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Overview of the 4 Main Barriers to Digital Pathology Adoption

BY Mark Lloyd. July 12, 2016

Overview of the 4 Main Barriers to Digital Pathology Adoption

Dr. Mark Lloyd, Founder and Executive Vice President of Inspirata, explains how to overcome the four barriers that have been hampering widespread adoption of digital pathology.

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During my introduction, I mentioned that I would describe for you some of the barriers to adoption that I see. And I think what you’ll hear is an echo of what you’ve just heard in our keynote address that we’re very well aligned on some these major barriers to adoption and what Inspirata has done as a company is focus on ways in which we can go beyond what digital pathology vendors have done in the past and to help us to get over these barriers to adoption and realize benefits along the way.

I come from a research background. I was in cancer research for the last 15 years and I saw digital pathology evolving from a researcher’s perspective, which was a fantastic tool, but I also saw that there were major barriers that were leading us not toward large-scale clinical adoption but toward more and more research, which was fantastic for me, but what I really wanted to do was to be able to push this into the clinical realm in ways that make sense for pathology departments and show you the benefits along the way. And, so, the four major barriers to adoption that you heard from Dr. Friedberg and that I’m going to reiterate are these:

The FDA Regulations for Digital Pathology

I’m going to describe what is regulated, what isn’t regulated, what the expectations are and what the timelines are that we can expect.

Change Management and User Adoption

This is not to be underestimated. This is not a new test. This is not a new assay. This is a major paradigm shift in how you interact with your samples. And, so, there are human factor changes, there are technology changes, and there are ways in which organizations can help you manage that change along the way. I’m going to discuss that.

IT and Interconnectivity

Dr. Friedberg also mentioned IT and interconnectivity. I hear anecdotally that sometimes it’s hard to get a new computer in the department; a new monitor … these kinds of things. How is my IT department going to help me to institute an enormous change in moving to a digital pathology platform. We have an answer for that at Inspirata, and I’m going to share it with you.

Financial Model

And then perhaps the most relevant and important barrier that needs to be overcome here is the financial one. This is not something that’s already in your budgets. This is not something that you are replacing. This is a whole new technology. It’s adding instrumentation. How do we pay for this? How do we get return on that investment? And if there are cost savings and new revenue opportunities what are they and how do we realize them?

So, let’s go through each one individually.

FDA Regulations

The first that I mentioned was FDA regulations for digital pathology. What can I use today? Who uses, by the show of hands, either secondary consults, remote frozen sections or images for tumor boards or conferences? How many? That is a boat load. See…, this is growing. This is how you see that change in imminent. And so then we would need to plan for that change. There are other things that you may not be thinking of that are [relevant] to your workflow and this digital workflow … the way that you interact digitally … not just with the images but other diagnostic aids. Think of ImmunoQuery from Elsevier or PathPrimer, which is a tool to help you understand what kinds of differential diagnoses exist … to be able to see images. Today we open a book to see staging criteria. We can put all of this information in one place so that you’re accessing and you’re accessing … all in one place; thus, eliminating your hunting and pecking for information. This is not just digital pathology; this is a complete digital workflow that can help you … all of that is unregulated. And then as we place that into a single presentation layer – a place where you can do all of your work – and a couple of monitors on your desk, with or without a microscope – that’s when the FDA will get involved just like your AP-LIS. It’s a Class I medical device, it’s a low barrier to entry, but a barrier that is regulated nonetheless.

That’s where Inspirata begins to get involved. Where we place these cockpits such that you have all this information at your fingertips. And then we have this primary diagnosis hurdle that we have been talking about as a field for, I don’t know…, a decade perhaps? We’ve all been wondering when are we going to get primary diagnosis cleared by the FDA such that we’re using a computer monitor rather than a microscope. Well, there are multiple companies that are working on it. What’s important for you to understand is that there’s a pixel pipeline that goes from the scanner to the monitor. And that can be plugged into any cockpit so that when you’re ready to utilize the digital images for primary diagnosis, you can do so alongside with all of the other advantages of a digital cockpit that Inspirata provides. And, in the meantime, you use those same digital images for the things you’re using them for today. You’re receiving outside consults; thus, providing a revenue stream for your department. You’re sending out your consults; thus, reducing your shipping fees. You’re preparing your tumor boards digitally as you’re going through the first time with your glass so that you’re not scrambling on the day of conference looking for the glass slides, wheeling them down the hallway to put them on the microscope in the conference room.

There are a lot of ways in which we can utilize digital pathology today and gain the benefits from it without having to wait for primary diagnosis; but, is it coming? Absolutely it’s coming. And so how do we prepare? We can already see a great deal of evidence from the FDA itself that they recognize the technology is there and that they need to be ready for it. And they’ve begun to work hand-in-glove with the DPA – the Digital Pathology Association – which is made up of both industry and academic partners – toward declassifying this from a Class III medical device to a de novo application, which is great news for us because there’s a great deal more clarity for how we are going to achieve the kinds of validations that are absolutely required as we move to a digital media in doing primary diagnosis. And they’re getting support from the pathology community. The digital pathology blog, just months ago has been talking about this … CAP Today. So it’s not just external; but it’s internal to us as pathologists … these conversations. So that we need to keep you informed as to the progress that is being made in this field so that you can plan appropriately your timelines and knowing when do I need to expect primary diagnosis. And, lastly, you’re getting a great deal of support from industry as well. White papers are out there. They’re available. They’re available on our website. They’re on the websites of many of our competitors. We want to make sure that you are informed so that you understand when it’s coming. And, if it’s coming, how do we prepare?

Change Management and User Adoption

That brings us to the second point here: Change Management and User Adoption. Essentially, as we make such a drastic transition, it’s not the flip of a switch overnight. You’re not going to walk into your office one morning and have a computer monitor and will wonder where your microscope went. That is absurd. Right? What’s going to happen is you’re going to institute a phased adoption strategy; one that Inspirata can help you to plan for, which involves a great deal of planning. When are we retrospectively scanning? When do the faculty have the confidence that they will then be able to diagnose with the quality of the images; that the scanning facilities are acquiring images rapidly enough; that they’re not slowing down the glass getting to your offices. So there are many ways in which we can help you plan for that. They’re set with proper milestones that the organizations and the industry can work together on and agree upon. And so, as those phased adoption milestones are met, what are the benefits that happen along the way?

I see a lot of opportunity in your existing workflows. When you get a case in your mailbox or on your desk, essentially you need to then go to multiple, different disparate data systems to understand why that patient’s glass is on your desk that day. You’re accessing the AP-LIS, the EMR. You might go to Endoscopy. If it’s a breast cancer case that’s got macrocalcifications, you might need to be going to the radiologic impressions. To the PACS system. You’re not spending your time diagnosing; you’re spending your time hunting and pecking for information. But once you have that information and you review the glass under your microscope, you start to formulate your diagnosis. Then you have some interactions with the histology lab. You order your special stains, IPoC studies, deeper sections, whatever it is and maybe that’s enough information to then render your diagnosis. If you don’t knock on your neighbor’s door, asking for assistance. If you’re not saving the case for a consultation later that afternoon like a consensus study or a tumor board or even shipping the samples out for an external opinion. There are many places in here – existing pain points – in which you can leverage digital pathology to minimize these.

So what Inspirata does is we have an accelerated workflow that you’ll see here in blue that begins as the samples are leaving the histology lab with a local scanning facility on premise in your hospital next to the histology lab with a bank of high-throughput slide scanners – the scanners that will be approved for primary diagnosis. And those scanners then can handle the peak volumes that you have in late morning, early afternoon, when the histology lab is the busiest, and so that we don’t slow down the glass getting to the pathologist’s office. And, with all that excess capacity, we begin to scan retrospective slides so that you have priors the next time a frequent flier comes back to your department. You can use these for an invaluable teaching resource, as you go back and scan retrospective slides. You can use it as a research tool as well. So that you’re not building just your own clinical workflow, but you’re also building the resources for the other parts of the mission in many of your departments, which are research and teaching. As the samples come out of the scanning lab, they’re made available immediately within the cockpit at the same time as the glass. And, so, your pathologists can be reviewing the glass but accessing all the information required that they would be hunting and pecking for here…, all in one place. They can sign out their reports – their preliminary, final diagnostic reports, synoptic reports, QA reports. And there are a lot of advantages here, because you can do now external QA, which is great because you can get another institution of NCI-designated comprehensive cancer center designated pathologists looking at your cases so you don’t have the group think that might happen in any one given department. And it then frees up your pathologists from no longer doing QA activities but doing primary diagnosis. You can then share these images, just like you can share with any other digital platform. You can share them in consensus studies. You can share them across the hall. Thus, making the time to final diagnosis shorter and enabling your pathologists to spend more of their time rendering the diagnosis and less of their time worrying about their workflow.

IT and Interconnectivity

But that’s all big promise. I’m talking about interconnectivity of a lot of different systems. And I already mentioned some of the confidence challenges that we have with our own internal IT departments and interacting with our enterprise IT departments. So, if this is true, how will it elevate my practice? Well if you have all of that information in one place, you’re more likely to go and look up this, that or the other thing to help support your diagnosis. But how does it happen? How will we access and analyze these data? This is a massive repository of ultimately petabytes of data. How do you ask for that? Ultimately, it becomes an integrated Enterprise Service Bus provided by Inspirata that incorporates all of that information into one presentation layer for you the pathologist. That feeds that information into one isolated appliance – the vBlock – which has all the compute, networking and storage needs to be able to manage all of this information for you. So our promise is to bring that information to you and then to store it without you having to have a massive impact on your local IT department… something that they absolutely love. Of course, it’s scalable because storage will continue to get cheaper over time, so you build it as you need it and we manage it.

The Financial Case

Finally, the financial case. And this is where I think I’ll spend a good amount of time. How do we justify the cost of this? This is not something that the Pathology Department can afford. This is something that at the institutional level we can gain funding for. But we need a return on investment. Where is that going to come from? Inspirata is uniquely positioned as a small, nimble company that is well-funded to be able to assist you with this. And what we ask for is a long-term partnership so you essentially get to pay as you go. In the early years, the costs to Inspirata are low because you’re return on investment is low because you’re just getting started with this new technology. But as you go, your benefits, your cost savings, your revenue generation increase and then so do your fees to Inspirata. This is backend loading. This is not something that you can get from most organizations. And it will help you to pay for it…, especially in those early years. But what then makes up that return on investment. How does digital reduce costs? I think you’ll hear from Dr. Tomaszewski when he presents his [talk] a number of places where you can reduce costs. It’s not just the pathologists’ productivity, it’s your techs’ productivity; it’s the ways in which we save on shipping and courier costs; it’s the ways in which we bring new revenue into the departments – not just by reaching pathology groups outside of our normal catchment area and having consults, but also then those patients – a small percentage of them … half a percent; one percent … getting a relationship with your institution and then coming to your institution for their clinical care. That’s where big revenue can be generated … when they come for their surgeries, their chemotherapy, their radiation therapy. So there are a number of ways in which Inspirata can work specifically with your organizations to be able to list out all of the things that you believe in … a sensitivity analysis; a worksheet that you can say: “I’m comfortable with this number but this number I don’t think we’ll ever achieve or we won’t achieve it until year three or year five” so that you can then build a financial case for your CFO and for your board and we will help you do that.

It’s being done today. LabPON is in the Netherlands. It’s a relatively small laboratory with 115 employees. They do about 55,000 cases a year. They’re 100% digital. They read everything digital. They scan everything digital. And they are now beginning to share their results … both pre- (before they went digital) and now post-. So that you can see the very real realized value of going digital. And I think if you have an opportunity to hear some of the talks after the fact that are occurring simultaneously with us here now – the Digital Pathology Congress in Philadelphia – you’ll be able to get some of those metrics from exactly these individuals.

And so, in summary, this is how Inspirata can help you to get over each one of these barriers to adoption … both through our solutions in a regulated environment, to our workflow changes and ways that we can help you be more efficient, eliminate some of the pain points that you have today using our technology – our Enterprise Service Bus – to bring information to you and make it available to you easily and, ultimately, make a business model for it that makes sense for your department.

The way that it looks is a consultation portal or a slide scanning facility that can be both cloud based or on-prem that allows any pathologist within our network to access these cases with the right credentials within their cockpit. And, in doing so, we build a data trust that is of great value for research and educational purposes and allows us – because this is my personal interest – to be able to create predictive algorithms, which will be the future of digital pathology … the ways in which we interrogate these slides in ways that they’ve never been done before.

The typical engagement is comprehensive. It is this business model that helps you to pay for this as you go in a way that makes sense for your institution. The program planning and project planning that is necessary. The hardware. There’s the slide scanners … the bank of high throughput ones as well as the small ones that have their own niche capabilities – whether it be large format slides or live microscopy. The monitors that are going to go in your pathologists’ offices. And, of course, the IT infrastructure backbone that is required to make it happen. The software of the cockpit itself. Come to our booth. See what the software looks like. See how it feels when we integrate information into one place … when you have it all available at your fingertips together with the digital image or with your microscope and to be able to then complete your diagnosis with your reports. It includes maintenance and it includes staffing. We don’t expect institutions to take all of this on themselves, so we will come in … into that scanning facility and we will provide the management, the imaging acquisition technologists so that we’re sure that we can be confident that we’re giving you the images that you need at the times that you need them and there’s no delays within the department itself as well as the IT support that you need. It’s a completely outsourced solution.

And it comes with next-generation imaging analysis algorithms, an Innovation Laboratory that allows you to interact with our developers because it’s you, the faculty… this is an evolution of something that is just getting started. We don’t know what the next tools are going to need to be. We provide sponsored research opportunities such that if your interests are aligned with our interests, we can work together, pay for that discovery and bring these things to market together. This is how we further the field of digital pathology and make it available to you. Thank you.


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Mark Lloyd

Dr. Lloyd is the Lead Scientist, Executive VP and Founder of Inspirata. He founded Inspirata with the vision of developing and delivering innovative solutions to transform cancer diagnostics. Every pa... Learn More