Stuart A. “Stu” Randle is president and CEO of Ivenix of Amesbury, MA.
Tell me about yourself and the company.
I’ve been in the med tech business for 25-ish years, a lot of that with Baxter in the early years. I’ve done three small companies, this being the third one. Ivenix is focused on transforming IV infusion therapy with a fundamentally different pumping technology, IT architecture, and interoperability that we think is unmatched in the marketplace.
One of the challenges in the marketplace today is that most of the pumps that are out there have a fundamental operating platform that’s 10-plus years old. We started with a blank sheet of paper to try to move us into the iPhone era. As an example, we provide infusion information on mobile devices and desktops so the nurses have the ability to understand what’s going on with the infusion when they’re not at the bedside. That obviously helps from a nurse workflow standpoint and also significantly helps for the patient because the nurses don’t need to be there for them to know what’s happening with that infusion.
The early generation smart pumps had a lot of programming capability, but always seemed to struggle with network connectivity and library updates. How hard is it to turn that 10-year-old technology into a true connected IT device?
Really hard. Think about the pumps in the marketplace today as your desktop computer from 10 years ago. If you want that desktop computer from 10 years ago to work like an iPhone does today with apps, mobile, cybersecurity, and everything else, that’s hard to do.
Where we think we are very different is that we started with a clean sheet of paper, understanding all the issues and developing a different pumping technology, but much more so a fundamentally different IT architecture that is relevant today and not a decade old.
What are the challenges in creating a user interface that works for nurses and that FDA will approve?
The FDA has pretty specific guidelines and requirements. You have to do testing. We’ve had nurses in every couple of months for a few years now to work on the user interface.
Again, the fundamental difference with our user interface is that it’s much more like an iPhone. It’s menu driven. It’s touchscreen, as opposed to the products out there today that are mostly buttons and knobs. We have a pretty big screen so the nurse can see the infusion information standing at the door to the hospital room as opposed to standing right next to the device.
What safeguards exist to help prevent nurse programming mistakes?
The more you can program in to alleviate those and make it very difficult for the nurse to make an error, the better you’re doing. We have a number of things that help in that regard. For all the drugs, there are guidelines that can be set up by the hospital. What’s the recommended range? We notify the nurse if the programming is outside the range but still acceptable. Then there are limits beyond that where the pharmacists have said, "Don’t do that." That’s one area where we put those guidelines in place.
Our pumps also know if there are other pumps connected to that same patient. You can’t give the same patient the same drug from two different pumps. We know that what’s going on with that patient from all of the pumps connected to them. We eliminate that. We know if on one of our pumps you can deliver through two inlets, if you’re going to deliver two drugs that are incompatible with each other, we’ll notify you of that when you try to program it and say, "These drugs are incompatible. You can’t do it."
We’ve built in a number of things, partially with the work of the hospital pharmacists and their drug library, as well as the guidelines and architecture so that you can’t do things that we know are going to be harmful to the patient.
What’s the ideal state of having a smart infusion device talking to an EHR system?
We worked at HIMSS last year with one of the vendors on doing that. The more information you can deliver directly from the infusion into the EMR without any integration engine in between, the better. We are working with those guys. We can provide all that information and data and make it smooth and seamless.
Likewise, we can download orders from the hospital pharmacy directly to the pump itself. The nurse is there to verify that, yes, this is the order that we have for this patient. This is the right dosage. Pretty much hit “start” and we can go. We try to make it as seamless as possible and integrate into the entire EMR.
We’ve heard from a number of the EMR vendors as well as hospital executives that one of their primary product areas with the greatest frustration and the lack of interoperability today is infusion pumps. We think with the architecture we’ve put in place that we’re going to solve that issue.
What improvements have been made in pump alarms that just make noise until someone shuts them off?
We’ve done a couple of things to reduce them as well as to eliminate the aggravation. One of the biggest areas of alarms is air in line. We have an air eliminating filter, so we can eliminate the need for that alarm to even go off because we eliminate the problem. If the patient bends their arm and kinks it, it will give an occlusion alarm, but if the patient moves that arm again, that alarm will stop and the infusion will continue.
What quality improvement opportunities do hospitals have in using the information the system generates?
They can look at reduction in medication errors. They can look at nurse efficiency and workflow efficiency. All of our pump data is available to the biomed department or the engineering department, so the pumps know when they need to be maintained as opposed to a regularly scheduled out-of-service process. The infusion data can increase charge capture.
We are working with the hospitals to say, we have this wealth of data. How would you like to receive that? How would you like to utilize it?
What are the IT implications of implementing your system?
We work with the pharmacy on uploading the drug library, which we will do as part of the service of the installation. We’re very different from the other guys in that we do everything wirelessly. If there are cybersecurity patches, if there are software upgrades, if there are other items like that, we can do that wirelessly.
At HIMSS, I spoke to someone who was responsible at his institution for a fleet of 18,000 pumps. They had a software upgrade. For them to implement that software upgrade, they had to take each of these 18,000 pumps out of service. We do it all wirelessly, just like when you get a new app on your iPhone. Things like that are huge improvements in productivity and also certainly help on the IT side.
How to you address theoretical security risks?
We started with this clean sheet of paper. Our software guys came from other companies where they were on the receiving end of this information and know the architecture. We architected it with encryption and security similar to the banking system. We always envisioned that we would be going to the home and other areas of care. Cybersecurity was always at the forefront of our thinking in terms of safety because we want to go well beyond the hospital to the entirety of the hospital enterprise or system enterprise. We built it in on early on. We feel quite confident of our security today.
Your competitors are mostly big companies that earn exclusive contracts to provide all the infusion technology for a given health system. How do you see the company changing in the next several years?
As you noted, it’s pretty much an oligopoly today in the US, but everyone’s using technology that is analogous to a 10-year-old desktop. We’re bringing something entirely new to the market. We think that disruption and the opportunity to better integrate with the IT systems within the hospital and across the integrated delivery network or whatever their system is provides us a distinct advantage. We think it is something entirely new and different. We’re pretty optimistic about the reception we’ll receive from the US hospital market.