What part of heart failure does ReliantHeart specialize in?
Rodger Ford: After a patient is diagnosed with heart failure, if the left ventricle isn’t vital enough to pump enough blood into the patient’s body, a system of support comes in called a Left Ventricle Assist Device, which is what we make.
And when the left ventricle needs assistance, what do you do?
RF: We have this little pump called the HeartAssist5 [HA5]. When the human heart can’t pump enough blood to the body, our pump is inserted into the left ventricle to increase flow. Like the ocean, with every heartbeat the human heart sends a wave of blood through the HA5, providing . . . a continuous flow pump with a natural human heartbeat. The HA5 is a super charger that harmonizes with and works symbiotically with the human heart.
What else makes it unique?
RF: Our competitors know how much power a pump requires and how fast it goes around. But in addition to those two variables, our pump measures the amount of blood going through the pump in real time. We have a patented Doppler flow-measurement probe on the outflow end of the HA5. Because we monitor all three variables of blood flow, speed, and power all the time, we can triangulate the information to predict and address potential flow problems before they become dangerous. We are the only company that measures the true flow of blood.
How does all that data get to a place where it can help the patient?
RF: Our pump is the only real-time, remotely monitored medical device in the world. The controller is outside the body and works like a cell phone. It collects data from the pump all the time and sends it to a cloud site called VADLink.com. Clinicians visit the site to get real-time data about their patients, and when something goes wrong, they receive text or e-mail alerts so they can intervene quickly.
That is amazing.
RF: And it gets better—VADLink also tracks INR [the amount of time a patient’s blood takes to coagulate]. Our system tests the INR, records the number, and if it is not between 2.2 and 3.0, it will alert the clinician. The website also monitors the patient’s blood pressure and weight, and it will inform the clinicians of potential heart issues caused by unusual changes in either.
This all sounds great for doctors, but how does it improve patients’ daily lives?
RF: The patients have the comfort of knowing they are monitored and observed at all times. Also right now there’s a driveline from the pump that leaves the body and goes into a controller. That wire is uncomfortable and can become irritated and infected. It also causes problems if the patient wants to go to the beach or wrestle with his grandson. So our pump, just this year, is being further evolved so it will require only three watts of energy—half the power that it currently requires—so that it will be able to be powered by an internal battery. By the end of [this] year, the pump won’t require the external wire. Instead, there will be a coil inside the body and a coil outside that transfers power into an internal battery that will work for up to six hours at a time on a single charge.
That seems like a serious game changer for patients.
RF: It is, but it gets even better. By the end of this year, all of our pumps will have forward compatibility to the new technology in process. New patients will have pumps that are upgradable, and in the meantime, if they develop a driveline infection, the wire can be removed without removing the entire pump. What we’re making today will work with what we make tomorrow—thus forward compatibility.
All of this is so innovative, but do you ever feel limited by regulations?
RF: You know, the perception of regulators sometimes causes people to be pessimistic. But we shouldn’t do what we do to please regulators; we should do it to get results. At ReliantHeart, we simply work with the system. Good businesses—no matter what the industry—need to begin with good business systems so that people are free to support the customer and innovate [through] technology. It’s my responsibility to create an atmosphere that allows for just that.
What advice would you offer others who are trying to build a healthy business system?
RF: If you’re going to do it, do it right. Be creative, and be curious enough to say, “We can do this.” Create the foundation for success—build it like you’re going to have a thousand more just like it. Make sure the system is so firm that it surpasses expectations. Use the system to trap the chaos, analyze it, turn it into order, and identify exceptions and emerging patterns. And never accept a compromise—ever.