#415: Neurotech: Accelerating Innovation in a Complex Medical Device Vertical

Etienne Nichols: Welcome to the Global Medical Device Podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. Today I. I want to talk in a little bit different format than maybe we've done in the past and I always try to do something different, so you're probably used to hearing me say that,

but in the past we've talked about quality and regular regulatory topics maybe associated with product development or founder associated topics as it relates to medical device and the medical device industry as a whole.

More and more I'm getting interested and hearing people more interested in specific verticals within the medical device industry,

whether that's orthopedics, maybe pediatrics or radiology,

as it pertains to AI assisted devices, et cetera.

Today I want to start though kind of a series talking about these different verticals, starting with neurotech, because neurotech is a it, it, it's a wide ranging field and it's getting a lot more attention than it has in the past and still lot of challenges that it's facing.

So with me today to talk about neurotech and some of the different challenges associated with this particular vertical within medical device is Matt Stratton. Matt Stratton is a seasoned medtech and neurotech leader with over 20 years of experience driving innovation and growth in regulated medical device sectors.

He's the Director and Principal Consultant at Coalition and he champions collaboration to accelerate progress in neuromodulation, neurodiagnostics and advanced healthcare technologies. Matt's held in executive roles across the UK medtech landscape, including Bioforum, Ekin Healthcare and forgive me if I get any of these mispronounced as well as well UK and is deeply engaged in building communities that foster innovation across emerging health tech technologies.

He has a. He is on a mission to bring collaboration across all the different narrow tech sectors and fill in the gaps. Where did I, where did I go sideways or what I miss at?

Mat Stratton: You've got the vast majority. Ben, thank you very much for having me here today.

So you're right, I've been in the industry for 20 years. At my heart of it, I'm an impatient soul with an interest in technology.

So what I've always wanted to do is to try and bring new technologies to the market as quickly and as safely as possible and to make those available to clinicians and patients in as Rapid a way as possible.

My story started off in neurotechnology and neurosurgery where I was involved in taking a company that wasn't involved in the medical device field into the neurotech space. So it was a huge leap into a really highly complicated and highly regulated area which left all sorts of lessons for us to learn and all sorts of challenges for us to overcome.

And as part of that journey, I found the value in the value in networking across all of the different areas that we were engaging with. We were an enabling technology helping the improve the accuracy of delivery of devices into the brain.

And therefore we needed to work with all the companies that were developing those clever devices that needed to be implanted with such precision.

And also as a naive entrant into the medical device world, I wanted to learn as much as I could from as many people as I could on how to operate a business in this field without slowing progress too much.

We had a board that were used to progress in industrial markets and not used to having to worry so much about highly regulated spaces. And therefore they were naturally impatient and wanted to see progress and I wanted to understand how we could get that progress.

So that's where my curiosity started and I walked right away across the medical device world, as you said. But I have a real affinity and real love of the neurotech space.

There are so many unmet needs that are sitting waiting for technologies to be developed and delivered in the neurotechnology space. And I want to see a rate of progress increase in this particular area.

I think it's important.

Etienne Nichols: Well, what are some of the challenges that neurotech and maybe you could give a little more definition around what neurotech is when we say that word. But maybe we'll start there and then talk about the challenges associated.

Mat Stratton: Yeah, that's a really great question because I think I define neurotech slightly broader than many. I mean, neurotech. You'll see people define neurotech as maybe neuromodulation devices, particularly implantable neuromodulation devices or brain computer interface devices which have become quite famous more recently because of investments from,

from leading industry titans into BCI technologies.

But I think that the neurotech space is a bit broader than that because there are so many interrelated areas that are relying and using very similar technologies and ultimately aiming for the same patient groups and to support those patient groups and rely upon each other and will come across the same regulatory structures.

So in that field, I see that some of the early technologies in areas such as transcranial magnetic stimulation are important, as well as neurodiagnostics and neuromonitoring. There's neuro, neurological, drug delivery, neuromodulation, I've already mentioned, and neurosurgical devices.

So my starting point, the heart of getting a lot of these devices into place as accurately and as smoothly as possible,

as well as a few other adjacent areas. But that's, I guess, the core of how I define neurotechnology.

Etienne Nichols: Well, when you think about the different issues, because you mentioned kind of you're an impatient soul and one of your goals is to accelerate innovation. And I think that's a noble and worthy goal to get to.

I mean, it, it's an asymptotic line of perfection and optimism. Engineers always, you know, they,

we could engineer forever. And in that optimization, in fact, I had one engineer who, he said, I hate the word optim, optimize, because we will never truly optimize. But I mean, what, what better word is there really?

So what are the issues that you see preventing that acceleration or that growth or some of the challenges within this industry?

Mat Stratton: I mean, this is not specific to neurotechnology,

but there are some additional nuances and challenges in that particular area.

I mean,

I saw you ran a poll recently and what were the big challenges on bringing medical devices to the market,

and 50% of your respondents opted for multifunctional collaboration or multifunctional teams was one of the most important area.

And that really nails it for me. From a medical device space, medical devices, because of the regulated environment that we work in, you tend to end up needing more experts around the table to be able to move things on and bringing those, that larger number of experts, you increase team sizes,

you create complexity because you bring different personality types with perhaps slightly different objectives into the area. And I think, therefore,

there's a lot in that particular space that could be done to really help align and streamline product development processes. And that goes right the way across the neurotechnology space. But when you come into neurotech, you are bringing in neuroscientists as well.

You're bringing in biologists. In lots of cases, you're just expanding that discipline a little bit further. So looking internally within an organization,

I think those are the challenges that are particular to neurotech. If you look outside though, this is where things get really challenging at the moment with AI and your technology really starting to push the boundaries of what the regulations were designed to or,

or predicted when they were created, you're starting to really bring in additional complexity that organizations are having to fill gaps,

to fill in gaps. And this is something where I think you can look at improving collaboration internally to try and address some of those multifunctional team issues.

If you start to look at collaboration externally to bring industries together, to start to understand how they can work together, to try and bring one voice in response to any changes in regulation, or one voice into any development of regulation, or look at benchmarking approaches on how to bring these new technologies forward,

I think there's a huge opportunity there to try and break some barriers down and speed progress up for what will undoubtedly be an incredibly important area within the medical device space and beyond for years to come.

Etienne Nichols: Why are those barriers up in, in the first place?

My mind, that's not the question I wanted to ask. What I'd like to ask is how do we bring those different sectors or areas you mentioned, biology, neuromodulation, neurosurgical, how do we bring those together into one place?

But maybe upstream of that question is why are they that way to begin with? Do you have any thoughts there?

Mat Stratton: Everybody really ultimately has the same aim. I don't think it's necessarily an issue that you've got people who are not wanting to collaborate together. I think you've just got a lot of people that need to collaborate together to be able to move things on right the way across the medical device space and particularly within the neurotech space.

I think some of the bigger challenges that would drive collaboration between organizations are in the regulatory space and that formation of regulations, the fact that ethics are starting to push boundaries and you need to be thinking in really quite big ways to make sure that advancing today doesn't cause real problems further down the line for the entire industry.

Etienne Nichols: Yeah,

I guess if I think that's a good answer.

My mind,

I was thinking about the difference in generalists and specialists for a moment because I do think that contributes to the depth versus the breadth of knowledge that, you know, a specific sector may possess.

This is a completely off the wall illustration, I guess. But this morning my son who is seven,

he is all about Pokemon right now and he's read I don't know how many books of Pokemon he could tell you anything about Pokemon. And he's gone very deep into that one subject.

But this morning I saw him reading a book called Lyme disease and it's being carried by the Texas a very specific ticket tick borne illness and it's Lyme disease and it's.

And so on and, and I told him I said there's a difference in a generalist and a specialist, you know, and it's good to maybe start with arachnids and go deep, or maybe there's two different ways to do that.

So anyway, if I were to bring that back to neurotech, when I think when you get a Ph.D. or whatever, you, you become the expert in this one very specific area.

And I think that's part of what's happened here.

How do you see bringing us together to open the aperture of the very specialist mindset so that they can see these other opportunities or these other things that are surrounding their industry?

Does that make sense at all?

Mat Stratton: I think so. I think so.

I mean,

the neurotechnology space is trying to address conditions that are not really very well understood in a vessel, in an organ that really also isn't very well understood. So you absolutely need great expertise and a huge amount of depth of knowledge in very particular areas to come in and join the conversation to advance the science side of things.

And that's a really important area that will undoubtedly need investment for many years to come and will yield all sorts of important and exciting technologies. The other side of things, though, is it's not really at the cutting edge of science so much, but it's really trying to understand how the technologies and the understanding that's available today in areas such as deep brain stimulation,

which is technology that's decades old,

how that can be used, how you can get the device reliably to the right point in the brain, how you can understand the impact holistically, not just in terms of symptomatic control, but also in terms of the side effects and disease progression and other effects that you might be having there.

And also how all of that sort of feeds back to a treatment protocol and a clinical protocol that allows clinicians and patients to get involved and how that can be then spread so that there's a much wider uptake.

So there's definitely that advancing high tech,

great expertise required to advance neuroscience. And that will yield, I'm sure, things that I would struggle to predict right here and right now.

I'm a bit of a science fiction fan and I think we're already moving beyond a lot of things that were predicted in the movies and shows that I used to watch when I was a kid.

But I think just today, now being able to understand what we've got and how to optimize what we've got and how important it is for a cross industry group to be working on things like this, to really Be able to look at all of the different aspects and provide the best solutions and also to take it through regulatory challenges.

I think this is where the challenges are to day.

Does that make sense?

Etienne Nichols: I think it does.

tic deep brain stimulation in: 2017

several years ago and it was relatively old technology then and most, most people who've worked in neurosurgery are familiar with that device and there's a lots of new things coming on.

But I mean even,

even moving away from the specific tech. When I think about just some of the different things I read about.

You mentioned the brain being not a well understood organ or how it works and so on, and then all of these like the enteric nervous system in the gut and all of the second brain and the adjacent systems that are, There's a lot there And I don't know how are you tackling these issues?

Because it is,

it's, it's a novel length conversation, I suppose, rather than just a synopsis, synoptic conversation. How do you, how do you have that with your.

I know you kind of have a collaborative community around neurotech. How do those conversations take place?

Mat Stratton: Well, I'm very pleased to say that there are people far better qualified and with far greater expertise to take on some of those challenges than me. What I greatly enjoy is bringing those guys together so that they can learn from each other.

So people who are working on,

you know, implantable brain computer interfaces for the restoration of sight are able to work and learn from those that are working on neurosurgical robotics that are able to help visualize and understand exactly where, and manipulate devices into the brain and people who are looking at neuromodulation and the, sorry,

neuromonitoring and diagnostics so that you can understand exactly what's going on during clinical trials and beyond.

So I'm fortunate that there are,

there's huge ecstasies. I mean there's so much going on. When I first joined the industry 20 or so years ago,

I really thought it was full of fantastic technologies. I was very excited by what was available.

If I look at what is being developed now compared to what was being developed then,

it's night and day. There's just so much going on.

And what I'm really keen to make sure is that all of those guys learn from each other and that they work together and face those challenges that not all of them are in the technology space.

Some of them are in the funding spaces. How do you bring these expensive trials through to successful conclusion? How do you make sure that you're investing in those areas in the best possible way,

Helping these companies learn from each other and helping these companies try and build best practice models and one consistent voice so that they can talk to all of those that influence the industry from outside?

Is.

That's. That. That's my sweet spot. I shall leave the neuroscience to the very experienced neuroscientist.

Etienne Nichols: Well, let's talk about that. And I that you bring that 20 year view from what was then to what is now. It's good to look back because sometimes we feel like, oh, you know, this is normal, this is whatever.

It makes me think of the quote. I can't remember who said it. Maybe it was CS Lewis who said we.

Well, if I can remember the quote,

we are. We're not surprised.

Sometimes we take for granted when we walk through the doors we once prayed would open. You know, we don't even think about it. I'm butchering the quote, but you get the idea.

But what can neurotech leaders learn from other medical device verticals? Are there specific verticals that you think of as having figured this out that maybe neurotech hasn't when it comes to VC funding, building the regulatory strategy, all these different aspects?

Mat Stratton: I'd love to say there were. And of course, I mean, I'm talking very much about companies learning from each other within the neurotech space. So of course there's a huge amount to learn from other verticals and some of those are further developed, particularly the CRM space, I guess in orthopedics is very well established.

I've spent a good amount of time in wound care,

which I really thought would.

Well, it certainly has an awful lot to teach the Neurotex space as well. But I think all of them suffer very similar challenges in reality. I think what's specific about bringing people together within one industry is they recognize the same patient groups and they recognize the same technologies in lots of cases because there's very fine lines between a neuromodulation device and a brain computer interface device.

In a lot of cases,

if you look at implantable and non implantable BCIs and non implantable BCIs, and there's a number of these becoming available now that are both from a consumer tech as well as a med tech perspective, they're using very similar technologies to neuromonitoring and neurodiagnostic technologies.

So it's bringing those common areas together that I think is really very helpful in teaching people. But certainly there is a huge amount that can be learned from the neurotech space.

Right the way across the medical device space. And I guess that's my journey. Right. I started off in neurotechnology. I started off with this neurosurgical organization.

During that time,

I think I met a guy called Andy Grove who was a Parkinson's patient. But before he was diagnosed with Parkinson's, he was the CEO of Intel.

And he'd taken that organization from being a successful $1 billion a year organization to in the 13 years that he was a CEO in the organization, to a $26 billion a year company.

Now that journey was.

And you're younger than me, so you maybe not won't remember the advent of the 386 and 486 chipsets before we went into Pentiums and beyond.

But I remember even back in those days, it felt like the cycle times between these enormous leaps in technology that were produced at increasing scales were getting shorter and shorter.

And that was Andy's thing. He. He really focused on learning how to bring product to the market very quickly. And he developed all sorts of processes and approaches that he wanted to teach the medical device and biopharmaceutical area because he was so determined and so keen to get a treatment for the disease that was causing him such challenges.

And through working and learning from him,

there was a huge amount that I've been able to take both into the neurotechnology space and then also right the way into wound care and general surgery and all the other spaces.

So, yeah, absolutely. There's a huge amount that can be learned from across the field.

Etienne Nichols: Yeah.

In neurotech, I suppose. And I love that you bring up Moore. Is it Moore's Law that's talking about the. The jumps and it's just applying that or figuring out a way to apply that concept to other aspects is really.

Is really intriguing.

I.

You made me think of something about,

oh,

it seems like neurotech is almost like a 3D chest situation versus something like wound care or other areas. And let me see if I can explain. If I were a patient, I think patient or physician, I think it's safe to assume if someone has a cut or someone has a burn,

you want that to go back to homeostasis, you want to get back to normal, everything back to where it should be.

When it comes to the brain and how it works, what is normal? It is so,

I don't know, fluid, I suppose, and everybody's different in these different ways, normalcy is hard to attain. So there does seem to be an additional layer of complexity there.

Mat Stratton: Yeah, absolutely. Particularly in a system that we don't understand so well. So lots of companies from a therapeutic perspective will talk about neuroprotective and neuro restorative.

So how to stop disease progression, how to stop the effects of aging on the brain, and then also how to try and recover some of those issues.

And again, that brings in some interesting ethical challenges. If you're able to start to restore function.

Wonderful. From a treatment perspective. But then again, I think it also needs to be thought about from a.

What could this mean?

Could you take somebody beyond their baseline, beyond their basis points? And these are the sorts of challenges that a lot of BCI companies in particular are really curious about and really challenged by what they're doing at the moment.

How can you make sure that that doesn't lead to a greater segregation in human ability by allowing certain numbers of people who can afford such implants to be able to have far greater capabilities?

Now that's a real sci fi type challenge. Or maybe not on, on everybody's radar, but these are the sorts of things that the collaborators in this community that have been working together tend to want to discuss and tend to want to explore further.

Etienne Nichols: Yeah, it, I mean you could get into a lot. I kind of want to sit in on one of your discussions at some point with your groups because I mean that, that is an interesting ethical challenge.

Let's suppose one group of people excels in this certain area. But it also makes me think of, I think it's Howard Gardner's theory of in multiple intellig where it talks about the different types of intelligence.

So how are you going to accelerate linguistic versus intra,

intrapersonal or naturalistic, physical, all these different potential intelligences,

could it negate one over another? Anyway, we don't have to get into any of that. But I do want to ask you a little bit more about just when it comes to neurotech.

Do you anticipate or do you.

Well, let me back up for a second. A lot of the medical device companies that I work with throughout the years, they keep things very close to the vest.

So in these conversations that you have,

I can see maybe a potential for the competitive nature to arise. And oh, this is ip, we can't really talk about this. How do you overcome some of those conversations because you're trying to increase the overall industry of neurotech?

How do you broach that conversation of competitive intelligence?

Mat Stratton: We tend to stay away from the innovative elements. And actually we have a rule, we have only three simple rules, but one of those is that nobody signed up to a confidentiality agreement so nothing confidential should be discussed in the community.

And I worried that that would restrict conversations,

I must admit. And I spoke to everybody I spoke to during the onboarding process had similar sorts of concerns. But what you very quickly find out is there's so much to discuss that's outside of that intellectual property area, that's outside of that cut, cutting edge product development space.

You know, simple challenges that are causing organizations great heartache and cost and bewilderment.

And those are the things that we focus on in the community. So we leave the really cool, exciting neuroscientist type stuff to those that really have got expertise in that area.

Not saying that the community don't have expertise because absolutely they do. But we don't discuss those things. We focus on what are they slightly more mundane. What are the challenges in structural approach?

What are the, what do the regulations bring to this area that slows progress down,

that stays away from the intellectual property side of things.

Etienne Nichols: So I worked in the combination product world for a little while in drug delivery device and I can almost see this being maybe a very.

They speak two different languages. If you're talking to somebody from far as big pharma versus medical device, it's, it's, it's a little bit of a language barrier to a certain degree.

When I look at this,

I can see that the gap may be closing between pharmaceutical and medical device. Not even from a combination product standpoint, but how we're approaching different products from a biological versus a physical.

Well, I'll just give an example. I talked with a company recently that was talking about their product. I believe they stimulated the vagus nerve and their goal was to have some similar effects of how you might like someone taking Adderall for example, you know, just, just doing things like that.

So do you see a neurotech closing the gap and how do you see the language of these two different industries evolving?

Do they communicate?

Mat Stratton: Well,

I watched your, your interview with Susan Needle, who's a. Yeah, somebody I, I know and I greatly admire.

And some of the complexity that she talked about in this area is something that I've experienced myself. I've also spent a bit of time in, in the, the drug device space.

And I hope that that area and neurotech will start to close the gap because again we're looking at common problems and common patients in lots of cases.

And even if it's not devices that are delivering therapeutics,

it's devices that are treating patients who are taking separate therapeutics in lots of cases and absolutely we need to be able to bring those places,

these very distinct areas together and there'll be a lot of cross training and a lot of cross collaboration required to be able to do. Do these sorts of things.

I think if any particular space, any one physiological discipline is going to drive this though, it will have to be the brain because this is the area of probably the greatest complexity and the greatest level of development required.

Yeah. So yeah, I really hope, I really hope so.

Etienne Nichols: I'm glad you bring up Susan Needle and her book. I always mess up the title but the Handbook for Combination Products, something along those lines. I can put a link in the show notes if someone's interested to listen to that, that conversation.

Are you documenting how just your,

your own observation of the language differences and, and how you're coming to agreement and approaching some of these topics.

Mat Stratton: We hope to create lots of output from the community as it progresses. I could use this as an opportunity to plug the book that I'm writing at the moment that I really need initially.

It's also intended to, to address this and it's the, the story of, of working with, with leading innovators and people like Andy Grove and how the industry needs to learn and adapt as a consequence, well,

to meet its enormous challenges going forward.

So I hope to be documenting that myself but I think the more important voices are coming from the community where you've got real deep experts in this area who can start talking these languages with each other.

Etienne Nichols: Yeah, that's great. When's the plan to have the book completed?

Mat Stratton: Oh, it's always about three months away, so be a rolling three months.

Etienne Nichols: That's a, that's good.

All right, well we'll have to circle back in three months and see what the next three months look like.

What are some other things that you feel like are important, related to their neurotech space that may not be well understood and that you'd like to explain to the audience or any calls to action?

Mat Stratton: I mean, my main call to action is what I really want is to bring as many people from right the way across the neurotechnology space together.

So the community that we're running, maybe I haven't mentioned is completely free to join and participate in.

My mission here is to try and speed progress across the field so that we're not looking in another 20 years time with a level of disappointment at what has been able to be achieved,

or at least if things don't get done, it's not because we've not been able to stitch together expertise and knowledge and address regulatory frameworks together in a collaborative way.

So my main call to action here is if you're involved in the neurotechnology space, you're curious to understand more about how we operate.

You're keen to work with others across the field and you're also impatient and want to see the technologies that you're working on get into the hands of caregivers and patients as quickly as possible.

Then please get in touch. We'd love to have you involved in the community.

Etienne Nichols: Okay, that's great.

We'll be. We'll be sure to include a link as well in the show notes, so look out for that.

Any other things you'd like the audience to go check out as far as where they can observe, absorb more information in this field, learn more things and join the conversation?

Mat Stratton: We are on LinkedIn.

We regularly post on LinkedIn. This is. This is opposite Grade Hub. The website needs a refresh, but this will be done over the next few weeks. So I'll put a.

I'll provide a link for that and then just come and join the meetings there. They're every four weeks or so.

They're at 5pm GMT. I'm based in the UK, so it's convenient for me, but it's also to get east and west coast in right the way across the US and bring some colleagues in across Europe.

We have one gentleman who's registered in New Zealand. It's about 4am for his time, so he's excused. Typically he doesn't usually join for lots of very good reasons.

But, yeah, please come and get involved.

Etienne Nichols: I don't want to take away from the evergreen nature of this conversation that you have, but I know right now there's a lot of difficulty across the global conversation, I guess due to just political.

Political conversations. How does that impacted you all and any thoughts on how to navigate that conversation in the. In the no check space?

Mat Stratton: It's not something that's caused any issues that I've noticed so far. I guess when you've got a group of people who are passionate about moving the industry forward for the benefit of all those that rely upon can pass through those political challenges.

Etienne Nichols: Yeah, I think that's a good observation. If what ties us together is greater than the soil we stand on, then yeah,

we can remain standing together. That's good.

Any last final takeaway that you'd like to tell the audience before we close the conversation,

it was just thanks for listening.

Mat Stratton: Thanks for having me. Etienne, it's been a great time to go through this with you and as I say, we're just keen to get people involved in the community.

If others feel like other areas across medical devices could benefit from similar sorts of approaches, I'd be delighted to talk to people to either help them or to give them advice on how they can start to pull together similar types of communities.

Etienne Nichols: All right, yeah, at some point we're going to have to come up with or find and locate. Maybe it's already out there for other verticals and maybe they can have some brown bag lunches across those different verticals.

But those of you listening, I hope this has been helpful in some way. And if you want to join the conversation, reach out to Matt or myself. I love hearing from the audience.

No matter what you have to say, good, bad and ugly, I want to hear what kind of feedback you have.

And if there are other verticals that you specifically want us to go a little bit deeper into,

let us know. Matt, thank you so much. Really appreciate you joining us for this conversation and sharing your insight and sharing the community,

and I wish you the best. I look forward to the next 20 years.

Take care everybody. We'll see you all next time.

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