The Wound Care Learning Network had the opportunity to talk with Martin Burns, CEO of Bruin Biometrics, about his perspectives on the terminology controversy with pressure ulcers/injuries, the updated National Pressure Injury Advisory Panel Guidelines, and much more.
Do you believe it was necessary to switch the term from pressure ulcer to pressure injury or the combination term [PU/I]? If you don't have thoughts on it, that's okay too. [laughs]
No, the issue is I've got plenty of thoughts and I'm just trying to make sure I don't get myself step on a landmine…
Frankly, I could care less what people call it. I don't care. I will take the name that I'm being given by the people who set the international guidelines, and I will work with the name. I'll work with it. It's not for me to set the name. I'm saying that as a published writer. I'm saying that as a person who's dedicated the last 10 years of his life to prevention, but ultimately, I'll take what's given to me in the guidelines.
Let me just make probably what will be a very controversial topic, term, statement even. But I think it's appropriate for the time that we're in. My very favorite book, which is a scientific book, is The Structure of Scientific Revolutions by Thomas Kuhn. He wrote it decades ago. It was [an] early ‘60s book, I believe. He was the guy that coined the term paradigm shift. If you ever heard of that term, that's where it comes from. It actually comes from his book.
In it, he describes the evolution of science specifically. If you take a crude example, how he moved from this idea that the world is flat, the world is round, or in a medical term, how do you go from using the back of your hand or the front of your hand to tell somebody's temperature, to actually using a thermometer…
What happens in this process? If you would just Google it, you would see these wonderful images of the cycle he describes, and it's called The Structure of Scientific Revolutions. He describes in there two different types of science.
The first one he calls normal science. Normal is hard science—physics and biology and chemistry, biochemistry, and so on. He talks about those scientific pursuits becoming more and more and more detailed, where basically you've got more depth being investigated over and over and over again to the point where people end up arguing over nomenclature.
Is it an injury or is it an ulcer? Is it a sore or is it an ulcer? I could care less about what it's called. I don't care. What I care about is the fact that my customers’ patients are dying while the arguments are going on about nomenclature.
If you look at how many conferences over the last four years have been occupied by an argument amongst scientists of whether this should actually be called an ulcer or an injury, it is a moral disgrace that those conferences were not also talking about the underlying etiology of a pressure ulcer, how they occur, [and] what you can actually do to prevent them.
If you think about the hundreds of thousands of hours of nurses' time that's been taken up in the last four years, the multiples of millions of dollars spent on conferences, the lawsuits that have taken place between guidelines writing organizations globally, and the vitriolic comments between academics about whether it's an injury or an ulcer, that reduce[s] itself down to very personal terms: I think's a moral disgrace.
We're dealing with a problem here that is the biggest patient safety problem in the United States. It's the only patient safety issue that got worse, according to the AHRQ, from 2012 onwards. It's the only one. It got worse by six percent.
That's in spite of nurses and practitioners throwing everything they have at the problem, and it costs our CMS system $28 billion a year and the VA another $3 billion. The very best that can be talked about is, “Is it an ulcer or is it an injury?” I don't care. I care about preventing it.
I think that is a really remarkable way of looking at it. You're right. At the end of the day, people can feel passionately about it, and I'm not going to say that they shouldn't necessarily, at least from my role as an assistant editor rather than a scientist. You can look at the human language and how people will ban books in libraries because they don't want children to read The Adventures of Tom Sawyer. It's the idea that people will argue over words and at the end of the day, that's always going to be the case.
It's the message that these things are trying to get across. The bottom line, at least what it seems like, is that people care and want to prevent these things, but sometimes energy might be going in the wrong place.
Yes. Last comment I'll make on that… Henry Kissinger once wrote about academics… Why is it so nasty? Why are academics so nasty with each other? The answer he gave was because they have so little to argue about. I think that's true here. That actually, they're missing the point. There's so much science that needs to be researched about how pressure ulcers develop, why they develop.
Why is it that you've got two patients who are ostensibly the same in terms of their demographics—80 years old, female, 120 pounds—but one patient develops a PU and the other one doesn't, even with exactly the same care? There's so much science about individual patient responses to preventive actions and to treatment actions that we don't yet have answers to.
I would much prefer to see a bigger, more ambitious agenda set by the NPIAP, by SAWC, by AAWC, by the EPUAP, UMA, all of them. A much bigger agenda about really tackling this problem rather than arguing about nomenclature. There's so much good science we need to be engaged in, and we're not doing it.
Jumping off of that, would you care to discuss the updates on the NPIAP guidelines?
I'd love to. I think the first thing for us was that I was very, very pleased in so many ways with what they did in the guidelines. First you should know, if you don't already know, that there were about 400 people involved in doing those guidelines, and the level of rigor that went into them was utterly terrific.
I sent congratulatory letters and emails to the people responsible for it because they put their heart and soul into making this document as good as it is. I think that broadly, there are a number of different sections of it. One section deals with the etiology, the why and how of why the ulcers develop.
The other thing I will tell you is that it then moves on to the regular sections on prevalence and incidence and characterization of an ulcer, how you actually grade them. It talks a lot about prevention; the prevention chapter's been expanded considerably. Then it goes on to treatment.
The commentary that I'm about to give you excludes any commentary on the treatment sections. It's well outside my area of expertise. If you want to speak to somebody about treatment, I'd recommend a guy called Amit Gefen. Professor Amit Gefen wrote the actual etiology chapter and does a lot of biomechanical research on treatment regimes.
That's terrific—he's a good guy for that stuff. What was my take on it? My take on it, number one, was that it was a terrific time to recognize in the clinical arena that the understanding of how and why pressure injuries develop and what can be done to prevent them had been updated in the guideline, and they've been updated.
My first comment was, this was a real opportunity for reflection. When you take the time just to press pause and just reflect on what's written in there, here's what I took from it.
Number one was that the understanding of the pathophysiology, the how and the why these things develop, has really advanced quite considerably in the five years since the time the last guidelines were introduced in 2014.
They kept this idea of a damage cascade, wonderful diagram. They talked about the sequential damage associated with direct deformation of the skin and tissue of the inflammatory response that's associated with that, the body's attempt to heal itself, and the ischemia that gets associated with direct deformation—in other words, the cutting off of the blood flow.
Then the resulting cascade of problems of hypoxia, a lack of oxygen at the local site. The inability to do the apoptosis of cells, voluntary cell death. I thought those were really helpful sections.
I also thought that they pointed out a number of areas of potential new research, one of which was, Why is it that you have similar patients with similar demographics responding differently to a direct deformation? Why does that happen?
There's a whole bunch of open questions that they posed, which I thought was actually terrific. The role of inflammation was expanded a great deal in this document. The 2014 document had, from memory, four mentions of inflammation. This one has I think about 30, at least 30 mentions.
Why is that important? It's important because there's a real focus now on identifying what's happening underneath the skin surface before you can visibly see, palpate, or tactically just assess any palpation changes.
Basically, there's a recognition that ulcers, the vast majority of them are occurring from the inside out, particularly deep tissue injuries, and that actually, there's a complexity of systems occurring underneath the skin surface that are invisible to anybody doing an assessment no matter how good they are during the skin and tissue assessment.
Finally, we've now documented what we've known for decades, which is that pressure ulcers don't just magically appear at the skin surface. They occur because of a number of processes that have occurred underneath and before they manifest.
The trick is to be able to then clinically focus on that latency period, the period between when the deformation starts and the period at which the injury or ulcer erupts at the skin surface. There's a time period there, where it gives you an opportunity to intervene.
That's the first one. This is understanding of pathophysiology, the how and why, has really advanced. I love that. Secondarily, the guidelines were pointing to… I wish they were more direct about this, frankly, and I wish they were stronger, but I respect what they wrote, which was that the days of using visual and palpation skin assessments for early stage diagnosis, where those are the only methods for early stage diagnosis, are gone. They're past. The text recognized clinical judgment as having primacy. In other words, it is the supreme method by which a diagnosis is done, clinical judgment.
By the way, I agree with that. What I don't agree with, and what I wish they had been more direct about, was to say, “Look, there are a number of biomarkers that we're aware of. And we can assess those using a range of tools. You should be doing that.”
They left their conclusion, I think, too weak in terms of giving direct guidance to practitioners. I understand why they left it too weak, which is that they're trying to ground their recommendation in the available peer‑reviewed published science.
At the time, none of the biomarkers that we now can talk about with more certainty had enough published evidence for them to reach a more decisive conclusion.
Nonetheless, at least it's there. At least they're pointing to the use of biomarkers, and they're pointing to the use of technology to be able to assess those biomarkers. Those are good steps. Not enough, but they're good.
Final comment from the guidelines was to me they, again, focused on patients with darkly pigmented skin. That they recognize there's a higher risk of underdetection of the category one and DTI pressure injuries particularly, so deep tissue injuries in particular. Why is that true? Let me say, first of all, what is true about that patient set? What is true about that patient set is that dark skin-toned patients have a four times higher probability of mortality as a result of the complications for a pressure injury than any other patient cohort.
If you're [a] dark skin-toned [person] and you get a pressure ulcer, you're four times more likely to die than if you're lightly skin-toned. Why is that true? The science points us to the fact that it's very hard to detect persistent redness on a dark skin tone patient than it is on a light skin tone patient.
It's an obvious point, but there's enough science now built up around it to feel credible in believing the truth of that statement. What they're saying is there's a stronger recommendation in there to use technology to assess these biomarkers particularly on darkly‑pigmented skin... I agree with that.
What I'll say to you is that Joyce Black recently issued....Again, I didn't expect this, but she was terrifically strong in her statement that actually practitioners need to adopt the guidelines as they've been stated. They need to adopt the use of these biomarkers and specifically focus on patients with dark‑pigmented skin.
For God's sake, use the technologies. Her call to action was use them and write about your experiences. I thought that was really very helpful from Joyce, but those are essentially my comments on the guidelines. Very welcome.
I probably should have asked this from the start, but what is your driving force behind your goal to prevent pressure ulcers or injuries, and is this a personal, professional, [or] combinational goal? Where did this all stem from?
I've never been asked that question before actually, so I very much appreciate you asking [laughs] as to why. Many people get into this field because they've had personal experiences of these things, either themselves or family members and that's definitely true in my case.
I've actually had, not personal experience, but family members having to develop these things, but that's not really the reason why. There's the emotional trauma about seeing your friends and family develop them.
Without dragging off down too deep a path, I have a very particular bent that I absolutely despise unnecessary suffering. I can't stand it and I hate waste, and I have a very deep emotional connection to both of those things.
When I saw this technology, my God, in 2011, I looked and I thought, there are so few times in healthcare where you can address an extremely large and growing issue with relatively low risk intervention for the benefit of a very large swath of population. Very, very few times.
I looked and I thought, “I can't let this pass.” I will tell you that the journey that I took personally was being a student of people like Amit and Joyce, and Janet Cuddigan, and Ruth Bryant… These people who have written very extensively about this topic.
I've really been an astute student of these people, because they've been leading in the field in terms of the research. There's a group of people around the world, who are incredibly committed to the cause of prevention. Those people, among them…there's a whole bunch of others. The current president of EPUAP, Dimitri Beeckman. Some of the former presidents like Zena Moore, Dan Bader…these incredible researchers that are really committed to it. There's a group of us around the world that are very committed to this.
The other reason is that from a policy perspective, the government here in the US and also in Europe, in many countries around Europe, is very, very committed to the cause of prevention of pressure injuries and pressure ulcers.
They've done a lot. There's a lot more they can do. They've done a lot in terms of advancing the cause of prevention and penalizing incidents that were avoidable. For me, the personal motivation was I despise unnecessary suffering and I hate waste. When I saw this, I thought I can go make a difference in this.
I joined the company in 2012 and committed myself from taking this idea from Barbara Bates-Jensen’s head, and commercializing it into a product offering that really provides an overall solution, frankly, to the issue of prevention. It works. It really works, which is just terrific.
That's definitely a great combination to have: to find many of your passions and things you know a lot about and putting that all to good use. I am curious about your background before you join Bruin, your time at university.
One of the other reasons [laughs] actually why I was so attracted to this field was because it has a systemic component to it. What [do] I mean by systemic?
I had the real privilege of working with a lady called Professor Nancy Leveson from MIT for the three years prior to joining Bruin Biometrics. I worked with her. She wrote a book called Engineering a Safer World. Nancy worked on the NASA accident investigation. She worked on the Deepwater Horizon BP disaster in the Gulf. She worked on Chernobyl, all these things. She's got this safety system, which is just brilliant.
The whole idea behind it is [that] oftentimes, you've got explanations for accidents that blame the operator. The plane crashed because the pilot messed up. The patient got a pressure ulcer because the nurse didn't do her job or his job. You got COVID‑19 because China didn't shut down the border. That's the typical way of thinking about it.
Actually, what she is really saying is you can't do that because oftentimes, these errors—why things go wrong—go well beyond what happens just at the, as she calls it, proximate event, the cause and effect right there at the bedside—in my case in pressure ulcers—or in the cockpit as it relates to an airplane pilot.
I was working with Nancy, the three years prior to joining BBI, specifically on a project for the financial audit practices across the US. The issue was, why is it that so many audits have a different finding for exactly the same topic? If you're dealing with a real estate transaction, why is it you got exactly the same real estate type of transaction, but two different audit firms will give you two different audit findings for the same thing, even though the rules are clear and everybody's trying the same way?
I ended up doing this enormous project, which we ended up presenting to the SEC, explaining why you get this variation. We used her methodology of explaining large‑scale systems where you've got human actors in them, where you end up with very disparate operators, in other words, people not talking to each other, in two different systems, but getting the same outcome.
In our case, nurses in Seattle and nurses in New York following exactly the same protocols and all getting an incidence of about three percent of all their patients having developed a pressure injury. Why is that the case?
The patients are different, separate, they've never talked to each other, they've never had any interaction. The nurses are different, never had interaction. They're following the same guidelines and yet they still get these errors occurring.
That was the grounding. By the way, we identified in the audit project as to why it was occurring. We presented those data to the SEC and the PCAOB. They made changes to their overall audit practice as a result of that. That was the academic background.
When I was a consultant, I also was working in MedTech and biotech. I got a lot of work with CareFusion. I did a tremendous amount of work with other MedTech companies.
Then, I learned a great deal about the regulated world that has medical devices and, truthfully, fell in love with it actually. If you go back slightly further than that, I did my MBA at UCLA here in Los Angeles, focusing on marketing and strategy, but I still lecture there as a guest lecturer on medical device R&D, new product launches, and medical marketing.
Before that, I did my undergraduate at the London School of Economics. I ended up studying economic geography, if you can believe it. The practical application of it was that I ended up looking at overall population trends, mental health provision in the UK, for example, disparate care in Ireland as a result of the Northern Ireland-Southern Ireland border.
What was the effect of that? It gave me very much of a spatial view of the world. Meaning, there's this disparate distribution of people and resources. The question you ask yourself is, How do you match up the disparate distribution of people and the demand that they create with the disparate distribution of resources and the supply that that provides?
You end up looking at a great deal of operational aspects, trying to match up demand and supply at the right time, and figuring out why it is that you get gaps in that system. That's directly applicable here in the pressure ulcer world, because you see very systemic effects playing out every single day in why pressure ulcers occur. That's sort of that part [prior to joining Bruin].
The SEM Scanner was something that was an invention by a lady called Professor Barbara Bates‑Jensen, where she developed it in collaboration with the UCLA Wireless Health Institute in the School of Engineering.
I saw this on the front cover of the LA Business Journal in 2011. The mug shot of my chairman and the former founder. I thought, “…the product looks cool. Let me go figure that out.”
I chased it down and ended up joining. I essentially put the product all the way through a developed strategy of—putting it through the scientific testing, gathering all of the data, designing the clinical trials, completing the clinical trials, getting a regulatory approval through the FDA.
The FDA has never, and still hasn't to this day, approved a product for the assessment of skin and tissue for pressure ulcers. We created that category and to this day, we're the only product approved in it. It's been a real journey, pleasurable at times, brutally painful at others.
The thing that keeps me going is the fact that when you use the [SEM Scanner] in clinical practice, our practitioners report getting the most monumental reductions in the incidents in their pressure injuries or pressure ulcers.
I'm talking a lot, but let me give you one example. Probably the hardest cohort of patients to treat, to manage from a pressure ulcer/pressure injury perspective, are palliative end of life patients. We started work three years ago with a group called Marie Curie, which is a UK‑based charity for palliative end of life care for cancer patients, hence the association [with] Marie Curie. They had an incidence problem in one of their hospices, and they used our device for a year. If you think about their cohort, these are patients are chronically hypoxic, their internal organs are closing down, and they're immunocompromised. Typically, [the ulcers] have been called Kennedy ulcers and the idea had been they're inevitable. These Kennedy ulcers, these end-of-life pressure ulcers, are just inevitable. Nothing you can do.
In fact, this was a topic of discussion at the NPIAP’s last meeting in February, and I thought the conversation was very ill‑informed. Here you have this nurse in the UK, Jeanette Milne, who manages to get a 42% reduction in pressure injuries/pressure ulcers in her site, and I remember these are grades two, three, and four, the broken skin ones, 42%. Now, that was two years ago. Since then, they've deployed the scanners across the entire network of palliative end-of-life care patients, patient sites. They have about 24 sites across the UK.
Jeanette Milne, I was with her last month. She's now reporting a 79 percent reduction in the incidences of pressure ulcers at her site relative to the baseline year. Nothing has changed about her cohort of patients; they're still end-of-life, oncological palliated care patients. To me, when you get those kinds of results, I get very angry about the fact that this isn't mandated across the country. It should be. I also understand that in healthcare, change takes time and you have to be careful so as not to introduce risk.
On the other hand, I'm extremely delighted that here we have repeated examples of practitioners having the most tremendous results, in even the very worst at‑risk patient cohorts you can imagine.
Shortly after you launched the SEM Scanner, you collaborated [with clinical practitioners] to make that strategy, which you had touched on a bit. How did that project specifically come about? What were the results?
What we're doing is we're trying to modernize the care pathway for pressure ulcer prevention and management. That's not a trivial thing to do. There are a number of very knotty issues that you get into.
The approach we took right from the very beginning was that we didn't know all the answers and that we couldn't go tell people how to do all this. What we needed to do was to be modest, to listen really, really hard, and to collaborate as well as we possibly could, and as deeply as we could, with people of like minds that were very keenly focused on prevention.
We formed a scientific advisory board. It's probably the best scientific advisory board in the world in any wound care company.
Then we followed this approach of basically knowing that we had to go off and develop the fundamental science, invest in clinical trials, publish those clinical trials, and make absolutely sure that we were getting the input, the advice, and the interpretation from these brilliant researchers and brilliant practitioners.
I've mentioned some there. Jeanette Milne. Equally, Pippa Nightingale, who is the chief nurse over at Chelsea and Westminster, has been amazing. Donald David is the chief medical officer of UHS in California. You've got these academics and you've got practitioners coming together underneath this ambition to make prevention a reality at scale for their particular practices. That was the approach we took. We spent a lot of money on research. We've spent tens of millions of dollars on research.
We've got a terrific advisory board, and we listen very deeply to them. We learn every day, frankly. Every single day, we learn better ways of communicating other topics that people are asking questions about. Request for data. We’ve got a whole bunch of requests for data today about pressure ulcers in the smoking community. What are the SEM Scanner values for patients who are smokers? We were able to provide those. It's very much a very collaborative approach.
People often overlook collaboration and the importance of communicating, even if there are different ideas at hand. Unless you vocalize them, you're not going to know. That's really fantastic that there is such a place in which these people can discuss and you can provide that information.