For decades, nurses have sent drugs surging through a patient’s body using the power of the circulatory system. Catheters deliver medications destined to travel through a person’s veins – but it doesn’t always turn out that way.
Sometimes, leaky veins cause drugs to seep into surrounding tissue or to back out of the insertion site, a problem referred to as an “IV infiltration.” In some cases, these problems involve caustic drugs, such as chemotherapeutics, resulting in an extravasation.
“It’s a drug-delivery issue that we have to be really concerned about,” Gary Warren told Drug Delivery Business News.
Warren is the chief executive of ivWatch, a medical device maker that markets a sensor designed to continuously monitor fluid as it flows into a person’s vein. The company’s FDA-approved device is the size of a pencil eraser, according to Warren, and it uses light to measure the optical density of the tissue surrounding an IV insertion site.
“We have done so many clinical studies that we know how the density changes the tissue and what it looks like when it’s leaking outside the vein,” Warren told us. “We map those signals that we get, in real time, to a huge database of what an infiltration or extravasation looks like, so we can determine if the IV is leaking or not.”
Warren, an aerospace engineer turned medical device entrepreneur, said leaky IVs are common – problems crop up in one of every six IVs. The company’s product delivers an elegant solution, according to Scott Hensley, the company’s VP of sales and business development.
“We offer continuous eyes under the skin,” Hensley said.
ivWatch is in talks with infusion pump players to integrate its sensor directly into their devices, but Hensley noted that the company isn’t interested in any exclusive deals in the U.S.
“We’re working with all of them at varying levels,” he said.
The company does have an exclusive distribution deal with Terumo in Japan and a global licensing agreement to embed the ivWatch OEM board into Terumo’s pumps.
Another line into the market is through integration with patient monitoring systems. Today, ivWatch announced that it supports Philips‘ (NYSE:PHG) IntelliVue patient monitors to provide in-room and remote notifications, as well as data capture from existing electronic medical records.
ivWatch last year deployed its sensor to the Cincinnati Children’s Hospital, where healthcare workers are monitoring thousands of IVs using the company’s technology. The hospital was involved in the ivWatch’s early trials and even offered to pay for the clinical work, Warren said. In the hospital’s pediatric intensive care unit, healthcare workers have observed a significant drop in the severity of infiltrations.
Asked for his insight as a serial entrepreneur on starting a new medtech venture, Warren said a bad fall fueled his passion for solving the unmet need of IV infiltration.
“If you want to solve a problem, if you want to get into medical, I would recommend people go fall off a roof and get admitted to the hospital. Because then you’ll learn how scary healthcare is,” Warren joked in recalling his hard-won experience in the U.S. healthcare system.
“I fell from about seven feet in the air, head-first, and put my arms up to break the fall. I ended up at Mayo Clinic in Rochester, Minn., trying to reconstruct my forearm. It was really odd. I got involved with this company and then I got to experience, firsthand, all of the problems of vascular access.”
Updated June 22 to clarify ivWatch’s distribution and licensing deal with Terumo.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.