Dr. Robert Kossmann has a unique perspective of kidney care as the chief medical officer for Fresenius Medical Care North America and head of renal therapies for the company’s global medical office.
Germany-based Fresenius is the world’s largest provider of dialysis equipment and dialysis services, offering treatments at traditional dialysis centers as well as in patients’ homes.
Medical Design & Outsourcing recently spoke with Kossmann about kidney care in the pandemic, the challenges and benefits of home dialysis, logistics lessons learned and growth opportunities that medtech designers and engineers should keep in mind.
This conversation has been lightly edited for space and clarity.
MDO: What does COVID do to the kidneys during and after an infection, maybe even years after an infection?
Kossmann: To state the obvious — but it’s an important grounding point — COVID’s only been with us since probably the end of 2019 … and that really influences how much we can predict about what’s going to happen in the future. What we’ve clearly seen is that COVID, like all viruses, is evolving. In the earliest part of the pandemic here in the United States specifically, but even globally, it really caught fire in the first half of 2020 and we saw a lot of acute kidney injury. A lot of people got severely ill from COVID. It was the original form of COVID-19, so a higher degree of illness, big time inflammatory storm in these individuals who got hospitalized, and then a high proportion of those that were hospitalized — up to 60% — had some kind of kidney involvement, particularly those in the critical care units, and we saw people needing dialysis on a temporary basis in a sub-portion of those.
MDO: What are you seeing more recently?
Kossmann: Fast forward two years later, the last six months we are seeing more COVID infections, but the virus has evolved. And obviously we’re all used to talking about the BA.1 variant, the Omicron variant, and happily we’re seeing less severe illness, less of that inflammatory storm and less acute kidney injury (at least getting severe enough to require dialysis) and less intensive care unit involvement. We do know because there’s data that the kidney is involved directly, not just from the inflammatory storm, and that there are some effects from the COVID-19 virus in the kidney itself. We’re not sure how that’s going to play out over time because not enough time has gone by. But some individuals who were already at risk — from diabetes, from hypertension, from preexisting kidney injury — that kidney damage they had coupled with the kidney injury they received during their COVID illness, we have real concerns that it is going to result in some further permanent loss of kidney function. How that may play out with respect to progression is yet to be determined. And particularly for those people who had these underlying conditions, some of the new drugs that are on the market that are allowing us to treat their kidney disease, like the SGLT2 inhibitor class, may help some of those patients. But it’s an unclear picture. What we do know is that patients will continue to progress, those who have chronic kidney disease. We know that they’ll continue to be people who will eventually need a kidney transplant or some form of dialysis.
MDO: Is there an adequate supply of equipment?
Kossmann: The predominant form of dialysis done as an outpatient is hemodialysis and inpatient, it’s predominantly hemodialysis as well. Early in the pandemic in the Northeast, a main concern because it was an immediate life-threatening issue was the ventilators, but there were some concerns about shortages of dialysis equipment. We were able to pivot and meet the need. It was uncomfortable at points, but we literally created the National Intensive Renal Care Reserve, which is equipment and supplies that could be moved around the country, as there was an immediate need and there may be a future immediate need. As we think about the lasting effects and the fact that COVID is with us, it doesn’t strike me that there’s going to be some major change in the need for devices and infrastructure. Most hospitals above the level of a small community hospital have either direct ability to provide dialysis in the hospital or they’re partnered with somebody close by who can do that. I don’t think that need is going to diminish, but if there’s growth, I think it’s not going to be something for which COVID is responsible.
MDO: Where’s your focus now?
Kossmann: We continue to focus on innovations that help our devices be more real-time connected, both in the critical care space and also in the home dialysis arena. That’s an area that we’re quite heavily focused on. Giving the opportunity for our chronic patients who need ongoing dialysis support to be able to do that at home, we believe that turned out to be beneficial to those patients not to need to get out as much during the course of the pandemic. They were able to do their treatments at home, and they had that connectivity that we’ve been enhancing over time and are continuing to enhance so they could stay in contact with their healthcare providers. And that included standing up a robust telehealth process and systems and processes that were HIPAA secure. We went from in 2019 doing what I would call basically a handful of telehealth visits to a robust telehealth system in a very short period of time, by about April of 2020. We now measure the number of telehealth visits in the millions.
MDO: How does that home dialysis support work?
Kossmann: First of all, patients need to see their doctors, nurses, the folks on their care team. Some of that can be done virtually now, some things can’t be done virtually, so the patient is still going to come into the clinic periodically. But they need supplies whether they’re doing home hemodialysis or peritoneal dialysis at home. Home dialysis is probably 85%-90% peritoneal dialysis and about, call it 10%, maybe a little bit more on the home hemodialysis. And that requires supplies each time they do a treatment. Peritoneal dialysis is done daily, so they need some solution and some disposable supplies daily. Home hemodialysis is typically done several days a week, and again, the same issues. So this is connectivity with respect to making it easier for them to order their supplies and understand what their inventory is. When they have questions, if there’s a technical question with the machine, somebody gets a message displayed on the screen of the device, we have 24/7 support.
MDO: And you make and deliver the home dialysis supplies?
Kossmann: We manufacture and we also deliver those. We have a delivery infrastructure — a logistics company, essentially — so we move things all around the country. These are sterile medical supplies and they’re highly specialized. You have to have the specific supply for the specific device.
MDO: So you’ve got truck drivers, and that’s a big issue right now in supply chain and labor. Is that going to be a bigger consideration down the road for companies like yours?
Kossmann: Yeah, I think it is. We have learned a lot from COVID that we are taking forward, including an ongoing preparedness plan, and it’s helped us evolve our preparedness plan. We are a company that, for many years, has had a robust disaster response system. We’re actually recognized by FEMA as a disaster response company because of the recurrent work we’ve done around hurricanes. But those are usually singular, geographically limited events. And part of what we’ve evolved to now is understanding how to respond on a whole country and frankly, a whole globe level, because two-thirds of the patients we serve directly are in the U.S., but another a 100,000-plus are outside the U.S. in multiple countries, and we have product in most countries in the world. Going forward, the thing that we are working with the rest of the healthcare community about and manufacturers about is not only healthcare personnel for whom there’s a shortage, say of nurses, but the logistics of making sure that we’ve got enough trucks and drivers. We had trucks, but at a certain point during the Omicron peak early this year, we didn’t have drivers and neither did anyone else. And we couldn’t get volunteer drivers because if I volunteer my time, I can help load a truck, but I have no business nor do I have a license to drive an 18-wheeler. What we tried to do is utilize people to their specific skill level and we’ll pull people from other places to help us cover the need in another pandemic situation where it’s a highly communicable disease like this. We will take the learnings about how we utilize folks and how we try to protect folks. But it’s hard to say that we can guarantee we won’t be facing another crunch. It’s hard to predict what it is you need to respond to. It’s important to plan, it’s important to learn and to be nimble and not rigid.
MDO: And are there any devices or components or materials that would be in greater demand if there’s an increase in kidney care?
Kossmann: The materials that we tend to use are not rare or unique. To my knowledge, we don’t do anything with rare earth elements. The flip side is that we like everyone else work in a global supply chain and we are a global company. We manufacture in North America, we manufacture in eight locations, but we have about 40 locations total across the globe where we do manufacturing. There have been points in time where actually relatively common materials were somewhat difficult to get, but it was not because the raw material didn’t exist, it’s because that company had actually its logistics troubles delivering to us. From our previous disaster planning and disaster preparedness activities — for example, the H1N1 influenza outbreak and Ebola in the U.S. — we took very hard look at how we do things both on the manufacturing side and on the clinical side. We also said, “What happens if we can’t get material for a period of time?” And we do have inventory reserves, both of some raw materials and some of certain finished products. “What happens if we’re not able to manufacture?” We think very deliberately about that. And then of course there’s management of that inventory. You can’t sit it there and 10 years later expect the same stuff you put on a shelf to be ready to use. That also requires us to have a process by which we’re rotating that in, being careful to stay on top of it. And I think other manufacturers need to be thinking about that as well.
MDO: How should medtech designers and engineers think differently about kidney care products?
Kossmann: Both in the hospital and outside, connectivity and the ability to be monitoring what’s happening real-time remotely applied to patients in isolation in critical care rooms where staff were trying to limit the amount of time they were in the room. But some of that ability to monitor the treatment across a doorway also applies to monitoring a treatment that’s occurring in a patient’s home across town. Think about how we evolve that equipment, making the equipment more user-friendly, making it more intelligent and more connected such that the practitioners are able to get alerts before there’s a technical problem with the machine as well as the treatment data. That is going to be very important. To the point about growth of in-home dialysis, the patient population on chronic dialysis has been one of the most vulnerable patient populations during the pandemic. In fact, the mortality rate among dialysis patients was as high as that of any other population. It’s just a smaller number relative to some. So while there was a lot of talk about the very sad situation with respect to outbreaks in nursing homes, vulnerable people, frail individuals and a lot of deaths, what got a little less press was the fact that the mortality rate for dialysis patients was effectively the same and their risk was higher. And for patients who had to keep traveling back and forth to the dialysis unit, we know that the measures that we put in place in our dialysis clinics kept them safe. We’ve done research on this and shown it. Fresenius was the first to require universal masking of its staff and patients in March 2020, well before others. … And our patients on home dialysis did not have to travel back and forth, certainly not several times a week, but really were able to limit how much they got out and still get their treatments and we were delivering their supplies. So our engineers think about — and I would encourage other engineers and designers to be thinking about — how do we as a community make things easier, less intimidating, more connected to the nursing and physician staff who are taking care of them. And these are some real growth opportunities.
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