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Dialysis Decade: How Devices Get To Market & (Re)Moving The Needle on Access
30 companies (re)shaping the dialysis landscape from lab to market
Welcome to the decade of dialysis, where exciting new technologies and products are forging their way from research labs to the clinics and bedsides of people living with kidney failure across the globe.
The only thing separating these life-changing solutions from the patients who need them is a decade-long, harrowing path to market. And like any great hero’s journey, these companies face a series of major milestones they must overcome to reach their final destination: commercialization.
Today we zoom-in on dialysis devices, while zooming-out on the timeline of these milestones along the way. My goals with this article are to show you (a) where current devices are focused; (b) where innovation is needed to fill gaps; and (c) where the next generation of devices are headed.
Remember, medical technology (“medtech”) innovation is no small feat, ever. It takes longer, costs more, and happens less often than you might think. And yet, most companies are Davids, not Goliaths. Globally, 80% of medtech companies have less than 50 employees. In Europe, that number is 95%.
A small number of “heroes” make it to the finish line. So let’s talk about why that is, what can be done about it, and how solving it could transform the treatment of kidney failure as we know it.
What's in this table:
Stages: The four (4) columns in the table above represent the major milestones device companies face: (a) pre-clinical R&D; (b) feasibility testing; (c) pivotal trials and regulatory submission; and (d) regulatory approval and post-market studies.12
Applications: The four (4) rows represent select dialysis types and care settings: (i) hemodialysis (HD); (ii) peritoneal dialysis (PD); home hemodialysis (HHD); and acute dialysis (I/CRRT).
Device category: The two colors seen in the table represent two broad categories of devices by their primary function. The purple items represent devices used in the direct delivery of treatments (i.e. cyclers, machines). The blue items represent devices used to enable treatment (i.e. ultrasound, detection, monitoring, assessment).3
Paths to market: The summary tables are set against the yellow background. They contain data that aims to highlight broader industry averages for medical devices. There are three summary tables: (i) development cost; (ii) time to market; and (iii) share of FDA approvals. Each table displays average data for two device types: Class III devices on the left (in purple), and Diagnostic devices on the right (in blue).
Labels: There are two additional labels to note. First, I’ve once again included a crown (“👑”) for companies with an exit, either through M&A or IPO. Second, I’ve added a globe (“🌍”) where devices are in use and approved, but outside the US (e.g. CE, PMDA).
Signals
We need 3x more dialysis capacity than we currently have.
Hemodialysis is the status quo— home HD is another story.
Why new dialysis machines take a decade and $50+ million to build.
It happens how often? Treating kidney failure in the hospital setting (Soon)
The future is artificial — and so can you! (Soon)
The global dialysis footprint has big shoes to fill — we need 3x more dialysis capacity than we currently have.
Across the globe there’s a massive gap between the number of people living with kidney failure and those who have access to life-saving treatments like dialysis. Worldwide, nearly 90% of patients on dialysis receive hemodialysis (HD), with the majority (>90%) of those patients on HD living in high- and upper middle-income countries.
The costs of dialysis care are high and will likely continue to rise. The US may be an anomaly in terms of national dialysis spending (~$40+ billion annually), but cost barriers persist across high, low- and middle-income countries.
60 years since the first dialysis treatment, we know we can do better. The question is: how can we capitalize on new opportunities to transform dialysis outcomes for patients here at home and across the globe?
A 2020 paper by Dr. Himmelfarb and colleagues points to the need for both top-down efforts (systems level policy, regulations, macroeconomic) and bottom-up efforts (patient-led, patient-centered, advocacy, innovators, investment). This bi-directional push-pull is vitally important to the health and potential of our ecosystem. Many of the “newer” entrants you’ll find in the table above are answering the call of recent top-down efforts that have emerged in the past 10 years.
Examples you might be familiar with include the Kidney Health Initiative, Executive Order on Advancing American Kidney Health, KidneyX, National Kidney Foundation Innovation Fund, Neokidney, and the Affordable Dialysis Prize.
Suggested reading
Dialysis Care around the World: A Global Perspectives Series. The Kidney360 Global Dialysis Perspective series launched in 2020 and showcases how dialysis is practiced, delivered, and financed in different countries across the world.
HHS and the ASN Announce Winners of $9.2 Million Artificial Kidney Prize Phase 2 at KidneyX Summit. Phase 2 of the Artificial Kidney Prize competition invited submissions focused on either developing prototype bioartificial kidneys or a new tool or component that can help enable the development of bioartificial kidneys.
NKF Innovation Fund Seeks to Accelerate Kidney Disease Therapies. Launched in 2022, the NKF Innovation Fund works to accelerate funding, development, and commercialization of therapies that kidney patients need and deserve. The fund has made 8 early stage investments to date, including Klinrisk, Diatiro, ImmunoFree, Relavo, and 34 Lives.
In-Center Hemodialysis Is The Status Quo — Home Is Not.
If you follow along with the dialysis space you know home dialysis is the “Sisyphean boulder” we’re pushing up our proverbial hill. In case you are new to this newsletter or the kidney space, let’s do a quick refresher.
Today only around 14% of dialysis patients in the US get their dialysis treatments at home. The rest, around 475,000 patients, do so in one of 7,600+ outpatient dialysis clinics across the country (dark blue line above).
Within the home setting there are two primary options for patients: peritoneal dialysis (PD) and home hemodialysis (HHD). Take a look at the first graphic again, rows B and C are what we’re talking about here.
Now take a look at Figure 1.2 above: the gray line shows the percentage of new dialysis patients on PD (12.7%) and Home HD (0.3%) in 2020. The entire chart spans 20 years, so you can see how little has changed in terms of the overall modality mix in a generation.
Progress, yes. Though, it’s uneven— and a whole lot slower than first predicted (and prescribed). Many would say the same thing about the machines we use to deliver those treatments. If we can make it easier for patients to access and use home therapies, more patients will have the opportunity to experience its benefits.
Lately there’s a lot of excitement around enabling home adoption through the use of innovative technologies. It feels like device innovation is catching up to the excitement we’ve seen around policy and payment innovation over the past decade.
Time will tell, but the chance to one day make these blue, gray, and red lines reverse course and meet somewhere in the middle is what drives dozens of my favorite mentors, peers and colleagues in this community.
Examples include Mozarc Medical ($400 million JV between Medtronic and DaVita), Baxter (about to spinoff its Renal Care Business into a public company called Vantive), growth stage companies like Quanta and Diality, and a few early stage innovators like Relavo and AWAK.
Suggested reading
Can New Technology Make Home Dialysis a More Realistic Option? (New York Times)
DaVita, Medtronic raise the curtain on tech company, Mozarc Medical, aiming to bring innovation to kidney care. (Fierce Healthcare)
Check out the Baxter careers page ahead of the Vantive spinoff. (Baxter)
Quanta submits 510(k) application for use of its dialysis machine for treatment at home. (Healio)
System-Level Strategies to Improve Home Dialysis: Policy Levers and Quality Initiatives. (Watnick S et al. 2023).
Why new dialysis machines take a decade + $50 million.
This is the part where we talk about why building a medical device takes a village. Specifically, it takes a village with $50 million, a decade to build it, and grit.
And that’s if it reaches the market. In other words, if you can raise the capital you need to complete each set of milestones along the way; if you can deliver on your clinical outcomes and navigate the regulatory submission process; and if you can find a way to sustainably commercialize your new medical device.
I trust you see how difficult (and how great) an achievement this can be.
This is why I spend so much time amplifying these startups and struggles — the road to building and commercializing a device takes all the help these teams can get.
The image above is from a 2022 paper put together by HHS and a research group that sought to understand the costs associated with bringing a novel therapeutic complex device to market. This category of devices includes dialysis machines — but it’s just 1% of all FDA approved devices per year.
For Class I-II devices and those seeking alternate pathways like 510(k), the costs and time to market can be less. That’s why I included both sets of averages in the first graphic above (yellow section).
Suggested reading
The Therapeutic Complex Medical Device Development Report (2022) from HHS and partners is worth a read if you want to understand the quantified impacts of clinical strategies on the cost, duration, and phase transition probability for a new dialysis machine.
The Greenlight Guru team put together their Complete Guide to Bringing a Medical Device to Market that contains a helpful play-by-play, especially if you’re in the early stages of development or building out your business case.
The 2010 Makower Study on FDA Impact on Med Tech Innovation is a 44-page document that contains data from a survey of over 200 public and VC-backed medtech companies. It’s a fascinating look at the role of federal regulation in this space, and just how much has changed over the last 14 years since it was published.
Getting in the weeds here, learn how the TPNIES payment aims to incentivize the use of innovative equipment for both in-center and home dialysis. These are the types of add-on payments that shift the economics of device innovation and are important to understand as you’re thinking about the business case. (The Post-Op)
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The medical device approval pathway differs from drug approvals in several key ways. Learn more about the FDA device approval pathways here.
This list of devices is by no means exhaustive— rather, it is intended to highlight a number of devices in development and in the market today. This is for illustrative and educational purposes only. This is not investment or medical advice.
This purple (delivery) vs. blue (enablement) categorization is my own and does not reflect any existing divisions or classifications I’m aware of. For example, most of the purple devices are considered Class III (high-risk) medical devices by FDA, but not all. Likewise, many blue devices have pursued 510(k) or are considered Class II, but not all. As always, I welcome your feedback on how to improve these educational materials for a lay audience.