Ivenix CEO Stuart Randle began his foray into drug pump delivery systems at Baxter in 1988, when he led the company’s effort to develop the 1st needle-free IV system. More than 20 years later, when he was approached about the corner office at Ivenix, Randle revisited the infusion pump industry and saw that the technology had not kept up with the changing hospital environment.

“The pumps that are in the marketplace today are like your desktop computer from 10 years or so ago,” Randle told Drug Delivery Business News. “What we’re developing is kind of the iPhone or the Tesla, the current generation of technology for IV infusion.”

Infusion pumps are used by hospitals to intravenously deliver large and small volumes of drugs from saline to hormones and opiates. The infusion pump market is poised to reach $4.7 billion by next year, according to Ivenix.

But problems abound in the industry – software can incorrectly register the intended drug dose, false or delayed alarms prevent proper patient care, and ambiguous or inconsistent user interfaces make the devices difficult to work with. There is also a general lack of integration between pumps and hospital IT systems.

Randle pointed to a recent report by medtech watchdog ECRI Institute which named infusion pumps as #1 on its list of top 10 medtech hazards. Infusion pumps have consistently topped that list, he noted, and the 3 major manufacturers that dominate the industry – Becton Dickinson subsidiary CareFusion, Baxter and Hospira – are not bringing innovative technology to market to address these problems. The FDA receives more reports of adverse infusion pump incidents each year than for any other medical technology, Ivenix reported.

While other companies have made incremental changes to their technologies, Randle says the Boston-based startup sees a tremendous business opportunity to develop something new. “It’s kind of the classic innovators dilemma,” Randle said. “What do you do with an old technology when there’s new technology coming along?”

The use of connected or “smart” devices is on the rise, with Hospira launching its EMR-connected LifeCare PCA infusion pump in May this year. Randle argued that Ivenix’s platform stands out because of its user interface, featuring a touch screen and menu-driven programming, and its interoperability.

“Most of the pumps that are out there today have lots of buttons and dials that you’ve got to push to get it programmed. You’ve got to kind of learn all the steps to do that properly, and there’s a little tiny screen,” Randle explained. “Ours, again, is like programming an iPhone. It’s all touch screen, it’s all menu-driven, so that significant improvement in the ability to program and the ability to program your infusions, we believe, will result in significantly fewer user errors and therefore infusion errors. The user interface is completely different from anything that’s out there today.”

The start-up touted its “intelligent infusion system” as a ground-up redesign of an infusion pump, which significantly enhances dose accuracy and reduces the chance of medication errors using an efficient pneumatic fluid delivery system.

The system’s interoperability is also a major advantage, Randle said, compared to the competition. The company’s management system has bi-directional electronic medical record communication and can use patient library data to ensure that the device is using the appropriate settings. The pump can also connect to nurse alarm systems, to alert professionals if anything goes wrong. “Really we can integrate with any and all systems within the hospital,” Randle told us. “Given that there is a pretty big variety of how integrated hospitals are, we can go across the entire spectrum of the least integrated to the most integrated.”

In the hospital of the future, Ivenix’s connected infusion pump system will be able to communicate information with other devices and optimize the clinician’s workflow, according to the company.

Although Randle joined Ivenix in January this year, the latest iteration of the company’s infusion management system has been 4 years in the making. Ivenix has completed significant bench testing of the system, including design and ease-of-use input from nurses and physicians, and it anticipates FDA submission in the 1st half of next year.