In this episode, Proscia’s Chief Product Officer Nathan Buchbinder is joined by Mike Rivers, President of the Digital Pathology Association, for a conversation on the impact of digital pathology during the COVID-19 public health emergency. They speak to the heightened focus on remote operations and explore specific use cases as well as highlight the regulatory relaxation that’s finally making it easier for pathologists to review cases at home. After sharing their thoughts on remote pathology in the post-COVID world, they conclude by highlighting some helpful resources for labs looking to go digital.
Listen or read the full transcript below.
Bruce Hall, Host (00:10): Welcome to Proscia’s “Zoomed In” podcast series, where you hear the latest trends in AI-enabled digital pathology.
BH (00:22): Hello everyone, Bruce Hall here. And welcome to another episode of “Zoomed In,” Proscia’s podcast series on all things digital pathology. Today, we’re going to focus on a very timely topic, the benefits of digital pathology in enabling remote operations, which has really been brought to the forefront by the COVID-19 pandemic. I’m joined by two guests today to share their perspectives. Mike Rivers is the President of the Digital Pathology Association, and Nathan Buchbinder is Proscia’s Chief Product Officer. Welcome, Mike. And Nathan, it’s great to reconnect. I know we spoke a few months ago on the Dell Healthcare PowerChat.
Mike Rivers (00:52): Hi Bruce, this is Mike. Thanks for having me.
Nathan Buchbinder (00:56): Nathan here. Looking forward to it as well.
BH (00:59): All right, guys. Thanks a lot for being with us on the podcast. Before we begin, Mike, can you share a little bit about your background please?
Mike Rivers (01:07): I’ve been with Roche Tissue Diagnostics for the last 14 years, and since late 2015, I’ve been the Vice President and Head of the Digital Pathology Business at Roche. As you mentioned in the introduction, in the last year, I’ve had the honor of being the President of the Digital Pathology Association and have really enjoyed working with the industry to bring digital pathology technology into the future.
BH (01:29): Nathan, let’s jump right in. When we think about digital pathology adoption, what has changed in light of the COVID-19 pandemic?
NB (01:37): It’s interesting because at the same time, a lot has changed and very little. I should start by saying that we’ve been talking about the need for digital pathology for years, focusing on concepts like the manual processes that make pathology less efficient than it possibly could be, some of the challenges in microscope-based pathology that amount to a significant amount of subjectivity, and the imbalance between pathologist supply and case demand. There’s too few pathologists to keep pace with the rising biopsy volume. And that’s always translated into the need to break through the status quo and transform this practice. All of that’s nothing new. And as a part of that, we’ve always focused on some of the core aspects of digital pathology like remote viewing and collaboration. But what has changed is that some of those core aspects of digital pathology like remote review and collaboration have started to get a lot more attention. COVID is really changing this as labs needed to quickly shift to remote operations.
BH (02:38): So, the recurring theme in your answer, Nathan, is about remote operations. Why do you think labs haven’t focused on the benefits of remote digital pathology until now?
NB (02:49): In large part, it’s because enabling this kind of a remote workforce hasn’t been as much of an issue. There have been some instances with consolidation and growth of different practices that have forced some prospective implementers of digital pathology to really consider this heavily, but it’s because of COVID and the demand and stress that it’s placed on these labs that we’re looking much more aggressively at remote collaborative workflows. They’re one of the primary reasons to go digital in the first place. And that’s actually been augmented and aided by a little bit of clarity and guidance that’s been granted by regulatory agencies. Groups like CLIA, which has relaxed its stance and issued a temporary waiver during the pandemic, have historically made it difficult for pathologists to review cases at home. And that’s changed.
BH (03:39): Thanks for that perspective, Nathan. Mike, anything to add here?
MR (03:43): I agree with Nathan’s comments about digital pathology. I think, as with any practice in medicine, there’s a fair amount of inertia to change. Digital pathology technology and use cases have been around for a long time, but often it takes a catalyst, I would say, to move things forward and to really force the issue, force people to try the new technology, and ultimately to adopt the change. And in this case, I would say COVID-19 is really serving as this catalyst. It’s shining the light on the value that can come from remote pathology, of enabling pathologists to work remotely in a safe environment and not be tied to the laboratory.
BH (04:21): Nathan mentioned CLIA and the regulations around remote pathology. What’s your take on that situation?
MR (04:27): I think the regulators have been, for good reasons, cautious about accepting digital pathology. So they’ve placed a pretty high bar on that up until very recently. In fact, up until March 26, CLIA mandated that the pathologist had to be onsite where the slides were created, the specimens were staying, and so forth, to make their diagnosis. As a result of actions from the DPA, CAP, and other organizations, they’ve relaxed that stance and issued a temporary waiver to allow pathologists to work remotely. At the same time, just a few weeks ago, we saw the FDA issue an enforcement policy that opens up their stance as well and enables labs to have much greater discretion and choice in terms of enabling and implementing digital pathology solutions for remote diagnosis. So I think we see an environment where the regulators are much more willing to enable this technology. And we see a real catalyst again in COVID-19 and driving labs to seek this type of solution.
BH (05:23): You both have been very clear that COVID has called attention to the need for remote pathology. And Nathan, let me ask you, from your perspective at Proscia, how have you seen labs respond to this requirement?
NB (05:36): There’s probably been a split between labs that have already been digital for a while and those that haven’t. The labs that were already digital were able to pretty quickly shift to a remote model pretty seamlessly. And that became a real differentiator for them. They could start sending cases out digitally. They had to maintain bare minimum lab staff to get these slides digitized, and once they did, it was everything as usual for them in terms of case review and case signout. So that’s been a really big advantage that they’ve had. For the other labs that weren’t fortunate enough to be using digital pathology in practice, they’ve had to deal with whatever situation they had on the ground. So some organizations have tried to adopt their research and education scanners for use in clinical practice. Others have started to look at accelerating their pace of digital adoption. Every situation with every lab is different, but we’ve seen, in general, very strong demand for getting set up quickly with digital pathology,
BH (06:36): What are the specific digital pathology use cases you’re seeing them implement?
NB (06:39): Use cases of digital pathology include remote case review and remote collaboration and access to expertise from institutions that might not be their home institution. And even for education, medical schools have had to go remote. These medical students and residents needed access to cases to help them learn, to become pathologists, and to become specialists. So like many of our peers, I know what we did to help with this effort was to set up a COVID Response Program and try to bring this rapid deployment of digital pathology to the hands of the pathologists and laboratories that need it. I should also note that like Mike suggested, there was a notable relaxation of regulatory perspective that made it easier for these labs to go digital and implement remote pathology. It’s not just CLIA but also the FDA guidance that they issued about a month ago that really has helped to improve access to digital pathology during this global health emergency.
BH (07:35): Those are some great observations, Nathan, and it’s so interesting to see how increased demand for remote pathology combined with temporary regulatory relief is coming into play. And Mike, I wanted to get your perspective from the DPA. What are you seeing, or perhaps even doing, from the DPA perspective to help labs get going here?
MR (07:54): I think that DPA has a very important role to play here. The DPA is a very unique organization that is comprised of professional members, pathologists, scientists, lab technicians, and then industry members like Roche and Proscia and many others that are combining together with the shared goal of driving digital policy adoption globally. What we see is that the need now for digital pathology is clear. The burning platform is there for everyone to see, and labs are really hungry for information that will help them know how to adopt this in an efficient and effective way. So the DPA has provided information on our website, digitalpathologyassociation.org, that includes helpful publications and references to guide labs in this process as they look to implement digital pathology.
BH (08:45): I understand the DPA is also undertaking a data collection project?
MR (08:49): The DPA is spearheading a real-world data collection effort to assemble a really powerful data set from labs that are now implementing remote pathology that will help build the comfort level of the regulatory agencies, specifically the FDA, as they consider how to regulate these devices. And we really think that that will open up the door wider to more companies and more solutions as we go forward.
BH (09:15): Guys, thanks for all this great information. Before we wrap up, I have a question for both of you. We have the short term catalyst of COVID-19 that’s driving the need for remote pathology, but I wanted to get your perspectives on where this is all going. In other words, as labs are settling into a remote model, will this become the norm moving forward? And Nathan, why don’t we start with you?
NB (09:35): You know, Bruce, it’s funny you ask. One of the most frequent questions we get is how long is this going to last? Is this going to become the new normal? And we tend to think that labs are going to hold on to at least some aspects of working remotely, if not most of them. For the first time, COVID has really made it possible for pathologists and laboratory staff to work remotely. They’ve otherwise been tied to the physical laboratory. And like many employees who work remotely in various industries and in healthcare, they’re seeing the benefits like shorter commutes, more structured schedules, and the ability to read cases whenever they want to or access the right experts from anywhere. It’s interesting that even outside of COVID, we’ve actually seen more and more studies that show that as labs adopt digital pathology, the pathologists grow to love the system. In one study that was conducted after three years of use of digital pathology in a large hospital system in Spain, 100% of the pathologists said that they would never go back to reading slides under the microscope again if they could avoid it. So I expect that from the pathologist’s perspective, it’s really going to stick. Now, obviously, the regulatory situation needs to be addressed. The regulatory situation is going to dictate, to some extent, how easy it is for labs to keep this virtual model in place. I personally struggled to think that pathology will ever shift 100% back to an onsite model.
BH (10:57): Mike, any thoughts from your perspective?
MR (10:59): I think, in short, there’s no question that tissue diagnostics is going through a transformation to full digitization. That is coming. And I think we were on that road already. The pandemic has accelerated that and made it more urgent and more pressing. But we’re absolutely on that road, and there’s no going back. The value is just too significant as Nathan has been sharing. We’re really focused in on remote pathology today, but there are a number of other incredibly exciting and valuable use cases that become unlocked once you have this technology in place. We’re moving forward. I think the trajectory is the right one, and I’m excited that we have an opportunity to go a little bit faster than maybe we would have otherwise
BH (11:44): One final question for both of you before we sign off. Where can listeners go to learn more about digital pathology, and more specifically remote operations? Mike, why don’t we start with you from the DPA perspective?
MR (11:54): Thank you, Bruce, Nathan. First of all, I want to thank you both for the opportunity to be with you today. I think, first of all, I would highly encourage all of our listeners to become active members of the Digital Pathology Association. We would love to have you. We have 1600+ members today that are very active in driving this technology forward. There are fantastic resources on our website, and I encourage you to visit digitalpathologyassociation.org and check those out and get involved.
NB (12:32): Mike, I’d second that. The DPA is a great resource. And if anyone is interested in getting up and running with that COVID Response Program that I mentioned earlier, you can find all of the details on our website at Proscia.com. That’s P-R-O-S-C-I-A.com. All of these are great resources for anybody who’s looking to get started.
BH (12:53): Okay, guys, we’ll leave it there. Mike and Nathan, thanks so much for being on this episode of Proscia’s “Zoomed In” podcast.