MedTech Expert Explains How to Get Innovation Adopted by the NHS | Pressure Tested

Hi, I’m Vee Mapunde, co-director for the NIHR HealthTech Research Centre in Accelerated Surgical Care, and today I’m going to be pressure testing. And now I am going to talk to you about the NIHR, the HRC, Accelerated Surgical Care, all those acronyms, and how they can support you as a medtech and healthtech innovator to innovate successfully for adoption and implementation in the NHS.

What does NIHR stand for?

The NIHR stands for the National Institute for Health and Care Research. It is an organization that is funded by the Department of Health for social care in England, not Scotland, not Wales, not Northern Ireland. They have their own versions of the NIHR.

What is the role of the NIHR?

Well, basically, the NIHR is the research arm for the Department of Health. We are here to provide the research capacity for the NHS. So if you think about it, the NHS is there to treat patients, it’s there to diagnose patients, it is basically there to look after your health. It does not have the capacity to end up doing research, and everything else associated with healthtech and medtech development, because that’s not what it was set up for.

So Department of Health set up the NIHR back in 2006, and our function across the board, not just for healthtech and medtech actually, but for pharmaceutical and everybody else, is to generate research evidence. And we do this in four different ways, and they’re all interlinked. So the first pillar of the NIHR is something called NIHR Academy, and this is where they train the next generation of methodologists, statisticians, clinical academics. If you’re a clinician and you want to move into academia, there is funding for that. The second arm of the NIHR is systems, and they’re the ones that develop the research systems that everybody uses in this country, the most famous being the IRA system, which is a research ethics application system where they collaborated with major providers, the regulators, to produce a system that actually is expedient and ensures efficiency.

The third arm of the NIHR is what most people will be familiar with, which is the funding arm of the NIHR. And there’s basically funding for every technology readiness level. So the NIHR does fund a lot of research, and I think it’s probably the largest research funder in the UK. And the final arm is where I sit, which is the health tech, the infrastructure, and that is where you have people who are actually paid to do the job and get things going. And I represent one of these centers called the HealthTech Research Center, and we are here specifically just for healthtech and medtech. There’s another part for pharmaceutical companies.

What do I do at NIHR?

Well, I’m the co-director for the HealthTech Research Center in Accelerated Surgical Care. My other co-director is Professor David Jayne. He’s a colorectal surgeon, and also a teaching professor at the University of Leeds.

This is a joint directorship position where he provides the clinical direction, whereas I provide more of the operational and strategic direction and make sure everything works on the ground. We do have a team of project managers and theme leads and experts in different areas, and those are the people you would ideally talk to, whereas my main responsibility is making sure that we are spending money on what we said we’d spend it on in our application to the Department of Health. And it’s also around performance management, impact reporting, and more often than not, things around business development. So I tend to talk to a lot of companies and help them navigate the NIHR.

For a founder without an academic affiliation, what is the most realistic first step to generate NHS-ready evidence?

Yeah, good question. Realistic first step actually is to figure out what evidence you are missing. What is the clinical area you’re looking at? What problem are you looking to solve? Most often, people are just looking to just generate NHS evidence without actually understanding whether that is the right evidence. So that would be the first step is, are you generating the evidence that’s actually going to get you the result and the outcome that you need.

What is a single biggest myth founders hold about how the NIHR or NHS evaluation process actually works?

I don’t really think it’s about more of a myth. I think people struggle with expectations, managing expectations around that. I think there is this thing that the NHS– There’s two sides to the coin, actually.

There’s one bit that says the NHS doesn’t want innovation, so it is not going to be in a position to do evaluation. They are, but we’ve got to be evaluating the right things, the right pathways for the right patient groups, and for the right clinical conditions. And then there is a school of thought that the NHS is desperate for innovation, and they’re crying out for evaluation. And once again, the answer is the same. The key thing always goes back to what are you actually solving? What problem are you actually solving? If we understand the problem you’re solving, it makes it so much easier to work out what evaluation needs to happen. The biggest mistake a lot of founders make is that they come to the NHS or the NIHR with a solution. And whilst the solution might be perfect, that’s not what we’re interested in. We want to understand what problem your solution is solving because we can’t make up problems for your solution.

So that would be the biggest thing. The biggest myth is the NHS just doesn’t know what it’s doing. It actually does. It’s just people don’t always understand how to pitch themselves in front of the NHS or the NIHR.

What signal completely tricks a founder into thinking they have a product-market fit when they do not?

Having a clinical champion or a key opinion leader or, “Oh, this surgeon or this so-and-so down in this particular area of the country loves it, and they said they’ll buy it any day.” Yeah, don’t get tricked into that because they do not have the purchasing power. They do not make the purchasing decisions. And quite often, they are only responsible for one part of that clinical pathway or process. So we get a lot of people that think just because you wave some famous professor’s name or some famous consultant’s name, that we have to take notice of your particular technology. That does absolutely nothing.

The NHS is a system. It is not a single organization that just works on referrals when it comes to technology. If you’ve got a technology, we have to understand how that fits within the pathway, how that fits within the system, and there isn’t a single person that can determine that or open the doors for you.

What is the one thing you wish innovators understood earlier about proving a health tech idea works?

I think they need to understand the sandpit they’re about to go into. I think if you understand as an innovator or a founder how the NHS actually works, how the system works, all the different components, how the money flows, how patients flow through the system, that’ll solve 80% of your problems because you’ll be able to determine relatively quickly whether you’ve got a space or a place within that market. And you’ll also be able to understand the challenges and the barriers that you’re likely to face, which means we can have a discussion about those barriers and challenges. If you do not have this understanding of the NHS, you’re going to go in there and make a load of assumptions about things. And you are going to be stubborn about your technology and your innovation, and that’s just not going to make life any easier for you. So the first thing I would always say is actually understand the environment thoroughly before you go in it.

You wouldn’t buy a house without doing all the surveys and everything else that goes in it. You wouldn’t just buy a car without actually doing a test drive and understanding its history and things like that. The same thing applies to the healthcare industry. It applies to the NHS And the downfall we see is mainly because people just stick to the superficial understanding of what the NHS is, rather than actually sitting down and exploring how their technology, how their innovation, the problems the NHS is having, how do those actually fit in with what you think you can do for the NHS.

What are the practical steps an innovation, particularly one involving data or digital technology, needs to go through from vision to product?

So practical steps, as I’ve mentioned, it’s first of all understand what you’re trying to sell into, what you’re trying to innovate into. What is the actual problem? If your understanding of a problem the NHS is having is of one of operational efficiencies, then you need to understand how that actually works on the ground. For example, if you’re going to be looking at software products that improve operational efficiency, do you actually know how people use computers in the NHS? Not every nurse has got a workstation.

Not every workstation is running to a particular software program. Not everybody has got access to a workstation. Workstations also have password access. They are restricted. So you need to understand how that element actually works.

If you are looking at a device, then you need to understand what patient groups are going to be impacted by that device. Is this something that’s for use in a pediatric setting? Is this something that’s used in an elderly population? If you’re using it for diabetic patients, for instance, is it type 1 or type 2, or is it both? And if you look at a condition like diabetes, they tend to come with kidney disease or some form of kidney ailment, that will probably also come with some cardiovascular condition as well.

So will your particular technology innovation solve all of these things? That’s the one thing that I would say, that as an innovator, you need to start off with. And then you need to look at what your technology is actually doing. What are you doing within the healthcare service? Are you a diagnostic? Are you treating? Are you predicting? Are you managing? All of those influence the likelihood of your particular technology being adopted, because if you’re diagnosing something, then there’s a whole lot of tests that need to be done. The NHS is not in the business of giving lots of false positives or false negatives, so we need to make sure that the accuracy is actually very important.

If you are doing prediction, then what are you basing your prediction on? Is it real-world data, or is it made-up data? We need to understand that. You, as an innovator, will also need to understand what the standard of care is. And in normal marketing speak, that is your competitors.

Who else is in that field? What equipment or technology are you competing with? Because that is what you need. You need to prove that your technology is superior to that competitor. If you cannot do that, then good luck.

And finally, outcomes. What benefits is the NHS going to see within four weeks, six weeks, eight weeks, whatever timeline, there needs to be something that the NHS can use to measure success and performance.

Why do so many promising health technologies never become routine care for patients?

Yeah, that’s quite an interesting one. Apart from sort of not solving the problems, I would say the biggest contributor to that is it’s something that just cannot be scaled, or it cannot be adopted, it cannot be implemented.

So we do have lots of examples of technologies where they met the patient needs, they did everything right, they generated the right data, but once you put them in a clinical setting, they basically disrupt the entire thing. They cause chaos, they cause backlogs, they actually increase waiting times, or they increase procedure times. And that is the benefit of having the conversations earlier on in the process where you actually find out what that pathway is. If your technology is going to increase consultation time by 10, 15 minutes, it’s highly likely that’s not going to make it to the patient or to the front line because the NHS operates by a specific set of rules. We may not like those rules, but it is what it is.

It’s not in our gift to change the way the NHS works, but what we do have as a gift in terms of time is actually we need to work with what the NHS has. So it will definitely be implementation, scalability, adoption. Once you can understand the challenges on that side, then technology tends to make it to the front line.

What is the biggest misunderstanding people have about why innovations struggle to gain adoption?

(The) biggest misunderstanding is the NHS doesn’t have money. In a sense, it doesn’t, but actually, the NHS is funded heavily. Would we do with more money from Department of Health and Social Care? Definitely. But the biggest misunderstanding is all the decisions are just based on a unit cost. So I’ve got this device and whatever the NHS is using costs £500, for example, my device only costs £50.

That is not what we mean by cost-effectiveness in the NHS. In the NHS, the money will be spent when we can demonstrate that a particular technology significantly improves a pathway, and by significantly improves, it means we actually spend less on a pathway overall than we would have if we didn’t have your particular technology.

What is a pathway? From the time you schedule a GP appointment to the time that you are discharged by the secondary care hospital or tertiary level hospital, as you’re good to go for the next five, 10 years, or whatever outcome measure they put in, how much money is your innovation going to save the NHS along that pathway? For example, when we look at the surgical context, surgeries cost money.

They cost thousands, tens and thousands of pounds just to have an operation. That’s what it costs the NHS. Do you have a technology that actually removes the need for surgery? Because if it does, you have saved money on that particular pathway. That is the type of technology that the NHS will pay for.

That technology might cost more than initially 10 surgeries to start off with, but actually, because we’re no longer doing 500, 1,000 of these additional surgeries, that is where the cost saving comes in. So understanding how money moves within the NHS is actually very important, and I think the misunderstanding just comes in because people really don’t understand how money flows within the NHS.

When you first encounter a new innovation, are there early signals that tell you whether it has a realistic chance of making a difference?

Yes. The early signals are usually not what people think. So I know people tend to think, well, the technology is terrible, or they haven’t explained it properly, when actually an early signal is how amenable the company founders, innovators, whoever’s developed it, how amenable are they to actually listening to reality? And I say this kindly, because a lot of innovators, you innovate with good intentions. It is coming from a moral place. It is coming from a good place. But because of that, people tend to get stuck in this fantasy of how things are going to go, how things are going to flow.

And people often assume that we are going to have that same emotional upswell about your particular technology, which we do. We do understand where it’s come from. But the NHS is reality. That’s the real world. And it is our job to basically make your fantasy a bit more realistic.

So the inability to work with you is actually the biggest sign that this technology is just not going to go anywhere. It could be the best technology in the world, but if we can’t work with you, if you can’t take feedback, constructive feedback, if you are not willing to share information, obviously keeping in mind These things around intellectual property, but there’s some questions that we need to understand as healthcare professionals and academics, and just being able to articulate some of those things is quite important. And sometimes we just come across founders who are arrogant, quite frankly. They don’t want to be questioned. They want to stick to the superiority of the technology, the innovation, when what we’re looking for from a healthcare perspective is we want to understand how all the good bits about your technology are actually going to translate into patient care that we can report to the Department of Health on, rather than this is good AI or this is a good use of nanotechnology.

We kind of understand that it’s good, but what does that mean in terms of bed days? What does that mean in terms of recovery time? What does that mean in terms of cancer remission? That is what we’re interested in. So that’s usually the biggest sign is if we can’t have a working conversation with you that is constructive, then yep, that technology’s not going to go anywhere anytime soon.

What separates organisations that successfully achieve adoption from those that gradually lose momentum?

Understanding the problem is actually what separates those organisations. If you truly understand the problem that needs to be solved and you take the time to co-develop a solution with the NHS, that is what makes you gain the momentum. Quite often, people think just having a clinical champion or a key opinion leader is enough to gain momentum. It actually isn’t.

It is helpful, but it’s not enough to gain momentum. What you need to do is work with a whole lot of other people within that particular process. So for instance, if you’re going to be working with surgeons, surgeons work closely with pathologists. They work closely with the nurses. They work closely with the theater operatives.

So all those people within that circle, within that workflow, those are the people that you need to work with because quite often they’re the ones that will be doing a lot of the work. For some of the surgeries, for instance, obviously the surgeons do the important bit, and they make sure that your insides are handled nicely. But when it comes to stitching you up, sometimes that is given to a trainee surgeon or a research fellow, someone who’s equally qualified in a healthcare setting. So don’t think that it’s someone who’s unqualified. They’re also qualified, but it’s usually not the surgeon that does that in some of these surgeries.

So understanding the people that work around this clinical champion that you’re working with is going to be very important. The organisations that lose momentum are the ones that focus on sales, that focus on getting rich, that focus on getting the money. Because money will eventually come if you’re doing the right thing. But if you’re so focused on making a profit or getting your investment back, the NHS does not move at the same pace as probably the way your bank balance is training, so you need to take that into account. Sometimes they lose momentum because if you’re investor-funded, the investors had one idea about how you should proceed, and the NHS is the NHS.

It’s not here to please investors. It’s here to treat patients, and they will move according to that speed.

What is the typical NIHR process?

Well, the typical NIHR process is there isn’t a hard line, one that is set in stone, but the key point is always to start by having a conversation. Find out what you need to do, who you need to talk to.

Now, if you go and Google NIHR, you’re going to get lots and lots of acronyms because, as I mentioned in the introduction, as part of NIHR infrastructure, there’s lots of different acronyms that sit underneath that. But the most useful infrastructure to start off with is the NIHR Research Support Services, which you can Google. If you talk to those guys and actually tell them what it is that you’re planning on doing, they will be able to direct you to the right part of the NIHR, and then we ask the more in-depth questions. So naturally, if you go to the NIHR Research Support Services and it’s something to do with surgery, then they will put you in touch with us, especially if it’s health tech, med tech-related. And key things we always ask is what is your surgical site? Is this a diagnostic? Is this treatment? Is this process-led? Is it operational? Because we don’t do the operational types of innovations.

We focus on the innovations that are strictly to do with patient care, so direct patient contact, direct patient care, or technologies that the surgeons or allied health professionals will use directly on a patient. That’s our thing, and that is where the conversations tend to flow from there. So it’s usually an open conversation to start off with because we do have a form, an expression of interest form on our website. But if you’re not quite sure whether your technology fits within that area, then we’re always open to a conversation, and we can usually tell straight away, within minutes, whether it’s something we can do or whether you need to be sent to another part of the NIHR that has got the relevant clinical or academic expertise.

What recent exciting technology made it into the NHS?

Well, from our end, in terms of exciting, I would have to say it’s a scalpelless surgery device. That’s the most recent thing that we worked on. And the reason why it’s exciting is it’s basically the most radical thing that we’ve probably seen in the surgical field, just across the world, not just the NHS. If I take it back a bit, it’s a scalpelless surgery device for patients with kidney and liver tumors. And obviously, they’ve got to be a certain grade and a certain stage, but basically, it gets rid of those tumors without the need for a single incision to the human body.

So if we think about the pathways that I mentioned in the beginning, where you’ve got your surgical consultation, you get scheduled in for surgery, and then you have the surgery, and you may or may not have a postoperative complication, and then you go home. All of that has got a cost to the NHS, and it also has a cost in terms of your time. Whereas this particular device is cutting the surgery time two to three hours on average, plus the time you spend in hospital from possibly three to five days to basically 30 minutes in an outpatients department. So we supported the evaluation of that particular device, and that was by a US startup company. We supported them with getting the FDA approval, so we generated the evidence that supported that process, and then we generated the evidence to support the MHRA, which is the UK equivalent of the FDA.

We are now at the stage where we’re doing a major health economic study looking at what is the best model to actually implement this in the NHS. So the device is in use at two hospitals in the United Kingdom, Addenbrooke’s in Cambridge, and Leeds Teaching Hospitals in West Yorkshire. And the key thing to look at now is if we want to scale this so that patients from across the country have got access to the same level of healthcare, is how does the NHS then model this scalability? How does the NHS actually implement this so that patients don’t have to travel to just Cambridge and Leeds for the treatment? So that is the health economics work that we’re doing at the moment to work out what is the best model for the NHS to use for treatment using that particular device.

But it is exciting because once again, with surgery, if you weren’t aware, your body doesn’t like being cut up, not a single bit, which is why we have postoperative complications, and that removes that possibility. It also removes the possibility of surgical site infections, which can be particularly dangerous for the elderly and for those with multiple long-term conditions as well. So in terms of the impact along that particular pathway, you can actually start to see how it’s reducing the cost across an entire pathway, but also how it’s improving the patient quality of life as well, which is the biggest thing. If you’re a cancer patient, the quality of life matters, not just the quantity.

So what innovation does NHS actually need?

So my answer to that, it’s a group of innovations that fall within one particular area, and it would probably have to be better diagnostics. And when we look at diagnostics, it’s not necessarily a case about being able to diagnose whether it’s MRSA or C. difficile or whether it’s a bacteria or whether it’s a virus. But what we do need in terms of diagnostics is more to do with the prediction.

So how can we actually predict who’s likely to get certain conditions? So if you think about it, when babies are born in this country, they get pricked on their heel. They give a blood sample, and that basically tells the healthcare service whether they’ve got certain genetic conditions, which then helps the NHS plan out healthcare services for children. Obviously, some of us were born way before that became normal, so we don’t have that kind of prediction in place. So what the NHS actually needs is the ability to predict certain things. So if we look at sepsis, for instance, it’s an infection into your blood, and it can kill you very quickly.

The symptoms are the same as the flu or a common cold. But if you’re immunocompromised or if you’re a child, it’s very difficult to articulate those symptoms. So when we’re looking at diagnostics, it’s actually who’s likely to get that. Can a tool actually accurately predict that this person, based on what they are saying, they are likely to have this, which means we better target their diagnostics towards something specific? If we look at surgery, for instance, there’s a condition called acute kidney injury, and you don’t need to be sick with any kidney condition whatsoever to get this.

So you can be a seemingly normal person that goes in and has just a normal surgery, nothing too serious. But then you end up coming down with acute kidney injury, which is where your kidneys just decide they’ve had enough, the surgery was too stressful, we’re just going to pack up shop and just not do anything. And that can be fatal for some people. So can we actually predict who’s likely to get acute kidney injury? Because it’s quite easy to plan for people with kidney disease, for instance, or diabetes when they go into surgery.

But if you don’t have any of those conditions, there’s no way of us knowing whether you’re going to get it. So diagnostics are going to be particularly key, especially as diagnostics also then provides other system benefits in terms of it reduces your referral times, it reduces the treatment times. The only reason we’ve got waiting lists is, well, not only reason, but one of the main reasons, is to do with the diagnostics and the prediction around that. We know how to do prediction around, let’s say, the flu. So every October, from October time, hospitals start planning for people to be admitted into hospital because of the flu.

It would be lovely if we could do that for other conditions, as well. So not just kidney disease, it could be cardiovascular disease, it could be respiratory conditions, but the diagnostics are the ones that hold the key to it. If you’re looking at in vitro diagnostics, which is the pee on a stick or diagnostics that come into direct contact with any bodily fluids, for instance, what the NHS needs is speed. It’s the speed of diagnostics. I’ll give an example with– There’s two examples.

So there’s one to do with infection. You can either have an infection that is led by a bacteria, it’s caused by a bacteria, or you can have an infection that comes from a virus. A viral infection does not need antibiotics at all. But the common protocol, not just in the UK, but in many parts of the world, is if it’s a suspected infection, they automatically start you on a course of antibiotics. Now, if it turns out to be a viral infection, you’ve just taken a whole bunch of medication you didn’t need to, and you are now contributing to the resistance for antibacterial, antibiotics medication, which is not a good thing because it means they’re not going to work for a lot of people that actually need them.

The current test we have takes about five to seven days, I think, possibly longer, to determine what type of infection that is. So if we have something that can narrow that down to minutes, the NHS will bite your hand for it. Another example in terms of diagnostics and speed of diagnostics as well is to do with strokes. There’s two types of stroke. There’s a stroke where the blood clots and it blocks the blood flow in a vessel, and then there’s also the stroke where the blood vessel actually bursts, and then the blood just goes everywhere.

It doesn’t go to where it should be going. We don’t have a way of telling what type of stroke you have until we get you into a hospital setting and get you under an MRI scan, and then that tells you exactly what type of stroke we’re dealing with. That is a lot of time that we could’ve been doing a suitable intervention, but now you’re looking at least an hour to two hours before we figure out what is going, what’s happening. And the reason I say one to two hours is if you have a stroke in Asda or Tesco or a shopping center, they need to call an ambulance. An ambulance comes and gets you.

It needs to get to the hospital. You need to go through all sorts of things. So it’s not going to be minutes before we figure that out. And we are working with an innovator who’s got a wearable MRI, sort of cap type thing that’s able to detect what type of stroke it is. We’re still in the process of validating it, but if the accuracy is good, if it’s consistent with that, then that is something that the NHS can actually look forward to, which means we improve patient care.

So in terms of what technology the NHS really needs, it’s more to do– It’s the diagnostics hold the key. But more importantly, things around prediction and speed of diagnostics.

What conversations simply aren’t happening early enough?

The main conversations that are not happening early enough is just conversations around understanding the true nature of the problems the NHS is facing. And I will give an example of this, with waiting list, surgery waiting lists.

So that’s all over the newspapers. Everybody complains about them, quite rightly. And what we get is a lot of innovators come to us with software tools that schedule waiting lists, and they tell us we’ve got an AI tool that can tell us how many beds you need to have available and when you should schedule operations and who you should put in a certain theater and things like that. Hospitals know how to schedule operations. They also know how to prioritize patients. That bit they know how to do.

Would a scheduling software do the job quicker? Yes, it would, but that’s not the problem. The speed of scheduling is not the problem with a waiting list. The speed to do with a waiting list is the fact that once people have surgery, we cannot discharge them safely into their home setting.

Some people might live on their own. Some people might live in a care home. Some people might be in a nursing home where there isn’t adequate medical staff or people who’ve got adequate healthcare training to look after them. So they need to stay in the hospital until we are able, we are guaranteed that actually they will be fine once they go home. So that’s one angle on that.

The other angle with patients not staying in bed a whole lot longer is to do with postoperative complications. So the operation went well, but for some reason, when they came out of the general anesthetic, there’s a lot of things that started going wrong. So instead of spending maybe three, five days in hospital, they’re now spending maybe 21 days in hospital. They could be spending a month in the hospital. And each day they go over the standard of care recommended for staying in a hospital, that is a day somebody does not get their surgery.

If we send them home too early and they come back in the back of an ambulance, your surgery can get canceled even though you had prepared for it and you are ready to go into theater within an hour. Now your surgery is canceled. So that is the root of that particular problem for a lot of the surgeries. So in that case, if people had those conversations with us, we would be able to tell people actually what clinical conditions are causing some of these postoperative complications. What is the nature of the postoperative complications? What types of technologies would help us monitor patients better and quicker and more reliably in a home setting? That is where the problem is going to be solved. It’s not going to be solved by operating Software scheduling software at all. That’s sort of like the least of our worries. So if people have these conversations with us early on, then you can decide whether you want to spend a lot of time on a solution that is not going to be adopted, or you can spend a lot of time on a clinical area you hadn’t thought about and actually come up with a solution that people are actually going to want to buy.

Do regulators stall innovation?

I don’t think they do, but I can see why people would say regulators stall innovation. So, it goes back to understanding the role of regulation. If we are happy to accept regulation in non-healthcare industries, I don’t see why regulation is an issue in the healthcare industry. If you’ve gotten on an airplane before, there’s lots of regulations there.

Those regulations are important. It’s to make sure you get from A to B in one piece. And obviously for the airlines, so they don’t have to pay out a lot in terms of insurance and that type of thing. It’s a similar thing within the healthcare system. Your technologies, your innovations have the potential to introduce harm to the patient.

They’ve got the potential to disrupt a healthcare system. So what the regulators are there to do is to set a minimum standard, as in whatever equipment or diagnostics or things we bring in need to operate to a minimum level. They need to conform to a minimum set of guidelines, and then at least that means that clinical assurances are in place. So, for instance, we’ve got the MHRA in this country. They are the main regulators, and they sort of set the tone for that.

And, yes, across the continent you’ve got CE marking. In the UK, we use CE marking and UKCA marking. In the United States, you’ve got FDA marking. But basically, you get the gist. Every single country has that.

Now, where people might think regulators actually stall innovation is when the innovation actually tends to be new, and there’s a reason why they need to stall that. We can’t have runaway innovation. We need to understand the implications of innovation. So I’ll give an example with an industry outside healthcare. If you look at driverless cars, at the moment, ever since vehicles have been invented, there’s always been a human being behind the wheel, which means if something goes wrong, we get to hold somebody accountable.

We get to understand what went wrong. We get to understand how to fix a problem if that comes up. So that’s where the regulations come in. And with driverless vehicles, then the question comes in is actually how much can we trust them? If something goes wrong, who is accountable? If something goes wrong, how do you fix that problem? It is the same thing with new innovations in healthcare. In particular, those innovations that have got artificial intelligence, otherwise known as AI, is one of the key things that obviously regulators are starting to look at, is how far do we take AI? Where do we use it? How much do we trust it? What is the human fail-safe? So the best way to look at a fail-safe is your calculators. If you’ve just grown up using calculators and you’ve never had to calculate a quadratic equation by hand, you won’t know where you’ve gone wrong. If you make the wrong calculation, then you’ve got no way of fixing it. You’ve got to start all over again, and starting all over again can be very costly.

So that’s why it’s important to understand the non-AI side of things, understand how that works, understand what your algorithm is being based on, understand how it works, understand the parameters. We need to understand all of that, not because we don’t trust AI, but if something happens and something goes wrong, we need to know how to fix it, and you cannot fix something that you do not understand. So that’s the reason why regulators exist, is that is where the progress in medicines and technology comes in. That is why we like to take medications. We go to hospitals.

We never think about, “I don’t trust the medication they’re giving me,” or, “I don’t trust this hip implant.” That’s because somebody’s looked at that particular bit for you. Somebody’s assessed that. Somebody’s made sure that we’re not using dodgy material or metals that could possibly infect you or do something to your body later on. All of those things are important. And when it comes to healthcare, regulation has to be there because it will affect whether you live or not.

You could die from something that’s not been regulated. So regulation’s very important. They do slow technology down. They do slow the pace of adoption. But that slowness is important. If staying alive is your concern, then yeah, just accept it. It’s an essential part of healthcare.

Is funding the biggest innovation challenge?

I would say partly. There is funding, and I think the reason why people struggle with funding is because they’re not articulating the problem, or they are applying to the wrong funding streams, or they want funding for the wrong things, or they’re still too early for certain funding streams.

That’s certainly what we see in our field, is the funding is just not appropriate. Part of it’s also to do with the fact that we have a lot of funding in this country that’s geared towards the later stages of innovation. We don’t have enough funding that’s at the proof-of-concept stage of innovation. So yes, in that sense, it can be a challenge if that’s where you’re operating. So it is far much easier for people to get £5 million than it is to get £10,000.

It’s almost like if you want £10,000 just for a basic proof of concept or an early health economics analysis, you almost have to prove that you are capable of getting £3 million in order to get £10,000, which doesn’t really work. And what that means is there’s potentially a lot of waste when it comes to funding, because then there are some of these technologies that have received the millions of pounds of funding, and then it just turns out, well, actually, they’re not going to go anywhere. And that’s because we could have done it with £10,000 to £20,000 earlier on, and we could have told you whether that was going to go somewhere or not. So funding, yes, it is a challenge, but it’s more to do with the type of funding that is available rather than the amounts of funding that’s up for grabs. And within that, I think some of it’s also to do with innovators not understanding the right funding streams to go for.

So if you’re looking at NIHR funding streams, their funding streams are really geared towards patient impact. So you need to be able to demonstrate some form of patient impact within a defined set of time for a specific condition. Whereas if you come to the NIHR funding streams and you’ve got, once again, some software which is to do with operational type things, that’s going to be difficult to get funding for from the NIHR because it’ll be difficult to, first of all, do an evaluation to demonstrate scalability, but it’s also difficult to do an evaluation because we can’t really articulate the patient benefit that’s going to be derived from that.

You’ve got funders like Innovate UK that sort of look at your funding application more like a business plan is, how profitable are you going to be if you get to the endpoint? So, the key thing to do when it comes to funding is it’s about identifying the right funding stream rather than just applying just because somebody said there’s money up for grabs.

And it’s quite interesting because now we’re seeing, I think it’s Innovate UK or one of these research councils where if you apply and they’ve got a high rate of good quality applications, they are now putting it through an AI lottery, basically. And whatever the lottery picks is what gets funded, basically. So you could have a very good technology, very good innovation, but once again, because of the competition around funding and the lack of suitable funding streams available, coupled with sort of the pressure to just get funding to move your project forward, just means it becomes a very challenging environment. So if you want to avoid those pitfalls, it just goes back to understanding what problem you’re trying to solve. Because as an HRC, a health tech research center, if we know what problem you’re solving and how we can solve that problem, then it makes it easier to target the right funders and put together a good funding application.

Is the NHS too big to adopt innovation at pace?

I would probably take it back to the original function of the NHS to understand that question and the answer a whole lot better. So NHS created, was it 1945, 1946, after Second World War? And the NHS remit is predominantly to treat patients. It’s there to look after health.

It’s there to make sure people do not die because they cannot afford basic healthcare. So when the NHS was set up, it was set up at a time when we didn’t have a lot of all these other medical conditions. It wasn’t set up to handle patients with multiple long-term conditions. It wasn’t set up for a whole lot of things. So that is where the structural bit comes in, in terms of adopting at pace.

So I think structurally, probably not. But the will is there to adopt at pace. But the key thing with the NHS is we’ve got to remember the structures that we have are the structures that were built back in the late ’40s. And in a way, that is how the foundation still works, to a large extent.

If we’re starting to look at adoption at pace, what would that take? That would require some form of structural change. Now, it doesn’t particularly work to the NHS advantage in that the strategies and plans change with every new government that comes into place. It just means we lack that continuity when it comes to setting things up. And that’s probably something a lot of people in the NHS will not be able to affect. They’ve got basically very little influence on that.

So this is something that’s not new. It’s been there in newspapers, in the media. It’s something a lot of people have identified. So what we try and do when we’re looking at adopting at pace, what’s happened so far is you’ve got a lot of organisations that have been set up to try and help this problem but deal with it on a regional basis. Instead of looking at it nationally, let’s look at it regionally, because each region will have its own healthcare challenges.

Yes, a disease is a disease, cancer is cancer, but you’re going to get more cancers in certain parts than others. You’re going to get more surgeries, orthopedic surgeries, in some parts of the country than others, and that’s just more to do with how the population is spread. So you do have organisations called Health Innovation Networks, and that is their function, that is their role, looking at how can we actually accelerate the speed of adoption in the NHS. Whereas from the NIHR side, we are just looking at how much evidence, what’s the right evidence to generate to support national adoption, and then we typically hand over to the Health Innovation Networks. But in terms of going back to the original question, yeah, is it too big?

Yes, it is, but it’s not to do with the people in there, it’s more the structures and the way the NHS manages things. It has always been set up for patient care. It hasn’t necessarily been set up for research and all these other things, which is why you now have all these supporting acronyms surrounding the NHS, because that’s what we are there to do, is to provide that capacity until somebody somewhere higher up decides, “Well, actually, we need to have a proper foundation that helps with adoption.” To be fair, the Department of Health and Social Care, I know they’ve launched a few initiatives recently in terms of the MedTech sort of innovation processes where they’re piloting something to see how we can actually adopt MedTech better into the NHS. So there is work that is starting. In terms of timelines, is this something that’s going to happen within weeks, months?

I don’t think so. It will probably take a couple of years, but it’s not something people are sitting on. I think we are acutely aware that we need to improve the adoption rate for technologies in the NHS.

If you could redesign one part of the healthcare innovation ecosystem tomorrow, what would you change first?

Ooh, that’s very topical. I think there’s lots of things to change within the healthcare ecosystem, but I think it goes back to one of my previous points.

There needs to be some sort of consensus, some sort of continuity. I think there has to be a general consensus about how the NHS should run. There needs to be some sort of consensus around basically funding pathways within the NHS and how we manage those processes, because each hospital is its own legal entity in its own right. They do operate to a common framework and a common set of rules, but I think that’s where the challenges start coming in, because you can have two hospitals 10 miles apart, hospital trusts, and they operate very differently. One might do really well in finances, another one might not.

But if I was to pick sort of one particular thing, I would change the performance measures. I would change what is getting measured by the Department of Health and Social Care. There’s some famous business management guru who said, “What gets measured gets done.” And that’s exactly what’s happening in the NHS. The NHS is not immune to that. They are managing financial performance, which then means there’s a lot of focus that is placed on costs and whether things are expensive or whether things are value for money, and not necessarily whether things are actually supporting patients.

That is not done maliciously, it is just that’s what is being measured, so they will be hyper-focused on that. There will be things they also measured in terms of things that to do with litigation and never events and clinical negligence and that type of thing. Those are still important things to measure, but we do not have a specific measure for the adoption of innovation. That really doesn’t exist in a way where we could say, “Well, actually, we’ve managed to get X amount of innovations within five years into the NHS.” We don’t have that particular measure. I wouldn’t know how to design it or what that would look like, but there definitely needs to be a measure for something related to do with innovation.

We have measures for the research side of things in terms of the number of clinical trial participants and the speed at which we can approve clinical trials so that they happen. So that is something that we are quite good at, actually, internationally. We don’t have a measure for adoption. So if I was to pick one, I would say that is definitely the one thing that I would do.

I’m Vee Mapunde, I’ve been pressure tested, and a key takeaway point from today is have those difficult conversations right at the beginning. They will save you a whole lot of heartache further down the line.