Esther: [00:00:00] The thing you said, it is good to always from now and time to consult with regulatory strategists. And not specialists per se, but in the beginning, a strategist, because then you can work together okay, what is it that I wanna accomplish in a few years from now? And how do I set it up?
How do I have the minimum reporting?
Aleks: So you are a strategist.
Esther: I’m more a strategist.
Aleks: So how much in advance, should companies consult their regulatory strategies? Like when do you think this is even gonna be the future for a product?
Esther: This one, I really say do it from the start.
Aleks: Okay.
Esther: Because it will drive your market access.
Aleks: Any piece of advice that should follow.
Esther: I always say start from the inception place. And I know that’s difficult when you’re in the sandbox, when you’re playing around, when you’re having ideas, you don’t want to go. Confine yourself or restrict yourself to certain compliance rules, right?
So you want to be creative and that’s also always what I advise them to do. Keep being creative [00:01:00] and be pragmatic.
Intro: Learn about the newest digital pathology trends in science and industry. Meet the most interesting people in the niche and gain insights relevant to your own projects. Here is where pathology meets computer science. You are listening to the Digital Pathology Podcast with your host, Dr. Aleksandra Zuraw.
Aleks: This episode is one of our special USCAP episodes that were all sponsored by Muse Microscopy. So let’s dive into it.
Welcome Digital Pathology Trailblazers, and I am joined by Esther Abels. She was a guest on my podcast already when she started her company, Solaris, and it has been over a year ago.
Welcome Esther to the show again. So a couple of words about you, and please highlight the most important things that you are famous for. And if you will not, I will say what she’s famous for [00:02:00] and then let’s talk what Solaris.
Esther: Yeah. Okay. Okay. It’s great to be here. That’s the first thing.
And actually it’s been, then if it was that I just started my company, it’s been two years ago.
Aleks: Oh, wow.
Esther: It’s my anniversary.
Aleks: Congratulations. Congratulations.
Esther: So I’m really excited about that. That is, I’m very delighted that I am celebrating that here a little milestone. Being two year in business. And what I’m focusing at is really at helping companies to get their devices to the market.
I am thinking with them besides understanding side to side with them, helping them to go through regulatory clearances. Coming up with regulatory strategy. But also thinking about, okay, what do we need to include with regards to evidence if we wanna go through reimbursement trajectory, if we wanna settle like claims and getting extra devices and features to added to our products.
That’s what I’m doing. Yep.
Aleks: Okay. So I do need to mention the, which company was the one [00:03:00] she helped first? She was part of the team that helped Phillips get the clearance for the first scanner. That was 2017.
Esther: 2017. Yes.
Aleks: 2017. Yeah. The first FDA clearance for a whole slide, imaging scanner for primary diagnosis.
She was part of the table. So that’s a big achievement.
Esther: Yes.
Aleks: You should brag about it.
Esther: Okay.
Aleks: Yeah!
Esther: It was a big achievement. And actually, I wanna highlight a few things about that because of course it, it was a team’s work. But yes, you need someone to lead it, to orchestrate it. So yes, I did that.
What I see happening now is what’s back then we had the scanner is viewer and the display all that need to be cleared as one device and now it’s a digital pathology association as well. We’re trying to start to break that up deep…
Aleks: Couple…
Esther: Because we always wanted to have that also with Phillips.
But back then it was not possible.[00:04:00] I, we’re now trying to get that all decoupled so that you can get a separate scanner cleared, a separate, fewer cleared, a separate display cleared. I’m not saying it’s gonna happen overnight…
Aleks: Nothing. In the regulatory world, happen overnight, trying to speed things out.
I know.
Esther: No…
Aleks: It takes passion for that part of pathology.
Esther: Patience and passion.
Aleks: Yes. But yeah, it was a milestone because it basically put the digital pathology in the diagnostic realm and, more other technologies wanna get there. The the booth that we’re at is MUSE microscopy and they’re pretty cutting edge technology.
They do direct to digital imaging. So when we have what companies, like you say, you help companies bring those devices to the market. When you think you have something that’s mature enough that it can be taken that way, what are the steps that one should take? [00:05:00] How do you work? Basically because many of these are messy research projects that suddenly something works and then like how not to scramble to have it compliant in the end.
Esther: Yes.
Aleks: Any piece of advice? Was it phone…
Esther: I always, always say start from the inception phase. And I know that’s difficult when you’re in the sandbox or you’re playing around when you’re having ideas, you don’t wanna go and yeah, confine yourself or restrict yourself to certain compliance rules, right?
So you wanna be creative and that’s also always what I advise them to do. Keep being creative, be pragmatic. The thing is that it is good to always from now and time to time to consult with regulatory strategists. And not specialists per se, but in the beginning, strategist. And why is that?
Because then you can work together okay, what is it that I wanna accomplish in a few years from now?
Aleks: Yeah.
Esther: And how do I set it up? [00:06:00] How do I meet the minimum requirements?
Aleks: So you are a strategist?
Esther: I’m more a strategist.
Aleks: Okay.
Esther: Yeah.
Aleks: So how much in advance should companies pass out the regulatory strategies?
Like when do you think this is even gonna be the future for a product?
Esther: This one I really say do it from the start.
Aleks: Okay.
Esther: Because it will drive your market access. And if you think about it from the start, you can think about already, and I’m not saying I’m a specialist in health economics. But what we help you with is thinking as strategists will help you with. Okay, what does this product do in the future? What is the clinical utility? What’s the economic utility? How do you phrase that back of bring that into the regulatory constraints or requirements that there are the boundaries and how can I use those boundaries to optimize my products?
And that’s what I’m always aiming at to help you guide that path. So it’s really the inception phase that I recommend to be involved. Then it slows down [00:07:00] a little bit. And then when you’re getting more towards proof of concepts, then it picks up again. And then we’re really looking into, okay, what are the next steps?
How do you build your roadmap? How you gonna execute? What do you comply with? What is your documentation? What are your, in setting that all, wait.
Aleks: So let’s say we have the strategy, and then there’s already a point in time where you wanna get everything together to, in the end. Submitted, what, how long does this process take?
Or what’s the, probably for every device it takes a different amount of time and including the review process. But like from your experience, more or less, yeah. How many years? How many years? I assume it’s years. It’s not gonna be months.
Esther: It’s typically not months, unfortunately. But that’s indeed where my, so I’m also a regulatory specialist.
That’s where that point comes in. But also the clinical specialty where you are thinking about how do you set up [00:08:00] all your tests, not an engineer. I understand what engineers do and what they have to do. I also then work with them to set up all those clinical studies that you haven’t to execute that in a real clinical practice mimicking clinical worlds.
And also the reproducibility studies. Can you reproduce it? Is your instrument precise? So all that from so I’m not talking about the inception phase with more, if you have your proof of concept and then start building a documentation that building documentation, that can take at some time.
So if you have not really done that yet if you have not done all the documentation and the testing, then yeah, that easily can take past a year. So depending if your hardware or software if hardware can take longer, and ifs a software it can go faster and thereafter you do all the clinical studies and that’s something I noticed that takes some time as well of course, because you need to get the contracts [00:09:00] with the size, with the hospitals, having them working with you, setting up the IT infrastructure…
So typically, depending on how material, your documentation and how much quality you have, it can take easily from starting it still getting a clearance 18 months.
Aleks: Oh, okay. Okay.
Esther: That’s not too bad. But if you’re documentation is behind, yeah you have to think about more and also depending on what kind of product you have, of course.
Aleks: So a follow up question, basically, because companies have internal regulatory teams and they work with consultants, and we’ve been on both ends of the spectrum. When does it make sense to have one or the other, or do you always need both? How does this dynamic play out? Yeah, so I think looking back at Phillips we also had consultants, and I enjoyed working with them because you then have some ideas from outside that can really help.[00:10:00]
I’m not saying that it’s. Needed because most of the time when you are with your company, you have capable people. So it depends on what you’re really looking for. I always think it’s good for mindset and putting things on perspective to have the resultants and of course I’m promoting now, of course, consultants.
Aleks: Yes.
Esther: And of course now this, no, seriously, I think it’s, it is important also regards to the FDA because co consults go more frequent to an FDA and they can have, when they go, to the FDA offices and now everybody has to go back.
Aleks: To the FDA, right.
Esther: They’re not allowed to work remotely anymore, so when you go to the office, you really see them there.
You can have a kind of it’s not a coffee chat, the coffee chats…
Aleks: I know this from the drug development space, that there is a relationship component Yeah. That you built while working at the agency that plays their role because people are working with people, and they have a lot of documents [00:11:00] to review. So there is a relationship component, like in every aspect of life, that’s a value that cannot be obtained in a different way because we’re in a company, we’re not gonna go work for 10 years to the FDA or whichever agency, and then come back and have friends. Yeah.
Esther: Yeah. So that’s, yeah, for me, that works.
Aleks: And then consultants, they have a relationship with regulators, they have an outside perspective. Does it matter for the FDA if there was both in-house and outside people involved? I know it’s important when you publish that a lot of weight is being placed on publications that don’t have that company team or no, like financial incentive.
And when you are working on the device, it’s not always possible to have somebody from the outside, especially if you need to get proof of concept per device. That’s not out there. So it ends up being the internal [00:12:00] team doing the publications. How can you I dunno, if mitigate the risk of this being discarded because of its internal team, that’s maybe not the right word, but how can you make the data that come from your internal team most solid when the regulators look at it?
Is there. Something that people could have in mind.
Esther: Yeah. And if you’re really thinking about the documentation that the FDA will look at, then I would recommend just follow your quality management system and make sure that you’re following also the standards and the regulations that are out there.
And then it’s not so much about publications.
Aleks: Okay.
Esther: I know that’s in the development of drugs, it’s bigger indeed than all them in devices. Although…
Aleks: I also know from tests from yeah, careful from diagnostic tests, basically.
Esther: Yes. Because that’s what I want to say with what we did with also an imaging devices, if where scan, [00:13:00] gathered all the information that was out there with regards to keeping needles who did do studies.
We show that primary diagnosis that you can use a digital pathology, wall site imaging system, compared to a microscope. So we gathered all that data and we have used that and analyzed it with meta-analysis and everything, and we showed it to the FDA, and that definitely helps.
Aleks: Yes, that there’s a little bit characteristic of the device that was widely available for research, right?
Yeah. So you had a lot of research data. It’s not always the case if you don’t have the device available for research. So that was a unique situation…
Esther: But I would say for algorithm companies that might be able, they might be able to do it too. Yeah.
Aleks: Because you can basically deploy it in that, in the research space, publish on it, and then the data is being analyzed, and amazing.
Esther: And even more so now, I think with all the, with the synthetic data.
Aleks: Yes. Yes. What do you think [00:14:00] about that? How do regulators look at it at large language models? I saw the guidance for drug development on AI. Drug development. What I’m seeing, the trend I’m seeing is very much risk assessment and risk mitigation.
It’s no longer oh, hard boundaries. It’s rather what are the risks? How is it gonna influence, how are you gonna mitigate, which I think is a lot more permissive than the previous approaches.
Esther: Yes. Yeah. Yeah. And I see that too. And when I was, it’s actually already a year ago almost that I was at NIH.
When they had a conference about it and talking about it. And it was very interesting because they, you see it more and more already, radiology. Digital. They were a little bit hesitant and mostly because there was no DICOM. Okay. And I find that very interesting because I thought it doesn’t have to do with DICOM, it has more to do with how do you collect your data?
Is it accurate? Is it reliable? What are your boundaries? And what, yeah, what is your criteria? [00:15:00] How, if you set it as you mentioned? How are you using it, and how are you analyzing it? That’s more important than really like those…
Aleks: Which standard do you… Yeah, I think have it easier if we both standardize.
Esther: Yeah, probably.
Aleks: I guess. Yeah. And it’s also, I don’t know, I think digital pathology has this other reputation of being all over the place because we didn’t have an image standard. So people think it’s actually like the information is all over the place. No, the way the information is being stored is a little bit, everybody is integra… integrating it and we’re going the DICOM way.
But the information, the diagnostic information in the images, it doesn’t matter if it comes from Hamamatsu scanner, whatever, scanner, or if it comes from the Muse tissue imager. If the diagnostic information is there, you can show that it’s concordant with whatever the standard of care was, then it’s okay that it’s not DICOM.
Although MUSE has that DICOM option. Okay.
Esther: So yeah, that’s good. I think it does help for the future of course, ’cause it makes the interoperability way easier. I’m not saying that’s the only solution and everybody also thinks that it is not the only solution for pathology.
Aleks: But I think it sets what was invented for pathology.
So I think they’re like retrofitting it to the standard, but there is the standard, so yeah. That. So what are the next, your next milestones for Solaris? Any growth plans, any new exciting projects that you can tell us about?
Esther: Unfortunately, I cannot tell.
Aleks: But of course, because we’re in the regulatory space and we’re not supposed to talk about it.
Esther: No, and I always, I’m not really disclosing about what my clients are doing.
Aleks: Geographically, are you just US or are you global?
Esther: No, I’m global and I am so what my biggest milestones would be is really thinking about how can we access and needs everything that we have in Europe. We leverage that in the US and the other way around, and I know [00:17:00] there’s a lot of discussions ongoing on that.
And focusing on that. Like how can we, yeah, how can we use that? Reuse that.
Aleks: So you’re also very involved in the Digital Pathology Association. You’re the past president. Any new developments there any way the association wants to drive the digital pathology adoption? Any new initiatives that you’re aware of?
Esther: I’m mostly involved still with the regulatory Stama Task Force and also with the AI working group. And that’s where we, yeah, what I mentioned, we’re focusing there on the interoperability aspects and also with regards to AI…
Aleks: Decoupling the components.
Esther: Yeah. And then with AI, we’re trying, so for example, last year we were focusing on the AI Act in Europe.
And how you can implement at best for your old company, but also not only companies, of course, healthcare providers also have to deal with it. Now we’re seeing what we have to do in the US, and there are many initiatives also from the government [00:18:00] on the AI. And they recently announced something that they’re looking for and developing more clearance, clear guidances and, yeah how to regulate it. So I think that’s something that DPA is interested in and also working on and yeah, focusing on this year.
Aleks: Good. Thank you so much for joining me. I wish you all the best, and if anybody needs regulatory guidance or, regulatory strategy, Esther is your go-to person…
Esther: In clinical as well.
Aleks: Clinical.
Esther: Yeah.
Aleks: Oh yeah. Clinical study design, right? And development.
Esther: Yeah. This is a companion diagnostics. That’s very interesting.
Aleks: Thank you so much for joining.
Esther: Thank you for having me.
