When Jim Moon, chief technical officer of Sotera Wireless, walks into the conference room, he brings several business cards. Not because he wants me to call him later, but because the key to Sotera’s technology is its one-to-one comparison with this daily, manageable object. “One of the early discussions was, ‘boy, if you could just put this device on your arm like a watch’ and one of the quick objects at hand was a business card. At that point, someone said, ‘it can’t be any bigger than a business card, otherwise it will be too big.’ That’s why the ViSi Mobile is the same size as a business card,” he says.
But the technology is more than a business card. And honestly, Sotera’s own CEO, Tom Watlington admits that the size of Sotera’s wrist-worn monitor should get smaller as technology allows.

But we’re getting ahead of the story. Sotera Wireless has developed the ViSi Mobile System, a patient-worn platform device for comprehensive vital signs monitoring, designed to keep clinicians connected to their patients, in and out of bed. The system measures and displays core vital signs including blood pressure, heart rate and pulse rate, ECG, SpO2, respiration rate, and skin temperature. The company claims that the monitoring accuracy and resolution is comparable to that typically found in ICUs.

The ViSi Mobile wirelessly transmits this vital sign data through hospital Wi-Fi. Components of the system consist of the wrist-worn touch screen device, several leads that attach to the body and other tools, and collected data that can be viewed on any computer or smartphone screen.

A New Standard of Care

Sotera’s platform represents a new standard of care in patient monitoring, according to Gunnar Trommer, Sotera’s vice president of marketing and customer service. “Today the standard of care in hospitals is that a nurse will wheel a large cart around and spot-check patients for blood pressure and other vital signs,” he says. The problem is that such a method doesn’t give nurses and other caregivers a good look at what is actually happening to patients in between spot-checks, which are taken only every 4 hours on average. “Over the past 10 years or so there have been numerous studies that show that the current standard of care for monitoring the majority of patients cannot be considered safe,” says Trommer. Sotera’s vision is that by providing continuous monitoring, caregivers can react more quickly to patient deterioration, thereby improving the health and safety of patients.

Sotera’s Visi Mobile fits in nicely with ongoing healthcare reform efforts, which depend on an increase in valuable and actionable patient data to lower costs and improve clinical outcomes. “There are several studies out that show that hospitals with the best patient safety are also the most profitable,” says Trommer. “We try to provide technology that enables caregivers to provide better care and better outcomes while also improving economics.”

A Continuous Blood Pressure Monitor

Key to Sotera’s device is a patented cuffless noninvasive blood pressure monitoring system. Trommer refers to the technology as something of a holy grail and several experts agree.

“I’m most interested in the continuous blood pressure monitoring,” notes Bill Betten, medical technology director at UBM TechInsights and a member of MD+DI’s editorial board. Betten explains that “continuous cuffless blood pressure” is a notable technology with enormous potential.

Eric Topol, who sits on Sotera’s board, says that a lot of people need to have a better understanding of blood pressure. According to Topol, the CDC recently said that there are 67 million Americans with high blood pressure, but only 30 million who have it controlled. “That means we have 37 million people walking around, some of whom are sitting ducks for heart attack or stroke. They not only don’t have it controlled—they don’t even have it measured.”

The story of Sotera’s continuous blood pressure monitoring can’t be told without Devin McCombie, Sotera’s director of science and research. McCombie came from MIT with a continuous noninvasive blood pressure monitoring algorithm. After graduating in 2008, he expected to become an entrepreneur. However, through the course of McCombie’s research, he found Sotera Wireless, which was working on a similar technology. “I decided to join and fuse some of the ideas that Sotera had developed independently.” McCombie’s research could also hold Sotera’s future. Once the ViSi Mobile has gained traction in the hospital and in emergency response vehicles, it can move into to the home, an infinitely more complex environment.

But before Sotera can invade the home of every patient who needs vital sign management, it has to convince hospitals that continuous vital sign monitoring is worth the upfront costs. It’s not a difficult conversation to have, says Trommer. “We’ve been welcomed by C-level folks in hospitals. They understand the importance of the technology.” In fact, Sotera received its first purchase order in August. The Palomar Medical Center, part of San Diego, CA County’s experiment in the future of healthcare, has the distinction of being the ViSi Mobile’s first customer. The facility is designed to bring the highest level of care to patients using a variety of technologies, including connected health.

Initially, Palomar will be using ViSi Mobile for a one care unit of post op patients, explains Trommer. His hope is that once the facility can realize the benefits of ViSi Mobile, it will roll it out to other hospital segments and then into the emergency services. “To ramp up sales, we know that we’ll need to find the innovators and early adopters,” Trommer explains.

An Integrated Environment

One of the first questions asked by hospital administrators is how well the system works within the hospital setting. “Hospitals often struggle because they have legacy IT—we have to be able to work in their network, with their existing IT systems and hardware, and on a nonproprietary open system,” Trommer says.

In the absence of interoperability standards, Watlington notes the difficulty hospitals face in adopting wireless technology. “Our job is to make sure there is enough quality of service on our end to work within hospitals and meet their expectations,” he says.

Moon explains that such a challenge requires a lot of attention to detail. “It has to work 24/7, error free, bug free. And it also has to have long battery life,” he says.

The complexity of the hospital environment is a challenge eagerly met by Sotera’s team of engineers, run by Moon. The team includes hardware design engineers, both in electronics and manufacturing, as well as a team of embedded software engineers.

Moon confides that the secret behind his strong team is that many of his engineers come from a single university that places high emphasis on real, not theoretical engineering. He won’t say which university it is (“I don’t want anyone else poaching our talent pool,”) but he mentions that it is a very prestigious California engineering institution, known for its practical engineering focus.

To house this talent, Sotera turned its boardroom into a war room. The war room is a collective space for the company’s system engineers and embedded engineers to work out problems and share knowledge. Right next store is the hardware department. “One of the advantages of being a small company is that you can have flexibility and design your office however it works best,” says Watlington.

In addition to building a team of communicative and, dare I say, combative engineers, Sotera also understands that it doesn’t, and can’t possibly have all the knowledge necessary to create a system that works seamlessly in a hospital. “We’ve built a sophisticated system to monitor physiological signals, and we are good on an engineering level, but we need a coalition of players who can contribute their piece of the solution.”

And so, Sotera engages freely in partnerships with companies that have complimentary technologies.

The Power of Partners

In the medtech space, Sotera stands out in its willingness to publically name its partners. Watlington says Sotera can afford to share its partners because of its extensive IP portfolio. But he also says that more companies should be willing to share and celebrate the accomplishments of its partners, because the healthcare market will require a higher level of cooperation.

Some of Sotera’s strategic partners are suppliers, such as Eastman Chemical, DD Studio, PolyOne, and Philips Medisize. Others are partners on investment side as well as on the commercial side. Trommer notes that Cerner and Qualcomm, for example, act as both investors and technology partners.

Commercial partners include Welch Allyn and fellow Manufacturer of the Year, AirStrip Technologies. (MD+DI editors had no idea the companies were announcing a partnership when they were initially selected.) AirStrip makes innovative platforms to remotely monitor and visualize patient data for clinical decision-making. “This is a good example for a rich partnership, we provide the vital sign acquisition front end, and AirStrip provides the user interface—it's synergistic,” Trommer says.

Sotera’s commitment to collaboration has taken tangible form. In October, the company announced the launch of the of ViSi Mobile on the Wireless-Life Sciences Alliance, an online portal dedicated to sharing and obtaining information about the wireless health ecosystem. Connected Health World includes a community-sourced database of products, services, applications, organizations, funding opportunities and research abstracts in the connected health arena. Site listings enable users to connect with each other to discuss and collaborate on opportunities.

Translating FDA Wins into Funding

All told, 2012 was a successful year in Sotera’s development. In April, the company received a 510(k) for the first generation of the ViSi Mobile Monitor, the stand-alone device portion of the system. In August, the company was awarded another 510(k) for the full system using WiFi (802.11). Up next, the company expects to gain clearance for its patented continuous blood pressure monitoring system. “We just started the 510(k) process for the continuous noninvasive blood pressure monitor,” Watlington says. He expects to gain FDA clearance for the blood pressure application in early 2013.
Along the process, Sotera has enjoyed (and worked very hard to get) the all-important financing required to build a medical device.

Sotera’s list of investing partners is long, illustrious, and unique in the medtech industry. “Sanderling Ventures remains our largest investor, but all of the other investment partners are strategic—they are leaders in their own industries with a vested interest in our technology,” says Watlington.

In 2008, the company raised $20.3 million in Series B financing led by Qualcomm Ventures along with Intel Capital. In 2010 the firm completed a $10.75 million strategic Series C investment round led by West Family Holdings, LLC (now West Health Investment Fund). Finally in 2011, Sotera finalized a Series D financing of $12.2 million led by Singapore’s Biomedical Sciences Investment Fund. Another new investor in that round was Cerner, a healthcare IT company. In addition, Sotera has a number of clinical partners.

Still, Watlington admits the struggle Sotera is facing to find it’s final round of financing even for a late stage device with the potential of Visi Mobile. “We’re in a difficult marketplace; raising the last round of financing is tough,” he says. The hope is that with FDA clearances in the bag and on the horizon, as well as the company’s first purchase order on the books, financing will follow. Watlington predicts that the company will make its first profits by 2014.

Next Steps and Home Health 

In the meantime, Sotera isn’t resting. The company is continuing to improve its product by adding applications of other types of monitoring that will further enhance its usefulness and usability. “Its actually incredibly easy for us to add algorithms or sensors for other biometrics,” Watlington notes. He and Trommer can rattle off half a dozen additional physiological parameters they expect to add to the platform over the next few years. One big near-term project is to use the accelerometer to help measure how patients are moving in the hospital. Trommer says such data will help hospitals understand whether patients are recovering properly, if they are prone to bedsores, if they fall out of bed, etc.

Sotera’s next step is obvious: home health. But as obvious as the application might be, getting to the home is a grand experiment.

Watlington’s ideal scenario is that ViSi Mobile will be facility agnostic. “I want it to be suitable for the patient in the hospital, accompany them when they are in transit, and protect them once they are discharged—my goal is to provide protection to a person if their health is deteriorating, wherever they happen to be.”

Sotera’s aim for home health is rather complex—exponentially more so than hospital monitoring. “Its hard enough in the hospital,” says Watlington.

First, the engineers will have to develop even smaller electronics. “It is pretty big on the wrist. It is not like a watch,” says Topol. “It isn’t something that you would walk around with all of the time. But, like everything else, it will get miniaturized.”
Watlington agrees, noting that the home system would have to look more like a bracelet or an actual wristwatch. Further, the sensors that attached to the body must be much thinner and more discrete—no more than the thickness of a Band-Aid, he says. Overall, Watlington is sensitive to the users comfort level. He says the really big challenge in the home will be battery power. “No one has the solution [we need] for energy yet,” he says.

Another challenge in the future will be the system’s ability to roam between networks and cell phone towers, potentially putting medical data transmissions on a higher priority than other types of data. “Network carriers will be an important player in the future for mobile wireless medical technology,” says Watlington. He notes that the device should ultimately accompany the patient beyond the home, for example, into the mall, grocery shopping, and perhaps even to work. “There are many challenges to continuously monitoring patients who are mobile and going about their normal daily routine,” he says. Inevitably this will require technology from a variety of companies and even industries that collaborate together.

Disruptive Healthcare

The scope of Sotera’s technology doesn’t end in the hospital, or even once it goes into patients’ homes. Continuous vital sign monitoring in a mobile and wireless environment is new and unexplored territory. No one can fully comprehend the opportunity that such information could bring to provide real understanding of the human body and how it reacts in the process of sleep, stress, and physical exertion, to name a few. The data collected through the ViSi Mobile has the potential to disrupt the process of healthcare in a profound way.

“We don’t even know what is normal. We are going to have people with continuous blood pressure monitoring for a week or a month through every night of their sleep and every stressful circumstance. We’ll learn some things about people that we have never learned before,” says Topol.
 

Heather Thompson is editor-in-chief of MD+DI. She currently enjoys low blood pressure, based on a demonstration of Sotera's vital signs monitor.