Constellation Conversations with Signals Group Founder Tim Fitzpatrick
What do you see as the biggest challenge in our industry in 2026?
I think the biggest challenge is that we’re still detecting kidney disease too late. And care is fragmented from where it needs to be.
Most people who have kidney disease don’t know they have it. In the States, an estimated 35 to 37 million people are thought to have kidney disease, and 90% of those do not know that they have it. So, there is a significant awareness problem.
Plus, most kidney disease is diagnosed after kidney failure happens. I’ve seen multiple sources citing 50 to 60% are unplanned ‘crash’ starts; folks who did not know they had kidney disease prior to ending up in the emergency room and requiring dialysis emergently.
We need to find ways to talk about kidney disease sooner to make sure people are aware of the risk and empower patients to talk to their physicians, be it primary care, cardiology, endocrinology, or, ideally nephrology (although that’s currently unlikely), to understand their risk.
It’s hard to believe 90% of kidney disease is not diagnosed, even though screening for kidney disease is in the clinical guidelines and the confirmatory tests are inexpensive and readily available. If you look at the ADA guidelines, or you look at KDIGO, even when you have a patient who should be getting screened for kidney disease, it’s only happening for a very small percentage of those patients. It shows up in the US-RDS annual data report.
There is currently no formal screening recommendation issued by the US Preventive Services Task Force. The body of primary care physicians who make recommendations for screening at a national population have looked at CKD and have not found it to be cost effective. However, the population is getting older and more complex, and the costs of treating kidney disease continue to skyrocket. In the US, a quarter of Medicare spend is on kidney disease, over $150 billion annually, despite “only” 600,000 patients being on dialysis.
I saw recently that even when CKD is present in a medical record, 80% of the time it’s not documented. That tells me that it’s much more than just a urine test and a blood test to confirm a CKD diagnosis. It’s not just screening, it’s diagnosis and follow-through, getting patients onto an effective care plan to slow kidney disease in its tracks.
We’re up against system and clinical barriers. There’s a lot more we need to be thinking about and doing at the point of care.
What do you think the biggest misconceptions are around kidney health and kidney care?
The way you’ve phrased the question is a hopeful thing. You asked about kidney health which is an important distinction and improvement in the language that’s typically used, which is kidney disease.
The story around kidney health and kidney care has always been dialysis. That was the only narrative. But that’s changing.
Dialysis is a microcosm of what’s happening in kidney care. From the patient’s point of view, dialysis is a treatment option. If you have kidney failure, dialysis is how you’re replacing function until, if you’re a candidate, you can get a transplant. And even then, a transplant is a treatment option. It is not a cure.
The more we talk about the web of clinical pathways and patient journeys, the better. We need to retell that story because kidney is overlooked, it’s underfunded. People don’t think about kidneys until they fail and then it’s a dialysis story and the costs are out of control.
If we can discuss the importance of kidney in cardiac function, in managing diabetes and in all of these other cardio-kidney-metabolic (CKM) health states, that’s the best thing we can do.
I continue to be amazed by all the things going on in the human body that are potentially impacted by the kidneys. If you’re a physician, or a drug manufacturer trying to get a heart medication to a patient, you should probably understand whether the kidneys are functioning, because if they’re not functioning fully, that will impact your ability to treat the heart. If the kidneys are not processing the medication, it’s not going to get there.
We need to get to the stage where cardiologists, primary care doctors, or other specialists who are trying to figure out what’s going on with a person’s health will think, “we need to look at the kidneys.” We need to figure out if there’s kidney disease to deliver optimal care for this patient.
That is the level of awareness that I hope to see happen in the next decade.
That’s the story. Kidney care is not a dialysis story. It is much broader, and kidneys are the lens into understanding the full health of the patient.
What innovations and developments are you most excited about that can help with some of these challenges?
In the last 10 years, we have seen new therapies for treating kidney disease. For example, some diabetes drugs, like SGLT2s, or GLP-1s, have shown incredible evidence of kidney protective effects, of the ability to slow the rate of decline for people who have kidney disease. It shows up in prescribing patterns across specialties.
One of the challenges we often discuss, is fragmented care across specialties. If you look at those specialties who are the highest prescribers of these medications, like SGLT2s and GLP-1s, they’re primary care doctors, they’re cardiologists, they’re endocrinologists. And then at the very bottom of the specialty areas, you have nephrology.
Many people with kidney disease are not seeing a nephrologist. In the most recent US-RDS annual data report, they found that only 41% of patients who have stage 5 CKD saw a nephrologist during the year. That makes it very tough for a nephrologist to prescribe the medications that can act sooner (or drive toward a planned dialysis start). The good news is that uptake in increased. SGLT2 use has jumped significantly from around 2% in 2018, to a fifth of patients with CKD as of 2023.
If you can slow someone’s progression by decades by getting them on the right therapy, that is an incredible opportunity. It helps to keep them from kidney failure, keep their kidney function going, and delays high-cost care, or hopefully avoids it altogether.
Another area I’m excited about is genetic testing. Some of the work that’s been done to identify patients who we should be screening to see if there’s a genetic cause tied to kidney disease has opened up our collective eyes.
There are clinicians who thought that a certain clinical profile was one type of kidney disease, say chronic kidney disease, but in reality, a significant amount of that disease is tied to a genetic variant. For clinicians who are treating these patients, they can now think about modifying their treatment plans. One study, which focused on a particular test, found that in 90% of cases where there was a genetic cause found, they’d modified the care plan; in response to the positive result. That’s significant.
It also means that patients can become aware that there’s something else going on, which is important for the patient and for their family.
And then you have patient advocacy groups saying, “We need treatments, and there are no available treatments for us.” The most recent case where this has been a win is IgA nephropathy (IgAN). Now, these patient groups are able to access genetic testing. Pharma may say, “Here’s how we would think about solving for this, but we need help figuring out which genes are the bad actors here.”
Together, they can go to regulators and say, “We need your help figuring out how to run trials to get these drugs to market.” I’ve heard this described as the diagnostics and therapeutic odyssey that drives the treatment flywheel. Now we have three approved IgA nephropathy drugs in the last four years when there were zero. And we have 10 or more in the pipeline. Hopefully we’ll see more of this happening with PKD, with APOL1, with Alport syndrome. There are a lot of exciting possibilities when you start understanding the root cause of disease, especially when it’s genetic.
I’ve also spent time thinking about how we help more patients and care partners carry out dialysis at home. How do we improve the patient experience to give patients access to therapies that will potentially allow them to have a better quality of life, lower medication use, and higher likelihood of transplantation. But how is that delivered in settings where access to care is low or complex? I’m thinking of communities where they do not have access to these services, or have other social barriers to dialysis at home.
I think we’re seeing recognition that despite a push in the last five to 10 years for more home dialysis, we haven’t seen that shift play out as meaningfully as we had hoped.
It’s hard with a life-sustaining treatment like dialysis, where safety is paramount. But, I’m optimistic that there are new devices coming to market that are getting approved and will allow for more flexible treatment and prescriptions, making it easier for patients to do these therapies at home.
There is also more thinking going into the wraparound support and services. Not just, can we take what’s been done for decades in an outpatient setting and move it into the home. That’s the wrong way to think about it. People are waking up to the fact that we need to build the model differently and provide greater support to patients during the transition to home care.
How do you think technology and AI can shape how care evolves?
Technology should address some of the unmet needs and gaps in ways that humans maybe cannot fully do on their own. It is a copilot. It is there to help reduce some of the tasks that humans don’t need to be involved in, like administrative tasks, and looking across massive amounts of data. A patient’s medical record is a great example. A lifetime of medical history is challenging for one person to review and understand in order to treat kidney disease.
AI in the short term is alleviating some of the burden associated with moving from a fee for service approach to value-based care. It is breaking down the silos of where patients are coming from and where they need to go, identifying and risk stratifying populations so they can get the best, most effective therapy.
There are narrow AI applications that are working, but I think most people would agree that AI’s greatest potential in nephrology is digesting the vast amount of data and complexity across care streams and allowing someone to very quickly understand not only a patient’s disease and their options, but also help everything around the patient to work. It could help the payer know what it’s going to cost, help the clinician know what treatment option to choose and how a patient might respond, and provide that overarching view based on every detail available at the point of care.
That’s the area I get most excited about because right now it’s so manual. I’ve heard the frustrations from many clinicians who have such finite time with patients. I imagine that there’s going to be a time when AI allows technology and data to work seamlessly so that we no longer have to spend 24 hours a day figuring out billing and can just focus on delivering the best care for the patient in and outside the four walls of the clinic.
Outside of AI, what do you think the hot topics will be this year?
I think the topic of Cardiovascular-Kidney-Metabolic (CKM) syndrome is just getting started. I hear it from a broad cross section of the kidney ecosystem; industry, academia, research, and advocacy. People are talking about kidneys. It even got a spotlight in a Super Bowl ad! CKM with kidney at the center has to be and should be top of mind.
The second area is transplantation.
Policy and regulatory changes are happening in transplantation, and hopefully expanding living donation. There are recent policy wins on the living donor side, so we’re seeing some movement there.
It’s still pretty early, but xeno transplant has gone through an incredible narrative arc. It’s been around for decades, but in the last three to five years, we’ve seen clinical trial approvals to the first patients being transplanted, and xeno transplant as a potential bridge to allotransplant. That is really interesting. It changes the math on wait times and on supply. If someone is going to face a 10-year wait time for a human kidney, they can get a xeno kidney that bridges them for a few years. And, we’ve seen that play out once. It’s exciting to consider what it could mean for the global organ shortage.
What are your longer-term hopes for our industry?
Very simply two things.
First, that we all start thinking more upstream. The way we pay for innovation in kidney care is quite limited. It’s stifled by our payment systems, which is a difficult thing for everyone to get behind and understand. Whether you’re a company, or an industry who wants to invest in new therapies for kidney patients, not having an ability to build a business around that or have confidence around your ability to get paid is a blocker.
We need to overcome some real hurdles to get there, but we all need to think more upstream to work alongside primary care.
The second is to have more treatment options for patients and we’re starting to see this. I spend most of my days talking to companies about strategies for getting new treatments, innovations and services to patients. That can be everything from new drugs for rare kidney diseases to new ways to remotely monitor the health of patients at home or as they go about their daily lives.
Continuous monitoring technologies are always interesting to me. The ways that we pay for and integrate those technologies are changing. New models from CMMI, from the Innovation Centre at CMS, like the ACCESS model and TEMPO, will allow us to test how some of these new devices will actually lead to better outcomes and establish how companies will get paid based on those outcomes.
It’s a fundamental shift towards a technology-enabled future in kidney care.
And finally, despite everything we’ve mentioned, many patients still need dialysis and a lot of options arise when you do the right thing at the start. By delivering better care long term, patients have a chance to get a transplant if that’s the right move for them, or they have a chance to transition to home dialysis and continue to work or continue to feel better by doing more frequent treatment options at home.
It’s one of those rare parts of kidney, of overall US healthcare and global healthcare for that matter, where doing the right thing by the patient also has a positive impact on costs.
Resources and further reading:
Catch Tim and Michelle during the ANNA Nephrology Nursing Summit being held in Scottsdale, AZ , September 15-20, 2026 for an AI panel discussion.
Tim Fitzpatrick is the founder of Signals Group, a media and advisory platform covering innovation, investment, and policy across kidney and cardiometabolic health. Signals reaches more than 20,000 professionals in over 60 countries and has become a trusted source for research, industry analysis, and community insights across the kidney ecosystem.
Tim previously founded and led IKONA, a healthcare education company focused on kidney care. Before entering healthcare, he worked in institutional equities covering emerging technology and media, and he is a U.S. Navy veteran. He now advises startups and public companies on the innovation, clinical, and commercial landscape as they bring products to market, and is actively building new ways to support early-stage companies with capital, strategy, and insights they need to improve the lives of patients around the globe.