Aleks: [00:00:00] What were the lessons learned that you guys had to go through?

Scott: There are many hurdles. Um, there are many points of concern that come up that you never even thought about. We have to be remarkably concerned about what we call the pixel pathway.

Aleks: How did you guys do it? Are there like processes, mechanisms, ways of enabling? This kind of integration.

Scott: If you think about the digital pathology workflow, as we move forward in the workflow,it’s the viewing is the next step.

Amanda: We interact with lots of different scanners, and we have IVR cleaners with Hamamatsu, including the other vendors as well. And we do see it as like, you know, laboratories may want to have different scanners. And we want to be able to provide that, you know, open platform for them. You need to make sure you’re looking at the big picture. Are your long term visions the same, right? Like, are you looking in the same direction? You gotta be holistic and long term, and not just, what are you gonna do today?

Aleks: Welcome my digital pathology trailblazers. Today we have an episode with two guests. I am joined [00:01:00] by Scott Randall, an Application Specialist for Whole Slide Imaging at Hamamatsu and Amanda Coble, Senior Director of Product for Anatomic and Digital Pathology at Proscia. The theme of the podcast is going to be compliant digital pathology workflow.

Let me give you a little bit of a context. So this podcast is brought to you by Hamamatsu and in March this year at USCAP, I went to the Hamamatsu booth to create content about their little scanner, the S20. That was a new product. I went to the booth and I asked, where’s the scanner?

Hamamatsu: So we have the S 20 over at the Agilent booth.

Aleks: So are you telling me it’s not here?

Hamamatsu: We have the S360 MD here.

Aleks: And the team took me to a totally different booth, uh, where there was actually a lot of different vendors displayed in the order you would go through a digital pathology workflow. So it was, uh, it was actually Agilent booth. Uh, and the theme was from staining to sign out and  [00:02:00] two of the vendors highlighted there was obviously Hamamatsu and Proscia.

Both of those vendors have cleared solutions for digital pathology workflow. But before we dive into it, let’s start with our guest. Welcome, Scott. Welcome, Amanda. How are you guys?

Scott: Very good.

Amanda: Thank you for having us.

Aleks: I am super happy to have you. We’re gonna start with short intro in the order of the digital pathology workflow.

So, scanning comes first.

Aleks: Welcome my digital pathology trailblazers. Today we have an episode with two guests. I am joined [00:01:00] by Scott Randall, an Application Specialist for Whole Slide Imaging at Hamamatsu and Amanda Coble, Senior Director of Product for Anatomic and Digital Pathology at Proscia. The theme of the podcast is going to be compliant digital pathology workflow.

Let me give you a little bit of a context. So this podcast is brought to you by Hamamatsu and in March this year at USCAP, I went to the Hamamatsu booth to create content about their little scanner, the S20. That was a new product. I went to the booth and I asked, where’s the scanner?

Hamamatsu: So we have the S 20 over at the Agilent booth.

Aleks: So are you telling me it’s not here?

Hamamatsu: We have the S360 MD here.

Aleks: And the team took me to a totally different booth, uh, where there was actually a lot of different vendors displayed in the order you would go through a digital pathology workflow. So it was, uh, it was actually Agilent booth. Uh, and the theme was from staining to sign out and  [00:02:00] two of the vendors highlighted there was obviously Hamamatsu and Proscia.

Both of those vendors have cleared solutions for digital pathology workflow. But before we dive into it, let’s start with our guest. Welcome, Scott. Welcome, Amanda. How are you guys?

Scott: Very good.

Amanda: Thank you for having us.

Aleks: I am super happy to have you. We’re gonna start with short intro in the order of the digital pathology workflow.

So, scanning comes first.

Aleks: Scott, tell the digital pathology trailblazers a little bit about yourself. Um, and you can mention the circumstances of the clearance that you guys got already in November 2022. You were pioneers.

Scott: Yes, thank you. Hello all. I’m Scott Randall with Hamamatsu. I am actually the Senior Application Specialist for the NanoZoomer product line and have been with Hamamatsu for approximately a little over 10 years working with the NanoZoomer product line.

I am proud to say that we were one of the pioneers, not the first, but one of the pioneers to offer an FDA accepted system, [00:03:00] whole slide scanner to the marketplace. And that was in 2022. That process was a lengthy where we actually had to go through some clinical trials where we put our scanners in specific locations for the validation process for digital.

Aleks: How many locations did you need to have the scans in?

Scott: I believe we actually used three different independent locations. And it’s, the validation process is where we scan slides, um, through a given process and procedure. And then those slides are validated, um, via battery of pathologists, where they look at the digital scans, and then they compare and contrast to the glass slides, and they compare and score their diagnostic accuracies.

So it’s, it is a proper procedure. We have to actually have to follow the, the process along in a very stringent way, and it was time consuming, [00:04:00] but very rewarding. I must say. Then we actually take that data, we actually present it to the FDA for their review, and they review the process. If they have any questions or if they require us to make any changes to our protocol or addendum, make an addendum to our protocol or have to go back and do some more work, we would do that.

Fortunately, we didn’t have to do much of that. And then we have to wait for the process of the FDA to review and accept or deny. And after…

Aleks: How long did it take you from like deciding? Okay, we’re going to actually getting the document. It’s cleared. How long of a process was

Scott: That was? I want to say that was approximately 9 or 10 months.

It could have been the better part of a year actually. And it’s something that you cannot anticipate. So you just have to submit and wait.

Aleks: Yeah, I know. They don’t give you like timelines. Oh, by this date, you’re going to have that, uh, you know, feedback from us.  [00:05:00]

Scott: Yes.

Aleks: I wouldn’t expect that.

Scott: You can’t say, Oh, we’re in this process.

No, you can’t say that. You just need to.

Aleks: Yeah. You cannot, because I remember, um. And that was so because Hamamatsu has been a sponsor for digital pathology place for I think, three or four years in a row. And I remember talking to your colleagues and I would know because we are, this is all, all my sponsors are under an NDA, but like you cannot mention what’s happening.

Uh, unless it actually happens. So when I saw, uh, your cleared scanner at this, uh, Agilent display and Proscia was there as well. I was like, Oh, wow. Now we are working on this end to end workflow. So now can everybody jointly go to the FDA and just do the work once? No, that’s not the case. Proscia had to do their own work and submit their documents to the FDA for the clearance that you guys got in February this year.

Right, Amanda? [00:06:00]

Amanda: Correct.

Aleks: So, tell the Digital Pathology Trailblazers a little bit about you and a little bit about what you did for your clearance. And how did you decide, how did you start working with Hamamatsu on this and why?

Amanda: So, uh, I’m the Director of Pathology at Proscia for the, for the clinical side on the product side, um, which means they can be diagnostics, but also there are a number of research, uh, in non diagnostic UK.

These cases within the clinical realm as well, as you know, very well. Um, my background is I’m actually a pathologist assistant. So I spent the better part of a decade actually working in the lab. And, um, it’s very, very, very familiar with workflows. Some of the challenges, um, of dealing with.

Aleks: Before. This episode, I actually listened to your episode with Dennis Strenk from People of Pathology Podcast.

So I’m going to link to this one as well in our show notes. So if you want to dive deep into Amanda’s background, which is very versatile, I would say.

Amanda: If you want to hear my life story, check out that podcast.

Aleks: Yes, exactly

Amanda: Um, and so I, I ended up coming over to the vendor side.  [00:07:00] I was doing work with the LIS and then moved over to Proscia about three and a half years ago.

Cause I really do think in seeing digital pathology as the future, atomic pathology will eventually just become pathology, right? We’ve dropped the digital altogether. So I was new to FDA, at least this side of the FDA. It’s very different how the FDA sort of rolls in terms of if you’re on the medical side, they’re not really, um, controlling your practice and that it’s an array, so I, it was a really big learning curve for me.

Um, doing submission at Proscia with Hamamatsu. I learned a ton. I learned way more than I probably ever really wanted to know about the FDA and, um, understanding the process. So in terms of how our, our relationship and our partnership with Hamamatsu came about, The coach already had a pretty long standing relationship with Hamamatsu for our joint life sciences customers.

We supported some of their scanners for a while, and with the S360MD being on that path to FDA clearance, it just made so much sense for us to partner up and do our, uh, a joint. um, submission together. [00:08:00] I think we also had customers asking about it as well, seeing some of the COVID with the, the way, uh, the LVT stuff was going, COVID and then enforcement discretion.

But it was interesting because as Scott was saying, they were going through a whole process to get their clearance. We were doing parallel work on our side, but we were basically needing to wait for their clearance to come through. So we could then do really finish it off on their final cleared product.

So it was like this really interesting balance of timing and what can we do in parallel? And what do we have to, you know, sequence? So it was tons of work. It took us probably a better part of the year as well. Like I said, it wasn’t my first so it was both. Crazy and exciting and, like, such an incredible learning experience.

It just made so much sense for us to partner together. There were other, uh, there are a lot of other scanners that aren’t even cleared, but actually they’ve been cleared for a while and they’re starting to go in the life. And so we were really wanting to, to do a clearance with a scanner that we knew had a long shelf life ahead of it.  [00:09:00]

Um, and, and that turned out to be a perfect match with Hamamatsu.

Aleks: The digital part of the pathology workflow, um, most of the time starts with the scanner. Scott, what were the, like, obstacles or lessons learned that you guys had to go through that you could then let the Proscia team know about? So that, was there anything like that?

Or everybody had to do their own thing because you were approaching it from different sides, uh, hardware versus software, although, uh, Hamamatsu also has the software component that was part of your submission.

Scott: Right.

Aleks: Any like, any hurdles, any problems, anything that you were able to say to let the colleagues at Proscia know that, Hey, pay attention to this or that, or anything like that?

Scott: Well, as, as you can probably understand, there are many hurdles, um, there are many points of concern that come up that you never even thought about. So, uh,

Aleks: you mentioned FDA. It’s kind of like equals. It’s greater or equal  [00:10:00] hurdles.

Scott: Well, they’re different. Let me say that. So, for example, on the scanner side, we have to be remarkably concerned about what we call the pixel pathway.

The pixel pathway needs to be defined to the FDA, and then we need to maintain the pixel pathway. So, that involves what is identified within the scanner configuration, what the pixel pathway is. Once that is defined and then accepted, let’s say, we need to maintain that. So, when working with Proscia, naturally, we’ve known Proscia for quite, quite a long time.

And, um, when they came to us, For their side of this FDA process, we were very happy to help them. When we went through our tasks to, to do what we needed to do, we, as I said, defined the pixel pathway. When Proscia approached us, then we needed to maintain that pixel pathway when we were started to, to acquire data for Proscia.

So that’s  [00:11:00] always, I don’t want to say difficult, but we need to maintain that and be assured that we’re maintaining that. And Proscianeeds to be assured that we’re maintaining that.

Aleks: So how do you, that is a, that is a super interesting thing. Um, specifically in the I want to call it new age or new era or more emphasis of interoperability.

The pixel pathway just like a super high level explanation is like from generating this pixel from the glass slide to actually seeing it by the pathologist. And it goes through a lot of transformations, a lot of different things, hardware components, software components. And now we’re introducing, so let’s say we had it defined, uh, in the first place.

Because a scanner gained, uh, the clearance, but now we’re introducing somebody else who also wants to be cleared, but wants to leverage this already existing pixel pathway. How did you guys do it on both ends? Are there like processes, mechanisms, [00:12:00] ways of. Enabling this kind of integration.

Amanda: Hamamatsu did provide us with an SDK.

So basically they gave us a developer kit for, uh, ingesting their images out of their pixel pipeline. And then on the Proscia side, so essentially in that cleared system that the FDA sees as a closed system, we would be replacing the Hamamatsu, um, MCU view. in the viewer, right? So the Proscia viewer is replacing the not close system.

Aleks: Okay, so you basically cut off the pathway. It stays as it was on the Hamamatsu sign, and Scott, correct me if I’m wrong, but I’m just like trying to figure it out for somebody who has not been in the trend yet, like you guys have been. So there is a defined pathway. You cut it at the place where you introduce a new component and the rest of the pathway is being taken care of of the new, by the new component.

Is that correct?

Amanda: I wouldn’t even call it a new component. I would have a replacement of a component.  [00:13:00] So the viewer as a component, our viewer replaced Hamamatsu’s viewer. And so we had their SDK. Um, to help us with ingestion of those images. And then of course, our software needed to make sure that we’ve returned the image at the same fidelity, at, you know, a good fidelity.

So that basically if I’m looking at the image in the Hamamatsu viewer, and I’m looking at the image in the Concentric APDX viewer, I can’t tell the difference. The image quality is the same.

Aleks: So I want to emphasize something because there are more cleared systems at the moment. But you guys were one of the first partnerships. Where you had cleared scanner with everything cleared, uh, and then a different component that partnered with this scanner that kind of opened this way of working, uh, for the other partners. I see it as the COVID heritage that we had in the digital pathology space where, uh, we got this, um, provisionary this emergency allowance to actually use whatever, whatever is working.

If you as a  [00:14:00] pathologist decide it is diagnostic quality, feel free to help patients. We are in an emergency state and I was kind of like hoping that they’re never going to take it back. But, uh, this is just my wishful thinking of a digital pathology enthusiast, um, at some point they did, they gave a cutoff and those who are serious about it and who kind of already knew, okay, we want to do it in a compliant way, regardless how long this emergency lasts, were those who, who got their systems cleared the fastest.

Scott: Yes. So the, if you workflow, as we just stated, we’re going to start with the scanner. So the scanner is doing its thing. As we move forward in the workflow, it’s the viewing is the next step and working with Proscia. Proscia offers the IMS, the next step, which includes the viewer. It makes perfect sense to us where Proscia would come to us and said, we want to work with you so that we can submit our software to continue down that digital pathway workflow. The nice thing from our standpoint is that we’re working with Proscia and we’re not actually offering an IMS ourselves because we’re not IMS. We’re not an IMS company. We build scanners very well, so we know we knew Proscia had a fantastic interface in an IMS, so let them do what they need to do.

To, again, go down the digital path pathology workflow. We go to Proscia. Proscia actually develop their viewer integrated into their IMS. Then the next step would actually be from there integrating into an LIS. That’s the workflow. And we are open. We’re open for other vendors to come to us and say, Hey, we’ll, we’ll willing to work with you.

Would you help us? And sure, because that now offers different choices to the marketplace for digital pathology solutions and for software packages to work best. For individual customers needs, which is wonderful.

Amanda: And I think the point you made earlier around [00:16:00] COVID and having that enforcement discretion, hell, a lot of laboratories using equipment, hardware, software, that was not cleared.

And without any issue. I mean, I know we were, I was a part of a meeting with the FDA shortly after, right, as the enforcement discretion was ending to talk about the data that was collected. Um, as part of the Digital Pathology Association DPA and, you know, collected a lot of data to show that we didn’t see adverse events, uh, events or anything like

Aleks: That was, like, the basis why I was so hopeful.

Maybe we’re gonna have enough data that they would just say, it’s all good.

Scott: Yes.

Amanda: I mean, to some extent, customers were using what they already had. So they might already had scanners that were, um, not clear, but they were using them for research purposes or what have, or at the time, still a lot of folks were focused on a laboratory developed test route, um, laboratories, the LBT route.

I think that sort of opened up the door and people were like, we want, we, We’ve already kind of done this in practice and you can see that there are different components that can work together very successfully. And  [00:17:00] so I knew from Proscia’s to seeing a point there, so our Hamamatsu, we interact with lots of different scanners and we have IVR clearance with Hamamatsu, including other, um, vendors as well.

And we do see it as like, you know, laboratories may want to have different scanners from different vendors and just a central interface, you know, a viewer interface and IMS, you don’t want to have multiple. Those, you want a central software and we want to be able to provide that, you know, open platform for them.

So I think the COVID thing sort of got, maybe pushed that a little bit more because people are already like we’ve been using lots of things that aren’t a part of like a, a connected system, but there are advantages to the type of clearance of a clerk system and the type of the partnership we have with Hamamatsu.

There are advantages that well than doing the sort of piecemeal component, you know, pick your own version of things.

Aleks: Yes, let’s talk about those advantages. Before we talk about those advantages, I want to ask a logistic question. Hamamatsu, you guys had to put the scanners in three different locations. Um, the Proscia team, did you guys just need to [00:18:00] get a certain amount of digital slides because you were comparing digital to digital, whereas Hamamatsu was doing glass to digital?

At all? What were, what were the different logistics between your, um, study designs for the submission?

Amanda: They’re slightly different. Um, you know, for our standpoint, we did a technical performance assessment testing. We also hear people refer to it as TPA for short. And that’s basically, um, their guidelines that the FDA have put out on performing that kind of, um, testing for digital pathology that are fairly prescriptive.

And that’s doing a delta E comparison between images. So what’s the difference in image fidelity between the two? So we did that kind of testing. And then we also did similar to, um, what Hamamatsu did is a clinical study…

Aleks:  The diagnostics…

Amanda: …but we had three different sites, but for us. We didn’t have to have the scanner at each one of the sites.

We just needed to have all of our slides that were using the clinical study scanned, and we can do that in a central location. But it’s interesting enough that during the study,[00:19:00] we actually felt some of the same logistics challenges that our labs face today with trying to transfer and do logistics of physical slides across these different.

Uh, participate in clinical sites, you know, once we got to the digital arm, you know, digital arm of the study, it was so much easier because, you know, you could basically just quickly distribute, you know, digital images for review. And, you know, it was instantaneous, you know, it’s paralyzed things a bit. So that was, I thought that was a nice take home where like, we basically proved our own value internally in our own practices with the, with the clinical study.

Aleks: Yeah, that’s what the, one of the advantages of digital pathology, like the most obvious one.

Aleks: But for the, um, for the users and then downstream for the patients, what are the advantages of such a system that can be combined? It doesn’t have to be scanner and everything that comes with the scanner. You can actually choose your IMS.

Scott, what’s your take on that? What is do you think [00:20:00] are the main advantages?

Scott: I believe the main advantages are potential customer or laboratory can actually. Fine tune their needs, match those needs with specific vendors that match closely with what they’re trying to achieve instead of trying to compromise what they originally would like and try to match a solution.

So the open architecture of this kind of relationship. offers a selection. It’s like what Amanda just said, that now people can pick and choose what works best for them.

Scott: And you know, whether it’s our scanners or other scanners, um, or other IMSs or other software solutions that they need. I anticipate a lot of labs have the, unique needs and desires.

They might all need the same larger overall generalized flow, but they might need a little bit different accessibility, for example, analysis. So they can go into Proscia, data goes into Proscia, Proscia could send it to an analysis software package. It can come back [00:21:00] into the IMS. It could go, they could bring in other imaging modalities into this file structure and push that forward to continue down the digital pathway workflow.

So it’s. Or it could be very simple. If somebody doesn’t need to have that accessibility, they can have a very simple architecture and environment. So it’s wonderful that we’re moving in this direction to offer flexibility to the customer.

Amanda: That’s really important, Scott. You can have it both ways, right?

Scott: Yes.

Amanda: And I think we see adoption, it’s sort of through phases, right? So initially sort of like the first type of customer we see they’re new to digital pathology. They have limited experience. They probably haven’t many, many investments and they need infrastructure. They don’t have hardware, right. And maybe their main goal is just kind of reducing the complexity and they’re probably spending as much time.

And we’ve seen this on change in management to move to from the natural scope to, uh, you know, the digital pathology viewer, they’re just trying to get implementation and  [00:22:00] adoption within their organization. They’re not necessarily thinking about all the future things. I just want to assist them. That’s sort of somewhat turnkey, which is what we offer with the, our FDA clearance solution.

It’s clear. I don’t have to worry about, I’m not doing any kind of LBT thing. You know what, how do you, and you, it’s great because we also have our. our shared partnerships with both Agilent and Siemens Health and Mirrors, where they may actually already have a relationship and a footprint in a lot of labs.

And it’s pretty easy just to add on the digital pathology piece of the workflow to the existing footprint and workflow that already exists. So that’s super easy. So you can start there. And as you, you know, develop and, uh, you get more comfortable and get you know, you start to really go fully digital.

Now you’re thinking like, obviously the second group of customers, and that’s beyond just having a turn box. I want a future proof of my system. I want to think of all the, all the different components. And then I really do care about interoperability.

Amanda: I think for us, we created our Proscia’s Ready Program, [00:23:00] which Hamamatsu was actually a founding partner of that.

And so we’re really focused on not just that technical interoperability, but also support and things. So that I can, you know, bring in and grow as a lab and as new scanners and new things come out, I can add them. Um, and it’s not just about, okay, they. They technically work together, but they’re actually a partnership there.

And I have the support and there’s already coordination in it as a, as a customer. I’m not necessarily spending too much time worrying about trying to coordinate between all these different figures and components. So I think, you know, what we offer you kind of can take you from your infancy all the way into maturity in your digital pathology journey.

Aleks: Several lab, many scanners, not just one.

Aleks: I’m just going to focus on, uh, Hamamatsu scanners because you have this that is cleared, but you have a lot of other ones that address different laboratory, clinical, nonclinical life science needs, big ones, small ones, uh, the whole S line, right? NanoZoomer, nanozoomer, S NanoZoomer [00:24:00] that you’ve been working on for 10 years, Scott, there’s a bunch of different scan. It was so funny. I saw your colleagues at CAP as well. And then at Path Visions and at CAP, they had this styrofoam S20 and I was picking it up and then we put it next to the big one. And the joke was, they start like this and then they grow to be the big one. So we were making kinds of jokes, different kinds of jokes, but basically you can.

Plug them in into one IMS into one, uh, concentric Proscia. I imagine that you can have, you know, a specific, uh. workflow that is diagnostic that goes in a very compliant FDA cleared way and then you can have a use it for all the other things that do not require that level of regulatory stringency. So you can, you know, plug.

All the scanners into concentric, whether they’re small or large.

Scott: That’s right. Absolutely.

Aleks: I’m gonna, there, there was a, um, [00:25:00] there was a blog post we wrote together with the Hamamatsu team, uh, small, large, or both. So I’m going to link to this one as well. Um, it’s a, it’s a super useful because it, um, explains, okay, what kind of need, um, would these scanners of different sizes and of different capabilities and what kind of problem would they help you solve and do you, you don’t need to.

Like, you can future proof, like you said, Amanda, you can future proof your lab, um, by just picking different, uh, devices for that. Question to both of you.

Aleks: What was the most unexpected or the most annoying hurdle that you guys had in the process? Something unexpected, like internal, external, whatever, something that stuck in your mind that was…

Scott:  Well, I’ll start with that one.

Thank you. try to describe exactly what we had to go through to scan the slides for Proscia. What really struck me was the amount of detail that was required, understandably, when we touched, not necessarily even scanned, [00:26:00] but when we touched a slide. So when we received the slide, we inspected the slide, made sure that everything was intact, and then when we started scanning it, every touch point needed to be recorded and dated and initialized.

So throughout the entire process, we had to record exactly what we were doing, even to the point when we were putting the slides back into the shipping containers to send back to Proscia. We had to document that for every slide, so the amount of detail. Was probably the part that I didn’t anticipate, but that was needed.

As I said, it was understandable, but that amount of detail takes time. And it takes certain individuals to be able to maintain that type of detail.

Aleks: Exactly. Certain character traits that I don’t have. Don’t put me ever in that position.

Scott: Yes.

Aleks:  Like, no, I, I know this. I mean, maybe not to that extent, but that’s also probably common for different regulatory [00:27:00] frameworks.

And the one I work in is the GLP, Good Laboratory Practice. I, when I think of the individuals in the lab that send slides to remote pathologists, they now have streamlined processes, but there are instances where they have to like record thousands of slides. Slide by slide. I have a lot of respect for them for because it stays traceable.

Many, most of the time you actually need to have a paper trail of this. It’s not that you can like click in an Excel spreadsheet and it’s going to populate. No, you need a paper trail. You need to sign a date. Oh my goodness. Okay, I can totally relate. I can totally relate to this.

Amanda: I agree with Scott. I guess I don’t know if it was surprising because having worked in the lab and having worked at large commercial labs. Where, you know, we were shipping slides all over. And I mean, I spent lots of time scanning, barcoding, scanning each block I would send for processing and each slide I was transferring when it was received.

Then, so I used to work for [00:28:00]  LabCorp and I used to make a, like, I’m just a, LabCorp is a logistics company that does a lot of lab. work because their logistic side of things is just incredible. It’s like, you know, on scale with like a FedEx or UPS and most of the larger commercial apps we’ve worked, you know, I’ve worked with on the vendor sides like that, they’re, they’re tracing everything now they’re using usually an LIS or something, tracking system.

We did not have that. So it was really tedious. And then I guess not another surprise because again, we see this and it’s another bane as a digital pathology is trying to make sure that as the slides. Traveled to the different sites. They all made it into the box and also that they didn’t get broken.

Scott: Yes.

Amanda: We had these like, and then it looked like you were, you know, carrying like huge amounts of money.

Like these huge, like, like something you would carry…

Aleks: from like a suitcases with money,

Amanda:I mean, you know, super padded. Um, and luckily we didn’t, I think we had one broken one, one or two broken slides. And you know, we had planned [00:29:00] for that. So again, not terribly a surprise. Um, but that, and then also, um, the randomization, I knew that for physical slides as our moving to sites was tedious.

Yeah. And it’s just like, wow, this is, it was so much easier once it was in the system, you know, to make sure that got done pretty easily. So I think largely the logistics pieces I agree with just. Yeah, maybe they weren’t as surprising to me just because I had kind of dealt with them so much in my time within the lab.

Aleks: I guess maybe not to a surprise, but like the extent or the how many extra miles you actually have to go to be compliant and make a compliant device is, um, you probably cannot relate to that unless you actually went through this. I mean, It’s a lot.

Aleks: So I have two questions, different questions for each of you.

Amanda, for you, I have one, uh, because you are a former PA assistant. Can you be a former PA assistant? Because I don’t think you can be a former pathologist.  [00:30:00]

Amanda: Former practicing, maybe?

Aleks: Former practicing, yeah.

Amanda: I’ve actually been on certification practice. Every three years, I get on my, um, see, I mean, I keep my certification.

So technically, if I wanted to walk back in the lab tomorrow, I could. I could do so.

Aleks: You could, right? So you formerly practiced as a pathologist assistant. How do you think this solution can impact the day to day work of lab professionals? Not only pathologists and PA pathologists assistants, but like everybody in the lab.

Amanda: So, I’m gonna, I’m kind of gonna put pathologists aside. I think we need to talk. a very different conversation about all the value of digital pathology, but I’m probably going to go back to you. So

Aleks: pathologists, you know what, as long as it’s compliant and they can see everything, I don’t think they care that much.

Like, I don’t care. Give me a good solution. And if I can see slides and diagnose. I’m fine.

Amanda: So for the day to day perspective of maybe the non pathologist, uh, lab professionals, PAs, histo techs, et cetera. I, and again, let’s get back to logistics. I think about the time [00:31:00] and the cost we spend on the logistics of slides, physical slides, I can remember sitting on the floor in a pathologist’s office.

Trying to find a slide that was missing that another pathologist needed to review was asking for and I I mean, literally just going through stacks and stacks of folders And I think we may have finally located in the pocket of the lab coat because he had carried, he had carried the slide, he carried this slide to another pathologist’s office to, to do a, you know, two headed scope review at some earlier point.

And, you know, he was out of office to give maybe a tumor board or something that we couldn’t find and we’re trying. I mean, I just think about how ridiculous that is. I didn’t even think about sitting on the floor trying to find these slides. I mean, just those kinds of like antidotal things, it’s just huge.

You wouldn’t have to do that anymore, right? And then having the slides, uh, digitized, it really just makes it readily, you can’t overstate the value of having things readily available and accessible. And I can assign, I think about how we had to do case assignment. I had to do a lot of case assignment.  [00:32:00] And often it was based on if like a pathologist was not located on site, they would get the first cases that came out.

And worry, not necessarily the cases that they were maybe best equipped or, you know, had the expertise or specialty certifications in, but it was just based on sort of the logistics on the physical sides of having to move them. So I think, you know, you can really optimize your utilization of the capacity you have available.

So if you have more people further away, it’s not a big deal. You’re not trying to ship things. And then the expertise. So signing by specialty and not having that be sometimes limited by where that specialty sits and being able to so easily get a collab session or do a consult in that many hours I spent packaging FedEx stuff and sending things off.

And then for some of the consults, having to go follow back up and make sure we got our slide back. Because it could take weeks to months to get the slide actually returned and you’d have to remind him, Hey, we need that slide back. It’s just inviable. And, you know, I think that will increase the utilization [00:33:00] of consults and things.

And ultimately that, you know, democratizes pathology.

Aleks:  You know, when, when it would increase, I think if LabCorp ever. Like goes fully digital and publishes what they were spending for the decades before on shipping and on the basically like manual slide shuffling labor. If maybe I need to reach out to somebody from there and ask, Hey, would you be willing to publish this report once you go fully digital?

And I think this, like the magnitude of the resources spent on this would be huge.

Aleks: Scott, the question to you is because you guys pioneered this, um, interoperable way of having a cleared compliance system, but what advice would you give other companies looking to pursue similar partnerships and integrations?

What are your words of wisdom? And Amanda, I’m going to ask you for your words of wisdom as well, but.

Scott: I guess the first thing I would say is make sure that you, your solution is sound [00:34:00] and you have actually thought through. From a scanner standpoint, you’ve actually thought through the pixel pathway and specifically the workflow.

You need to keep the workflow always in focus because you can help yourself and you can also bury yourself in details unnecessarily. Second thing is patience and focus. You really need to pay attention to the details of what you’re doing, what other people who are involved in the process are doing.

Just have patience, but be thorough. Don’t be afraid of it, but prepare for a time investment and an investment to go through this.

Aleks:  Solid year of work or more to prepare this stuff. Amanda, any words of wisdom from you? What would you recommend other people, just other software vendors? Focus on when pursuing a partnership like that.

Amanda: I mean, you need to make sure you’re looking at the big picture, the holistic picture. Um, where does the partner fit in? Are your long term visions the same, right? Like, are you moving in the [00:35:00] same direction? Um. Cause I mean, I’ve seen that happen, actually, when I was in a customer position at the lab where we get a partnership and then the two companies would sort of go in different directions.

And then we were kind of left hanging because they no longer supported things. I think this is a, and to me, anytime you’re going to these other partnerships, it’s a long term commitment. Yeah. You need to be thinking about. Not just today, but what, how are you going to maintain that partnership as you do changes to your software?

If you add additional features or even new software, new hardware, new scanners, how do I make sure that I’m staying in step with partners? And then I also go back to sort of the Proscia Ready thing where it goes beyond just the fact that they technically work together, having a good process and plan for how you’re going to do deployments and support training with customers so that the customer has.

So you really need to think about all those things, um, when you start moving forward and make sure, you know, say, well, all that comes later, you gotta figure it out earlier, right? Cause sometimes [00:36:00] it may change even how you may develop things a bit differently. Knowing that a third party is going to be doing certain things where you, how you would do training and things like that.

So that’s like, I think my advice is you gotta think holistic and long term and not just. What I’m going to do today,

Scott: good words, Amanda, good words,

Aleks: the highlight on for that as well, because I wanted to interrupt you and say, yeah, you’re going to like each other. Uh, but basically along those lines, you need to have the same vision and you’re going to be working closely.

So, if, um, there is friction on the. Conceptual planning level or whatever, that’s going to be a more difficult process than it already is. And it’s not easy.

Aleks: If people want to learn more about, uh, if somebody was interested in purchasing the, um, Hamamatsu-Proscia combo for their lab, uh, where should they, uh, look for info on the Hamamatsu side and on the Proscia side?

Scott: On the Hamamatsu side, they’re, they’re more [00:37:00]  than

Aleks: buy a scanner.

Scott: Digital slide scanner or solutions. People are looking for solutions for us. We’re going to bring Proscia into the into the picture and to help with that solution. So we can we can be reached through our web page. You can actually put in a comment or

Aleks: I’m going to link to this in the show notes as well.

So that whoever is ready. Can just easily access that. So…

Scott: That’s one, that’s one vehicle. You can actually go to any of our, our sales individuals or our service folks, application people. Um, you can go to Proscia and say, Hey, we’re interested in putting together a workflow. I’m interested in the Hamamatsu scanner and your software.

And we work together in this way, bring it together as a project. We’re flexible. We’re, we are out there. If you can’t find us, please look us up online and, uh. And you can just let

Aleks: me know as well.

Scott: Yes.

Amanda: Same thing for us, our, our website, but I’ll, I’ll make sure we get you a link that is more direct [00:38:00] that you can provide to folks that are watching the podcast.

So that’s like a direct, you know, basically call for us to reach out to you.

Aleks: Is it okay if I include your LinkedIn profiles in the show notes? Sure. Okay. I’m going to do that. And if anybody approaches me, I’m going to forward them the message to you as well so that they can learn how to be digital, how to basically work more efficient and help patient faster.

Yes. I believe that. Digital pathology is the gateway to fast diagnosis and everybody has the right to fast diagnosis. Thank you so much for blazing the trail for this particular use case. You’re, you keep blazing the trail with new products, new offerings and, you know, supporting more and more customers.

But this particular thing, you guys were the first that did it. So thank you so much. And, um, thank you for joining me.

Scott: Thank you, Alex. Thank you. Amanda.

Amanda: Thank you guys. And thank you for Alex, for, you know, helping Trailblaze and get this information out to the people that need to know it. [00:39:00] I mean, a lot of people are struggling to figure out how to get started or how to take the next step.

And I know your podcast is super valuable for that.

Aleks: Thank you. Okay, sir. Thank you.

Amanda: Take care.

Aleks: so much for staying till the end. It means you are a true digital pathology trailblazers. More and more companies get clearance and it’s being expected. And like we said, at the end of the episode, it never ends. I just wanted to emphasize one more time, how much effort that is and how much of a heavy trail blazing, this type of FDA submissions are and making possible for the different components of the workflow to be interoperable.

So another big shout out to Hamamatsu, who was the sponsor of this podcast and to Proscia for working together on that. All the links are gonna be in the description. If you’re ready to embark on the digital pathology journey in your lab, uh, use any of the links or just let me know and I talk to you in the next episode.