125: Direct-to-Digital Tissue Imaging | Interview with Drs. Rao and Edwards, Muse Microscopy

What if we could skip glass slides altogether and go straight from fresh tissue to digital image? Muse Microscopy's SmartPath device aims to do just that, capturing diagnostic-quality images directly from fresh tissue. 

In this episode brought to you by Muse Microscopy, I sit down with Dr. Rao and Dr. Edwards to discuss the insights, challenges, and future of this groundbreaking technology. 

We explore its regulatory ramifications, change management in veterinary and human pathology, and financial feasibility. 

Tune in to learn why SmartPath could be a game-changer for both pathologists and patients.

00:00 Introduction to SmartPath Technology
00:54 Meet the Experts: Dr. Rao and Dr. Edwards
01:08 FDA Approval and Implementation Plans
01:35 Change Management in Pathology
01:56 Training Pathologists for SmartPath
03:48 Translational Tissue Banking and Clinical Applications
04:29 Impact on Breast Pathology
05:49 Pathologists' Reception and Adoption
14:33 Financial Viability and ROI
19:44 Conclusion and Future Prospects

Links and Resources:

• This episode on YouTube
• Muse Microscopy Website
• SmartPath Device Demo Video

Transcript

 What if you could skip glass slides altogether and go straight from fresh tissue directly to digital image? That's exactly the future Muse Microscopy is building with the device called  SmartPath, a tissue imaging device that captures diagnostic quality images directly from fresh tissue. Join me as I ask them about their first hand insights on what's easy.

What's challenging and what went wrong as they bring this technology to life? Let's dive into it. 

I have Dr. Rao and Dr. Edwards here, an MD pathologist and a veterinary pathologist. And we just came out of a panel about Muse microscopy. Muse is the technology that lets you image tissue direct to digital. And I have a couple of questions because the plan is to have this device, uh, approved by the FDA in Q1 next year, 2025.

And I wanted to ask you when, it's going to be implemented. They're, they're, you know, commercial plans and everything, but when it comes to change management, uh, for the decision makers in the veterinary pathology space and MD pathology space and the users. So we have decision makers and users change management.

How is it going to differ? What is, what are these? These issues in change management are going to be in veterinary pathology and in MD pathology. Well, you mentioned FDA approval, that's not something we need to worry about in veterinary medicine. The deployment of veterinary medicine will be point of care at hospitals. 

The first group that will have to be trained and  see this in a different way are going to be the in use of the pathologist. Pathologists are not used to seeing these native images. And the virtual HD images look somewhat different than what they've used to on a two dimensional, uh, glass slide or whole slide image.

So it's going to require, um,  training to learn how to interpret some of these images and to get comfortable with diagnosing them. And that will be very similar to, we have, we have a great historical case to, to ease that transition. And that was the transition we did from, Glass slides, whole slide images.

And when we did that, uh, some years ago, at Antec Diagnostics, and we went all in, um, full blast, 40X, all slides  were imaged. But we gave the pathologist two modalities to look at, obviously, and that was the whole slide image as well as the glass slide, and gave them some months to be able to make that transition to prove to them that they, that what they saw as a whole slide image was in fact compatible, uh, similar to the glass slide.

So it's going to require the same sort of thing with MUSE, um, with the MUSE images, the SmartPath images. They're going to need to look at the SmartPath, SmartPath images and the Hallside images that are sent to the reference labs from the hospitals where the, where the, uh, SmartPath image was done to be able to see those side by side and so that they get the confidence and build on that confidence that yes, my diagnosis I made here is in fact the same as what I'm used to looking at Hallside image or not.

Right. And then decide what, what, um, over time learning from that experience and what they feel comfortable doing. Is it similar or different than veterinary in, in, in human pathology? In human pathology,  there's one area that actually is the same. No FDA needed, which is translational tissue banking. Okay.

Okay. Yeah. So that's something that we can immediately do. In my institutions, we have, uh, several, uh, big program project for cancer. One of which is prostate and typically, you know, for banking of the tissue of the prostate, we have to do a lot of, you know, processing, you know, frozen section and analysis to find the tumor area.

Right. So, so this can help us on that front. So I can immediately implement that even without have to wait on, uh, on the FDA study. Now, um, that's nonclinical, it's translational.  Now, in the clinical setting, I think, uh, you know, the area that we can do immediate kind of like helping us would be like, for example, breast pathology, you know, when we receive a lumpectomy, mastectomy, you know, um, when we do the grossing, we maybe see different nodules and the patient may have already have chemo, right?

So the nodule may not be in a tumor anymore, right? Oh, there may be necrotic. So, In order to really be more efficient in processing tissues for most of the molecular immunostudies, um, that important for patient care, right? You know, for the, for the management.  You know, this can help us to find in that  area of tumor and then say, Oh, you know, this is it.

So let's take the tissue here to directly to the molecular study or immuno study. And that will be, you know, affecting the the whole management scheme because the oncologist can get the results much faster and, and probably even more precise because we have showing that the, the tissues processed by MUSE gave a better RNA quality compared to tissue that fixed informally.

You know, and that's why important for the patient care. Do you think how do you think? Pathologists are gonna feel about it in terms of change management, or are they gonna embrace it immediately? Or is it they're gonna be a transition period like what's gonna be the thing that?  Will need to happen to convince them that this is then you think that they want to use very important question And so I'm just to use the breast as example.

Okay here But there are many other settings that we, pathology, need help, we see immediate, this can help us. But let's start with the breast, because again, you know, I think one thing that  this can help us is to be able to know where the tumor is. While you, you see a growth, uh, even very experienced, uh, pathologists You know, if it's just by naked eye, you know, we won't be able to tell, right?

So this can give me immediately say this is the tumor and I have to, you know, think about, you know, using that area of tissue to do this study, you know, that's something can be immediately helpful and that's the key. Yeah, you know if you  have a technology try to take away my job That's a different story.

Okay, but this is now this is actually help us The other setting that really can be helpful is, like, when you do the intervention radiology biopsy, co biopsy, we have to send our cytotecs, we have to send our, you know, sometimes pathologists to go to do the adequacy, or to do, like, rapid assessment, something we call LOS, and sometimes preliminary diagnosis too, based on that.

But anyway, so, if I have this tool, that I can immediately utilize it to  to do this job for me so that I can do, you know, put my time on other important things. So, so that's kind of the reason that I think this can be helping us in practice, not just in, you know, see this as a way to replace pathologists, you know, responsibility.

It's totally different. It's the addition, you know, it's something that can help the patient care down the line, but you know, help everybody. So, I think you, you touched on a key point. This is not something that is in, that is going to take away anybody's job. It's making pathologists be able to help the patients faster.

And I think this, regardless, you know, there's going to be a learning curve. There's going to be time for pathologists to get used to. And Jeff, you mentioned that. There needs to be incorporated transition period for people to feel comfortable and and that's regardless whether it's veterinary pathology or Human pathology basically the pathologists can help the patient faster.

And so I think that's It's something that people are going to be super excited and that's going to help adopt the technology. Anything veterinary pathology or MD pathology specific that people are going to be excited about other than that, that they can be faster and help patient faster? Well, I think that for instance, once, uh, additional studies are done and we would finish one study showing a pathologist that it was a hundred, a thousand reads compared 90 percent concordance plus minor discordance  agreement.

When they see those kind of studies, and we have a library of what these tissues look like that they can see for themselves, they'll gain more confidence. I firmly believe that the pathologists working for companies that have this technology, and I know this from when we did the digital pathology conversion, the first veterinary laboratory to do that, well in advance of other laboratories, there was this amazing, one of my favorite words, esprit de corps in my pathology group.

This. Wonderful feeling of we did this together  and we did something, a tremendous accomplishment that has greatly helped veterinary medicine. The same thing is going to happen with this. Whatever company gets this and those pathologists that use it and they see how quickly they can make diagnosis that's going to improve patient care, decision making in patient care, they're going to realize we're ahead of the pack.

We, we revolutionized. A hundred years of the same old stuff, we did something different, a massive breakthrough. That in itself is going to be a wonderful feeling for the group that did that. And as far as replacing jobs, I agree, there's not going to be any of that. The glass slides, whole slide images are going to be the gold standard for years to come.

There will be a time in the future where reference laboratories start seeing some of the biopsies being replaced by this sort of technology. There may be some pushback in time. It reminds me of when the medical transcriptions slowly got pushed out for  voice activation like Dragon It reminds me of that that's what's gonna eventually happen slowly over time in the future, but that's years to come So this feeling of accomplishment that you're mentioning we did at Charles River Laboratories where I work we did Go digital the first time for primary reads in 2020  Two or 2021.

I don't remember. I was on the validation team and I totally underestimated the joy when you actually accomplish it. I thought, okay, it's your job. You work for a corporation. It's like part of your job description and you just do it. But now when I think about it and I think, yes, we are ahead of the pack and I did it together with my colleagues, we did it and we're using it and it does gives me this sense of pride that I think you don't really get from, I mean, you do, but in this context of, uh, that you get it more when it's a startup environment, it doesn't really matter what kind of environment it is, it matters that a group of people together achieve that and are leading.

And it, it is a joyful feeling. That's a pure morale boost. And, um, yeah, again, the pride of collective joy and, um, freedom Corps, there is no substitute for management for that magic. When that happens, it sure makes management a lot easier. Yeah, I know. Yeah. I can see that. Uh, just come back to the, um, job of like, you know, loss of job issue.

It's actually not, I mean, ob obviously, you know, we still, pathology has to read the image, right?  But the problem we are facing today in our pathology practice is the shortage of technologists. Um, so we used to have a lot of people interested in cytotechnology training, cytotech school. And now we are facing problem.

I'm the head of the medical director for cytotechnology  school at UCLA. I'm looking to close that soon.  And there's only one  school left in California. So no more cytotex in the future. That's dangerous, right? And then histotex,  you know, shortage. So what  things can do to help with that problem? Technology. 

So I think this can help us, you know, um, to really alleviate some of the problems that we are seeing in the technology training. Because it's not a, because something driving, it's not a, I mean, there's so many factors driving those changes. Why, why don't we don't have cytotechnology anymore, right? The cytotech was developed because of the pap smear.

The pap smear, people try to push it away because of the HPV,  you know, uh, testing and vaccine and all that. Out of the whole country, everybody's struggling with, you know, how to deal with that. Because typically cytotech training is very rigorous. And, you know, so,  again, you know, I think this is,  to my mind, this is technology that can help to fill the gap. 

to deviate the problems that we've seen in, in that front. Alex, in the seminar we just gave,  did it surprise you? And or make you feel good?  When one of the MD pathologists said, how many times do we have to hear that our technicians were short technicians and the slides are delayed?  That made me feel great.

I mean, I'm sorry for you guys. We deal with that all the time, right? So it seems to be a universal issue. Yeah. I always thought we would lose our technicians to, to the MD pathologist. Mm-hmm . But I guarantee the problem is the same with you, you know? Yeah. So, and it's the same in talk safety basically. And the, the, the, the point to emphasize here is it's not that it's gonna be taking away some jobs.

There are no people to do those jobs. Exactly. But the job still needs to be done. How are we going to do it? That's, that's the key work and, and. This is where, you know, any technology comes in. So I'm excited about this one. One more, one more question about the finances. Obviously veterinary pathology, veterinary medicine and human pathology, human medicine are financed differently.

And how is the implementation going to be solved from the financial perspective? Jeff, you mentioned it's going to be point of care. So it's going to be the  investment of those managing the clinic. How, how do you see it being financially viable and, and like, in general, what do you think about that? How do I see it being financially viable at the hospitals?

Yeah. And basically like who's gonna be paying for this technology? How is it gonna, how will they, how fast and how will they get the return on investment? Sure. Well, that's critical return on investment. I mean, there's no third party pays in medicine, like in, in, um, in Ralph's profession. But I think this has been worked out pretty well.

We looked at Muse with Antec some years ago and, and subsequent to that. The, the diagnosis that's made from a, from a SmartPath image at a hospital will be charged a stat fee.  So that's gravy on top of the regular biopsy fee. And many owners are being willing, I would, I would pay that in a moment. If I'm going to get my dogs, my beloved dog Taz's diagnosis.

Immediately. On some skin mass that he has right now. If I can get it today, if I know, and if it's malignant, did they get the margins? Well, every margin is checked. That's another stat fee, right? That's another tissue put into the SmartPath unit. So that is how that's going to pay for itself. Mm hmm. Um, and also, um, you know,  the more samples that are run, well, the cost-effectiveness becomes even, even better.

Yeah. I'm going to say that's the way it's going to work. I like the, I like that you say it's going to pay for itself because through the benefit for the owners and for the patients, um, the added value justifies the investment from all the parties from the party who has to purchase the unit and actually invest ahead of getting revenue from that.

And it totally justifies this, um, for the patient, for, for the pet owners. Well, you've seen the video that we did,  where, um, a veterinary surgeon, in surgery, with a large breed dog, takes a piece of an organ, say it's a spleen, if the surgeon knows right away, within a few minutes, if it's a malignancy, they then have the, instead of sewing this dog back up and waiting four, five, six days for a spleen, it could be a week to get a I'm going to do a diagnosis.

In the meantime, if it is malignant, it's poor patient suffering, right? And then the decision has to be made, you know, whether it's chemotherapy or whatever is going to be done or not. But if they knew right then, the surgeon knew right then, if it's a malignancy, they can then call the owner right then and say, here's the situation.

Here's how bad this malignancy is. Here's the life expectancy. We can make a decision right now. So the owner is then empowered to make a decision not to move forward or to do so right now. Understanding, um, the prognosis and what the cost will be for treatment. That is an extremely important thing for owners.

And they're going to be willing to pay for that knowledge. Well, I think on the human side, it's probably more complicated. Yes. Yes. Let's talk about that. Always. Always. Uh, I think this is tremendous. I mean, this is music to the ear for the administrator, hospital administrator. Because, think about it, if the, you know, you have to set up a histology lab, and how much you have to invest for that, right? 

You know, is the place, I mean, you don't have to worry about embedding machine cutting, machine standing station and all that, and the human cost, you know, so of course everything's driving by CPD coating, right? Yes. So the magic and the CD. Um, but so I think for this to be viable, you know, obviously I don't know, you know, this has to be a new, probably have to get a new ct mm-hmm 

Because it's just like digital or any other me. So we typically have like technical component and professional component, right? I mean, obviously this is not going to change anything. Professional component stays the same. Yeah, stays the same. The technical component may be something that needs to be added.

Now, um, that can be also replacing some of the things. So in the end, I mean, obviously it's tremendously, you know, financially saving,  um, project. So I think that's, that's the way that I see it. At least on the human side. Which is in contrast with the classical way we're doing digital pathology. Where, you know, there have been return on investment calculators developed and, uh, but it's always very long term.

And you are not cutting out anything from your current workflow. So there is no direct savings. And as much as I love digital pathology in any shape or form, And this shape and form seems to be easier to digest for the decision makers because it provides direct financial incentives to implement. Thank you so much for joining me.

Thank you. It was a pleasure and I hope we meet again. Yeah. Absolutely. Very good conversation. you. Thank you so much for staying till the end. It means you are a real digital pathology trailblazer. And if you're interested to learn more about this technology, I'm going to link in the cards and in the show notes, the podcast with Matthew Nunez, the CEO of Muse Microscopy. 

And if you happen to meet them at any pathology conference, be sure to check out the booth and check the device yourself because you can get the real life demo and have a look at the images created with the SmartPath device yourself. And I talk to you in the next episode.