Lumea Podcast: Overcoming Barriers to Digital Pathology Adoption

Welcome to PathPulse: Pathology Innovators in Action, your go-to podcast for practical and implemented digital pathology insights and solutions. This podcast is sponsored by the Digital Diagnostic Summit and Lumea.

In our inaugural episode, we are honored to host Amanda Lowe, a distinguished pioneer in digital pathology. Amanda began her journey in this field over twenty years ago at Bacus Laboratories, the first U.S. distributor of the Hamamatsu NanoZoomer. Since then, she has held various roles in the pathology industry, from consulting to directing business development at Visiopharm. Amanda’s story is both inspiring and rich with practical insights for anyone looking to overcome common barriers in digital pathology.

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Transcript

Bianca Collings: Welcome to PathPulse: Pathology Innovators in Action. We are thrilled to announce that we are rebranding from Ask a Pathologist podcast.

This podcast is dedicated to showcasing the pioneers, the innovators, the movers, and the shakers who are actually transforming digital pathology from theory into practical, implemented, and viable solutions. I am Bianca Collings, your host today. I’m the executive director of the Digital Diagnostic Summit and the VP of Marketing at Lumea. Today, I am delighted to welcome our esteemed guest, Amanda Lowe, whom I had the pleasure of meeting earlier this year. Amanda is not only a legend in her field but also one of our featured presenters at the upcoming Digital Diagnostics Summit in Park City, Utah, this September.

In today’s episode, we will explore the evolution of digital pathology, where we are, where we’re going, and removing those barriers in digital pathology. And I truly believe Amanda is the perfect guest for this discussion, given her extensive and pioneering history in digital pathology. So welcome, Amanda.

Amanda Lowe: Bianca, thank you so much. It’s such an honor to be here today. And I’m really excited to spend the next 30 minutes or so with you and all of your viewers and listeners here at PathPulse. And I’m honored to be part of the innovators you’re highlighting on the podcast today.

Bianca Collings: Absolutely. Just to get started, give us a little bit of a history of where you are right now and your bio, your intro, let us know who you are.

Amanda Lowe: Yeah, well, thank you. So I’m really, really proud to say that I have spent over 20 years – I don’t know where that time went. It’s like, whoo, 20 years – almost my entire professional career in digital pathology. How I got involved and got going is I started with a company called Bacus Laboratories when I accepted a position as their national sales manager. Bacus was one of the founding whole slide imaging companies. We had a microscope face scanner, a web server and viewer. We even had some IHC image analysis tools. Yeah, it was really different back then, but we had it. We were also the first distributor of the Hamamatsu NanoZoomer in the United States

So, we did a lot of kind of groundbreaking things back then. And Bacus was a great, great start in digital pathology for me. They were a really small, innovative company, and I just knew I could make a difference. It was really important to me that I joined a company that was going to invoke change and meaningful impact, and I definitely found that with Bacus.

Bianca Collings: Let me ask you, did you know when you applied for this position that this is what you were getting into? Had you ever heard, and I’m guessing digital pathology probably wasn’t a term.

Amanda Lowe: Yeah, no, we actually called it virtual microscopy back then. Okay. So, and no, and one of my favorite stories that I love to share is that when I was interviewing, they were showing me the scanner and, you know, the computer, and they had the viewer moving around the whole slide image. And it was a big wow factor. And it was, I still think it is a wow factor, you know, what we do. But it was a really a -ha kind of pivotal moment for me in my life and career because scanning of glass slides, computers working as microscopes just makes sense. It was really clear to me that that was the right thing we should be doing. And that truly continues to be a motto for me, that digital pathology is the right thing to do for science and patient care. It just makes sense.

Bianca Collings: Absolutely. Getting our technology and our healthcare to align on the same timeline. I feel like we are a little bit behind with the way tech is. And I feel like the word pioneer can be overused in an industry. However, I would say this truly is a, you truly were a pioneer.

Amanda Lowe: That’s very kind to kind of you say, and you know, I’ve just always been very committed to you know, what we’re trying to do as an industry. And you know, for folks that know me and for folks that don’t, you know, that’s really kind of been my commitment throughout my career. Bacus was actually acquired by Olympus, and I spent a few years working under their clinical digital imaging team. I then ran my own consulting business, which was really to help the adopters and the industry as a whole with how to make value out of digital pathology. I used to see so many scanners Sitting in the corner collecting dust, and it was just sad It was sad to not see the value and the utility Happening in digital pathology, and that was really my driver in developing my consulting business

And then, when I joined Visiopharm 12 years ago, it was because, again, I knew that now we have all these images; what are we gonna do with them? How are we gonna make value out of those images? And so that’s what the team and myself at Visiopharm have been working really hard to do for the past 12 years, or at least my time there, 12 years.

Bianca Collings: Okay, and tell me, give us a little background. What are you doing right now with Visiopharm?

Amanda Lowe: Sure, I have, you know, like a lot of smaller companies, I wear a few different hats, maybe a few less than I did. When I started with Visiopharm, we were only 12 employees. I was one of two employees over here in the United States because we’re a Danish company.

And we’re definitely not that anymore. We have over a hundred employees globally. So we’ve changed a lot, but I wear two hats today. I’m the managing director for Visiopharm Corporation, which is our largest subsidiary, global subsidiary. And so I run all of the U.S. and America’s business. In addition, I am a senior vice president in charge of our customer success team, which really, globally, looks at all of our clients and how we maximize their best interest in how they are successful with the software. And just like most companies, we offer subscription services. So my team’s also responsible for a lot of that renewal business.

COVID-19’s Affect on Digital Pathology

Bianca Collings: Oh, fantastic. So, as we’re moving forward, you’re with Visiopharm. This is when COVID hit. And actually, this is where you came on my radar. I heard from our co-founder, Dr. Matt Leavitt, that you were a critical piece of a group that helped accelerate the adoption of digital pathology for obvious reasons. I’d love to.

Amanda Lowe: Yeah, well, it’s always been great to work with Matt. Matt and I go way back, and so it was very natural for us to kind of jump in together as a team.

And there were a lot of people around us that really helped to try to make a difference during COVID. And we’re just one of countless examples. But when we think about COVID and the impact of it on digital pathology, it helps to think about “what was digital pathology before COVID.” And frankly, especially in the United States, we were really struggling with slower adoption rates. And the main reason is there just wasn’t a clear business case for it. And this was compounded by lots of regulatory and licensing challenges and, frankly, a lack of real-world evidence of how it makes a difference.

Another interesting thing is telemedicine throughout healthcare, even pre-COVID, was definitely more advanced than it’s been in pathology. It was not a norm in any way, shape, or form in pathology. I mean, there was telepathology, but that was primarily used for second opinions, international consults, and even some surgical consult scenarios. But telemedicine was still really, really limited by IT infrastructure, safety concerns, you know not as much was in the cloud back then, and even safe use of video technology. I don’t know about you, but do you remember when there was a huge issue with Zoom?

We were all on Zoom. Everyone’s on Zoom from home. And then there’s encryption freakouts.

I remember at the Visiopharm, they were like, stop, don’t use Zoom. And we had to go through a whole re-validation of it.

And, you know, so the fact is we were all just trying to adapt, right? And figure out what to do.

Bianca Collings: The entire world, we were, if you weren’t ready to adopt, and I’m moving away from even telemedicine, a life in video and streaming and be it work, and we’re talking children and their education.

We were forced into it and the infrastructure for a lot of the software platforms, they weren’t, it wasn’t ready. We weren’t ready. It almost goes back to the car analogy. It’s like all of a sudden, we have a shortage of gas.

It’s gone. No, I mean, no, but it would be gone. Like the gas is gone. So you’re forced to use this electric car that the infrastructure is not even set up for.

Amanda Lowe: Yeah, I mean, did you ever meet with a doctor virtually prior to the pandemic?

Bianca Collings: I never would have thought it was possible, but I’m going to tell you, it made my life so much easier, right? Because I’m sitting in the waiting room for 45 minutes, right? Now I go about my life until I get my text, and yeah, but it’s true. I mean, so many advantages, but it has to be done in the right, the proper way.

Amanda Lowe: The pandemic completely tested the limits of our healthcare system; there’s no doubt about it. And like how medical operations were impacted across the globe was significant. You know, what was amazing is how like organizations and individuals really came together quickly to face those challenges and create that meaningful change.

And when the declaration of the public health emergency occurred, you know we scored a few wins in digital pathology. For example, leniency was provided by the FDA to manufacturers like us, really to enable the use of the technology. Laboratories received enforcement discretion so that pathologists could sign out cases from home, even though it wasn’t a CLIA-certified site. And, you know, pathologists were advised to use their clinical judgment. I kind of laugh because they’re always using their judgments, right?

But, you know, exactly.

But, you know, to determine whether it was a good quality image, to determine whether they can make this diagnosis from home was always up to them. But at least now, and during the pandemic, it wasn’t they were concerned with compromising their medical license to do it.

Bianca Collings: Right.

Amanda Lowe: And, you know, these regulation changes were really essential. And again, the right thing to do. And it helped to minimize, you know, minimize that delay of diagnosis and the compromising of any form of patient care. You know, that really created that opportunity for us to demonstrate the value of digital pathology and those benefits that, of course, we didn’t expect, but we had to, you know, maximize that opportunity.

Bianca Collings: So it’s the perfect storm, really, to accelerate, I would say, the adoption based on this need. And a lot of success in many companies, you know you talked about industry, we realized throughout that time and –

I don’t know if we’re ready to like, jump into the barrier portion before we talk about all the good I mean, COVID was a very hard time, but there was a lot of good that happened. So, we’re shifting back into our normal lives, and, you know, telemedicine is still a thing. Now there’s requirements if I want to see my doctor. I can’t use that method every time it’s an every three or something like that, so we’re kind of now in this hybrid mode. What happened after?

Amanda Lowe: Yeah, I think, I think a couple of things, you know, we took What we could gain from, you know, this unfortunate situation, and we really tried to maximize it. And there’s a couple of good examples, and it kind of feeds into some of those barrier conversations, but I think one that’s really worth noting is there was a study that was done by Memorial Sloan Kettering, a validation study. And this one was where they basically looked at 1200 digital slides which was like 108 cases that the pathologists read remotely from home. Then they went back to the lab, they looked at them under the microscope under their normal like surgical procedures, and the amazing outcome of this study, this comparison study, is that they received 100% diagnostic equivalency between the digital and the glass side. So, this study was so important. So we took a bad situation; we utilized that to grab the critical information, and that’s what helped keep CLIA certifications of the secondary remote sites for pathologists’ homes intact, right? They used that information to show that it was a valid and valuable technology.

You know, the other big piece that I think, you know, we carry forward from COVID was that collaboration. So you mentioned how Matt Leavitt and I kind of rallied and worked together in that, you know, virtual community that we all started to build. And it was just remarkable. All people from all over the world really, you know, jumped together.

And what Matt and I were trying to do was, you know, there was so much need for knowledge of what COVID was doing to our bodies. And so, of course, the desire for pathology tissue samples was significant across the globe.

And there was a few different groups, Royal College of Pathologists, the NIH, and then Matt and I were working under the Alliance for Digital Pathology.

And the thought was like, can we help create this global repository and get some samples together? And so we worked with the WHO and they had a framework for their Blue Book tumor classification system that a lot of pathologists are pretty well aware of. And our goal was to kind of use that framework to create a way in which people all over the world could upload samples. The challenge was, is that sharing data securely? Not so easy. It wasn’t easy four years ago. It’s still not easy. Right.

And so, some things worked, some things didn’t. This was one that didn’t ultimately fully play out. We weren’t able to fully get that infrastructure in place.

But people did collaborate. People did share their knowledge and really made every effort possible to help support COVID research. And obviously, there’s been a lot of important science published since then. We learned through that process. And those learnings are really, really useful today. But there’s no doubt, I think you mentioned this, that labs who were digital prior to the pandemic definitely were able to cope with it better.

Bianca Collings: I would say yes. Yes.

Amanda Lowe: Yeah, there was no doubt about it.

They could adapt quickly and get their pathologists home. They could continue to offer those pathology services in a much more fluid way. And, of course, it benefited patient care. And what I’m really confident of is that diagnostic labs will never want to be in a position again where they cannot provide that safe working environment for their pathologists or another position that compromises patient care. Research labs don’t want to stop their studies and have to, you know, leave all that work at the bench. They want to be able to do things from home. They probably are, you know, as we work in this hybrid world today. And pharma companies and CROs they need to keep those clinical trials going and those drug development studies.

So, the pandemic gave us the opportunity to show that digital pathology is essential.

We don’t ever have to stop again in the face of such a challenge like this. And we all hope we never find ourselves in that scenario. But if we do or anything close to it, we’re prepared.

Bianca Collings: We’re prepared for it too. Heaven forbid.

So, did you see, to me, it’s almost like a team of rivals, this collaborative effort. Not that this industry was necessarily as competitive prior to COVID, or maybe it was, but I saw and heard that it was this collaborative effort where we’re not going to focus on who’s doing what, who’s selling what, who, you know, is producing, it was, we’re going to come together and figure out what is actually best for healthcare, for the patient, collectively. Am I right with that?

Amanda Lowe: Yeah, you are right, but you’re also speaking to someone who’s a firm believer in that no matter what.

Bianca Collings: Yes, I know. It’s fascinating to me that you and Matt are cut from the same stone. You really are. Because he is all about, you know, “Sure, you sell this, I sell this, they sell this, but we’re gonna work together to figure out what’s best for the patients.” Or “Oh, they need data. We’ve got data. Oh, they have data. We’re gonna come together and figure out how we can make this successful.” And I found that yeah you’re, you very much think the same way. Which..

Amanda Lowe: There’s a lot of business to go around for all of us.

Bianca Collings: No, absolutely. And it’s gotta be for the greater good. And this stone sometimes that, you know, we feel like we’re rolling it up the hill and if there’s five, six, seven, eight, nine, ten of us doing it together, we’re gonna get to the top of that hill so much quicker.

Amanda Lowe: And when you’re on the top of that hill, there could be barriers, which may be a good segue.

Bianca Collings: Okay let’s talk about it! So you’re pushing this stone with this amazing group to the top of the hill you get there.

Barriers to Digital Pathology

Amanda Lowe: Well, I would like to say that digital pathology is a never-ending obstacle course, or there’s many, many hills after your hill. You know, there’s ups, there’s downs, there’s loop-de-loops but it’s really a fun ride. And I think you know, as we just said, after we overcome one obstacle or barrier, the next one’s in front of us, and it could even be bigger. And I think I mentioned this earlier like the barriers we faced ten years ago are definitely not the ones we face today. And who knows what’s in front of us because there’s so many things that are changing around us in this constantly evolving innovative world.

But right now, I think there’s really three barriers that we’re facing. One, and I hinted at this in my spoiler alert, was data security, the integrity of the data, and how we manage it all. Understanding standards is number two, and how to improve interoperability. And then three is really how do we navigate in our ever-evolving regulatory and reimbursement landscape, obviously very specific to the United States, but I think also a globally relevant learning topic.

Barrier One: Data Security

And if we dive into a little bit more about those barriers, you know, when we think of the world of data security, it’s still, data-driven pathology is still a newer thing. It doesn’t always feel new to me, being in the business for 20 years. But a slide that was 250 megabytes 20 years ago was huge; now it’s tiny, right? And so it’s just a different game. But what I think is really also transforming is the protection of that data. So, like the desire to steal a glass slide is very minimal, but the desire to steal personalized healthcare data is a real threat.

Bianca Collings: And – That’s a good visual actually, because who’s gonna walk in and steal a glass slide.

Amanda Lowe: You can’t, you know, and again, you don’t have the contacts even if someone did. But no one’s gonna do that It’s kind of like, you know, If I was gonna rob a bank or if I wanted to steal money, I’m not gonna walk into a bank these days and go into the safe and take it You’ve got cyber security cyber, you know, criminals that are out there trying to hack it online. It’s no different.

Bianca Collings: It’s very mature, right? The strategy that goes into stealing money, right?

That’s a good really great visual too – robbing a bank versus hacking into a system.

Amanda Lowe: Yeah, and so as you know as whole slide images and AI data become a part of that patient, you know health record It’s much more possible for a breach with that data or, you know, unauthorized access to it.

There was a paper about a year ago in Nature Communications, and it was interesting because they were really focused on this topic of privacy risks for whole-slide imaging. And they did a risk assessment where they wanted to take tissue samples and see if they could figure out patient information against images that are out in the open-source community databases. So, they were comparing existing confidential data to materials that were out in the open. And it was really interesting because they found some, it wasn’t easy, but they definitely found ways in which they could kind of link it back. And a lot of that was like if there was more slides from the flock available, or if it was a rare type disease, or if there was some unique characteristic of the tissue that made it more recognizable.

And the paper also created like some guidelines, some recommendations of how to like think about these things as we think we’re anonymizing, we think we’re pushing data out that’s safe, but just to be mindful of what are the possibilities that it could eventually be linked back to something that is confidential.

So it was really interesting.

Bianca Collings: So from that image, they were able, within unique cases, to match?

Amanda Lowe: Roughly, I mean, it’s a very extensive paper.

Bianca Collings: It’s like taking an image, plugging it into Google and having Google tell you where you are, you know, or what that means. It’s not that, it’s not that intense.

Amanda Lowe: No, no, not at all.

Cause I think, you know, that would be overwhelming. It’s just more to think through those questions.

To put a pause, right? I think a lot of what we do as scientists and researchers out there in digital pathologies, think through those hypothetical situations. So I really, you know, acknowledge the work that the team did on this paper to just think outside the box a little bit of like, we believe it’s anonymized, and we’ve got permission to go use that data, but what if that patient comes back into a clinic and then information is then tried to match up, right? And again, it’s, and I think, we just don’t know how data is evolving in this rapid world of AI. And you know, that word, that’s a trigger word these days, right?

AI, I mean, it brings up a lot of emotion for people, especially when it comes to like ethical use and concerns around potential misuse or unintended consequences of use.

And it seems like every day, new ways, safe or bad, or not safe ways of using AI, pop up.

There was this; I don’t know if you heard this on the news, but it blew my mind. There was this case where or this like situation where an AI candidate is on the ballot for the UK Parliament, “AI Steve,” and he’s basically a co-pilot to the actual politician, and I was like, wow. I was like what I was going out here. Like, I had never seen that use of AI, right? Like, again, we don’t know what’s happening. We don’t know what’s coming in the world of AI.

Bianca Collings: I totally agree, and it’s our brains I don’t think can maximize the ceiling of the potential here. And I know yes in pathology. It is a, it’s a double-edged sword.

A lot of, there’s a lot of hype, excitement. I think I saw that’s where investors got very excited: those that did not have necessarily the background, the history of what we’re doing. This is where really everyone wanted to jump in.

Amanda Lowe: Oh, yeah.

Bianca Collings: This is the next big thing without knowing the consequence or the data, the barrier that we just talked about, you know, there’s…

Amanda Lowe: Yeah. In healthcare there, you know, I think the concerns around AI are really triggered around patient privacy-informed consent. Data bias is a big one in pathology. And, of course, there’s like an ownership of data, right? We hear a lot about these data lakes and how people want to pull from all these specimens so there are, you know, I think, genuine concerns, but

the fact is, is that we all just need to learn how to use it responsibly, like anything we do, right? And use it in a meaningful way, whether that’s chat, GBT, or a hurtful algorithm, we just need to know how to use it responsibly. And I think that’s what, you know, we can’t ever shy away from is just understanding that.

And obviously, as an AI manufacturer, I can say that it’s just about using it in, in the right way.

And it’s our responsibility, also, to ensure that adopters understand that. And I’m a firm believer that it’s meant to augment our knowledge, not replace it. You know, we have unique intelligence, and we have real-world experiences. And at least so far today, I don’t believe that can be replicated in AI, but time will tell.

Bianca Collings: And those of us on the front lines do absolutely believe that, believe that, right? You can’t be replacing this human.

I had Dr. Kahane, who has, I think he has signed out more cases using AI clinically than any pathologist. And he said, tell me the day you’re willing to fly on an airplane without a pilot. Like, well, let’s talk when you’re there.

Amanda Lowe: Exactly, exactly. Great, great analogy and so, so true. And I think that, you know, it really segues into, like, okay, we can overcome those variables, right? We have a lot of advancements in data management, IT security, like there’s so much that’s going on there, but it’s a lot. And I think there’s a lot of unknowns, but we have a lot of great support teams around us that are helping us there.

Barrier Two: Understanding Standards and Improving Interoperability

And I think that kind of leads to the second barrier that I want to talk about, which is standards and interoperability. And I really feel like those go hand in hand. As digital pathology has grown and evolved over the past 25 years, so has the presence of these large data silos. We have countless image formats that have occurred over the years and ever-changing system requirements. But a lot of really, really great work has been done across the healthcare and DigPath community to help with this. I think the most well-known example is the DICOM Working Group 26 and how they’re really working on ensuring that whole-slide images can be stored, transmitted, and displayed through DICOM and through DICOM Web to create that interoperable exchange of information with systems.

And there’s so many other standards, too, like high trust for AI, HL7, which has recommendations for pathology, there’s IHE, clinical and lab standards, and of course, lots of work that CAP’s done, too, but all that ongoing work around standards and requirements is excellent and needed. However, it’s really difficult for novice people to know what to do and how to follow along. It becomes pretty overwhelming.

Bianca Collings: I was just saying, in a world where we’re required to be consistently moving, I’m not saying this in a bad way, but it does slow us down because we have to make sure we’re meeting those standards.

So how do you, how do you approach that with, with the…

Amanda Lowe: It’s funny, as I was thinking about this topic a little bit. It dawned on me that I don’t know if there’s really a clear roadmap on how the standards overlap, where they intersect, and there can even be standards that are conflicting in some, in some ways with each other. And it’s difficult, depending on your role in the industry, to know which ones you should prioritize.

It’s not really clear, but I think just like anything, you have to, you have to try. You have to try to understand, you have to try to learn.

I think there’s a big growing space for consultants and advisors in our industry. And it’s also why the subspecialization of pathology informatics is growing so huge, too, is because we need experts.

We need people who can really help guide us through this process and aid us in ensuring we’re doing as much as we possibly can without creating more barriers for ourselves.

Bianca Collings: I think there is a growing need for consultants; interesting because you’ve left that role, but you probably, because you were in that role, can see it more clearly. But we need experts, right? Not just –

Amanda Lowe: I think that’s what it boils down to. Yes. We need experts.

Bianca Collings: Yeah.

Amanda Lowe: And I think I was a little ahead of the curve on the consulting side of things, you know, and that was okay. I think it really helped a lot of people, as I took that on a little bit, but there’s, it’s a different, again, it’s a different world from 12, 15 years ago. And, you know, I think it also – really leads into, you know, this, this unknown of how to navigate standards and interoperability, I think, is also very similar.

Barrier Three: Navigating in our Ever-evolving Regulatory and Reimbursement Landscape

And in my third, which is how do we navigate the regulatory process and the reimbursement process because there’s so many questions and concerns too that’s also going to keep consultants and advisors very busy. So it’s, it’s definitely challenging and I think the, the need for understanding there and for learning more is very similar to the challenges people are trying to deal with the standards and making things interoperable too.

Bianca Collings: Yeah here we go we have the AI, the trigger right, and then number two we have these standards that we need to make sure we’re educated on and we’re following but the third we have to be able to make this, it’s got to be viable at some point. And then what we’re really trying to do because you’re trying to do that, Lumea is doing that, the foundation is. That really creating a solution with those challenges that doesn’t sink a small panel. We’ve got to stay in business.

Amanda Lowe: We’ve made really, really good steps. And again, I think so much of this is thanks to the hard work of data captured during COVID. That’s why we have 43 Category 3 digital pathology CPT add-on codes.

Now, of course, it doesn’t mean we’re getting paid on those yet. There’s no national payment rate. But obviously, that’s the plan, right?

Bianca Collings: Exactly. Fingers crossed. That is the plan.

Amanda Lowe: And what we need is the entire community to demonstrate and advocate. Use those codes to show. But that’s not always easy, too. There’s many barriers that have occurred in trying to report those category three. And I remember the Digital Pathology Association talked about some of those barriers. And they’re very similar to some of the topics, which is integration and interfacing with billing systems, lack of understanding from leadership, insufficient knowledge around the codes for labs and for payers.

And when you have that lack of understanding, the codes can sometimes be over or under-reported, which risks, basically, that claim being rejected.

So there’s a lot of concern around how we do it, but we’ve got to do it.

And, and I think that, you know, with the confusion around reimbursement, it’s only, I think, added to the continued confusion too around the regulatory landscape and, of course, the uncertainty with the FDA’s final ruling on the regulation of LDTs as medical devices.

And, you know, that’s a hot topic these days.

Bianca Collings: All the things that keep us up at night, we basically mentioned, but yes.

Amanda Lowe: Yeah, you know, and I think it’s keeping some of us up more than others because I hope pathologists and adopters of digital pathology are, of course, conscious of this, but they keep doing what they need to do, which is integrating digital pathology into their workflows, to keep signing out those cases, to keep working through it and building the right teams to help us break down these barriers. And, you know, the timeline for the final ruling under the FDA is five stages over four years, and that begins in May of 2025. And though there’s a ton of moving pieces, including legal and political challenges at play, and we think it’s the final rule, there’s still so much opportunity for change, right?

Conclusion

Bianca Collings: The final rule is that, like getting to the top of the hill and realizing, oh, there’s another, there’s another hill we just…

Amanda Lowe: Exactly. And I know at the DDX Summit, you guys have a whole topic on this, and I’m really, really excited about that because I believe that we must all continue to really engage and learn on this topic together and how we support, you know, labs, manufacturers… everyone as we continue to understand this ruling.

Bianca Collings: And that’s what it is. You need to understand it does not need to be a fear tactic or necessarily a fear. We’ve seen people halt the adoption of digital pathology because they don’t know what’s on the horizon. And so that’s our goal with Stacey, who’s speaking. But she’s actually doing a hands-on workshop. And part of it for me is, let’s get past the fear. And what is the best medicine for fear? It’s education. And it’s just really understanding what that looks like. What are the next four exactly?

Amanda Lowe: Do not stand still.

Yeah, do not stand still.

Bianca Collings: Because you will be left behind.

Amanda Lowe: Yeah, exactly. People will say, oh, no, I don’t think, know things will change, but you’ve got to move forward. We have to take those steps forward.

And I wish I could say that of the three barriers I highlighted, that was it. That’s all we have. But the fact is that each company, each laboratory, every manufacturer, we all face our own barriers, depending on where we are in our digital pathology journey. But here’s the good news. We can absolutely collectively move forward. There’s just no doubt about that. We just need to make sure we take those steps. I read a book recently, Atomic Habits, by James Clear. And it’s a great book

Bianca Collings: A great, great book.

Amanda Lowe: And the tagline is “tiny changes, remarkable results.”

And we’ve all got to jump in. We’ve all got to continue to take those steps forward, even with these barriers and our own barriers in front of us. And I just want to give a shout-out to my fellow technology manufacturers out there who may be listening. We have got to stay agile, innovative, and collaborative, even in our competitive landscape. And really, we must learn for each other. So see, I’m definitely a team player here.

Bianca Collings: I love that. And those teeny steps that we need to make sometimes when you can’t see the big picture or what’s over that next hill, it certainly makes it easier if we are doing this hand-in-hand. We are doing this together. We are sharing our learning. And yes, it is a competitive landscape, but there’s so much good that we can, we can do together, and I appreciate that. And you know that is our whole we develop the summit with this in mind. I mean, no, it’s no mystery that you know Dr. Leavitt was kind of behind that too, that you know, let’s find a stage where we can all continue to come together not just in crisis mode, not just you know during the pandemic but we’ve got to have a stage where it can to move this forward together and you know those barriers do sound daunting, but I love that you know that really is the solution is don’t stop keep rowing that boat is going nowhere you’re just going to sit.

Amanda Lowe: Trust me, they’re not daunting. They’re just here, they’re present, right? And the only way they’re daunting is if you let them become daunting, right? If you don’t just continue to learn and to understand ways to move them out and overcome them. So, you know, it’s all about our mindset, right? And how we consider this. And that’s always been the case, you know? To kind of circle back to my starting story, I just want us all to agree to never give up on overcoming these barriers. Never give up on digital pathology because it is the right thing to do. It is and still and always will make sense. It’s what we have to keep moving forward.

Bianca Collings: Oh, that is so beautiful, so true. And well spoken again, I would say, pioneer, a legend, you saw it

I mean, so very long ago, you knew it was the right thing. Regardless or not if it’s the right thing the train has left the station.

It’s happening. You saw that it was the right thing before the train left.

So I think that’s beautiful, and I am really excited that we get to hear more from you, see you again, see you in person at the Summit. I’m gonna give a little plug. We do have a discount code for our listeners that would like to join us in person. I have to tell you One of our sponsors, Pathology News, that you know it’s not a conference. It’s like a retreat with a lot of education.

You know, at the top of a mountain in Deer Valley at the St. Regis and the admission to the summit actually includes your hotel stay, your meals, your horseback riding, you know, whatever it is you’re gonna do where we bring people together in this unique environment to collectively move this movement forward. So, you know, for our listeners, you can use PathPulse10 for 10% off. And again, that’s 10% off your hotel, your meals, everything. So it’s a beautiful conference.

We’re really excited to have you there and continue this conversation. I know that our attendees are going to absolutely love you, so.

Amanda Lowe: Thank you so much, Bianca. I’m so excited to be there.

Bianca Collings: There, and thank you for, for recording with us today. We’re just grateful that you’re one of those arrows in our quiver and for everything that you’ve done to help this industry. Thank you so much, Amanda.

Amanda Lowe: My pleasure. We’ll see you in September.

Tune in next month for our next podcast. Thank you to the sponsors of our program, Lumea and the Digital Diagnostic Summit, our listeners, and our guests for making this possible and for your support.

Interested in learning more about digital pathology and getting a step-by-step guide to overcome these common barriers? Get in touch with us at Lumea – our experts love to collaborate, help, and empower groups, small and large, to achieve success in implementing digital pathology.

SOURCE: Lumea