Our Journey Building a Safer, More Efficient Infusion System from the Ground Up
By Jesse Ambrosina, Chief Operating Officer at Ivenix
Today is a wonderful day at Ivenix. Today, we received clearance from the U.S. Food and Drug Administration (FDA) to market our very first product, the Ivenix Infusion System. It’s a day that has been years in the making, and the road was long and at times exhausting. But we never lost sight of our end goal — to transform the infusion industry.
I’ve been a product development guy my entire career. I’ve lived and breathed commercializing new products and technologies. I seek hard problems and go after new challenges. But Ivenix is much more than that.
The opportunity to tackle a very difficult and complex problem like infusion pumps — it’s not just pushing the limits of technology; it’s addressing patient issues and user needs. We set out to build a better, safer infusion system. And we did it.
The infusion industry and calls for change
The FDA and organizations like the ECRI Institute and the Association for the Advancement of Medical Instrumentation (AAMI) have been advocating for change in the infusion industry for years. Take the FDA, for example: In 2010, they undertook the infusion pump improvement initiative, which aimed to make infusions safer and published a new guidance in December 2014.
Why? Infusion-related errors account for more than 50% of the 1.5 million adverse drug events reported annually to the FDA. Many of those errors result in serious patient injury or even death. In addition to the many lives affected, the cost of these events are significant. Infusion-related adverse drug events cost our healthcare system more than $2 billion in the U.S. alone.
In 2010, the FDA forced a public company to remove an IV pump from almost a third of U.S. hospitals. That sparked the beginning of change in the regulatory climate for infusion pumps. Soon after, Ivenix began contributing to the new guidance and industry standards. We’ve always believed that more stringent regulations were needed.
We honestly thought because of the gravity of that recall that the industry was going to change. It didn’t. So when we started building our product, we completely embraced every piece of guidance we could find from the FDA, AAMI and ECRI. Equally important, we reviewed reports and stories shared by clinicians and patients.
Building the right team
In order to tackle such a multi-disciplinary and complex problem like this, George Gray (CTO) and I had to essentially restart Ivenix development efforts back in 2012. We knew then that if we were going to change the way infusions were delivered, we had to go completely back to the drawing board, we had to question every assumption. To do this, we revamped our entire team and its mission. We assembled a diverse group of clinicians, human-factors and regulatory experts and engineers from multiple disciplines. Then we created a culture where the best idea wins and data drives the final solution – a culture of getting outside your comfort zone, iterating quickly and aspiring to create the very best work.
Over the past seven years or so, everyone at Ivenix is over-the-top passionate about what they’re doing and why they’re doing it. Their loyalty and dedication to the company is unwavering, so much so that it’s changed me as a leader.
As we set out to solve this problem, we took a “what if?” approach. What if you could design a pump that was inherently safe and secure from the onset? What if you could design it so that errors could be prevented? What if our device was part of all the information flowing through a hospital and could take advantage of the information around it? What if you could get rid of alarms all while reducing the hospital’s overall costs of infusing medications?
Then, we did it. All of it.
We designed a smarter, more intuitive infusion system, architected from the ground up to be safer, more secure and more user-centric. Our platform includes a large-volume pump, a smartphone-like user interface and advanced technology that precisely measures flow to maximize accuracy, all built on an infrastructure that predicts and avoids common use errors. Adaptive fluid delivery means fewer variables for nurses to worry about. We provide integrated, data-driven insights by securely managing data and linking to the electronic medical record (EMR) and pharmacy to power informed, individualized care.
Our FDA journey started years ago. We’ve been designing and building our system to meet that need all along. It’s been an incredibly rewarding, albeit humbling and, at times, a difficult process. We’ve been shocked more than once at how high the bar really is and how precise and demanding the FDA was going to be in this process. But just imagine the challenge of being in the reviewer’s seat — we dropped a culmination of a five-year development program, millions of lines of software and over 50,000 pages of documentation in their laps and they have defined timeframe to sign their names and say, “yes, this is safe and this is effective.”
Though we’ve come a long way with the agency, our FDA journey is long from over. We’re going to be in some sort of review process for years to come as we develop new capabilities and new types of pumps. The FDA process is not some singular event; it’s something you have to embrace. It’s a way you need to think. That said, today is a wonderful first step. Today we look forward. And we’re confident that our product will usher in a new era of infusion delivery.