Tandem Diabetes Care is setting plans for brand new gadgets and increasing to a broader group of sufferers. The San Diego-based maker of insulin pumps has set a aim of reaching 1 million customers by 2027, up from 400,000 customers final quarter, by increasing to sufferers with Type 2 diabetes.
The corporate final yr shared the outcomes of a examine of its t:slim X2 insulin pump in sufferers with Type 2 diabetes, and Tandem lately acquired AMF Medical, an organization making a tubeless insulin pump patch, creating a possible rival to Insulet, whose tubeless Omnipod pumps are disposable. Tandem is also getting ready to launch its Mobi system, a smaller insulin pump managed with a cellular app.
Elizabeth Gasser, Tandem’s chief technique officer, talked in regards to the current acquisition, plans to increase to extra sufferers with Type 2 diabetes and the way the corporate takes the environmental affect under consideration when designing gadgets.
This interview has been edited for size and readability.
MEDTECH DIVE: Massive image, what tendencies are you following going into 2023?
GASSER: I feel there are actually three which might be prime of thoughts:
All of us stay in a wise pump world now. As we take a look at the panorama round us, we’re attending to the purpose the place the narrative is [automated insulin delivery] programs, it is beginning to get to that place the place everybody generally is a little bit good. So how are you going to be the best good system on the market for sufferers when it comes to the outcomes you are delivering, when it comes to the benefit of use and usefulness?
Outdoors of the software program area, you additionally see a market the place there’s significant diversification in type issue. We moved the needle with X2 [insulin pump] and the usage of touchscreen interfaces. Our competitors clearly has an answer within the patch area, and there are a number of new market entrants coming to the fore looking for to take part at one finish of the spectrum or one other. For us, we have been very public about the truth that we have now a portfolio philosophy on the subject of {hardware}. We do not suppose one dimension matches all. Trying on the growing range on the market out there, it offers me conviction in our technique, however then additionally it is one thing that I proceed to observe.
Pharmaceutical corporations are making strides in extending the time over which long-acting insulin takes impact, which has attention-grabbing implications for a way you concentrate on methods to go previous the place we’re as we speak with insulin supply for the broader Type 2 section. We’ve an funding in CeQur, which is a bolus-only system, which enhances tendencies just like the transition to long-acting insulin and is a really completely different set of decisions than a basal-only pump.
Tandem closed its acquisition of AMF Medical this month. What was the technique behind that?
We began in the beginning of 2022, actually considering lengthy and arduous about how we fulfill the promise of serving the section of the market that very a lot needs patch-first [devices]. We had inner R&D efforts. As we went by way of the yr, we continued to mirror on whether or not we wished to be within the enterprise of delivering disposable gadgets or we wished to remain true to our rules, our sturdy gadgets, which candidly are just a little extra environmentally pleasant, whenever you’re not having to throw away a battery and chips each three months.
So we began to canvas the opposite alternatives on the market and take into consideration whether or not there have been inorganic alternatives for us to pursue the identical finish. We had a relationship with AMF Medical, we continued to discover it by way of 2022, and we grew more and more enthusiastic about the truth that it was a extremely ergonomic, small form-factor system, very a lot designed with environmental rules in thoughts, designed for these prefilled cartridges, so actually beginning to level comfy of use. And [we] obtained to the purpose the place we have been like, that is the answer we wish to pursue.
The crew may be very skilled, [with a] long-standing historical past in designing miniaturized gadgets for top scale manufacturing. We have been excited to have the ability to add the system to our portfolio, and that is the illustration of how we intend to pursue patch and tubeless.
There is a tendency to conflate tubeless and disposable as a result of the one tubeless possibility out there’s disposable. And it is not the identical factor.
What about AMF’s product helped alleviate these environmental considerations?
Should you take a look at the design of the product, there are three items to it. You have got the on-body website, which is the tubeless infusion website. You have got a cap that’s the docking level between the location and the pump, after which you might have the pump itself.
There’ll at all times be some stage of consumable hooked up to the supply of infused medication. The pump itself is a multiyear sturdy [device]. And so the actual focus for us there’s how do you reduce digital waste?
There’s been a number of dialogue lately in diabetes expertise about increasing to extra sufferers with Type 2 diabetes, not simply Type 1. How are you excited about this?
I feel as an trade we throw across the phrase Type 2 with out actually reflecting on the underlying segmentation of the inhabitants. So once we’re speaking about Type 2, there’s the headline quantity, the rising incidence of Type 2 on the macro, nationwide stage the place we find yourself speaking about 30 million customers. For the world we function in, there are two classes inside that group. There are the people who’re on basal [insulin] solely after which there are the people who’re on a number of day by day injections, who use rapid-acting insulin. And so for us, once we’re speaking about Type 2, we’re actually centered on Type 2s utilizing fast performing insulin on a number of day by day injections. For that section, there’s greater than 2 million folks within the U.S. as we speak, and pump penetration amongst that group is lower than 5%.
There’s clearly a possibility for us to proceed to adapt our product to the wants of the Type 2 consumer. I feel there is a mixture of issues. There’s the expertise itself, can we make it very extremely usable, simple to undertake? Can we exhibit the efficacy on this inhabitants in a approach that encourages physicians to have a look at pumps as a reputable possibility for remedy?
You may see us speaking an increasing number of in regards to the outcomes that we’re having with Type 2 sufferers when prescribed off-label. [It’s] very efficient in delivering improved outcomes. And that can lead us to a extra formal indication for Type 2.
We and others within the trade proceed to have interaction with Medicare to take away necessities like C-peptide exams for Type 2, which is presently the proof for getting a pump. It is not essentially a clinically related bar in all circumstances. So there’s work occurring to take away a few of these hurdles to entry.
From a tool perspective, we imagine this group of customers extremely worth discretion. [People] typically come to being a Type 2 later in life after years of weight loss plan, medicine, and being advised they don’t seem to be attempting arduous sufficient. And so a few of our considering on the Mobi product that we’re bringing to market this yr, is with a smaller type issue, with a cellular management interface, you may ship on a few of that discretion as a result of you do not have to drag it out to work together with it.
What insurance policies are you watching going ahead?
Medicare protection for pumps for Type 2 is one thing we’re occupied with and advocate for.
Additionally, simply wanting extra broadly at the price of insulin and state stage initiatives, I feel it is related to our area. It actually informs the insulin assist roadmap for a corporation like [ours], particularly with pathways in the direction of biosimilars and alternate initiatives just like the California state initiative round producing insulin.
It is all within the vein of what does the world appear like for our sufferers and our clients shifting ahead.