Making the Unseen, Seen
Innovation is a tired term. Overused. Oversold. So when you find something that actually does innovate, what sets it apart? What differentiates it from all the others that attempt innovation? What gives it its power?
Dan Fong, PhD, director of software development at Certus Critical Care, is knee-deep in innovating a new medical device, and when he’s asked, ”What gives it power?”, his response is simple.
“Batteries.”
The smile on Fong’s face keeps you from taking his answer too seriously, but the levity only lasts a moment. Then, the engineer tells you the real power behind the company’s first innovation:
“We’re making the unseen, seen.”
“We call our engineering team a herd of unicorns because of their unique skill sets and how they integrate into our team.”
Fong is part of the engineering team at Certus, a medical device development company focused on creating the next generation of tools for medical professionals treating critical injury and illness. The innovation he speaks of is the Endovascular Aortic Control (EVAC) System, the company’s flagship product is currently undergoing preparation to submit for FDA clearance.
EVAC is a single-use aortic balloon occlusion catheter that provides precise and variable control of blood pressure and flow on a minute-by-minute basis. It was developed to treat severe hemorrhages, cardiac arrest, and stroke. While that may sound like a lot of jargon to the untrained ear, the scientific foundation of the product–precise control of blood pressure–is a concept that could change emergency medicine and trauma care.
“The EVAC system brings the unseen inside the body–blood pressure–outside,” Fong says. “Blood pressure, particularly in trauma, is hard to gauge externally–it’s an unseen dynamic in treating patients. Our technology makes that factor visible so doctors can understand what’s going on inside and act upon that data.”
“And that’s not routine,” David Poisner, director of engineering at Certus, adds, referring to the internal measurement of blood pressure. “That sets the EVAC technology apart.”
An EVAC prototype
The Difference Pressure Can Make
To most people, blood pressure is completely intangible. It is something you get taken at the doctor’s office, and you’re fine as long as it hits within some nebulous range. But for surgeons, medics, EMTs, and any other professional who works in trauma, blood pressure–particularly stabilizing rapidly fluctuating blood pressures–is essential in treating the critically ill or injured.
Blood pressure is particularly important for treating severe hemorrhage, which can result from battlefield injuries, car crashes, gunshots, and knife wounds, among other things. Severe hemorrhages kill millions around the world every year. Current emergency procedures and technologies require medical professionals to monitor and maintain blood pressure during treatment either with tools susceptible to interference and error or, in many cases, by touch and intuition alone. In some cases, the treatment can be extreme.
Fong at work
“We chat with helicopter paramedics in London,” Fong says. “In emergency situations, when they’re unable to get control of uncontrolled internal hemorrhaging, they’ll sometimes need to crack open the chest, reach down inside, and squeeze the aorta shut blindly, because they don’t know where the hemorrhaging is happening.”
Even in more controlled hospital settings, doctors still have little to no information about what’s happening inside the body while they try to stop the bleeding. Some have turned to a procedure called resuscitative endovascular balloon occlusion of the aorta (REBOA) to attempt controlling the bleeding while repairing the hemorrhage.
“What doctors do now is they insert a balloon up the aorta, but they’re still blind,” Poisner explains. “They get very little reliable information about what’s happening to the blood pressures, even after the balloon is in place. They might have an arterial line pressure sensor in there to measure the pressure downstream, but not upstream of the balloon.”
What that translates to is rudimentary knowledge of the blood pressure happening in a patient and a limited amount of time to fix the hemorrhage before the REBOA starts causing tissue damage and death downstream of the balloon by blocking blood flow to the rest of the body. The EVAC system improves on the REBOA procedure to offer a more effective, safer option for treating severe hemorrhage.
Poisner (left) working with Kobi Iki (right), COO of Certus
“What we’re doing is building a device that shows what’s happening inside the body without having to crack open the chest,” Fong says. “It can tell you what the blood pressure is and an estimate of the aortic flow status, so you can more effectively do something about it.”
Poisner adds, “It’s pretty cool.”
While EVAC is also a balloon catheter like REBOA, it has features that give medical providers control that they’ve never had before and will lead to more lives saved and better outcomes for patients.
“It has a sophisticated sensor system that measures blood pressures inside the aorta and a mechanism that relays those pressures to the user,” Poisner says. “It allows the provider to pick what they want the blood pressures to be and automatically inflates and deflates the balloon to hit target pressures.”
In contrast, current technologies cannot automatically inflate or deflate the balloon in a precise and controlled manner. And without precision control, devices cannot make the minute changes required to maintain blood pressure stability.
Engineering Behind the Scenes
Together, Fong and Poisner direct the development and testing of the EVAC system, along with the other critical care products in the Certus pipeline. Poisner, who came to Certus after retiring from a long career at Intel, is technically the first employee of Certus (by five minutes) and heads up the hardware aspect of the company’s technologies.
“Anything that touches a chip, that’s where I get involved,” Poisner says. His work includes getting circuit boards fabricated and assembled, as well as testing the boards themselves.
“He also does everything else,” Fong adds. “David has been invaluable in helping us with everything–not just helping design the board, but also sourcing the parts and vetting each one to figure out which sources of which parts are the best combo of reliability and availability.”
“It’s a start-up,” Poisner says with a shrug. “You do what you need to.” For him, that can include everything from negotiating leases to moving office furniture.
Fong is the other half of the dynamic duo, both of whom are located in Sacramento, CA. While Poisner handles all things hardware, Fong leads the software development team for Certus.
“David and I sync up a lot, whether it’s about debugging or coming up with new ideas,” Fong says. “Because I got an undergraduate degree in electrical engineering, we have the same vocabulary, which really helps me translate what David is conceptualizing into software or firmware.”
Fong joined Certus after completing his doctorate work in electrical and computer engineering at University of California, Davis. Fong directs the development of software and firmware that make up the EVAC system and other Certus products, as well as software tools developed for testing and calibration.
“When you’re doing something this new, sometimes the tools you need just don’t exist,” Poisner says. “We’ve had to build what we need ourselves.”
What Makes EVAC a True Innovation
With versions of REBOA already on the market and more undergoing development, the key to innovation is in what the REBOA procedure can’t do.
“One of the things that set us apart are the sensors we use in the EVAC system,” Poisner says. “The solid-state sensors can accurately and reliably report blood pressure and flow from inside the body.”
Existing products can inflate the balloon on the catheter and have limited blood pressure reporting, but provide less reliable data.
“The next generation of medical devices will embrace the data generated in hospitals and create systems that help physicians make more informed decisions.”
“The EVAC catheter has two different sensors, so that we can indicate the blood pressure upstream of the balloon and downstream, “ Poisner explains. “That’s one really unique capability we have, and, from that, we derive capabilities like the estimation of flow. Competitors can’t really do that at all.”
The marriage of software and hardware in the EVAC also offers something that competitors can’t–very precise control over the inflation of the balloon.
“If the provider wants the blood pressure to be a particular value, the system will make super-precise micro-adjustments to the balloon volume to achieve the desired blood pressure,” Poisner says.
EVAC monitors the blood pressure and flow and automatically makes the adjustments needed to keep them stable, while simultaneously increasing the amount of time that doctors have to work on their patients. EVAC decreases the downsides of the REBOA procedure–the tissue damage and death that can occur downstream of the balloon–by optimizing blood flow, which can triple the time a doctor has to fix the cause of hemorrhage.
“Imagine if a surgeon had to do this by hand! They’d be fiddling with the syringe and moving it every six seconds or so, trying to make the smallest movements they possibly could,” Poisner says. “By the end of two hours, they’d be drained. Well, that’s what our software and hardware are good at doing.”
From Fong’s perspective, Certus’s technology is also making use of an under-utilized resource–data.
“One of the pieces that is really unique and interesting about Certus is that we’re beginning to involve the analytics portion of data and incorporating it into actionable, useful information within the system itself,” Fong says.
There’s a ton of data generated in the emergency room, for example, but little of it is translated in a meaningful way for medical providers to use in making decisions. Much of the monitoring is still done by providers, depleting resources and reducing capacity.
“The next generation of medical devices will embrace the data generated in hospitals and create systems that help physicians make more informed decisions by providing analytics and statistical models of a patient’s status that let the physicians focus on making diagnoses based on that data, while also taking care of all the mundane things,” Fong says.
The Intangible Drivers of Innovation
When everyone is trying to innovate, what makes a company actually succeed in that venture? What’s the power behind an innovative product like EVAC? Well, it’s not batteries.
It’s probably not a surprise to most, but what powers innovation at Certus is the people—the team. In addition to Fong and Poisner, Certus has a team of engineers and staff across the country who work together to make the magic happen.
“We’ve hit the jackpot with our engineering team,” Lucas Neff, MD, FACS, says.
Co-founders, Neff (right) and Williams (left) conducting an experiment
Neff, co-founder and chief business development officer of Certus, cites the importance of bringing many of the engineers in early on and their ability to work well together as key pieces of the company’s success.
“We call our engineering team a herd of unicorns because of their unique skill sets and how they integrate into our team,” Neff says. “We’re amazed by the level of talent and sophistication they bring. There’s a lot of excellent collaboration, even when we have to work remotely and have faced all the challenges of the pandemic.”
“They really understand that the things they’re doing today will save lives tomorrow,” Neff continues.
For Fong, that understanding of just how powerful the tool they’re developing could be is one of the things that makes the team so effective.
“We’re all aligned in the ideas behind our technology. We all believe in what it is we’re trying to build,” Fong says. “That goes a long way to motivate you to get up everyday and hustle.”
And hustle they do. Since the company is charting new territory, the challenges and opportunities are vast. But for an engineer, half the fun is tackling the problems that pop up in the design, assembly, and testing of new devices.
“The Certus team is determined to never never settle for good enough.”
At Certus, the workflow involves a lot of back-and-forth and team brainstorming.
“As a team, we’re pretty good at brainstorming,” Poisner says.
Fong concurs, “Not one of us could do this on our own.”
This collaborative approach to device development comes from the very top of Certus and is embedded in the company’s roots. From the founding of the company, the founders–Tim Williams, Austin Johnson, Lucas Neff, and Jason Adams–have determined to never advance any device that wasn’t absolutely as good as it could be, to never settle for “good enough.” That conviction has infiltrated every fiber of the company’s culture and mission, creating a team bent on making devices that make a difference by pushing critical care technology into the future.
Because for Certus, the EVAC product is just the beginning.
“We’re not just developing one product,” Poisner says. “We’re building platforms that will allow for implementing new ideas pretty quickly. We have a pipeline of future products planned, and we’re creating the foundation for future innovations.”
“The fun of working at Certus is that, at the end of the day, you’re doing things that no one has ever done before,” Fong says. “Love it.”
Partner with Certus
If this team sounds like an adventure you want to be a part of, good news! Certus Critical Care is always on the lookout for talented engineers and medtech innovators to join the team. But we’re not just hiring; we’re also looking for financial, industry, and clinical partners who share our vision for saving lives.
Interested? Get started by filling out the form.