An artificial pancreas for hospital care: The Admetsys story

Admetsys, a Boston, Mass.-based start up is looking to take the math out of nursing, literally.

The company has developed what it calls a first-of-its kind artificial pancreas for hospital and surgical settings, which officials say will eliminate the need for nurses to hand check glucose levels for patients at diabetic risk during his/her hospital stay. Admetsys officials say their solution could free up as much as 20% of a nurses time on shift.

The company, which is still in its early stages, has been racking up the victories at various innovation contests across the globe over the past year, including the new venture competition sponsored by the Massachusetts Medical Device Development Center (M2D2) out of its University of Massachusetts Lowell campus.

MassDevice publisher Brian Johnson spoke to Admetsys CEO Jeff Valk recently about the company, thanks in part to our partnership with UMass in helping to publicize the contest.

Umass is currently accepting applicants for its upcoming new venture competition, now dubbed the $100K challenge. Click here for more information on how you can get your product entered. The deadline is January 29, 2016.

Brian Johnson: Tell me about the problem Admetsys is working to solve?

Jeff Valk: Cardiometabolic disorders, including what’s generally diagnosed as diabetes, are fundamentally transforming the demographics of hospital, about 40% of all hospital patients admitted are diabetic or a diabetic risk. In the more acute areas of care, those numbers go up. In critical care, that number is nearly twice that. Then there is the phenomenon where glucose is imbalanced in hospital patients when they’re diabetic or not. For instance, in cardiac surgery, they administer catecholamines, they induce hypothermia. As a result, patients end up with hyperglycemia post-surgery, whether those patients are diabetic in the first place or not, and they still need intervention. Those patients need to be treated for what would otherwise be a diabetic imbalance, but it was actually caused by the dynamics of the procedure.

Brian Johnson:  When we say treated, they actually need to have their glucose levels measured and then actually be infused with insulin?

Jeff Valk: Those patients would have an IV, and the standard of care treatment for patients in acute care is continuous insulin infusion into the IV line.

Brian Johnson:Does a nurse currently administer that treatment? Who’s manually doing that?

Jeff Valk: Generally, what happens today is a nurse will take a blood sample, and that could either be using a pullback from an existing IV line or it could be by a capillary finger stick measurement, and a meter which is not too different than the one that you might get from Walgreen’s or CVS. Pretty much the same thing we’ve been doing for 30 years, and hardly imaginative. Nurses have to calculate dosages, if they’re lucky using a calculator; if not, sometimes literally it’s longhand arithmetic on paper, and then turn a pump up and down. As you can probably imagine, that doesn’t really scale with the epidemic that we’ve seen of diabetes.

Brian Johnson: Are there any other risks associated with that?

Jeff Valk: Medication delivery error is obviously something that hospitals are very interested to avoid. There have been studies conducted at very reputable institutions, including Mayo Clinic, which showed that the error incidence in this endless repeating cycle of manual processes is something like 5% per iteration. That adds up pretty quickly. You get that sort of error-prone nature, not to mention the imprecision inherent in the technique. You’re asking a nurse to do arithmetic by hand. You can only ask her to do math that’s so complicated, particularly when this is done every hour or two, as opposed to a technique that potentially could be a good bit more sophisticated, but now has that limitation imposed simply by the nature of the human interface.

Brian Johnson: Right, and then also, there’s the matter of lost time on care, I would imagine.

Jeff Valk: The American Association of Critical Care Nurses says that it takes 6 to 7 minutes to perform that cycle if you’re a skilled, experienced nurse. If a nurse in critical care has two patients to care for, both of them need this, the recommended standard of care being hourly, that’s fully 12 minutes an hour. That’s 20% of her shift doing nothing but measuring glucose levels and calculating the dosages to turn pumps up and down for diabetic control. It’s hardly labor efficient.

Brian Johnson:This is the opportunity, right? This is what you guys saw as you’re launching this company?

Jeff Valk: Yes. It was an answer to a question that needed one. We have a technology that’s more flexible than this. Fundamentally what we do is metabolic control using what we like to call push/pull, so two or more counterbalancing biologics to control a physiologic parameter. This is the basis of the technique that we’ve developed, and the basis for the IP that we’ve developed around it.
The initial application came from a critical care nurse calling my chief scientist. It actually happened about 3 in the morning, and she was none too pleased, let’s say, basically observing that the standard of care is not particularly precise, and the nurses hate it. What she literally said to him was, “Doctor, if you doctors are so smart, there’s all this technology out there today, why can’t somebody build something to do this better?”

That was the genesis of the project, was answer her challenge, to build technology that prevents nurses from having to run errands, and the standard of care for being really stuck 30 years in the past.

Brian Johnson:Tell me about the technology.

Jeff Valk: It’s the first fully automated glucose control system for hospital setting. Term of the art is it’s an artificial pancreas system. I didn’t come up with that, but the industry has standardized on it. When you talk to somebody who is perhaps a little bit less lay of a person, that’s what inevitably comes up. Then from the standpoint of actually describing what that is, the short version is that it attaches to a patient’s IV line, uses a chemical biosensor to measure several analytes, including blood glucose concentration, models the patient’s metabolism, and then infuses two medications. Insulin to lower glucose levels, and dextrose to raise and support them.

Brian Johnson: Tell me a little bit more about the company, and how you’ve leveraged some of these opportunities you see. I see you’ve won a lot of awards for this device, so tell me a little bit about that.

Jeff Valk:There were 3 co-founders of the company. Myself, I’m a hardware and software engineer specializing in adaptive systems by background. My chief scientist also happens to be my father. He’s an endocrinologist and nuclear medicine guy. You heard the genesis story of the company that came through him. My third co-founder is an industry veteran, came through the Johnson & Johnson leadership development program, worked for a number of different J&J companies and helped them develop and commercialize quite a few technologies that came to market. Awesome operations and supply chain logistics guy. Those are the nucleus of the team. Covered a lot of bases in the early days. When we were in the very early days of technology and development, we stayed pretty heads down and internal. I think there are a lot of people who might wave their arms in the air and say, “We’ve got this idea, we’re going to come out there and change the world with it.”

Our approach was really, go out and get the data. If you’ve got an idea and you’ve got a design, go validate it. Get the data, see that it works. We did that. We had an open IDE with FDA back when that was a challenging thing to do. I’ve done 3 clinical trail protocols under that with extremely strong results. About 14 months ago, something like that, give or take, we found ourselves in a position where we had fully featured prototypes, good engineering behind the concept, we have clinical data which, quotation finger here, “early stage medical device companies” usually don’t have. We didn’t know anybody. It really all came at the expense of outreach. We were sitting on technology and sitting on clinical data with a relationship with FDA, and we didn’t have contacts in the community.

All the awards that you mentioned, the places that we’ve shown up over the last 12 months or so, have been in the name of outreach. It’s an opportunity for us to introduce ourselves, to let people know what we’re doing, and how we might interface with a high value environment, solving an important problem. It’s been fantastic getting plugged into different communities, not just across the country but across the world. Spent a good bit of time in Europe this past year as well, with the understanding that medical device commercialization, at least the regulatory side of things, is obviously a little bit more predictable in timeline on that side of the pond. We’re no longer an unknown entity. We’re not front page news at this point, not in the mainstream press, but we’re getting some recognition for, I think, doing something that’s on people’s minds. At this point, our focus is really to deliver the technology in a way that’s production ready and has all of the right characteristics behind it to meet the need. I think that’s what the next 12 to 18 months is really going to be about for us.

Brian Johnson: What does a contest like the UMass $100,000 Challenge do for a company like yours?

Jeff Valk: It’s exactly what I was just talking about. Obviously the medical device community in Massachusetts is as strong, if not stronger, than any other community in the world. When an institution like UMass brings people together from that community and invites a small company like ours to get out there in front of those people, it’s a fantastic chance to introduce what we’re doing, to introduce the advantages that we believe that we can bring, the novel thinking that we believe we’ve engaged in, in a way that solicit feedback, but also elevate the profile of the company. That’s absolutely fundamental to the success of a small organization. You don’t succeed as a small organization if you stay a small organization. You have to grow, and that begins to some degree by growing in people’s minds. You have to be fresh in the world view of people who have the ability to impact that problem, and there are a number of different types of people like that.

Obviously the clinical community and the hospital administration community in our case, but it’s contract manufacturing, it’s the opinion leaders, it’s the finance community. It’s supply chain partners, it’s distribution. It’s people who have experience in areas that you know are going to be key operational areas of the company as you grow. Small companies don’t necessarily have in-house marketing, sales, compliance, operations, all of these sorts of things. Those people come to events when somebody with the club of UMass asks them to show up. If we just raised our hand and said, “Hey, we’re holding a lunch, could you guys come,” we’re not going to get the same response. Being able to be part of that environment has been a great experience, and also something that really helps us connect with the people who are going to be able to help us build the company as we progress toward delivering this to market in broad scale.

Brian Johnson: Has your story, though, improved as a result of these kinds of early wins?

Jeff Valk:Yeah, absolutely. I think investment is always about confidence. Fundamentally, what an investor does is allocate resources and manage risk. If you have organizations giving you the floor and saying, “These guys are doing something interesting,” that inspires confidence. Psychologically, there’s impact there. These guys are not risky in the sense that you just met them off the street, we have no idea who they are. There are obviously fundamental risk components, what’s the technological, the clinical, the regulatory, the marketing pathway. All those things need to be addressed on their own merits, but from the standpoint that you don’t know somebody, now you’ve got a warm introduction. Yeah, that’s absolutely something that these sorts of environments can create, and bring people together in a way that’s comfortable for both sides. The companies need people, the potential investors need companies, and you see like-mindedness there. You see complimentarity.

One thing that’s really important for any company, really, is to find compatibly minded investors. There’s a lot of capital in the world, but it’s really important to build a team. You want those folks to be able to contribute things from their own experience and worldview that assist the company in growing and developing. Not just the, I guess, quintessential dumb money, as it’s said.

 

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