Invent: Health

Rapid Innovation: Reducing Time from Idea to Impact Transcript
Speakers: Matt Parker, Luella Trickett, & Edwin Stone
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Matt: Hello, and welcome to Invent Health, a podcast from technology and product development company, TTP. I'm your host, Matt Parker.
Over the course of this season, we're going to be exploring the fascinating future of health technologies. Today, we ask how can we reduce the timeframe from idea to impact and achieve rapid innovation in health tech?
Speed is not normally something you would associate with the highly regulated world of health tech. Whereas consumer products might be updated on an annual release cycle, a typical medical device development might take five years or even longer for more invasive devices or drugs.
Obviously, the stakes are much higher, but how can we reduce these barriers without compromising safety or quality? So, what does rapid even mean in a healthcare context?
When the COVID pandemic hit a few years ago, this changed people's thinking. Prior to 2020, the fastest vaccine development had taken four years, and that was back in the 1960s.
A vaccine for COVID was rolled out in less than one. But this isn't an isolated example. Something we're intimately familiar with at TTP, in March 2020, against a backdrop of a predicted ventilator shortage, we answered an urgent call from the UK government.
Covent, TTP's Rapid manufacture ventilator for COVID-19 patients was ready within five weeks of the initial call. The kind of war footing the pandemic put the industry on, proved that rapid innovation is possible when you have the means and the purpose to do it.
But what can we learn from this in more normal times? Today, I want to dig into this phrase, to see what rapid innovation actually means, and how it works across a number of different healthcare contexts.
I want to find out what the barriers are to working at genuine speed, and what we can learn from the pandemic on projects in the future.
To start things off, I spoke with someone who's working at the heart of the UK's health tech industry.
Luella: Thank you for inviting me to join you. Luella Trickett, the Director of Value & Access at the Association of British Health Tech Industries.
Matt: Luella Trickett joined the ABHI in 2019 after having spent 25 years in the pharmaceutical and health tech industries across the UK, Europe, Middle East, and Africa.
The ABHI are a really important organisation in the UK's health tech ecosystem. They represent and support the entire industry to stakeholders, including the government, NHS, and regulators. And her role focuses on how new innovations can be adopted faster by healthcare systems.
I started off by asking Luella what we mean when we talk about rapid innovation in a health context, and what the key barriers are to achieving it.
If we look into other industries in the consumer world, Apple are bringing out a new iPhone twice a year, and we don't see that in the world of health. I wonder why don't we see that? What are some of the barriers and the blockers to seeing that peace of change?
Luella: It's absolutely true. Yes, some health tech is evolving very rapidly. Apps, we've got lots of apps. They're relatively straightforward to bring to the marketplace, but more broadly, technologies used in the healthcare setting are highly regulated.
And even if you can come up with the idea very quickly, you then have lots of steps to go through before you can actually bring that innovation to market. Regulatory approval, you have to test something to be sure that it's going to be safe for use in patients.
Now, what testing is necessary does depend on the technology, and there are different classes of medical device. And when we are talking at the highest risk end of the spectrum, the sort of class three, you’re going to have the most rigorous testing and evidence needed to be able to deploy them.
Again, the MHRA is looking at ways in which it can allow promising technologies to come to market where the evidence is still being evolved in a careful way because there is a bit of a tradeoff.
If it takes you a long time to bring an innovation to market, patients are not benefiting from that innovation. But if you bring it too quickly and without control, you risk finding unintended consequences later.
But that's one of the reasons why we don't see the sort of big consumer sort of iterations every year that we get used to in health.
Matt: Absolutely. But there is still that kind of the opportunity there to potentially have sort of maybe some slightly new approaches that might mean we can adopt things more quickly where there's real urgent need.
Luella: The only caution I would say is regulation and gaining your regulatory certification is not the only barrier to the adoption of innovation in the NHS.
You then have the stage of, okay, how does the NHS know about it? How does it judge whether it's cost-effective? How does it decide that it's the right thing in that patient's pathway?
So, we do have nice, as one place where some of those assessments are done, but people who've heard me speak before will have heard me say this — the NHS is not one organisation, it is a number of organisations.
And often, as the saying goes, more pilots than BA going on in the NHS. And that means that every innovation almost has to be started from the beginning when it's introduced into every NHS organisation.
This is recognized and there are lots of people trying to work out how to solve that problem. And there are already some things being done, being led by organisations like the Accelerated Access Collaborative to really look at some of these things.
But the regulatory hurdle is not the only one to actually get your innovations adopted. And with an SME-heavy industry, you can imagine that's quite burdensome.
If you're an organisation of 25 employees, how do you get around 200 plus NHS hospitals to talk to them about your innovation and then run through a pilot with them?
Matt: And is there a new scheme that the NHS is running as well on top of that to kind of boost the NHS's access to these innovative medical technologies?
Luella: Yes. So, there's something called the Innovation Service. Again, this is something the Accelerated Access Collaborative has set up. It's a portal. Once it is submitted, your submission will be assessed by some experts who will then decide who may be suitable within the health system family to help you.
It could be that they suggest that you might need some more help with research and development. They might put you in touch with the National Institute of Health Research. It could be that they refer you to NICE, or it might be that your innovation is ready for procurement, and they'll put you in touch with the appropriate procurement organisation to get that ball rolling.
Because every NHS organisation has to comply with public procurement law. And so, you have to have a compliant way to sell your product to market as well.
Matt: I noticed sort of many of those things are around sort of initiatives around bringing people together and sort of collaborating. Do you see that as a sort of key aspect to enabling these things to happen faster?
Luella: Absolutely. We often talk about the culture of adopting innovation. The NHS is understandably conservative with a small “c” because you are always going to be thinking what's the implication to patients of bringing in this new innovation.
And so, it does require people to work together. It does require industry who could be the experts in their innovation to be helping the clinicians, particularly if you implement a new surgical intervention.
The surgeons have to learn how to use that intervention. And so, there's a training and a learning curve there. You need the industry to support the NHS, and then the NHS needs to support each other. So, yes, collaboration is absolutely critical to this.
Matt: And I think you touched on some really interesting points there in terms of just how fast something can roll out if you're relying on a kind of one-on-one experts to kind of bring in innovation in like some of those surgical examples.
That in and of itself is a real barrier to things moving more quickly.
Luella: Absolutely. It can't really be understated how much some of these technologies transform the whole patient pathway, the delivery of care.
And some of it is if you are used to managing your patient in an outpatient setting, and suddenly, there's a remote management technology that means that that patient may be able to look after themselves at home, you have to have the confidence that the technology allows you to have the oversight and the patient's condition can be managed as well as if they traditionally came into outpatient clinics every three months or so.
So, there's a lot of change that can be delivered from implementing a health tech that is radically different from the way you traditionally treated that patient cohort.
Matt: And is that sort of maybe a better way of framing the sort of the role of the regulator here? Not as a sort of a checkpoint before you can release something into the market, but actually someone who can help with that balance of risk in terms of making sure that a new thing provides enough benefit to justify its risk in the market?
Luella: Yeah, definitely. And certainly, if we're talking about vaccines, no corners were cut in bringing those vaccines to market. What happened was that stages that would've usually done one stage after another were run concurrently.
So, instead of waiting until all the data was available, they were looking at the data as it was released and as a result, had a picture of what was possible much, much earlier.
So, it's that kind of thing that can bring innovations to market more rapidly. But it's all about control and management, doing it carefully.
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Matt: We often think of the NHS as an unmoving monolithic entity, but I was interested to hear from Luella that a lot of the inertia in the NHS can actually come from the way it is compartmentalised.
As she notes, the important part in achieving speed is getting all these parts working smoothly together, seamless collaboration between all the cogs in the machine. This is something that was absolutely needed during COVID, which is perhaps the best example of how collaboration can change the pace of an innovation’s adoption.
Next, I wanted to find out some more about how we can accelerate the other end of the product development process, to speed up time from concept to clinic. So, I sat down with TTP’s, Dr. Edwin Stone.
Ed leads cellular origins, a TTP spinout created to enable scalable and cost-effective manufacture for cell and gene therapies. Most of the time, this is where you'll find him.
However, a couple of years ago during COVID, like many of us, he took up the call of developing a COVID-19 ventilator for the UK government in as shorter time as possible. This was of course the only place to start our conversation.
So, I wonder if you could tell us a little bit about what your involvement here was in the ventilator development at TTP: how that project came about and how did it play out from start to finish?
Edwin: I mean, the fundamental answer of how it came about was a call from UK government recognizing there could be a need for thousands of ventilators in five to six weeks’ time. And knowing those weren't available.
And the short answer is, is that possible? Would've been, no. I mean, no one had done anything like that before. No one even contemplated something like that being possible. The idea of a three to five-year development being quite normal, the idea of five to six-week development just seeming utterly outside of the norm.
The interesting thing I think about was just how much it could be crashed in timelines. I think things were able to move very, very quickly. And at the end of a five-week period, we had a ventilator that we could submit and that we could build in large quantities, which give or take versus a normal development was pretty much a 26 times acceleration factor. Each week, we’re doing what you'd normally do in six months. That was quite enlightening.
So, my role was principally around the technology. So, I was deeply into both the concept that we took, but also, how that then evolved into a physical thing. So, early initial testing was very simple breadboard prototypes built on available parts, that then evolved into much more sophisticated machine systems.
And then later, a lot of what I was doing was trying to react to information we were learning from the field around new specification, look at kind of ways we could now put things in. And then finally, through to the verification testing of that system.
What that meant was interacting very closely with the people that they're more reassuring us from a regulatory point of view that we were heading the right direction and feeding back any changes.
People from a supply chain point of view assuring us the part availability of the approaches we were taking were going to be suitable; people from a manufacturing point of view looking at it, saying, “Yes, we can put this together and work with it on the lines that were simultaneously growing while we were developing the system.”
So, it was an incredible team effort that was brought about across hundreds of people on multiple sites.
Matt: What do you think some of the key challenges there were that you needed to overcome to make that work so quickly?
Edwin: I think one of the ones I reflect on was there was very much an ability to fail. I mean, almost by definition, we had to be willing to take a risk. We were trying to do something that not only had not been done before, but fundamentally, everyone had discounted before that something like this could be done in those sorts of timelines.
And so, a bit of almost suspension of disbelief there and that was actually, I think really important, than in terms of how we behaved. Now, different times of course, and we always have to view this with … it was within a very particular moment.
But I think actually that recognition, that a mindset where failure is possible, I think for us was really powerful in, for example, just enabling quick decision-making because we knew always there was one clear priority beyond all others, and that really was time scales.
Now, I don't think you can do that on every project you ever do, of course. But I think you probably can start to circle those decisions that actually speed of that decision is more important than necessarily being absolutely confident in that decision.
And I think that is the sort of thing that can be transformational to some of our timelines of development in general. I mean, we can start going, okay, we can take six months out here by making this decision. Maybe if we're wrong, we don't save that six months. Maybe even actually that six months becomes eight, but the upside is worth it.
Matt: And with that increase in speed, obviously, it's a very, very highly compressed environment here in terms of the ventilator development. Is the cost the same as it would be of a five-year development compressed into a small time? Or does it amplify?
Edwin: So, yes, it's a great question. I think one of the sort of slightly surprising things for me and something I share slightly cautiously for the ripples it could create, but it certainly didn't multiply up by orders of magnitude.
Which again, at the front, I think if we’re asked to guess, we could have easily have predicted a sort of two threefold escalation cost even if we found some way to do this.
The reality wasn't that — they were increased compared with normal development times, partly because we did run more things in parallel than we may have chosen to otherwise. Partly because we did accept obviously a degree of inefficiency. Having people available to do things was definitely much more important than knowing people were occupied all of the time.
But the reality is doing something in a very fast time scale, I think has some cost benefits in that there's only so much time you can spend on things and a degree of efficiency has to emerge because knowing that time is your key driver, you are trying to be efficient, not from the cost point of view, but to make sure you can deliver on time.
And so, certain things you might have otherwise done, you choose to ditch. Things like feature become a lot easier to manage. If someone wants a something else in terms of a feature, it's very easy to say no when you know the deadline is two weeks away.
That, I think, that discipline is really valuable. So, I think that's quite interesting. I think in terms of accelerated development cycles, I think the cost implications certainly can play out in ways you might not necessarily expect.
Matt: I think it's a really interesting perspective there. I wonder if there's anything else you've learned from this experience in terms of what is needed to make a development like this run quickly?
Maybe in terms of how you structure the team, how decisions are made, how particularly, project critical decisions get made on this type of development.
Edwin: Yeah, I think the team structure was fascinating. And given the fact it was the first time anything like this undertaking, I think actually on reflection, the route that was taken was pretty impressive.
The core of it was the teams went through a few different evolutions. So, because we were moving through this different phase in the project really fast, which started off with these relatively unstructured teams, but then as we moved into what you'd normally refer to as a more formal development part of the process, the teams also evolved in parallel.
I think reflecting how that looks on normal developments, quite often it'd be quite hard to move a team through those different development cycles, move from that early innovation mindset to a much more controlled, perhaps specification-driven time because we were seeing it happen very quickly and things always didn't have time to take root.
I think that did actually help us make those changes. I think that's again, something that I think is really important to look at when we're doing developments generally, is how we move through those.
Matt: The horrors that COVID brought with it, notwithstanding, 2020 was a pretty fascinating time to be working in health tech.
As Ed outlines, it put the whole worldwide industry on kind of a war footing. This forced decision-making based on time scales rather than cost, while maintaining the rigorous regulatory standards needed to keep people safe.
It was a true experiment for how rapid innovation could happen at scale. So, how then do we balance that against the inertia that we so often associate with the NHS? How can we get things on the market and to patients as quickly as possible to save more lives?
I went back to Luella to find out.
And do you think that there is a level of inertia in an organisation like the NHS that might not be present in some other maybe more private healthcare systems because of that sort of maybe hesitancy in being a bit more conservative about new ideas and new approaches?
Luella: I think there is. I think also, we can't forget that the NHS is working at full capacity, and to implement change requires the capacity for change management, potentially running this delivery of care in the old way and the new way at the same time.
So, often, it's not just the cost of the tech, it's the cost of making the change that can be part of the barrier. But also, if you are a private organisation, you can think longer-term.
You can think, I'm going to spend this money now because in three, four years’ time, I'm going to see the improvements in productivity and efficiency, or I'm going to prevent waste happening later.
Or dare I say it in a private healthcare system, I'm not going to have a patient who is costing me a lot in five years because I've managed to do something now that stops them getting to that point.
So, you can look at things a little bit differently, but still, everything is quite short term and we aren't in a position to easily spend money to save, which is what industry would do.
Matt: Absolutely. And in some ways, I'm thinking about a number of the technologies that we've talked about on this podcast, things that are looking maybe slightly further forward, sort of preventative medicines, digital technologies that maybe can help and prevent certain conditions at an earlier stage.
Is there a barrier therefore for those kinds of technologies to be adopted as well because of those same barriers?
Luella: Absolutely. I mean, diagnostics is a classic case. If you can diagnose somebody quickly, you can treat them with the most appropriate intervention or you can rule them out as needing an intervention.
But if you constantly refused to spend the money on the diagnostic, you're going to be having other costs in the system later. So, yeah, definitely, prevention is a real tough one because the benefits of preventing things like cardiovascular disease and diabetes are a long way down the line.
So, if somebody says to you, “Hey, I've got this amazing tech, it's going to cost you 10 million today, but in 10 years’ time, you'll be saving 20 million every quarter on what you're spending at the moment …” (I'm obviously using made up figures) but it's really hard for the person who has to sign the check for that 10 million pounds today to do so because they're not going to see the benefit, and neither's anyone else in the near future.
Matt: It's a real dilemma there and I can see why that's such a barrier to many of these things being adopted.
We briefly touched on COVID earlier and so, that had changed some of the thoughts in terms of approvals and approaches in terms of how quickly things can change.
Do you see that as something that's going to continue into more areas of the healthcare system, that kind of approach of being able to do maybe quite rapid transformations in terms of how care is actually delivered?
Luella: I think it has to, quite frankly. We're not alone in the UK. All western countries have a higher and higher cost burden for health.
We are ageing populations with all the comorbidities associated. We cannot keep up with the growth in healthcare demand without looking to innovation to help us transform the way we deliver care. It's not a nice-to-have, it's an absolutely must-have. It's a bit like the climate situation; you know what, we have to do something about this.
Matt: I think that's really powerful. And are there any sort of specific examples about the work you've done with the ABHI that's sort of really indicative of some of those challenges?
Luella: So, yes, that's a very, very big question you've just asked me. The challenges with the adoption of innovation have been well-documented for the last 20, 30 years. There are very few people who can't rattle off where the barriers are.
The difficulty has always been how you can put a mechanism in place that is sustainably going to transform and remove those barriers. People talk about funding being the barrier, it's not the only barrier.
If you give a hospital money to buy a certain tech, but you don't give them the money to transform the way they're going to deliver the care, it doesn't matter how much money they got for the tech, it's not going to work.
Equally, if you give somebody the money to buy something for two years and then you stop giving them the money, what are they going to do? They've got to stop buying it or keep buying it, but stop doing something else and nobody's helping people work out what it is they need to stop doing in order to keep adopting the new innovations.
Now, that should be improved with the integrated care systems because it's a system money, not a primary care money, secondary care money, commissioner provider, whose money is it thing. It does help some of that.
So, we've, on the back of these known areas of challenge, we are identifying a small number of areas where we think a suggested change could make that difference in a sustainable way.
You may be aware that the Department of Health and Social Care launched a Med Tech Directorate shortly after the worst of COVID in recognition that they'd had a Medicines Directorate for years but didn't have the same focus on health tech.
They launched a strategy last month that set out a number of areas that they want to focus on: resilience, enabling infrastructure, some specific areas. We’re working really closely with them on the implementation of that because it is really exciting that we've got this focus on health tech.
What we want it to do though is deliver the life sciences vision of this country being a fantastic place to bring innovation and to do business. And what we don't want to see is sort of focus on how can we buy as little for as low a price as possible. We want to look at value not cost.
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Matt: The Medical Directorate that Luella just mentioned feels like an important step in the right direction from the UK government, in outlining a way forward for the NHS to implement new innovations on quicker timeframes.
It's something that's going to be absolutely vital to make sure the UK is actually able to use some of the things that our incredible scientists are creating, but at real scale.
So, to end, I went back to Ed to find out a bit more about what he learned from the ventilator experience during COVID, and what this could bring to future projects.
It's interesting to sort of reflect on and look at some of these differences between what was common, what worked well, and what is something that we do anyway and in any development. I wonder how much of the, this example we can apply to future projects.
Are some of these things common or was there something fundamental here about the fact that we were on a bit of a war footing, and this was an emergency that we were developing in that allowed us to move this fast? And does that sort of stop us from using this as a great example of moving quickly?
Edwin: Yeah, I think there are a bit of both. I mean, there are definitely things that would be really hard to replicate. The one I cite is things around the broader network we were able to pull upon around parts availability.
So, if we were requesting a fitting for a particular part of the system that we needed, we could call someone up. In fact, more often than not, actually, we'd be able to ask someone else to call someone up so we could keep doing what we need to be doing.
And then an hour or two later someone would arrive in the carpark with probably 10 of those fittings and a whole dozen other different variants just in case that was slightly the wrong one.
That was incredibly enabling to us, and it meant we could do in a few hours what typically might be a few days. Replicating that more commonly I think is always going to be hard.
Actually, some of those things about that freedom to make decisions at risk about thinking about the team's structure and making sure it evolves and perhaps critically, the clarity of purpose, I think we really can replicate.
Matt: I think that brings us on really nicely to kind of where I wanted to go next, and explore it's been a couple of years since this very rapid development kicked off in anger.
I wonder if there've been any projects that you've been involved in since where you've been able to use some of the lessons that you've learned from this project and this experience in other developments.
Edwin: So, yeah, there's certainly been several developments since where we've turned around in under a year. I think the key ones that really helped us, have been getting that clarity of purpose really, being now emboldened to wrestle with that topic more than perhaps we might have done before.
And I think the other one that's obviously comes starkly into focus since then — so, whilst I commented we can't normally necessarily get a component in a couple of hours and in fact, in a way the world has flipped around supply chains in the last few years, where components we might have previously been able to get in a few days or a month, and I'm looking at silicon chips and the likes here as prime examples — are now on lead times that are 10, in some cases, a hundred longer.
And back to this kind of whilst would we have chosen to be in that situation? Absolutely not. But those sort of moments give us an opportunity to then really, I think, think about how we do things and look for opportunities.
And so, I think we've become a lot more focused on that supply chain piece earlier on. And supply chain resilience, I think more broadly, obviously, the world has become aware that just-in-time manufacture is perhaps not the silver bullet. I think that's been a really helpful thing in terms of making sure we bake that thinking in really early in the development.
Matt: I think that's a really interesting way of thinking about it. Your sort of focus now, where are you sort of looking at areas of healthcare that could benefit from a period of rapid innovation like this? Where are you seeing the big bottlenecks and what are you doing to solve those?
Edwin: So, the bulk of my work is in cell and gene therapy. And that really is one that is arguably hitting almost its ventilator style pinch point. We've got hundreds of therapies now in late-stage clinical trials, and it's widely acknowledged no way of manufacturing those and getting those to patients.
And the problem isn't one that's biological in nature, fundamentally. The problem is one that's one of manufacturing. Arguably, therefore, one of engineering. And in the broadest sense, I would say there.
And we need changes to happen really, really fast if in one year, two year, three year, four years, five years, we're not going to be sitting there with an embarrassment of riches from a therapeutic point of view, but we can't actually get to patients.
And that is a really terrifying situation to be in. There are examples even today where people, clinicians are having to make decisions about which patient to save because there are not enough manufacturing slots to make the therapies which I point this analogy to a hospital that has ward with 10 patients on, and one operating room and a clinician choosing which of the patients in the ward they're actually going to give the life-saving operation to.
If that were to happen, there would be uproar. And yet we are heading towards that in cell therapy. So, it's really important that we do start turning the wick up.
And actually, one of the examples I mentioned there of getting a product from concept to first show, really driven by that we need to get these products ready on the market and manufacturing therapies so that we're helping patients before we end up in a situation where the therapies exist and yet, we can't get them to people.
Matt: Looking not just the technology development, other parts of the puzzle here, which are also ripe for some innovation. I'm thinking about the clinical process, clinical trial process, regulatory routes. Do you see sort of potential there as well?
Edwin: Yeah, I mean, I think it's interesting with cell and gene, we've had to be innovative around that because we're typically dealing with very small patient cohorts. We typically don't have a model system we can go into that's not a patient and so we have to adopt quite different routes.
And then actually, interestingly, in the payer setup, we’ve had to, because they're so expensive, payment by results has started suddenly to become a thing. Again, it's just the commercial imperative often ultimately drives where the end result happens.
I think you look at sort of digital health and what that's bringing and how that might revolutionise the way we do trials, giving us much richer feedback, much more rapid feedback.
I think there's so much potential to look at how actually synergies between the different innovations could really help us bring those things together and enable step changes in almost every part of that process.
Matt: And do you sort of see a future where this is going to be the norm? Are you optimistic that this is going to happen across all these areas?
Edwin: I think we will see rapid changes across certain areas. I think inevitably, some areas will be more incremental than others. And I think the thing that always ultimately underpins this is the commercial imperative.
I do think we will see some pretty substantial shifts in terms of how these things happen though. I think we now have the tools available, and I think my general sense with healthcare broadly is it does tend to reflect a lot of other industries.
I think whilst it's innovative in its core of its technology, I think actually, it has sort of a risk averse shell around it protecting it sometimes. And so, certain things take a little bit longer to permeate, but they do permeate, they do happen, they do make the changes.
And so, I really do think over time, we are going to see it happen. I just think we're going to see a bit of a lag compared with elsewhere.
Matt: That's absolutely fantastic. Thanks for coming on.
Edwin: Thank you, Matt. Been a pleasure.
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Matt: Thanks so much for listening to this week's episode of Invent Health from TTP, and a big thanks to Luella and Ed for sharing their thoughts with us.
We'll be back next time with our final episode of this season, where we're taking a deep dive into data to see just how transformational, having huge amounts of data available could be.
If you enjoy this episode and you want to let us know, please do get in touch on LinkedIn, Twitter, or Instagram. You can find us at TTP. And don't forget to subscribe and review Invent Health on your favourite podcast app, as it really helps others find our show.
We'll see you next time.