6 areas of UK health policy for Medtech to pay attention to

How is the UK political landscape evolving and what does this mean for Health Technology and Medical Device innovators?

Robert Hull (Senior Consultant – NHS Insight & Interaction, Mtech Access) speaks to William Lee (Head of Policy and Compliance, British Healthcare Trades Association [BHTA]) about health policy, regulation and its implications for Medtech, Health technologies, and Medical Device market access.

With the challenges of the pandemic and the changes brought in following Brexit, policy and compliance in the UK has been on shifting sands for several years now. With many predicting a change in government at the next election, this continues to be a time of uncertainty. What does this political landscape mean for health policy, the regulatory regime and market access?

In this on-demand webinar, Rob asks Bill about 6 areas where Medtech should be paying attention:

• MHRA and new medical device regulatory regime
• UK health and social care supply and procurement
• Sustainability and social value
• Addressing capacity challenges with effective health and social care packages
• Innovation
• Export and import – the implications of Brexit

This episode was first broadcast as a live webinar in July 2023.  Learn more about this webinar at:  https://mtechaccess.co.uk/uk-health-policy-medtech-bhta-webinar/

Learn more about our services for Medtech companies at: https://mtechaccess.co.uk/medical-device-market-access/

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Chapters

• 0:00 Welcome and introductions
• 5:26 Key challenges Medtech companies consistently face
• 11:03 MHRA and new medical device regulatory regime
• 27:25 UK health and social care supply and procurement
• 36:00 How can Medtech be part of the solution?
• 45:14 Innovation and policy
• 52:34 Export and import (Brexit implications)

Transcript

0:00

- [Narrator] Welcome, to this Mtech Access webinar. At Mtech Access, we provide health economics and outcomes research and market access services from strategy through to implementation. Our unique NHS relationships guide and validate everything we do in the UK. We work with over 80 NHS associates to bring our pharmaceutical and Medtech clients authentic insights into the NHS. We can help you answer key questions related to the NHS. From how to communicate with integrated care systems, places, and primary care networks. To how to capture pathways of care. Get in touch today to discuss your market access goals. First, though, I hope you enjoy the webinar.- Hello everybody, and welcome to this Mtech Access webinar. I'm Robert Hull. I'm a senior consultant at Mtech access, within the NHS Insights and Interactions team. And today we're going to be having a webinar, in which we've called six areas of the UK health policy for Medtech to pay attention to. And before we kick off, just sort of a couple of house rules. So unfortunately we're unable to take sort of verbal questions, but there is a chat running. So if you have any questions throughout the session, please do pop them in the chat and we'll try and pick those up, as we go through the session and sort of answer them if we can. We've got a sort of question and answer format. And sort of at the end of each section, if we sort of feel it's appropriate and we have the time, then we'll ask. We'll take some of those questions from the audience. And if we have some time at the end, we'll also try and answer some questions there. For those of you who don't know Mtech access very well, we're a specialist health economics outcomes market access consultancy. With a strong track record in expert delivery. We provide a lot of specialist support to pharmaceutical and MedTech clients. And we work as a collaborative partner with the NHS. Both sort of with them and for them, sort of going backwards and then forth there. But today we're focusing on MedTech, and sort of the evolving policy and regulatory landscape, for these technologies. With a focus on, as I said, those six areas, that would be really good to pay attention to, if you're in MedTech at the moment. And I'm really delighted and excited to welcome our guest today. This is Bill Lee, from the British Healthcare Trades Association. And he's here to provide us with some expert insight into this really exciting, but rapidly changing areas of policy and regulation. So, hello and welcome, Bill. Would you be able to take a moment to introduce yourself in the BHTA?- Yep, absolutely. Very pleased to be here, Rob. And very pleased to be speaking to the Mtech Access audience. As Rob says, my name is Bill Lee. You can hear from the sound of my voice, that I'm American. Don't worry, I've lived here for 20 years. So, I think every time, I think I've just about got everything there is to know, to learn about the UK, test cricket reemerges. And I know that we're in the midst of that. So, please bear with me. But, you know, all by way of saying I feel like a, a cultural Brit. If you know, an American by birth. The British Healthcare Trades Association of which I am the head of policy and compliance, is a trade organisation that was founded in 1917. To look after the needs and interests of soldiers returning with life-changing injuries from the Great War. And that makes us one of Britain's older trade associations. And we've expanded now, and changed over the years into, you know, what is more traditionally recognisable as a trade association. Looking after manufacturers, distributors and resellers of retailers rather of assistive technology and health tech, in the, you know, in the mobility space. And in the assistive technology space. So that's everything from stoma and continence products, through to mobility scooters and powered wheelchairs. Many, many items that are medical devices and therefore, the new medical device regulatory regime is something that our members are, you know, consistently interested in. I've been at BHTA since June of 2021. My previous health tech experience comes from working at the Quango and UK Central Government level in special projects teams that helped bioscience and research organisations deal with violent extremism. And before that I had a career in research and advocacy across a number of fronts most prominently. Helping survivors of the Holocaust and their families get back bank accounts, insurance policies and art that had been stolen by the Nazis. So every time I think to myself, well, the UK regime is complicated, and then I think back and think, Hmm, but you know, there are more complicated things. But it's that perspective that I am bringing to the regulatory piece of things. So, delighted to talk to you today about, you know, what this landscape looks like.- Thank you. So, It's a really interesting career. I'm glad that our regulatory regime is less complicated than some things. This gives us some succour. Before we sort of dive into these six areas, I just wondered, would you be able to sort of run over maybe some of the key challenges that you see that MedTech companies consistently face. What's your sort of from your role in the BHTA?- Absolutely, yeah. We, like many trade associations, we survey our, you know, members on a semi-regular basis. You know, I think it would surprise nobody on this call to know that, you know, 9 out of 10 of our members, when we surveyed them in the autumn of last year, said that they were facing, you know, extraordinary financial pressure. Fully, a third of them said that, some of the pressures that they were facing, or rather the pressures that they were facing were enough to make them consider leaving the UK market, or deprioritising the UK market in favour of other easier to negotiate regulatory landscapes, market access landscapes. And I think there are a lot of reasons for that. You know, certainly production costs, if you're a manufacturer. UK manufacturers have absorbed around about a 20 to 25% increase in raw materials. If you look at the last five years. If you're not a manufacturer, if you're a distributor, you know, you face very much more expensive and frankly, complex distribution. Channel costs and administration. No one needs reminding about the rise of shipping container costs across 2020 and 2021. You know, that's shipping container prices shoot up by as much as 800%. I think another across the board issue that we hear quite a lot, is the cost of staffing. And, you know, with ONS figures showing, you know, between a 15 and 20% rise in weekly earnings since 2017. Fairly consistently. You know, that is a major issue for many of our members. UK inflation, again, I don't want to give anyone hives by talking about inflation, but you know, although it's creeping back down, you know, UK inflation at record levels is certainly not helping that staffing cost piece. And finally, you know, I think one of the most commonly, mentioned pieces of overhead expenses, of course, the cost of energy. I think this too is changing for the better. Although not, you know, as quickly as anyone would like. And indeed, you know, we have spoken to some manufacturers who were exploring things, like purchasing industrial natural gas power generators. Because of their belief that it was cheaper to make their own electricity rather than to buy it. That is an extreme case, and I don't want to be, you know, making the logical error of arguing the general from the particular. But I think, you know, the fact that anyone is considering that, you know, does speak to the severity of the problem. So, I think that's kind of the general, you know, that's a handful of factors that affect industry in general. And, MedTech in particular. I think as well for MedTech in particular, there are some really vexing and interesting questions that we're going to get into, in our discussion of the six areas around things like sustainability and social value. And I think the use of plastics, is something that's particularly, you know, of interest for MedTech. But that's a sort of flavour of the general background.- That's really helpful, thank you. I don't want to dwell too much on the more systemic issues. But if anybody sort of from MedTech background is listening at the moment and is thinking, well, you know, identify with these challenges, I understand them. Is that the sort of thing they should be coming to the BHTA with. Maybe from a little bit of advice or guidance?- Yeah, I think, definitely. I mean, I think one of the strengths of the BHTA as with, you know, any membership organisation, is the ability to, you know, put people in touch. To talk about how this problem is being addressed. You know, in a variety of ways. So, one of the things that our members regard, I think is most helpful is, you know, the creation and the facilitation of a safe space to have some dialogue about you know, different companies are approaching this differently. And there are different ways to approach it. I mean, there are particular approaches that an SME might take with regard to sustainability and social value. That will be different to the approach of a large corporate. Likewise, you know, there are things that if you're a small company, you are not going to be able to do, to defray. For instance, some of the systemic economic factors. So, I'm thinking specifically here, of things like transfer pricing. Or the movement of costs, you know, between operational units. But absolutely Rob, I think the, you know, the power of the BHTA, it's membership lies in members being able to say, yeah, this is really vexing, and here, you know, here's one way that we've approached that. I can't think of anyone who would even get close to saying, they think they figured it all out. And I think everyone feels like, they have quite a lot to learn.- Yeah, it's definitely a very challenging landscape. To sort of dive into those six, then key areas. I think it leads on quite nicely. I think it's fair to say that, that the MedTech regulatory regime in the UK, I think we say it's an evolving landscape. But it's sort of every couple of weeks, paradigms shift, and the ground moves underneath us. So, you know, there have been, you CA marking and UK CA marking, and how those deadlines have been changing them. Would you have any advice or maybe expand on that. Any advice, sort of MedTech companies, how do they position themselves so they can make sure that their current and future products or technologies are going to meet those regulatory hurdles, as soon as possible? Or, you know, maybe anticipate what they might be doing next if such a thing is possible?- Yeah, yeah, absolutely. Just to set the background, we'll, you know, certainly kick off with that piece. That is the, you know, the regulatory piece. Just to give you a preview of the six areas. You know, really the first of those six as Rob says, that we're going to talk about, is regulating for safe, effective UK medical devices. The second is about regularising sustainability and social value. The third is around releasing NHS capacity. Specifically industry partnership, you know, for effective health and social care delivery. The fourth is around rethinking procurement. The fifth is around rethinking innovation adoption. And the sixth is around reducing export barriers. So six Rs for lack of a more heartful term. And the first R, Rob, as you said, that's absolutely vexing people, I think to a degree that, you know, I certainly, I have not seen in the UK before now. I struggle to think of a time in the US when I worked in with state and federal governments in the US. You know, I can't think of a time when the regulatory landscape has been more uncertain. I think the first thing to recognise, and the first thing for MedTech, MedTech companies from the regulatory standpoint, to communicate outside just the specialist regulatory team. Is the sheer uniqueness and complexity of the issue right now. And what I mean by that is, that right now, and for one could argue the foreseeable future, there is no single law regulation or market access route for UK medical devices. In a very real way, UK medical devices and the regulation, that governs their sale exists in a sort of past, present, future state. That will only, you know, become more complicated and deliver unwanted results for patients for NHS, for social care systems. As well as for UK PLC. Unless industry, in partnership with the regulator, MHRA, you know, plots a very careful course. And of course, this is a fantastic example. Something else that I think regulatory professionals can do well to remind their other corporate colleagues. This is a great example of the box of things that you can control. Being, you know, a matchbox, compared to the lorry load of things that you can't control. So I think the first thing, one of the first steps that companies, you know, we see successful companies taking with their approach to regulation, is identifying the factors that are within their control. And the first of those is, is really identifying, you know, well, what does the landscape currently look like? So we at BHTA, have worked quite a lot ourselves and in partnership with other trade associations to, you know, create guides, templates, pieces of collateral that explain, you know, what the landscape looks like. And how to progress through it. So the currently applicable, you know, UK Law of the Land, is UK is the UK Medical Device regulations 2002. And its amendments. And that is the piece of secondary legislation in the UK, that enacted EU MDD or the EU Medical Devices Directive. That as listeners here and anyone who has had the privilege of working with medical device regulation for the last few years, will know, that is the subject of a lot of change and a lot of discussion. MHRA has, you know, consulted on this in the autumn of 2021. And is in the process of reforming the UK medical device regime. So, you know, the second thing that's important to remember is that, although UK MDR 2002 is the applicable sort of UK law of the land at the moment, there are market access provisions in the EU medical device regulation or EU MDR, which have to be taken into account for market access purposes in the UK. And really there we're talking about the things that allow a medical device manufacturer to put a CE mark on their product. And the UK regime in the form of of MHRA has, I think we in the trade association world, would like to think with our help, but maybe sometimes in spite of our insistence, you know, they have made concessions that see, you know, some transition deadlines that mean that the CE mark will be accepted in the UK until quite some time from now. So between 2028 and 2030. Depending on the class of UK medical or of medical device. So currently applicable law of Land UK MDR, but have to take into account EU MDR for market access purposes. And that again, is while, you know, we're awaiting the continued opera. Why I would call the continued operationalization of future UK regulations via the MHRA. Now those are going to require per market in the UK. a UK CA mark for GB. A CE mark for any product that's sold in the EU or Northern Ireland. And finally, in some circumstances for Northern Ireland, a UK and I mark. So any of those three marks, unless the medical devices of the simplest kind, that is class one medical device, which doesn't require third party assessment. But can be declared in a declaration of conformity by the manufacturer itself. Unless it's that simple class one medical device. Any of those marks, obtaining any of those marks, has to involve, you know, a conformity assessment body, or an approved body here in the UK. And in the EU, those are EU notified bodies. And there are a finite group of those companies. Again, people on this call will need no reminding that, you know, it's not like there's an unlimited supply of those kinds of companies. And one of the things that we would encourage companies to do, and we've seen the more successful companies in our membership do, is to really communicate early and often with your existing approved body. Whether that is a UK approved body or an EU notified body. Because capacity at those bodies is, you know, a serious, is a serious issue. And it's something that we and other trade associations have been, you know, working with MHRA quite a bit to hammer home, in terms of the importance of transitional arrangements being as lenient as possible. So, all of that's a very, sort of long lead in to saying, I think the first piece of dealing with all of this uncertainty is identifying the things about which you can be certain. I think that when it comes to keeping abreast of the changes that, you know, are certain to come down the pike, again, BHTA along with our other trade association colleagues, try very hard to keep our various memberships, you know, informed. I think one of the things that we're trying to work on with MHRA. And this isn't just an MHRA problem. Although I would argue, it's particularly acute in MHRA, is, you know, recognising the reality of corporate. The ability of corporations to move when you announce a change. That is, you know, one thing that corporations in the markets that they make up don't like, is uncertainty. And we have been really pressing MHRA quite hard to say, here is our roadmap, to what the future medical device regime will look like. Here are the times when we anticipate making changes. Here are the areas where we don't, you know, we can't predict with any certainty. And here is what the end state should look like. I would say that MHRA is getting much better at doing that. I would just as strongly say, that I think, and I don't think MHRA is unique in this regard. This has been a difficult journey to use the American word, for government over the last, you know, 24 to let's say 36 months. And I think it's, you know, I think, I think anyone in a regulatory function would do well to make plans now that, you know, sort of for the corporation, and from an internal company standpoint, you know, can be flexed to deal with whatever shape the government might take, in the near future. Our conversations with those who are much closer to the, you know, political grindstone than we are, you know, indicate that will come as a shock to nobody that, you know, it's going to be an interesting 18 to 24 months in UK political terms. So, I think companies having a plan that is, you know, flexible enough to deal with, you know, whatever that government looks like and whatever that regulatory regime might look like is, you know, and that's a pretty obvious and non-controversial thing to say. But for instance, at BHTA, one of the things that we've built for our members is a guide for registering medical devices in the UK. That sets out at a very fundamental level. Here are the steps that you have to go through. From defining whether something actually is a medical device. To figuring out which class it is. To figuring out exactly what kind of marketing you have to put on it. Based on its risk classification. And based on the law under which you are declaring compliance. And unfortunately, I think that there is, in this regard, when it comes to policy right now, you know, I don't think there are a great number of shortcuts. I think you actually kind of have to do the homework.- Yeah.- So that you're ready. That said, I think MHRA really wants to, it sounds to me from our interactions with them, like they really want to return to the days when they were regarded as very pragmatic and very sort of straightforward. That is when they were one of, you know, 28 competent authorities. I think the challenge they face right now is, you know, sticking the landing on the move, from being one of 28 competent authorities to being a sovereign regulator in your own right, is a very difficult thing to pull off.- But yeah, I guess maybe the key takeaway if I'm pulling that out there, is to engage early and stay up to date with that landscape. So making sure that if you know, you contacted your regulatory authorities you are in the queue, if you need to be in order to have your device assessed. And do that well ahead of time.- Yeah, I think that's absolutely right. And I think the good news is, as I say, for, you know, for the vast majority of class one medical devices that is, devices don't need, you know, third party involvement. You know, you have, you have as a company more control, because you are the one responsible for keeping the technical file. I think even if you do work with a, you know, with a notified body or an approved body. Because you have a class two or above device, you know, as you say, Rob, interacting with them early and often is definitely the way to go. I think the three things that are really important to remember about the landscape right now, as we know it, is the new UK medical device regime, is planned to come into effect on the 1st of July, 2025. And the transitional arrangements state, roughly speaking the following. For devices that are CE marked under EU MDR, that is medical devices, CE marked under EU MDR, those can stay on the GB market without a UKCA mark. That's the new mark, that will be required under the UK regime. Until the 1st of July, 2030. So that's up to five years after the new regulations take effect. The second transitional arrangement, says that devices that are CE marked under EU MDD can stay on the GB market without a UK CA mark. So, with their existing CE mark. Until the sooner of one of two things. Either the current CE certificate expires. Or for three years after the new regulations take effect. So that takes us out to the 1st of July, 2028.- Thank you.- So, I think, you know, I think those are the really important landmarks from the regulatory, you know, from the regulatory standpoint. I think that, you know, to the degree that companies are, you know, comfortable talking about how this complicates their decision making. You know, for those that are working with, you know, consultants, regulatory colleagues at trade bodies. You know, I think communicating really clearly what it means for you as a company to lack a, you know, clear, sensible, consistent roadmap for the new UK medical device regime A clear, consistent, sensible timeline. Worries about classification disputes. That is where the MHRA might have a different view on the classification of an object. Is it a class one device? Is a class one or class two? Versus let's say a sister regulator in the EU. And I think to the degree that companies are comfortable sharing how frustrating that is. There can never be too many examples for government to listen to. And I think that, you know, when the sort of silver lining that I would point to is that when we as a trade association have made those kinds of representations to MHRA on behalf of our members. You know, in all the you know, vanishingly rare handful of cases, they have, you know, they've done the sensible thing. I think what we struggle with, and what many companies struggle with, is that's not a very scalable way to, you know, if every time you have to write a special email saying, you know...- Yeah, It's just not cost effective or time effective, rather.- Correct, cool.- To move us to our next topic, just to make sure, we have the time for all six. So we've got the regulatory pictures is moving. That's also sort of the emphasis of the NHS has been placing on social value, sustainability, and sort of value-based procurement. That's been really increasing. We're sort of seeing that, sort of through the initiatives, like the net zero agenda. What are the key messages that you would say to MedTech companies that they should be trying to convey to the NHS to sort of, you know, have the best chance of having their product to be taken up?- Yeah, so I think this is, you know, this is a really interesting, this is a really interesting piece of discussion. And, and the reason... One of the things, I think, makes it so interesting, is that this is relatively, relatively new for all of the participants in this process. It's new for the NHS. It's definitely new for supply chain. NHS supply chain that is. And it can be new for many companies. I think what we hear from our membership is, the work that the NHS in particular has done around saying, look, here is how we define sustainability. Here's how we define social value. Is quite good. And that's work that's going on via things like, the NHS Sustainable Supplier Forum. If you're a supplier to the NHS, and that's, you know, not something that you've heard of. You know, please feel free to drop us an email after this and we can tell you, how to get involved with that. You know, I think when it comes to implementing the two policy procurement notes that you know, that govern the cross governmental approach to sustainability and social value. And that's PPN 0620 and PPN 0621. The NHS has actually done quite a good job at saying, here's what we expect. And really what they expect is that, you know, on a sliding timescale, you know, companies will start to share the burden of their scope one, scope two and scope three emissions in the sustainability piece. And will, you know, make positive moves to responsible social value at the same time. I think all of that, is the good news. I think the challenging news, is that what we see in here, is that there is still a less than consistent application, of scoring and weighting of sustainability and social value across the NHS. So you might have, you know, one trust that scores and weights social value in a certain way. Or you might have one framework agreement, right. That that scores and weights sustainability and social value in a certain way. And we as a trade association have really been concentrating a lot of our effort in regular way. Saying to government, look, in the form of things like the NHS sustainable supplier form, the NHS central commercial function. And I think this is an interesting note for those who've been around the NHS long, you know, the NHS has only had a central commercial function for a little over a year and a half. And sustainability and social value are cited within that function. It's the same function that also governs NHS supply chain. So from an organisational standpoint, this is, I think, a statement of how important they deem this. What we have been saying is, yeah, look, there are a lot of good efforts going on there. You need to now put some real resource behind that. And you need to say, this central commercial function and the sustainability and supply and social value programme that they're running, you know, they have the power to not just invite Trusts to participate. But to be a little bit more instructive. And that, you know, again, those of you who've worked with the NHS for much longer than I have, need no reminding that the attention between the command and control element of a national approach and the flexibility at the local Trust or ICS level, you know, if we skin that cat, then we've done something quite miraculous. So I'm not saying this is easy. But I am saying that that is an area, you know, that we as a trade association are focused on. I think for companies, the thing that they can do, is really, again, either working with a trade association like BHTA, possibly working with some consultants. And really, I think some careful internal thought. There are quite a lot of things that companies either already are doing or can do, relatively easily. That can fall under the sustainability or social value banner. And I think it's important to, you know, think about what one very senior NHS England Sustainability Executive said to our membership, at our conference. Around this time last year, September of 2022. And that is that the NHS position is not, you know, here is a box ticking exercise, here is, you know, something for you. Here are a bunch of hoops for you to jump through. If you really believe this, becoming sustainable and having a modern approach to social value doesn't make business sense. The rejoinder from NHS is, well, we think it does.'Cos now, if you want to do business with us, you know, we'd like to hear why you believe it makes good sense. I think what we, you know, again, at Trusts and within NHS supply chain frameworks that are functioning at what we would consider to be the most productive level. There is an interest in hearing about how companies do this. You know, on an individual basis. So, there may be some things that your company is doing. You know, that are really valuable, that might not quite fit in, you know, one tiny box of definition. But indeed, you know, do excite a response. So, I think, you know, understanding, and again, this can be done through your trade association. Hopefully it can be done, more and more in direct conversation with procurement officials. You know, but really explaining some of your efforts, your corporate efforts, and making sure that, you know, you're getting credit for some things that you might already be doing. That just haven't been sort of calculated under the banner of, you know, of sustainability or social value. But could very well be. And we work with, you know, again, one of the things that BHTA is going to be calling for in a sort of, we would like this. No matter what stripe the government is. You know, is a national stakeholder forum. To share some of this best practise. Because, what I do see often, is sometimes, you know, a particular Trust or a particular ICS will have a really good idea. And the minute that another Trust or another ICS figures that out, you know, everyone wants to copy that. And again, the NHS central commercial functions, and part of one of the major things that they're trying to do, is identify those opportunities, those efficiencies. Those nifty things that are going on. And figure out how to deploy them at scale across the NHS.- Yeah, it's always that tension between what's sort of the national view and how you can implement that effectively on the ground. And I think, I'd be really excited if and when that forum becomes part of it. I'd be very interested to hear what they have to say and to take part. I think just be good to understand, because at the moment, our understanding is that you just, yeah, you go to one place and they'll have one set of understandings of how net zero works. And what they should be counting and go somewhere else that's very different. But I guess, in terms of another problem that's sort of on the list of things that may have a more local impact or has to be worked out more locally anyway, is, you know, capacity and challenges with effective health. So, you know, we, hear about urgent care, patient flow and discharge, and that we're still hearing about those. And it hasn't gone away for as long as I can remember. So I guess the question, this is next on my list, is why are these still priority issues? Why have they not been addressed? And, you know, what can MedTech companies be doing to signal that they can be maybe part of the solution there. And I think all links into social care as well. Which I don't think anybody's cracked yet. But, you know, how can MedTech companies basically address the capacity challenges within the NHS and ensure that their social care packages are suitable for use in the NHS?- Yeah, I mean, I think it's a, you know, it's a great question. And I think it's one of the things that makes right now, a fascinating time to be alive and considering this, is that integration of health and social care, you know, have been the subject of so much attention in the form of green papers, white papers, government statements. That, and a very fundamental level. I mean, if you, you know, if you look at what the government has said about the move to ICS, from CCGs to ICSs, essentially what they're, part of what they're trying to do is drive organizationally, a set of efficiencies that will allow more flexibility at the local level. And should, in theory, if done right, allow more integration of health and social care budgets. You know, I don't think for a moment that, that's, you know, a simple task or easily done. and BHTA and others, have been trying to hold them. You know, the government to account on this. Because in some ways, you know, the metaphor that I've always used is, you know, you're shrinking from several hundred CCGs to 42 ICSs. So that's a centralization move. So the sponge of your cake is centralised. But all of your communications says that this is to promote local flexibility. So you're frosting your centralisation sponge with a federated buttercream, right. Which is a difficult streak to pull off- Yeah, yeah.- But I think that, you know, one of the first things to think about for health and social care companies is, and you know, health tech, in this space, is really to hold the NHS and the government to account to some things that they've said very publicly. And we've heard for about two years, NHS leaders getting up at public forums saying, there is no way, that the modern NHS can deliver without strong partnership with industry. We cannot do this without our suppliers. And I think that all you need to do, is keep in mind a statistic. You know, something like this happens to be one of my favourites. You know, here we are living in a time where the lifespan of the NHS is 75 years. Is now longer than the average healthy life expectancy of UK adults. According to the latest global burden of disease study. 68.9 years. Right, so the NHS is now outliving the healthy lifespan of UK adults. And UK adults are you know, can be expected to spend, you know, between 12 and 12 and a half years living with illness or disability. So I think, I think that top line is the place to start. And then I think, you know, tying some of the things that companies can do, to things that are very hard for the NHS. Would be very hard for them to look this gift horse in the mouth, for instance. So think about things like workforce expansion. You know, there are some BHTA members working in you know, in, various of our sections. That's what we call the different parts of our membership. So I'm thinking here of, in particular, our prosthetics and orthotics companies. You know, they're investing a great deal in the training and future of health and social care professionals in their area. Prosthetists, Orthotists and specialist occupational therapists. So whether that's sponsoring more school places, expanding postgraduate training programmes. And all with an eye toward, you know, better recruitment training and retention of these folks. Now, that's one way that they can positively influence the workforce. You know, struggle that the NHS is currently having. I think staffing flexibility. If you look at the things that the NHS says about staffing flexibility. You know, we have some members of our independent living mobility and stair lifts and access companies, that during the pandemic, you know, developed what amounts to essentially a brand new care pathway. I mean, it's a little bit overblown to call it that. But what they did, was to develop virtual assessments. A way to do assessments for equipment that would be used in someone's home via a video call. And this not only reduced burden on the NHS, but ensured that, you know, patients and carers still could get these technologies. This was at the height of the pandemic. At a time when there was a huge community care backlog. Estimates range from 750,000 to 900,000 people in 2021. We were waiting for these kinds of things. So I think there again, are things that companies might be doing already. In terms of, you know, a move to the virtual world. That you should look at and think about, when you're thinking about, you know, helping the NHS to help itself. I think that extends to things like technology adoption. And this doesn't have to be particularly fancy. So for instance, we have some community equipment suppliers, who are using a... It would be going too far to call it a telehealth solution. It's really a quite nuanced and sophisticated automated calling system. That has driven a huge uptick in the return of community equipment. Community equipment like crutches, wheelchairs. Those often gets forgotten. And a Trust can find itself out of pocket, when in fact, a lot of the stuff isn't being used anymore. It just hasn't been returned. So, you know, I think, I think those are at the easier end. I think at the more sophisticated end, you know, you have things like the possibility of partnering with the NHS. So for instance, we have a company that, you know, has pulled forward essentially a reablement programme. So this is physical therapy and equipment trialling into the hospital, And it's led in their particular area to a 42% reduction per patient days per stay. And it's impressed this particular NHS trust, that they're rolling it out, at all of the hospitals within their trust. And again, that's something that this company developed. You know, with an eye toward serving their customers more quickly. In a way that, you know, reflected their customer's needs. You know, more accurately. And then, you know, I think there are things that can be done, that if, you know, if you are involved, for instance, in... If you're an existing supplier on an NHS framework, for instance, I think there are things that you can do from within that, from within that framework. Whether that's, you know, for instance, talking about, you know, if it's say a service to provide mattresses to an NHS trust, right. There are a number of steps in that plan, that a company who's trying to operate that service at a profit can identify that. It can probably streamline things. In ways that, you know, the NHS might not necessarily think of on their own. So, you know, I think that any... Again, I would be very surprised if, you know, conversation partners at the NHS alongside any of the people on this call today would sort of turn away from those kinds of opportunities.- Yeah, thank you. That's really interesting. My next question was around sort of, you know, how MedTech companies can understand the sort of, you know, what you know, basically their customers need. But I think you've covered that pretty well. It's really important to understand who your market is. What sort of questions they're going to be asking. And, you know, and having the evidence that aligns with that. To demonstrate it that, you know, when we put in whatever it is, you're going to put in or whatever service it is, that you can actually really deliver that value and probably at quite fast pace. And if it's going to have make a cost saving, then, you know, when will that cost saving land? But yeah, in the interest of time to make sure we get to all those bits. My question after that was, you know, a big push around innovation at the moment. So, you know, MedTech is really, I think, at the forefront of that. And we see a huge amount, you know, in new technologies embracing AI. It'd be really great to sort of understand what you think is happening in the policy environment. And, you know, is it keeping up with it? How can companies best align there?- Yeah. So I think innovation is a perennial topic, that is of interest to certainly to our members. And it's something that I know, you know, the NHS has grappled with for quite some time. And to hear again, folks who've been doing this with the NHS for longer than I have, I think really, one of the things that they're almost always talking about, but is sometimes said is you know, what companies are really concerned with is innovation adoption. I hear companies saying all the time, look, I can be as innovative as I want. I can even succeed in getting that innovative product onto an NHS framework. But I can't make them adopt it. And I think, you know, the sort of glass half empty view, that I've heard expressed several times is, yeah, the NHS loves innovation that's tried, tested cheap. Universally available, and is essentially a commodity, Which is, you know, an oversimplification. But I think does capture industry's frustration to a degree. I think the good news is however, that you've got now at... So for instance, within the Department of Health and Social Care, there is the MedTech directorate. And this is effectively a sort of internal policy, Thinktech. And the Medtech directorate is headed by a gentleman who was the head of procurement, for guys in St. Thomas's Hospital Trust. One of the largest London Hospital Trusts. And so, really understands from the procurement point of view, how difficult is the challenge of driving innovation adoption. I think that what companies can do, is take advantage of the existing NHS approaches to innovation. So for instance, I'm thinking of things like the NHS Accelerated Access Collaborative. This is again, a programme that we can tell you more about if that doesn't ring a bell. And this is a collaborative effort of NHS England Allied Health. What used to be called AHSNs. Robbie, you're going to have to remind me. I know that they've changed their name.- Academic Health Science Networks. But I think they're becoming Health Innovation Networks soon.- I think exactly so. Exactly so. With an eye toward underscoring the importance of innovation. So a process exists whereby companies can register their product. As innovative, and bring it to the attention of the, I guess, for lack of a better word, the NHS buying public. But I think, the thing for companies to do, is to come with as much data as possible, right. This is always easy. Some of our members work in areas. I'm thinking here of stoma and incontinence products, right. The end of your statistical sample is not ever going to be big enough to present randomised controlled data or something really statistically valid. I think we and other trade associations have succeeded and it's going to take the next two or three years to figure out. You know, whether we really succeeded, in getting government in the form of DHSC, in the form of nice. In the form of MHRA. In the of NHS to realise that there are other ways. You know, whether that's pre-market data. Whether it's post-market data. You know, there are things other than just randomised control trials. So I think coming armed with the data is an important piece. I think coming armed with an understanding of your company's definition of innovation is also important. People bring up innovation, I'm always tempted right off the bat to just completely halt the conversation, and say, what do you mean by that?- You ask two people, and you get three answers.- Exactly. Exactly. And I think, you know, again, at the risk of an antiquated term. I think NHS and DHSC are grasping the nettle, right, on this one. And understanding that to be successful and really BHTA full disclosure. BHTA has not been backward in coming forward, about what we consider to be a lack of performance on the NHS's part. So, for instance, we asked a parliamentary question, in 2021 about, you know, how many technologies had been. Innovative technologies had been taken up through the NHS's immediately previous innovation adoption programme, which was called Health Tech Connect. And the answer was, in the 12 month period about which we asked, which was 2020,2021. A 180 technologies had been submitted. 142 had been passed on to NHS supply chain. And zero had been taken up.- Yeah.- Which is a crushing. I mean, that's exactly the kind of thing that's crushing for, you know, an R and D department at a UK, you know, health tech manufacturer here. So I think, you know, government is you know, we and other trade associations have worked hard to say, look, this is a sector that contributes 13.5 billion to the UK export economy alone. For instance, or sorry, to the UK economy alone. 6 billion of that, or there's an additional 6 billion for UK health tech exports. So this is not, you know, this is not an industry that's small. So, I think they're beginning to, you know, I think they're beginning to understand that, you know, the NHS needs to be a little bit more innovation friendly. I would say, and I suspect this might lead on to, you know, one of your next questions. One of the things that's always important when thinking about innovation adoption, is to think about making life as easy as possible for people in the procurement function to understand, you know, why is this innovative? And what makes this attractive? And I think the degree to which you can, you know, the degree to which you can make that easy for them is a very important thing to do.- Yeah, absolutely. So we're running out of time. So I think, yeah, I think aligning that value proposition is a big part of what we do at the Mtech Access’ NHS Insight and Interaction team is, you know, going and having those conversations with those key people and saying, what do you actually want to see? You know, what evidence is going to make you engage. You have to get some clinical people in. Let's get some clinical people in, so that when you bring that product to them, you know, you already have those answers. You know, might be in a slightly different Trust or whatever. But you know, at least you're not sort of grasping for what you think they might want. But hopefully what they do want. So I guess I, yeah, I think we, we've got... sort of a couple or a minute to sort of go into, sort of anything else that you'd like to talk about on value propositions. But then sort of moving into export and import implications. You know, they're getting increasingly difficult. Obviously no one likes the word Brexit. But it's omnipresent. And it has to be one of those nettles that is grasped. So yeah, just any sort of quick remaining thoughts on the procurement side. And yeah, onto Brexit, if that's okay?- Yeah, absolutely. I think, you know, just to close off the procurement and innovation discussion. I mean, one of the things that we and others are calling for, is a, you know, a single front door, right. A unified information office, led by DH. And a reorganisation of health and social care procurement around the value-based procurement principles, that we hear senior leaders at NHS England and NHS supply chain talk about. But seem to be a little thin on the ground when it comes to conversations with, you know, for lack of a better word, the coalface procurement partners. Again, BHTA, if it's of interest to people on this call, has provided for its members, you know, some toolkits. That are aimed at helping people have that conversation. That is the value-based procurement principle conversation, with NHS supply chain and other large commissioners. When it comes to export, and reducing export barriers. You know, as you rightly say, no one really wants to bring up the B word. But, you know, it seems clear that for our members, and I suspect for, you know, anyone listening today, you know, what's really desired is a consistent frictionless trading relationship between UK health and social care exporters, and their global partners. Especially the EU. I think, again, here, like sustainability and social value, we are fortunate to have three things that are in the public domain. The first of those is the 2025 UK border strategy. Which is an HMG document. The second is the UK export strategy. Which is a treasury. I think, and bays as it was co-production. And then the UK single trade window consultation. And in those three documents, you know, there are many principles, that, there are principles that we think if enacted properly, will actually deliver what UK exporters want. So whether that's the 12 point export plan. As expressed in the export strategy. Or whether it's a single trade window that, you know, that sees off some of the technology challenges that are currently bedeviling people at the border. We think that, you know, the tools are there. It's now just time to deploy them and use them.- Yeah. Okay. Thank you. That's, yeah, it's really helpful. No one wants to say the B word. But unless you sort of take the steps and engage with, you know, how, how the policy is going to change. And that may, you know, it will continue to change probably for many years to come. Then we won't be able to address it. So, I guess, my last question for now, is to round it out, you know, what do you think could be on the horizon? Maybe other than Brexit. That's coming down the track. Maybe just sort of a couple of things that MedTech companies can just think about. You know, probably don't have to do anything yet, maybe. Or maybe they do. But, you know, in a couple of years, what should they be looking out for?- So, I mean, I think, I think the role of AI is certainly something that, you know, MedTech companies should be thinking about. Probably already are thinking about. I think that, again, MedTech companies probably have a, you know, a unique opportunity in comparison to some other sectors, to bring to the AI offer. Some of the clinical rigour that would have to be present. In, let's say, innovative R and D on a medicine. Or innovative R and D, or, R and D on an innovative medical device. I think the risk with AI, is that a lot gets said. And it's, you know, sounds like a very sort of, you know, interesting. Sounds like one of those things that everyone thinks, Oh, I better pay attention to this. But I think MedTech companies have a, you know, have a, a perhaps a leg up on other industries, of being able to hold AI up to the light of the critical examination. That, you know, clinical developments have to undergo. That would put them ahead, right. In their ability to say to commissioners and government buyers, you know, look, this will deliver actual benefits and here's how. I think that's a very big piece. I think international regulatory harmonisation, even though that's one of those phrases that should come with a warning, like, do not operate heavy machinery while saying this phrase.- Absolutely. Yeah, yeah, yeah.- I think to the degree that companies, you know, can understand, Okay, our main markets are, let's say Australia, the UK, and the US. You know, I think keeping abreast of how those regulatory systems are either moving closer together or moving further apart is, you know, a really important thing to keep an eye on. I think that you know, some of the debate within MHRA and within the Department of Health to a degree, you know, I think, there is an acknowledgement of the need not to reinvent the wheel. And to make things as harmonious as possible. What I think is difficult sometimes, is that when you listen to lots and lots of these presentations, not just from MHRA, but from other global regulators. When they talk about international harmonisation, they are usually adopted, what I call the Wizard of Oz scarecrow pose, and say, well, we're going to recognise the, you know, the regulatory system from there. And everyone's pointing, you know, at a different regulatory system. And if you're, in harmony I think, is the thing to achieve. But the question is, if everyone's pointing at... Who's actually responsible for saying, and this is, you know, this is the regulatory regime of this device that has been produced. And finally, I think that, a clear understanding of supply chain has never been more important. And I think that we see successful companies in our membership, you know, building redundancies, of they're manufacturers into their supply chain. Whether that means, you know, looking at different suppliers that you can sort of engage in a retainer like relationship. If you need, for instance, raw polyester. If you buy, if you are a manufacturer who buys raw polyester by the mile. As some of our members do. You know, it's good to have a number of different sources like that. And, and then my final plea, I guess would be not to underestimate the employee value proposition hook, that comes from taking a responsible sustainability and social value stance. I've talked to a lot of graduate programmes. And although I envy absolutely no one entering the world of work, right now. I think it's clear that, you know, the employee value proposition is going to have to take into account a company's approach to sustainability and social value. No matter how big or small that company is. And I think the opportunity really is here. You know, to do something very positive about that. That will have virtuous effects. You know, create a sort of virtuous circle at your company. Because if you want to work with the likes of the NHS, you're going to have to be doing these things anyway. Many companies either have been doing them or are doing them already. But I think those four things. If in the future gazing peace. I think it's those four things, I would emphasise.- Thank you, It was really good. Thank you Bill for sharing your story at the start. And I think the policy insights that you brought today, have been really useful in particular. Any MedTech company looking to move forward. There's a lot to think about there. For pretty much any companies looking to get into the NHS, if they're not thinking about and engaging with these topics, I think they'll find it much more difficult than they can need to. Thank you to our audience today for listening. If you have any questions, please do email them in and we'll try and follow up on them, if we didn't have time to cover them today. Just as a one last final thought, Mtech Access is running a symposium event, this coming September. So, for those of you who might be interested in hearing more about sort of the work that we do, and sort of the things that the companies and the organisations that we're paired with, like Bill, the BHTA. And please do have a look at that. I think it's going to come through in some follow up material. But yes, thank you again, Bill. That was a really great and insightful talk. And thank you everyone. Goodbye.- Thanks for the opportunity. Thank you.- [Narrator] Thank you for watching. If you'd like to find out more about our work with the NHS, or how we could support your market access goals, please email info@mtechaccess.co.uk. Or visit our website at, mtechaccess.co.uk.