade. He and his partners (who include an orthopedic surgeon) launched Starcade inside Rosedale — just as the pandemic broke out. That slowed business at first, but not for long. Last summer, Paul and his partners moved Starcade to a larger location inside the Keg and Case Market on West Seventh Street in St. Paul. While Keg and Case has lost tenants and was foreclosed on by its lenders in November, Starcade continues to operate. “The foreclosure doesn’t have any short-term impact on us,” Paul says. “Business has been as good as it was at Rosedale, if not better.”
So how do two married entrepreneurs share one roof? “I’ve given a lot of thought about how we’re able to work together without wanting to kill each other,” Annamarie says. “When you go through something like we went through with Eve, something that traumatic, I do think that’s a glue that binds you together.”
That noted, “I know that I could not have done the Newborn Foundation or Bloom Standard without Paul. There’s no universe where that happens, because there’s an inherent understanding and support. The bad things we’ve seen happen to babies around the world who have conditions like Eve — we both consider it our responsibility to try to do something. I think that’s why we work well together.”
“I have no problem taking a back seat and watching Annamarie flourish as a CEO,” Paul says. “Frankly, it’s better for me to do that.”
As for work/life balance, “our kids are at that age where we can have honest conversations with them” about how their parents need to schedule their evening time, Annamarie says. She’ll bring them to meetings with, say, a ministry of health or a university research department. That way, “they can absorb, in a really meaningful way, why Mom and Dad are so deeply committed and why it takes up so much of our time right now.” When it comes to balancing family and business, she adds, “all you can do is your best.”
Family support has been crucial. So has the backing of numerous local and global organizations —including (in Minnesota) Medical Alley, the University of Minnesota, and regional entities — that help entrepreneurs turn their visions into companies. Other groups like Children’s National Hospital in Washington, D.C., and Stanford University’s Byers Center for Biodesign have been a big help, too.
And in December, Bloom Standard was awarded a Launch Minnesota Innovation Grant from the Minnesota Department of Employment and Economic Development.
“There are lots of things I am, and lots of things I am not, as a leader who wears the CEO hat,” Annamarie says. “One thing I am not is someone who throws in the towel.” Fulfilling Bloom Standard’s mission “might take longer than we want it to. There might be a lot of variables. But the one constant is that this isn’t something that’s going to fizzle out and go away. It’s going to happen for sure.”
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