#454: Slow regulation is killing health tech innovation

0:02Everyone knows that the only way to build good software is to build it iteratively, to climb the hill week by week. You can't climb the hill because there's this artificial constraint on iterative development and deployment that Scarlett is today, which is to build a notified body, the ground up, oriented around providing a process that makes iterative medical device development possible.

0:29hey everyone this week i've got jamie with me co-founder and cto of scarlet uh jamie how you doing man i'm well thanks for having me on you're very welcome you're very welcome um should we talk about the weather that's pretty standard to do in the uk isn't it like complaining that it's hot should we just do that for like 30 seconds and then we've just got it out the way uh it's really hot isn't it i'm sweating loads look at this background the sky is blue arm it It looks like you're in the basement, though. Honestly, are you in the office in your... The Tate office, is it? And this is why everyone should come and join Scarlet, because we have a beautiful office here in Fitzrovia.

1:06We've got a wraparound balcony at the top. The sun is shining. Oh, in Fitzrovia. Look at that. This is the place to be. Honestly, it does look glorious. And if there's ever a candidate that's weighing up an offer from SOMAX or Scarlet, they'll look at your basement there. They'll look at this beautiful terrace, and they'll say, is this is the this price ever made i know honestly honestly they'll be like do you want i'm trying to sell them on this like underground bunker which is actually just a spare bedroom in my house that's like got a barely painted room like enough that you can just make this podcast background look good and there's you in fitz rovia on some rooftop honestly unbelievable just one of the many reasons why scarlet is a glorious place to work hey jamie exactly well listen looking forward to getting into this i've had james on the podcast previously so um we've we've heard the story of scarlet before i guess for those people that have listened to it um not expecting everyone to listen to uh every episode of this podcast although i did meet a guy ali yesterday at an event who had actually listened to every episode of the podcast first person i've ever met that has done so how many have you done um 400 and something almost 500 basically so he's your whale have you do you know that idea like no like uh people on only only fans have very skewed distributions of who watches them and it's just one guy it's yeah interesting he's doing all of it this explains the watch hours the 10 000 the 10 000 downloads a month are just ali is your whale ali well you are i was gonna say if you're listening you are listening but thank you for saying that to me last night because actually that gave me a real boost um and i love that and you know what he said as well it's just really nice he's like it's just good content just enjoy it well it doesn't need to be that deep like you just just enjoy it lovely so scarlet jamie you tell me your founder story because um you guys were at babylon together weren't you you and james yes we were at babylon was this like 20 2019 um so we're at babylon we were working on the the triage the the chatbot and we were in the in the same team we're trying to make the chatbot better i'd actually i was there and like a big part of my role so So my background, I originally did medicine and then became a software engineer.

3:24And then ended up doing a bunch of data science. We can go into that if you want. So when I landed at Babylon, these problems at the intersection of a bit of medical domain knowledge, a bit of data science, a bit of software engineering, that was really my wheelhouse. So the problem of interest was trying to measure the performance of this triage app. So you're asking questions like, do you have a headache? How about is the headache? Where is it? And so on. You're trying to ask few enough questions that don't abandon the flow and enough so you can come to a high-confidence triage decision. Like, this doesn't sound serious.

3:58You should stay at home. Or like, this does sound serious. Go to A &E. This kind of thing. And the problem I was interested in was like, how do we measure the performance of this thing? Which is obviously an interesting question. There are various angles on that question. Like, what is the clinical performance? But then, like, what's the user experience? like you could you could get like very good performance if you have like very long flows potentially and this is all the information but in reality yeah you ship that thing no one's going to get to the end right so you have to like penalize a bit for that and then figuring out like what's a what's a good way to measure whether this is good or not and if it's safe and if it performs as we intend it was was what i was doing so i built out a bunch of like benchmarks and built a bunch of automations so that those would run um in our continuous integration uh environment and the idea was like, you know, we make changes, we get results, we hit the button, we ship the software.

4:51And that turned out to be a fantasy because you can do all of that, you can automate away all of the admin part of running those kinds of things and figure out what numbers you want. And then at the end, you have to go through a regulatory process and part of the automation is involved like trying to inject bits of that data into like Google documents and then those documents going into a sort of vortex. You don't know what's happened for a long time and before you know it, it's been a long time before you've shipped any software. So that was really like the insight that I had at Babylon was that it was, I was surprised by how hard it was to build medical software iteratively.

5:39like everyone knows that the only way to build good software is to uh to build it iteratively so to to climb the hill week by week and this is kind of counterintuitive to some people like um particularly from the medical device world like um there's this assumption um that you know if you change things frequently maybe you're going to break it like it's safer to leave things alone um turns out not to be the case with with software the analogy i used to use when i was talking to people um about the importance of doing iterative software and particularly through like the lens of like safety was like um remember when there was this like artificial constraint on um how often you could ship your software because we used to have to burn it onto cds and then you can mail the cds up and be like how many bugs were in that software and how long did it take to get it fixed but like like and and right now that's kind of where we are with like medical software because like you like you can't get the you can't get the release that you can't climb the hill because this artificial constraint on iterative development and deployment.

6:42So it really limits what you can build. And so that was really the insight. How can we make it possible to build great products in healthcare that need to be built iteratively? And it turned out that when you scratch away at the surface of that, our background, James and I, we weren't from regulatory backgrounds. We were technical people like with software and data science and some domain knowledge medicine. And we scratched away at the problem and eventually we found the solution that Scala is today, which is to build a notified body, a new one that is from the ground up oriented around providing a process that makes iterative medical device development possible.

7:30So you want to ship an MVP quickly, then you want to iterate fast. And building a native body from the ground up today, you don't have to do it the same way as it's been done before. You can get new kinds of people with new ideas that aren't from the legacy industry and have various biases around how it should be done. You can build technology and you can have a process that anticipates that you are going to build technology for your process. you can build your notified body iteratively itself and figure out what works um so we're able to do something quite different um and it wasn't easy like i think at the beginning it's one of those stories where like naivety can be um a benefit like when we landed on this solution like we're gonna we're gonna start one of these things i remember taking phone calls and just like the day-to-day was just like hustling trying to talk to anyone who knew anything about about that like who'd like done a notified body before or like was close to that or knew someone who had and the universal message was like uh why would any regulatory agency invest time in like two bozos in a basement who don't have any like like hard experience in testing inspection certification um and I think we were like maybe not think well like it like we're just going to kind of go for it anyway um and and it took three years right to get to get through the process and several thousand pages of documents later and many uh learnings later and um we were lucky to find some great people who helped us do that.

9:16Some very, some more forward-minded people, particularly in the Dutch regulatory, in the Ministry of Health, Youth and Sport in the Netherlands, who really wanted to do this the right way and saw the problem. And so we were able to make progress and get there. And that was really the big first milestone in the company. It's kind of a weird company to build right like the normal story of building a company is you're trying to find product market fit at the beginning like can i offer something that someone wants and how will i know when i have um and really it's racing fast on even on the problem you're trying to solve not just the solution um and for us the problem was always the same like and we knew that the solution a part of the solution was going to be getting uh becoming a notified body so we We weren't in the first three years flicking around then.

10:10We didn't have any customers. Our customer that we're trying to delight were the regulators who had to approve us. And that was the first three years of the company's life. And then after that, the next, that was like 2020 to 2023, something like that. Then the next big milestone was issuing our first certificates. And that was the story of 2024. It's all very well to have things down on paper, but when the rubber meets the road, when you're actually trying to do this thing and to get through a process with a customer and certify a medical device and meet all the requirements and do it the right way and do it in the most transparent way for the regulator, yeah, there are some surprises there and it takes longer than you think it will.

11:00That was the story of our first certifications in 2024. We learned a bunch from that. and then last year um we'd done it and we knew that the process that we had like there were there are a lot of improvements we can make on the on the customer side to make the customer's life easier on like what we required from them to make it easy for them to submit stuff to us and make it very clear up front what what they needed to submit um so to make the process go faster and we worked on a bunch of like product features to to help customers do that well and and then 2025 was it was like the first year we really ramped up we signed like quite a few customers we issued a bunch of certificates we started getting devices under our belt and and that brings us to today and where i think you have to have a really good reason not to choose scarlet if you're but you want to build a medical device iteratively um that that's what we're here for um and increasingly we see that the most innovative companies choosing us because they because they see the value in that i want to ask you about the i guess notified bodies in general because to just to give people a bit of the lie of the land here notified bodies obviously assess the conformity of products before they then go to markets you're assessing does this device and it could be software as a medical device that even that could be ai as a medical device or it could be a hardware device but you're assessing does this conform to a set of standards in order to be safe to hit market and that's broadly what you are doing as a notified body so you are given that power by a member state to do that I guess is broadly how you'd define a notified body but it's really interesting because even on I was looking earlier actually before you joined I've got up here like even even the wikipedia page for notified body says that one of the main criticisms of notified bodies is the varying levels of expertise among them including differences in test results and it's like you said you know there's not not all not all are created equally and actually that a problem to solve is to create a notified body and what you described is solving a problem that we have at the time which is the iterative nature of software and actually that being quite front of mind and it's interesting isn't it because i mean how how did how did you see i mean like you said it's really bold to be like i'm going to start a notified body like that is a that is a bold thing to do and and but at the same time if you see a gap then there's a gap right so when you were looking at it and initially making that decision that this is what you were going to do is it that you looked at it and went okay in the innovation pipeline the the biggest bottleneck that i can see or the biggest enabler of innovation broadly that i can see is a notified body that gets this was it that way round or or did you then look at all of the notified bodies that existed and go well actually they all lack expertise in this specific thing and we want to be you know we want to be specific in this thing and that's how we're gonna we're gonna go to like how did you think about the go-to-market for like developing a notified body yeah i think this story is actually kind of a typical one for for a new company which is we just experienced the problem ourselves we're trying to build a software medical device we wanted to build it iteratively we wanted to incrementally add new features to it um and it was how that would be handled by a notified body was quite ambiguous so yeah i think like a common misunderstanding when you talk about like what the problems are or have been dealing with notified bodies is like you assume that the problem is oh the delay is you have a complete application you hand it in and then you wait for six months and then you get the results and that's the delay like that's the difficulty is that like it's just in their court from time and that that may be true sometimes but i think it's much more nuanced than when you get into the details of what actually slows down the process like for example if you're building um say the chatbot and you want to add new indications to it or like change the patient population um there's a question in the development process like like what does this imply for like the regulatory work that this will require for us to do this and and it's not always like objective It's like a kind of consultation, like, well, let's go and talk to a regulatory team about that.

15:36Or let's get an opinion from someone else. Maybe we can try and get in contact with the notified body and align with them on their interpretation of this. And all of that's happened before you've created any paperwork. And it's just this ambiguity creates a lot of delay. And I think it's reasonable. If you actually look at the medical device regulations, they have a really hard job to do to people who write those. because the puzzle they have to solve is they didn't want to rewrite it every six months. So it has to be very general. So it has to cater to the diversity of all kinds of medical device.

16:06They have a bit of an escape hatch, which is they can provide, without changing regulation, these guidance documents afterwards. But this is how to interpret these in the context of, for example, new technology. But there's a limit to how quickly they can do that. And there remains often ambiguity for the most innovative devices.

16:28So that's the gap, right? It's like if you have, you can have like a notified body, like a storied notified body that's like got some great devices on their books. Like if you look at some of the all-time classic medical devices like Medtronic's Pacemakers that are probably on the books at the BSI, they've, I would imagine, built an in-house assessment team for that product family. it has a lot of compounding context on those products and has done for decades and they probably anticipated that and over time warped a process around that but then if you have a new kind of product family or new category people trying to build software that addresses new problems it's not obvious how you talk about the indications because they're quite general and they have like new considerations or require reinterpreting the requirements of regulation like it's quite natural that like existing these companies might not have like uh like catered their process to that or have built teams around those and that's the gap and so that was like the gap we identified and the gap we experienced um um the that that was our go-to-market that was our beachhead it was like well for product for projects like these and we think that what we're building here could be valuable like it's kind of obvious the value to the healthcare system if you could do a really good medical triage um people could could do that without you know like going and making a's more more busy or like having unnecessary appointments with gps like the benefit of that is obvious and it's kind of obviously a problem that is difficult to develop software like that let's go and see if we can provide like as a go-to-market uh a service that's really great that's what you're doing and that category turns out to be quite large like um The other classics in that category, like you mentioned, like radiology software, like computer vision on radiographs.

18:22That's been around for a while as well. I think that relative to the magnitude of the medical device industry, incentives maybe haven't played out for anyone at the Legacy Notified Bodies to sit down and really say, what does an excellent process look like for the people who build products like this? Who are these people? What are their expectations? and what would help them with what they're trying to achieve and that's what we did um so we don't really like try and compete with the other notify bodies in like the categories that they serve their customers well in sure um that's not the name of the game the name of the game is is to provide an optimized pathway for the next generation devices um that where there isn't like a good prick that's coming yet and we can do that for them so the big question then is are you in the game of regulating ai yes i assume but llms specifically and are you in that game and i guess what i'd like to understand is there must be people trying to get llms regulated i believe it has happened in europe that an llm has been regulated um and i know people like well there's some AI mental health chatbots that have got you know an LLM being or a signal being monitored on the way into the LLM and then checked on the way out of the LLM so the LLM is a small part of a larger stack and that getting regulated so it's being regulated as part of lots of different things but I guess the conversation has moved on somewhat I think I might you know I think I chatted to James about this last time about you know do you see the day where an LLM will be regulated and the answer then was yes i think it's actually moved even more nuanced now in terms of it's definitely being regulated as part of different stacks um but what are you seeing who's coming to you from an ai llm perspective and asking for regulation as a medical device and and i guess do you have any feelings on it as to what good looks like or you know is that more or less intensive for you guys do you have to do extra checks and balances in your process i'm just interested in your process when it comes to that obviously there's like there's a lot of like um like it's tempting to frame the question in that way like like lllm as a medical i say is medical advice but you know if it's necessarily like the most like uh most like helpful framing of the question like um like at their best like companies that are trying to build products that solve healthcare problems they're like that they don't define themselves by like whatever like the details of the solution they're building are like technically they care about the problem they're solving and i like what what does llm as a medical device mean i think it can mean a lot of different things to different people like there are companies that are interested in in in problems where an llm is going to be like a part of the solution but it's rare that like like the like the lm the actual like token generator is like uh is the product like it's not going to be right it's like a component in a much bigger architecture that solves a particular problem so i think like llm as a medical device is like, it's useful to the extent that people, like there is a conversation around that, so it provides some anchor.

21:51But really, like with what we see, that there are a bunch of workflows. Normally the architectures, like it involves lots of different components and LM is a helpful component in many of this. And there's lots of useful problems in healthcare where we're applying them successfully. Like right now, you see the scribes. Clonicians love the scribes. And they're having explosive growth. And companies in the US and Europe are building products that clinicians love. But it's a component, right? If you're recording a conversation, yes, you can generate a note. be a very good note if it was just like a direct subscription so you can do a bit of summarization that's interesting like lms probably have something to say about that um then maybe you're interested in like um suggesting a differential um probably quite interesting uh shape for that as well um there the input is text and the output is something more more categorical it's not not continuous right you're just picking items from from a discrete set from the differential um But then maybe there are other parts of the workflow where say you want to automate a

23:12triage play which involves phone calls and you want the model to make some decisions and you have more of an agent set up there where you have a harness for the model and you provide some tools that enable it to take actions like call patients, order tests, these kinds of things and then the LM is a component in that architecture um and I just I I think that it's it's like these things are obviously valuable there's no debate about that um and it's not the final thing right I don't know if you saw the um the demos I think it was a couple of weeks ago DeepMind put out some some nice demos of um obviously these models that show um um so it's a it's like a tele consultation um and um there's a um a person's like oh i feel like my eyelids drooping and um the the um system is passing the video feed says yeah come a bit closer um and then starts giving instructions like can you look upwards can you look to left can you look right and this is this is not like um like a turn based um text in text out text in text out it's like a fully like continuous like um uh video in uh audio in uh and then video out audio out like not turn-based like what can interrupt you and like this this is like so we're not talking about like what we currently consider because i mean lms i think when i say lm right now most people mean like some turn-based textual exchange is what most people mean when they when they say that and so i i i didn't see i i see it like more more continuous i wouldn't want to draw like a massive distinction between like uh which involves nllm um and some other things and like a architecture like the deep mind demo um which is like quite different um and involves um a multi-modal multi-modal um and i i i think really it's about like it was like the best productive framing is like the problems they solve and then the technologies are interesting but then i think zooming in on a particular component and being like how are we going to regulate that is like the wrong frame for the question you need to look at the aggregate and the architecture and the problem it solves and like the risks inherent in like the the aggregate and how you could test the aggregate which is like the all the components in the system and the way it behaves at an input output level for the system not just like this component that you draw the box around it's like that's the idea yeah i understand i have a question which is so when you're in fact i have a couple of questions on this is there anything when you when you see an llm involved where it sparks you to apply any extra rigor in any areas that you're looking at um and and does it force you to think about things in any kind of different ways you would anything else or is it just the same line of questioning and evidence as everything else and I think the second part of this question is what's your motivation as you are assessing something like that because I'm wondering what are you on the hook for like are you on the hook if something goes wrong do they look at what notified body passed this in the first place like let's say it's used on a patient and a patient dies like what does that process then look like and where does where do you fit into that where's your liability in this whole process like what what's your kind of what are you being paid to action what risk are you being paid to hold if that makes sense yeah i mean there are examples um about like where medical devices have had um problems like um and the native bodies who certified them have been like taken through a legal process as a result interesting okay the two most recent or the ones that i remember uh like a few years back there was the um it was in the news a bunch there was the there was a vaginal mesh um yeah i think it might have been bsi that i don't want to slander them so maybe it wasn't but um and that they injured a lot of women um like there were some biocapacability issues um and there was another example i think actually this example might have motivated some of the the changes between the previous medical device regulation in europe and and the current one there was the metal on metal um um uh hip implants or something like that um yeah these things like on the articulating surfaces you'd actually get like particles of the metal kind of like that's often it would cause like local inflammation and then even like the ions like leaching into blood and accumulating like distant tissues and a little people were injured from those as well and um the way the liability breaks down there that if you're um making a medical device and you're submitting information to an identified body like technical information about how you built it and the tests you've done if you're dishonest like if there's like evidence that like you are synthesizing like this is this is a lie like there's there's like criminal liability there and like this is like um just like it's fraud basically like you can't like do that um so like particularly if you're submit if you're submitting data and it's falsified like that's where it sits on the notified body side as a notified body is like we are like one of the things that's hard about it is you have to have a kind of like on proof system of record and you have to document everything like crazy and you have to um have um you have to designate like the people in the company that have responsibility for these kinds of decisions and on what basis they're qualified to make those and they have to have the right training and there has to be a review of everything uh and there are lots of steps and there's a lot of documentation along way so if something like that was to happen um um heaven forbid to scarlet um the our regulator would come to our office and they would say let's go through this and we would find all of that and we would come through all the details and we would determine whether or not there had been a breach in our process like well it says here that for devices in these categories you should there should be someone with this experience who um um documents these aspects um and and that's not here so this is this is your liability um so that that would be on on the notified body that makes loads that makes loads of sense actually and that actually makes me start to understand more why the innovation here is you getting comfortable with a new technology or a technology doing something new so like you said you know you guys wanting to get comfortable with regulating software that can be iterative it then makes loads of sense that why two guys that are building this software and understand the process of building it would then be best placed that starts to make a lot more sense now um and and that that really being the innovation here which i think is great um the i have one more question which is um on that actually we saw was it a year or two ago humor came out and said they'd regulated they'd regulated a thing a software that was then going to create loads of things and de facto they were going to be regulated i they were going to create lots of software as medical device things that automatically were regulated because the central thing that made them is regulated and i believe now other companies are doing something similar and regulating you know the factory so to speak can you explain that to me and it explain i think for a lot of people wondering like how that's even possible like surely you need to apply the same level of rigor to everything it creates and how that could even be possible and not to say that you guys regulated that with humor um i don't know if you did or not but um we didn't and i do you remember the story i didn't actually like um spend too much time with this i don't remember the details but like something that's quite surprising and interesting about medical device regulation and and the way it's designed is like that idea that you described that like that you're like kind of like approving the factory and then like it can produce like whatever that idea is actually like kind of a core idea in medical device regulation oh interesting okay so i don't know if you've heard of uh like i'm sure about a bunch of people who listen to this podcast will have but this idea of like a quality management system yeah exactly like a central concept in all medical device regulations but that's the idea right like you should have a quality management which is kind of like the factory in this analogy which documents a bunch of processes and procedures for how you how you make the sausage um and and and then the idea of that as like a as a as a regulatory mechanism is that then then you might be able to say something about the sausage as being good if if the process for producing the meat's particular characteristics.

32:25In addition to that, of course, depending on the risk class of the device, sausages that are produced from the sausage maker, in this case the QMS, are also scrutinized. You make a technical file submission for those as well, and that is scrutinized. But that idea of there being merit in not just assessing the artifact, but assessing the system that produces So it is an accepted idea in medical device regulation. And actually, in the European regulations, the way it works is that there's an assessment of the quality management system. And then depending on the risk class of the device, you might actually be able to put multiple devices on one certificate and they're assessed on a sampling basis.

33:11So you can have a certificate with a bunch of devices on it and the rules will be that, say, it's a class 2A device, like a lower risk classification. And within the period of the certificate, like each of them will be sampled um but like you could add a new certificate a new device to that certificate and it wouldn't have like a full device assessment and the reason the regulator is comfortable with that is because something's been said about the sausage maker got it understood um so with all that in mind and everything going on at the minute what are you excited about like what's going on for you guys what have you got cooking um it's all the talk of sausage now has got me onto kitchen metaphors but um a little bit hungry what's what's going on in the yeah scarlet kitchen i don't know we're stretching this now but um yeah what are you what are you excited about what's going on what are you guys regulating at the moment of what you can say yeah i tried to stay with things that are in the public domain i've lost track of all of the ndas i've signed so it's easier to just keep with things that i know i mean it's pretty safe that's good that's safe we really like i kind of said at the beginning of the podcast like you really do have to have a good reason not to not to pick a skull if you're planning on building like devices iteratively um now we um we have i think some some of the cuts some of the stories i'm most proud of are actually like you you're answering this question you would think that the best stories would be like who we who did we sign this week and like are they representative of like the latest greatest the current buzz the most exciting some of the stories i'm most proud of other companies we've been working with for for a couple of years now and um they came to us um with a with with a device and uh we're able to give them like a great like timeline on that device that enabled them to raise a bit more money and then they were able to grow their team they're able to build more products they're able to relatively early on in the company's life assume an iterative development process so they're not like trying to retrofit that into a process that's been running for a while and these companies there are having a lot of success and really really like proud that we caught them on the way up and many of them now have like large numbers of medical devices serving large numbers of people um and and they're they're like category wise or theme wise i wouldn't put them in like buckets of like they're in like anesthesiology or cardiology or whatever it's it's but they're a mixture we see successful companies that are building um um like in the in in all those categories like to pick a few examples um one that we're talking about at our recent event um was uh floy who builds um um computer vision models for radiology but the insight is for opportunistic screening so if you come in and you've had an accident you've had a um an x-ray or a ct scan or even a routine like a mammogram to use that as an opportunity to screen.

36:09So for example, screening for like bony lesions in x-rays that's not the indication for the x-ray or cardiovascular risk scores on mammograms from calcifications in the vessels, these kinds of things. I've recently learned actually, I think you have more recent medical experience than me. is it is it the case that most lung cancers are actually picked up incidentally on on on routine cts rather than on or rather than like being indicated because they turn up with uh with uh with a i don't know classic medical school exam answer i don't know i would have to go away and look it up um but early early stage i mean you can imagine that being the case in in the early stage i was actually at um a guy called jack kreinler who does a lot of expedition medicine and is very involved in longevity stuff and does a great kind of futuristic healthcare conference um i was actually at his house he kindly invited jesson around for dinner and he was talking about we're talking about full body mris and the controversy around full body mris and you know him actually saying you know anecdotally on an n equals one basis like he he knows someone um the you know lung nodules picked up there so so it's like it it yes i i am aware of the cases where um yes incidental findings can discover things early and that genuinely being a force for good it's just that you know in the wider full body mri conversation that can uh a lot of philosophical and ethical and moral questions start creeping in but avoiding those yes yes yes i sort of get it is what i'm saying yeah and so like i guess why i like this example is like this is kind of a cool idea like i think it's an interesting idea that it has merit and i think in a in a pre-scarlet world like pursuing this idea where they've been relatively a lot harder because like you probably need like many devices because you want to do like not just the opportunistic screen on on the mammogram for like altifications but you also want to do the CT for any of the lesions you also that you want to do brain MRI you want to do you basically want to do the more all of these things are going to be like new uh devices so it's not like a kind of product where it's like I'm going to raise much money I have this flagship I'm going to raise like a bunch of money it's going to get me through this tunnel of difficulty where at the end I might have a product this one was much more about you need you need traction you need to be iterative you need to figure out which ones are going to be valuable and which ones are, to experiment a bit and explore which ones are good and which ones aren't and which ones provide the most value in the healthcare system.

38:50And they've been able to do that and they're very successful. We really enjoy working with them. And I'm proud that they've been able to achieve that. And I think it's a nice story because I think that what I'll be most proud of, of Scarlett's legacy, is if in a few years' time we look and we can see all of these examples of companies that exist that otherwise might not have, or like products that exist that otherwise might not have, or that are way further along because they've been able to be built iteratively or previously that wouldn't have been possible. And I had this line, like, what's Scarlett trying to do?

39:22What's its goal? The goal of Scarlett is to try and pull medical technology from the future into the present. And that's the way we're going to solve healthcare by trying to, like, hasten the arrival of the technology that's going to solve the problems. problems and i think these stories um wait when you see that and you get a sense that they that it would have been a harder time if we hadn't been there for them um that i find this very motivating yeah and i've actually i was actually going to say very similar thing i actually wrote down that you're you're basically responsible for a whole load of new health tech stuff reaching market because if you extrapolate what you've just said and not treating regulation and notified bodies like the examiner and actually treating them more like the tutor who then kind of guides you through and assesses you on the fly then it becomes far more of a like a horses for courses like it makes more sense to me then that notified bodies that specialize in certain areas then guide certain people through and and crucially drop the cost and i think that's the thing is that i think in health tech at the moment it can be really daunting looking at the the cost of bringing a product to market and what that generally means is that people have to raise money and they have to raise lots of money when they've raised lots of money they now need lots of scale because especially if you've raised venture capital money you now need venture capital size scale and that now pulls you into a region of doubling revenues every year and all this exponential growth stuff and blitz scaling and this other like you know war type terminology well i was at babylon remember of course yeah well of course and you'll know the types of environments that that that sets up um and i can't i can't see that always being a good in a new version of healthcare because if in a new version of healthcare we've got more local problems solved by more local solutions that didn't need that level of scale if companies like lovable are dropping the price of you know bringing software to market people like you guys are then dropping the amount that it takes to actually get this stuff regulated i can see a world where far more things are brought to market with far less kind of massive raises needed and therefore it just being a better market for solutions i don't think it happens overnight by any means but i'm starting to see those signs and it being i don't know less scary i think for people to imagine software as a medical device into the world and then to go about a process and so i think you're very much part of that very much part of the you know can we drop the the ridiculously high barrier to entry um that does kind of currently exist uh and i think i genuinely think that's that can only be a good thing spoken like a true bootstrapper you got from alex yeah the bias is clear isn't it the bias is very clear i don't think that we necessarily have the opinion on that i think in in general i i celebrate um when we meet customers and they're very ambitious and they sincerely tell you that what they're building is going to be important for every person on the planet and they want to do that as soon as possible because they see every minute that someone doesn't have their technology available to them is limiting their life in some way.

42:57And I find that inspiring and compelling. So do I believe that there's space for local solutions? Maybe, but I didn't know if I have a strong opinion on that. I think that what's important is that people who want to build things have a shot at that. and I think creating the conditions in which that's like celebrated and becomes easier is very important and like I was saying before the podcast like I admire the work you do with SOMEX because like you're part of that you you tell the story of innovation in healthcare and that's very important because like it has been hard for people to get like returns on on whether it's like investors getting returns or whether it's like people with their careers like joining companies investing like five years of their career in there and then sometimes end up with like a product that didn't make it to market in the end um or that it was in research and the thing they worked on like never impacted um a real patient and that's a kind of investment as well and it's like really deeply unsatisfying um when that happens and it creates a very um um well to frame it positively if you can do that the other way around so people can come and innovating in healthcare like it's commonly understood that this is an attractive thing to do that there are opportunities for outsized returns that there is money available there to go and pursue those opportunities and as a talented person you're going to be able to rapidly see the impact of your work like that that's the thing flowing in the right direction and you're a part of that with some ex telling the story and we're a part of that as well by trying to clear the obstacles to make it possible for people to to to realize their ambitions and to innovate in afghan to make that a thing that um you don't need to be such a masochist to uh to to try and attempt building companies in any category is hard building new products inside companies is hard and and we don't need additional obstacles to that i think you're right we're very much aligned on that very much feels like we're in the same game for a lot of that it's just people don't you're right with the masochism people don't need to suffer like they don't need to suffer through this and anything that you're doing along those lines is is i just think making a better health tech ecosystem it is an inspiring mission and spoken like a true leader and i imagine that does galvanize people and you guys you guys are seeing a lot of success at the moment um with more and more people coming to you you're you've got lots of lots more work to do um which in an economy like this is only a good thing but you need lots of people to do that as well um so how do you guys uh where are you guys at in terms of i mean your raising cycle and your growth and what you guys need and how you're growing as a business we're growing quickly um like um we we we um we we have new uh custom projects kicking off every every week um we um are growing the team quite quickly we an important statistic for us having having lived through the the the the the babylon blitz scaling experience um like a heuristic that i keep in mind is i think what you want to do um to preserve the things you like about um a culture or working in a team you want to look left and you want to look right and you want on average to find someone who like kind of knows what's going on rather than everyone thinking left and right and they're like i don't know i've been here for five minutes as well right that That doesn't help you to compound a productive culture.

46:28So in general, we have been growing the team at about 2x year on year, but not exceeding that. If you go too much faster than that, on average, if you look left and look right, your odds start to diminish on at least finding someone who's been in the team for a year and knows which way is up. So that's the kind of speed that we grow the team at. um we we have um like like we have a bunch of teams um with and every every team in the company is like um i've i've the privilege of having and they've been there from the beginning so going through in the last six years so i've kind of um how to spin most of the things um and i don't there's a single thing that we do that isn't surprising and interesting.

47:20We have, I can go through some of the teams, maybe interesting to us, where we are hiring and talk a little bit about the kinds of things that we do and why it's interesting and surprising. We start with the customer. We have an amazing customer experience team. So in customer experience, what we're trying to do is obviously we have account managers who's like a point person for our customers. We also have what we call like evangelists. Some of you might have seen Mr. Stephen Byrne on some of our content. People who can, you should have them on here actually, people who are very deep in the details of the domain and can go and evangelize the work that our customers do with us.

48:05But as an account manager in the team, it's like the day-to-day is one of the best things about what we do is we have amazing customers like you can't say that about every company like if you're selling like you know h risk software and you're cutting and your your icp is like smbs in dash it's like like like you're gonna get a real mixture there and i'm sure there are some great companies but they don't they're not like thematically aligned enough for you to build like this compounding sense of um what people are doing and to build like knowledge in that domain and all of our customers are building bleeding edge medical technology and you get to meet these people and talk to them understand what they're building because to serve our customers well you have to understand what they're building and the domain is very interesting you have the the medical domain obviously like what the like what diseases is this thing going to solve and like how does it work and like who's in your team that works on that and like what are the plans for the next release like these were very interesting questions and you also have the the regulatory domain next now as well like like like how risky is this thing like what risk class is it going to be in?

49:08Like what's your strategy? Like are you going to go with like a product here and then ascend the risk class? This is like a fantastically interesting conversation to have and to be able to like have that with all these different customers who are building different things and to see that, to be on the front line, I think is amazing. And like I still get to spend a lot of time with my customers and it's always like a huge pleasure to do that. So that's like a customer experience team as an example. And then we have some teams in the company that are domain experts who are really responsible for the decisions we make that hold regulatory weight.

49:47So we have a devices team. Do you know Sandy? You met Sandy? I don't think so. Sandy? Okay. He's been around. You should have him on as well. But he's the player coach in our team of clinicians, and we call them software safety engineers, people in the team who have experience in safety-critical software systems. And these folks are very interested in the puzzle of, like, what is the most efficient way to make high-quality judgments about the data that customers submit to us? And we design that process. We're constantly iterating on it. and again what an amazing like uh what an amazing role that is to you actually get to see the the the the action like most customers who send the technical file this is something that's like quite privileged right it's got like architecture diagrams of how their thing actually works it's got the clinical data they've generated from the studies they've done or how they think about measuring safety for these things and this is fascinating um and very privileged and so i think like uh the roles we have in in those teams as well like uh like it's very rare to be able to go and to go and do that um so i'm like um a bunch of folks in those roles have um uh clinical backgrounds um so that's also like i think a very interesting place to go for folks with like a like a portfolio-ish clinical background and did some clinical medicine but then like kind of got the data science bug, did a bit of that, maybe worked at a health technology company.

51:25I think that those people really, really enjoy the opportunity to come in and get into the details of what's happening on the bleeding edge of medical technology and scrutinizing the detail. And so we also have, I won't go through all the teams because we have a few of them, but I'll give a couple of other examples. We have a product organization, so design, engineering, applied machine learning product. We work together and this team provides the technology in our processes. I describe Scarlett as a bit of an iceberg in that 20 % of it's above the water. That's what our customers see, which is the materials we provide.

52:04We call it the knowledge base, which help reduce and resolve ambiguity in what we're expecting. We have some tools there where people can upload submissions and get automated feedback and so on. But that's really just above the water. Really, Scarlett, as a technology company, what we're doing here is the 80 % below that, which is we have a devices team that want to make high-quality judgments on documents and data that Smiths by our customers. What is the optimal experience for doing that? What technology can we bring to bear to make that experience really fun and really fast and very accurate?

52:48And that's an amazing puzzle for us to solve. And I think one of the fun things about working in our product organization is that because 80 % of what we're building for is kind of internal, you can just sit next to people using your software. And that's an amazing feedback loop. You're just in the mixer and you can build things that are good quite quickly in the feedback loop like that. Sitting next to people who are smart, have domain expertise in the problem you care about and you're building things that they can use immediately. So this is also a very fun and very iterative dynamic that we have.

53:28I think there are other product roles where maybe you don't have that and it's harder to really connect with your user and you have to like i don't know like use like tons of analytics rather than just sitting next to them like all day um which is kind of kind of a bit more like fun fumbling around in the dark and really knowing what it is you're trying to solve it's kind of obvious to everyone in the team that what we're doing is important it's easy to leap out of bed um for our customers because who doesn't want the technology from the future to be available sooner so they can help people with diseases that currently don't have good solutions like it's very easy to leap out of bed for that um so that that's what that that's the the foundation of why it's attractive to work at scala yeah and we also have all these kind of interesting nuances about the kinds of work we do because we have lots of interesting data from our customers we build technology for ourselves which we get to use on the same day um well i think that last line that last line that you said you know the work's important I I love that because I say this well I I understand this from even just like speaking to my friends in different sectors that one thing that we we don't have to worry about we didn't have to worry about it at all as as clinical medics but we certainly hardly have to worry about it now is that purpose side of it and it's funny you know most of my close friends at some point or another will turn around and be like hold on a minute like I'm just making rich people richer this isn't really fulfilling and we've never had to worry about that and actually it that in itself is a really privileged position to be in and so I can only I can only think back to when as well like I don't know when you trained but like when went back when we were doctors or or certainly when I was like I can you know hearing about this type of job even being available to me you know dragging the technology of the future into the today like i i it just would have it just would have like lit me up and i i can't believe that you know our generation has managed to now create a world where this is actually possible for for people like we're and they say that you know entrepreneurs will solve the problems that they had so that the next generation doesn't have to go through them and i do kind of feel the same way of what we've built so actually it's kind of the place for if you if you love health tech and healthcare but you're also a creative and that's kind of the position I was in you know in order to solve things creatively and and help people out with you know the commons marketing side so it's funny how you know we we have managed to create that world but the final thing I just want to say as well is that it's also it's also really nice and and actually makes things very easy to work for people that are passionate and you know your passion for this comes through and I I'm a firm believer in that passion isn't something that you say it's something that you show and I'm glad that you haven't used the word because it's kind of backed up that point of um I don't I don't want to hear that you're passionate I want to see that you're passionate and that's very difficult for people not to hear or see that depending on how they're absorbing this podcast so um that's also really nice that those problems still and will continue to light you up because you're right that you've got one eye well you've got both eyes on the future when that technical file comes through when that architecture comes through you've got an eye on the future and you're the one i guess choosing to some regard or certainly helping into reality like what that future actually is um and you're right it's an incredibly privileged position it's also a really cool position to be in for the people that think that is cool and for those people that are on the front line frustrated with tech and they want to bring it into the now i think that's an incredible position to be in so all that is to say i i i understand and i get it and i think it's a great a great position to be in that you're able to give those people as well that feel like you know ducks out of water to give them a home to give them somewhere where they can feel lit up to go to work so it's a yeah it's an awesome position to be in yeah i think times are good enough because like i remember like when i was doing medicine like medicine is obviously this like very interesting subject it's like it's like a very broad field it's a very deep field it's full of like surprises and interesting historical stories uh and um and it has a technological aspect to it but i remember going through medical school and then you hit like the like the years when you're in the hospital and you get struck by like the vocation of being a doctor yeah and and it's like It's like trying to reconcile an enjoyment, an intellectual appreciation of the domain and of medicine as a subject with some of the difficulties of the vocation of being a doctor in an NHS hospital, which is what you get experience in.

58:22You go to medical school in the UK. It's quite challenging, right? Because you have to make a decision, which is, I love the subject, but there are many things about the vocation which are unattractive. And in other careers or interest in other subjects, there might be more alternatives. But you're quite railroaded, because medicine in this country, at least, I don't know if it's different in other countries, but it is vocational training. There's a job at the end. um and i i think we're going to enter into like a golden age for um for the biomedically curious people because there are really a lot more options now you don't have to go and go through the foundation program and then do specialist training and then and then do whatever there are other ways to have um like a high impact um uh career and and to um to explore your genuine intellectual curiosity a bit more you railroad into service delivery i've got an 18 month old and like I get asked the question you know by fellow doctors or ex-doctors and I've got a lot of friends that still practice you know would you would you want your would you want your kid to do medicine and for a long time it was like oh god absolutely not like there's no way I want them to you know experience loads of stuff actually you're right and and this is what I'm starting to feel now is that the the medical shoot some medical students that I speak to and it's it's a you know it's a self-selecting group because they've in the same arena as me at that particular point in health tech but they see the medical degree not as the path to automatically being a doctor they just see it for what it is they just see it as a really good degree and actually in the medical sphere and they can do other things and actually they're starting to plot other things the unfortunate thing i think for a lot of them is that they sort of feel like they have to do that and i think that's where it's tricky with training numbers and competition and all the rest of it they're kind of being forced into looking at other careers which is a position that we didn't also certainly I didn't have to be in it was one that I fortunately chose to be in but yeah it's a it's it's an interesting time but I think you're right as a result I think all of it ends in the same place which is that actually I think people can can be more uh they can they can they can find jobs and careers that are more aligned to them and their personality because it is just a it's a self-awareness game isn't it like knowing what you are knowing what you like knowing what you want to do knowing how you want to spend your time and then just trying to find like okay what skills have I got what qualifications have I got and how closely can I align those things and that is like wading through treacle for our generation as to like taking this risk of leaving and then trying to force yourself into a career and then you end up becoming an entrepreneur because it doesn't exist you want to create it into the world and that is just wading through more treacle so it's been historically very difficult but at the same time we've benefited from not many people doing it so the competition in what we were doing was actually a lot less it's a lot more now so there's positive negatives but that is all to say that if anyone is lit up by what you just said they've got to root straight into it at scarlet so that's kind of ideal yes yes definitely um drop me an email um i think also maybe a footnote on that one is because like i wouldn't want uh anyone who's listening to get the impression that like oh it's great that like you don't have to be a doctor when you finish medical school like i think that we doctors are like uh like it's like we obviously need large numbers of doctors and i think being a doctor is also about to get a lot better like um yes you have the scribes and so on we had a bunch of folks at our summit event and exhibition you know i might go back because like heidi's getting pretty good well it's interesting isn't it that it's having that much of an effect that is fascinating And there's that, but then there's also, like just, I really, really believe that in the coming years, we're going to see new technologies that offer options for doctors for their patients that previously weren't possible.

1:02:18There's an amazing, there's a company I really admire. They're called Science Corporation. Go to their website. It's a great company name. I think it's science.xyz. But they have a device coming. It's a retinal implant. And there's an amazing video on their site. and you can look at the products called Prima. And they have an interview with an ophthalmologist and he's talking about one of his patients who participated in the study. And it's a Rethyl implant. It sits at the back of the eye. It's for diseases where you lose the rods and cones. So like AMD, like macular degeneration or Rethylitis pigmentosa, these diseases.

1:02:52Put the Rethyl implant in the back of the eye and it kind of sits there and then you put a pair of glasses on. Glasses have a camera. There's a laser beam that shines onto the Rettel implant, and the Rettel implant will activate the neural cells that are downstream of the modern currents. And in their trial, they had patients who had complete loss of central vision from age-related macular degeneration, couldn't see their grandkids' faces. They put them on, they can read again. They can see their grandkids' faces. And in the video, you should watch it. There's an amazing interview at the end with the ophthalmologist, and he talks about this patient.

1:03:24um it's like patient um there's an older lady with a huge family and he he just has to wipe away the tears because he goes like and like uh and we could do that for her and like being a doctor like today and throughout history where like a lot of the stories you have are like you have no options for your patients like that's really hard and as we have like more and more technology and more and more great options for the patients it's going to be it's going to be such a fulfilling role to be able to to have just better tools like to practice craftive medicine that can solve like problems like blindness for patients giving someone back their sight is such an incredible thing to be able to do for someone and who wouldn't want to be a doctor who could go and do something like that for one of our patients um so i think being a doctor is still going to be a great job too love it um jamie it's been a pleasure thanks for coming on mate um for people that want to learn more particularly if they're interested in joining you guys what's the best way for them to get in touch with you send me an email uh jamie at scarlet.cc pretty straightforward um any final thoughts jamie or should i let you go uh this has been fun thank you um for having me on and yeah again thank you for what you're doing with some x i really think it's important that like we have as many stories as possible so people can see um that building new things in healthcare is not only possible but actually a great thing to go and to go and do and uh you you are a great champion of that so thanks for what you're doing with SOMEX.

1:05:01I've managed to articulate this I think uh relatively recently which is that I think the thesis running through everything that I do which is SOMEX and this podcast and Health Tech pigeon it's that I'm trying to solve the information problem for people and I think there's a huge lack of innovation because information doesn't get from a to b quick enough or at the right time or early enough or whatever it is and I think through all these different mechanisms what I'm trying to do is just get the right information to the right place as soon as physically possible and it's great like last night like going to that event and hearing that people have been listening to the podcast for the last like 100 episodes and because of that i've done blah and it's like that's that's excellent that that's exactly what this is for that's exactly what this is for that you've got some information that was locked into an entrepreneur's head that they said it out loud on here they listened to it and then they went and did a thing that was different to the thing they'd have done had they not have heard that and i think that is that's this working so i appreciate you saying that thank you and um i i think i think you're going to be really busy if what our customers are doing has anything to say about innovation that's coming you're going to have to do a lot of events there are going to be a lot of people from very successful um you're going to want to get the message out well i look forward to it mate i look forward to it's been a pleasure you're in the pocket thank you um thanks so much see ya