Evidence strategy for Medical Technologies and Diagnostics

Here, our experts explore evidence strategies for medical devices, diagnostics and digital health technologies.

Have you established the clinical and economic value of your medical device, diagnostic or digital technology? Do you have the evidence required to support your value proposition? Would a health technology assessment (HTA) route be appropriate for your product? What will payers, HTA agencies, and other key decision makers be looking for? And how should this information be presented?

In this episode, our experts in HTA, health economics, and commercialisation explore:
- How to identify and communicate the value of your product for patients and the wider healthcare system
- How to build a robust evidence package for successful launch and commercialisation
- Key requirements for the National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) or Diagnostics Assessment Programme (DAP)
- Next steps to take your innovation to healthcare leaders across the NHS and beyond, with an impactful customer communication strategy

This episode was first broadcast as a live webinar in January 2023. Learn more and request a copy of the slides at: https://mtechaccess.co.uk/evidence-strategy-for-medical-technologies-and-diagnostics/

Discover how Mtech Access can support your commercialisation journey at: https://mtechaccess.co.uk/medical-device-market-access/

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Transcript

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- Welcome please, everyone to today's webinar. Delighted you can join us as we look today dive into I think some of the intricacies of developing an effective evidence strategy for medical technologies and or diagnostics. And I feel, as I'm sure many of us do, that we're a currently the crucial juncture in our sector whereby successful integration of medical technologies into clinical practise is really starting to hinge on robust evidence strategies more so than ever. So our agenda today is really intended to empower you with the knowledge and the tools to navigate rather, in a necessary manner, this new and emerging landscape. Today we'll start off with a brief round of introductions for today's presenters before exploring the items that are listed on our agenda slide as we see here. And I think it's fair to say that the highlights, the key thrust of our webinar today is the introduction to, to those on the line to the NICE MedTech early technology technical rather assessment META Tool. The META Tool and NICE have developed the META Tool, META Tool in mind of really helping any and all developers of medical technologies at any stage of development. It's a process that in of itself is intended to help med tech companies and product developers to understand the evidence requirements for NICE or indeed other payers, maybe other HTA bodies or indeed other payers, as well as the impact actually that may persist or be relevant of differences between regulatory and payer frameworks. So we consider different frameworks in this regard and ultimately the META Tool is all about helping MedTech developers, product developers to reduce their costs and indeed the risk profile associated with developing that MedTech product. And towards the end of today's session, we'll look to touch on appropriate next steps resulting from engagement through the META Tool process, hopefully helping you to leave this webinar with at least the beginnings of a clear action plan. So I'll now be delighted to pass to my colleague Samantha Gillard to kindly kick off a brief round of introductions for the three presenters today before passing on to another colleague of mine, Hannah, and lastly myself. Thanks Sam.- Alright, my name is Sam Gillard. I'm HTA director here at Mtech Access. So I have more than 20 years experience in health technology assessment for both pharma and medical technologies and have helped and led on over 50 HTA submissions. The speed of innovation in the medical technology field is exceptional and one of the things that I really love about my job is being able to work with MedTech developers and help support them on their journey. I'll pass over to Hannah.- Thanks Sam. So I'm Hannah Palin, I'm one of the associate directors here in our market access function here at Mtech Access. And I guess my area of expertise is around the commercialisation and demonstration of value, usually intended for a more external audience perspective. So in or around launch, whether that be developed at a global level all the way through to a local market level. Hopefully many in your line have worked with either myself or the Mtech Access team in different roles. And so you'll know that we have a real wealth of experience in the team with supporting critical technology devices, diagnostics or any of those kind of attributes that fall under this category. And so it is one of our strengths here and it's fantastic to have Sam and Calum who are obviously gone through the META Tool facilitator process and it really is a fantastic offering alongside our other level of experience. So I'll hand over to Calum.- Thanks Hannah and thank you Sam. So my name's Calum Jones. I'm a Senior Consultant Health Economist at Mtech Access I day-to-day over the last 10 years. And to this point now specialise in developing cost effectiveness models, other forms of economic evaluations, econometric analysis as well for HTA submission purposes, or indeed perhaps more esoteric commercial local to regional submission or appraisal purposes. To that end, what I'll do is pass to Sam to take us into the next slide for simulation consideration leading up to the META Tool, thank you.- Thank you Calum. So market access in MedTech really refers to the strategies, activities, and that that ensure medical devices, diagnostics and digital health solutions are made accessible to both healthcare providers and to patients. MedTech for market access is a multifaceted process involving a complex landscape of regulatory and stakeholder challenges. And while many of the challenges facing MedTech market access are comparable to those with the pharma industry, there are some distinct differences. So one of those is around the life cycle. You think about drugs and the pharma environment, drugs typically don't change once they've gone onto the market and this is different. So medical technologies may often undergo updates and improvements as the device moves along their lifecycle journey. And this can have additional regulatory approval challenges and could impact on their market access as well. You think about the HTA criteria and health technology criteria, MedTech HTA focuses solely on costs, whereas for the pharma environment, it's more around cost effectiveness. So what's the cost and the benefit measured offered in terms of the cost per QALY. So if you think about that cost environment, costs for MedTech aren't just the cost of the technology itself, it's a much broader. So it's thinking about what's the impact on the NHS workflow, what's the need for training on the NHS, thinking about the product durability and any maintenance or training costs. And these all get incorporated in that overall cost for HTA. So when you are developing a product, and we'll talk about this in a moment, you really need to be aware of all of those aspects to incorporate into your overall sort of cost assessment. I guess along the similar lines, pricing needs to encompass all of those costs associated with the medical technology. Thinking about things like is there a cost associated with installation of the technology, what's the maintenance costs, how long and what's the life cycle of that product as well, and are there any training costs they all need to be considered within that pricing and reimbursement piece. Stakeholder engagement is obviously a very critical part of any market access strategy. And for medical technologies that group might be larger than it would be typically. So as well as people like payers and physicians, you may need to be talking to hospital procurement as well to be understanding their challenges and their needs. So the key aspect for all market access is identifying the value of your product and these fit within four key categories. So you need to understand your disease or the area that your device is treating or diagnosing. So what is the needs for that disease? How does your product fit within that? What's the treatment pathway? Where does your drug fit into that pathway? What comparative clinical value does your product bring? How does it fit? What is currently being used? How does your product better the current scenario? And then coming back to the economic, what is the economic value? Is the cost that you have that the NHS would have to pay? Is it worth that value to them? So all key values that you need to be understanding. And of course there are common challenges in that value demonstration. You may have challenges in terms of defining that treatment pathway and even identifying your comparators, particularly if you have a crowded area where there are lots of different competitors. Thinking about, and this is generally one of the key limitations in terms of medical technologies is the trial design. Have you got, have you got a trial is the first point. Sometimes you don't. Sometimes it's how do you even gain that evidence if you do have a trial, what population are you looking at? Are you looking at the full population that you're hoping to get approval for? Or is it just a subgroup? If it's a subgroup, how do those results translate to the wider population? What's the duration of your trial? Is it sufficient to be able to show a key benefit of your product? And how many patient numbers do you have? Is it representative enough to be valuable and to be seen valuable by both regulators and HTA bodies if you go down that route. One of the key challenges is a lack of head-to-head comparisons. So you may have a trial in a subgroup or a group of patients. How does it compare to what's currently being used or standard of care? One of the key challenges that is often faced and coming back to the trial design as well. One other common issue is your outcome that you are measuring the end outcome or is it a surrogate marker? So if you think, I'm trying to think of an example, something like, you know, something that may prevent deep vein thrombosis. Are you actually measuring DVT or are you measuring something different, for example, blood flow that you are then trying to link to that end outcome. Quality of life is something as well that is, it is good to measure. Again, coming back to medical technologies and of course it depends on whether you are working with a diagnostic rather than a device. But if you can, quality of life does help in terms of showing the value of your product. And then resource use, which is a key one as we mentioned, as I mentioned before, for that economic case, you need to be understanding what resources are associated with your device. If, for example, the use of your product reduces length of hospital stay for example, you need to be capturing that'cause you can include that in your economic analysis. So these are all challenges that need to be tackled. Ideally, early on in your development of your product, you need to be understanding where the gaps are and what you need to understand. And one of the sort of things that is key is thinking about this early strategic planning early. The earlier you can do that, the better outcomes that you'll have, and this is the case whether you're a startup company with a product that you are not planning yourself to take to market. It could be that you are a developer that then wants to sell on your product. You're still going to have to have this package of data that shows the value. And there are is things that both HTA bodies and investors will want to see these type of outcomes to show the value of your product. So it is really key to be able to look at these things early and have a strategic plan for them. So how do you build that robust evidence package? So again, if we come back to our buckets, which have shifted slightly but are overlapping, the first bucket is around unmet need. So you've got to understand the whole disease, the disease pathway, what's the burden of that disease both to the patient and to the healthcare authority. You need to be able to understand the current treatment pathway. Coming back to how does your device fit into the current treatment pathway and what does that mean for... What are the relevant comparators? Again, coming back to clinical evidence, which is key. Have you got clinical trials that show evidence and clinical effectiveness of your technology versus comparators? What have you got in terms of safety and adverse events? In thinking about things like medical devices, the adverse event profile may be very different, but it might, if you think about something like a pacemaker or some kind of implantable device like that. Part of those safety adverse events might be things like battery life or does it cause irritation? How many times have you had to have the device removed'cause of adverse events. So these are all things that need to be captured and sort of fitting in with that premise is well is quality of life. What is the quality of life impact of the technology? If we're looking at a a diagnostic test, obviously you need to go have to account for the accuracy of the diagnostic technology compared to current clinical practise. The other things to think about if clinical trial package is potentially a little bit weak or if you have real world clinical evidence, that's something that you would want to try and include there. And I guess the final bullet on this point is where there may be challenges with the clinical evidence, it's always worth getting clinical opinion or clinical expert elicitation as well. And then finally going back to the economics, as I've already mentioned, you're going to be wanting to assess the treatment costs, any healthcare resource use costs as well and think about the overall budget impact that the technology will have to the healthcare system. Okay, so I'm going to talk here a little bit about regulatory and HTA requirements. And this slide is based mainly on the UK landscape, but bear in mind that all of the evidence requirements that we've talked about will be common for whichever market you are you are looking for. But in terms of the UK, the medical devices and technologies, you need to have registration with the MHRA appropriate CE or UKCA marking. And then for digital technologies, it's around the DTAC approval. And in terms, if you do decide that you want to go for HTA, there's a number of different routes that technologies can go down at NICE So there's a diagnostic assessment programme, the medical technologies evaluation programme, where the majority of medical devices do go down in rare cases you may get rooted down the technology appraisal programme. This is relatively rare these days, but in the past technologies that did go down that route were things like hip replacement or (indistinct) devices and there's also the interventional procedures programme as well that they can be rooted down. So these are all things to bear in mind. I'm going to hand over to Calum now who's going to talk a little bit about the NICE META Tool.- Thank you Sam. So yes, thinking more specifically then about off the basis of what we've just gone through with Sam, what is the META Tool? And the META Tool service, it's worth first saying to that end, relating to the last slide, can be used on all medical technologies that have a CE mark or their expected or indeed required to obtain a CE mark. It's also suitable for advising on digital products and digital health interventions. It is worth noting that the META Tool isn't suitable for technologies that won't be used within a healthcare setting context. So we really are talking about healthcare implication and purpose here. And also to note that, and this is probably clear to most in the first instance anyway, but going through the META Tool process doesn't constitute a formal economic evaluation by NICE. It's an advisory capacity independent in nature by the facilitator. The potential benefits of going through the META Tool process really is subject to when you as the product developer opt to do so when you feel you, you require to do so. And in that respect, for example, in the early stages of product development, it could help you to understand the types of evidence you are likely to need further down the development pathway. And in that respect, hopefully guide efficient evidence collection strategies and broader sense of strategy development in contrast, in later stages of development of your product with a META Tool process and the consequence somebody report you'd receive through the META Tool process. This can act as a robust gap analysis, right? So it's helping you to understand and sense check just how ready you are for submitting to your target intended HTA body and or payer. To that end, be it NICE or an alternative HTA body or indeed more generally speaking other payers that you may be may have in your nascent strategy at this present time. We can see here on the left hand side, a summary of what the META Tool broadly aims to introduce and serve in terms of key objectives. The first, as we've touched on to some extent, albeit indirectly, is what it's looking to do is in the first move, understand and establish what the true value of your product is, both for patients and indeed the healthcare system. If we consider both in how we want to frame this value of a product that's most appropriate. And by using the META Tool, it can help or extensively the idea should help you to provide insights into how your product can make a key stakeholder relevant difference. In what way are you really changing the existing paradigm or portfolio available to payers? What's the nub of the benefit that's being introduced here, the value. Secondly, it should help you related to that to actually guide you to understand the evidence that your HTA or payer to stakeholder ultimately that you're aiming for will want and need to see from you. So it should help you to understand and establish a foundational understanding of the evidence that's required of you in your product more pertinently. And once you've established that, the META Tool process should help you to identify any gaps in your current package, right? So your package as is what's missing, where are the weaknesses perhaps. So of course this should help you towards ensuring that you and your team are well prepared and appropriately informed as to the strengths and potential areas for improvement in your evidence portfolio. And lastly, the tool process is intended really to help you to decide actually in a basic sense whether an HTA route is appropriate for your product. We've touched on this of course to a varying degree already, but it may be the case that it is not actually the either the prudent or the necessary approach instead a more regional or local focus may be preferable. And indeed to that end, it may not be, this may be a NICE META Tool, but it's not a UK only or NICE only tool in terms of the benefit it could provide, this could be for other HTA bodies. So in terms of the process of using the tool, I'm glad to say it's fairly straightforward and it comes down to three key steps that we have outlined here. The process as a whole is flexible, but it usually takes around a month, four weeks in all. Step one starts off simply with the product developer completing an online synopsis form. And this form asks you questions that cover a broad range of topics so that the independent facilitator of the process, the META Tool process, who's guiding you through this, is able to fully understand your product and where it is in development. And the areas that the synopsis covers would include information about your technology, what it's indicated. i.e., going to be used for, to treat for. What benefits your technology should does have for patients for the and for the wider healthcare system, considering both there, and what clinical and economic data have you collected to date, what do you have thus far and subsequently what evidence generation plans or related to that rather what evidence generation plans do you have for the future? So this is laying down a foundational assessment of what your technology is, what benefits and value you believe it to have and wish it to have and whatever economic and clinical data is collected thus far, what the plans are. Crucially, therefore, this first step, the online synopsis form completion should help you to think about the issues that most matter to payers and indeed how their needs may be different from the needs of regulators where necessary or were relevant. Step two, once the facilitator that you are working alongside in this META Tool process has your synopsis in hand, that'll be reviewed by the facilitator. The facilitator will then follow up with a tailored meeting to discuss the different sections of the META Tool and any key issues that might have arisen or be have been identified in your development plans. And you can undertake the facilitation actually in as mentioned, a very flexible manner really in any way. So either in person over a video link or over the telephone even. And thirdly, once this is complete, the facilitation session complete, the developer would then receive a comprehensive META Tool report from the facilitator. The facilitator will have filled out the report partially during the session and over the next couple of weeks more completely in the wake of that. And the report in summary, would look to summarise potential additional evidence requirements that you'd need to support your value claims and a story. It would dispassionately, careful you say that word there, provide options for any potential next steps. Essentially it's a nascent consideration of therefore what is perhaps necessary next. And it will highlight areas where you should consider undertaking further work to generate evidence for demonstrating that that intended value core to your product relevant to the patient body and the healthcare system. It's worth noting because as I note there, the report itself is a dispassionate consideration for what is appropriate in the wake or in knowledge of what the evidence is, what's required and where the gaps are. So to that end afterwards, some facilitating organisations that you may work with may offer additional services further to the META Tool process to help you with collecting additional required evidence as highlighted in your META Tool report. And in that respect, collecting and advising on what to collect in that end and methods by which to achieve that. To that end, Mtech Access, of which we're all employees on this call today, we are certified NICE META Tool facilitators and an organisation and we would be one of many, but we'd be well placed to help you in fully engaging with the META Tool process and thereafter partner with you to determine specific appropriate next steps. Next slide, please Sam. So considering or rather continuing from what we've been just looking at there in terms of what the NICE META Tool is and how we do it, we can consider there or now rather going into the specifics of the report itself. And it's worth stating from the outset as we've touched on a wee bit already, that the META tool report is essentially a gap analysis, right? It provides critical guidance for MedTech developers, but it's all done within an an objective capacity. This is objective advice, it's holistic, it's all encompassing, it's very comprehensive, but it's objective, it's not specific normative guidance as to what the specific best course of action is subsequent to this foundational advice. Specific recommendations as noted on the previous slide, could be established in subsequent conversations and partnerships. And that would be using the report of the META Tool process as a foundational basis for this purpose. It should be noted that the guidance that's laid out in the report, you know, while it should be intention is for it to be highly useful for the product developer. There's absolutely, of course, no obligation to act on any of the advice that you, the developer receive, certainly no obligation. We can see on the right hand side there essentially a structured list of exactly what the META Tool report covers. Hopefully most of it seems fairly intuitive and expected, but ultimately, if we start from the top regulatory and HTA requirements, of course it's key to understand what the regulatory landscape and HTA assessment criteria are relevant to your product and your value story. So the report will detail where your product stands in relation to these standards and gives us insight into what would be required to address in light of these. It'll touch on value proposition quite specifically and here intended to clarify your product's unique benefits and why it's a valuable addition to the healthcare system with the treatment pathway. We're thinking about how this relates to your product, how it fits into the existing clinical workflows, how it fits into existing healthcare, healthcare delivery paradigms. The PICO statements, I'm sure most on the call are familiar with this concept, but this will be defined as a population intervention, comparator outcome assessment defined in detail within the report. It's all about, of course, clearly and succinctly expressing the key question at hand for evidence generation and value for the product. And the report itself will assess how the established PICO statement aligns with the established evidence requirements. How well aligned is this? Is it perhaps worthy of a tweak perhaps in a scenario sense or a fundamental core base case sense measuring clinical effectiveness. So this is about the actual impact of your product on health outcomes, right? So it's how do you define that impact? This is inherently linked of course to the value argument, but how are we measuring and defining that effectiveness? Economic data collection. So the result, sorry, the report rather will assess what data has been and is indeed to be collected and how this is intended to be interpreted, right? So this is... What are the intentions with respect to how this is going to be used and under which circumstances it's considered to be relevant for whom the funding and commissioning. So for securing funding, this is a common plight for many MedTech developers and an understandable one. And understanding commissioning processes, it certainly can be complex and to that end, NICE within their META Tool template have endeavour to ensure that it outlines what's expected to be necessary to navigate and understand these areas in appropriate manner. And with success, adoption and impact, similarly, a something of a service offered as part of the inherent structure of the report. Towards the end of the report we're outlining key considerations that we should bear in mind in relation to ensuring adequate adaption, sorry, adoption rather of your product. And finally, resources that you may find useful. So this is a essentially a composite list of additional links and references that could potentially support you and your team in gathering and or generating required evidence in light of what has been addressed or stated earlier within the report. And then to close this slide and this consideration, once you're in receipt of the META Tool reports, you should then be armed. The idea is you are then armed with a fundamental assessment of of what you are required to collect, what you currently have, what the gaps are, hence what the relative strengths and weaknesses are of your current evidence portfolio and your facilitating organisation or perhaps even an additional party could then help you to build what should be a compelling narrative that presents the benefits of your product, what it offers to patients and to the healthcare system. And thereafter, proceed to identify the next steps that could well be critical for your product's commercial success. But I'll pass now please if I could to Hannah, my colleague who will touch in good detail on some of the commercial as opposed to HTA specific considerations for subsequent next steps.- Thank you Calum, thank you Sam. So yeah, here, here we're going to just explore very briefly within the context of the time allowed to us around how the META Tool and the findings from going through this META Tool assessment can ultimately support you in your ultimate commercialisation of your assets, irrespective of whether you choose to go through a HTA or more formal regulatory approach and approval process or whether that doesn't suit your particular wants needs. And obviously it's also always worth recognising that irrespective of if you do go through HTA review process, ultimately there is an element here that we're talking about here about ultimately commercialising your asset and having the tools available to you to support the discussions that you would have. So I guess this is what Calum and Sam have alluded to is that the META Tool assessment, the findings and the assessment of the report itself can ultimately help support and lead you towards in the most ultimately efficient and effective process as you look to plan and ultimately deliver on your engagement strategies and whatever materials you may choose to develop to support that. So here we're talking really about how those findings, a true frank understanding of your available evidence, which is fundamentally going to be the foundation to everything that you can build off as part of your commercialisation, the value that would be able to present to your payer, your customer, whoever they may be. And knowing truthfully what potential challenges you may face. Obviously if you've conducted the assessment and address these at an earlier state, then they may long no longer as you approach this development of your market access strategy and ultimately launching your product, they may no longer exist for you. You may have already proactively addressed these and so you already know the evidence that you need to present. However, if it's not been possible for whatever reason, you are well placed to have appropriate strategies, objection handling, whatever it may be in place. So you are ready to have those effective conversations. And I guess this is where the extrapolation of the META Tool comes into play and where for instance, you may want to have a facilitator that potentially provides a long-term partnership in this way such as ourselves here who offer many of these services. There may be others that for specific needs you may need to partner with elsewhere or you may need a hybrid of partnerships going forward. So all the information that you gather as part of this assessment ultimately allows you to create your market access strategy and also understand and implement it appropriate to your particular asset, the particular area that you are working in, and ultimately who you want to talk to.'Cause obviously all these factors do change and adapt. It also allows you to identify to very early stage what you will have available to you. So depending on material you may need to develop these quite early on prior to launch. For instance, maybe they're available for early engagement, early uptake, or maybe they are only intended for post-launch and maybe that's when you've got your CE mark or whatever it might be. And then also I guess it can take you further along the line. And this alludes to what Sam was indicating by the very dynamic nature when we are talking about MedTech and how it evolves in terms of the landscape, but also your asset itself. It can help support you future plan in terms of your lifecycle management. So what are the attributes that you ultimately want to show and how do you support appropriate collection of the available evidence? And obviously, evidence when we talk about this has many different guises and it's all appropriate to the customer. So for some customers it will be that economic value, it will be the cost associated, the resource use, how can they save time possibly how do you change the standard of care? The customer could be more of a clinical expert. So ultimately they want to deliver the best possible care for the patient. And how do they go about this? How does this improve their current way of treating patients? It also could be around the patient. Maybe your device is significantly less burdensome on that. Does your diagnostics, for instance, not require them to have an inpatient stay? Maybe it could be done at an outpatient setting, maybe they only have to attend for half an hour versus a full 24 hour stay. So all those, those types of attributes that would be identified through the META Tool process and allow you to formalise, strategise and as a collective, as an organisation, form all these different attributes that take you throughout your lifecycle. Again, it will be slightly different depending on the timing of your META Tool assessment. And it isn't to say you may not have to revisit all of these attributes as more information becomes available to you. You wouldn't mind moving on Calum. So here we've just pulled out a few of the activities that potentially you may wish to adopt or commission once you have received your META Tool report. And this is just the most likely in our opinion, obviously every individual device asset diagnostics will have their own specific needs/wants. It also will depend on if you are looking to only support or to specific local level or whether you're looking at commissioning activities that maybe support multi-market. So do bear in mind that this isn't an extensive list and this is where potentially an experienced facilitator can get involved and really help navigate the next steps once you've got the report. So obviously, if the report has identified gaps in your covered and evidence package, it would seem prudent to within the best of your ability fill in those gaps in essence so that you can complete your value proposition, your proactively managing the objections or the sort of pushback shall we say, on your evidence going forward. So for example, literature reviews or statistical analysis may help you fulfil these needs. It's also obviously not on screen here, but for instance it could potentially if you were at an earlier stage of your clinical trial design, help inform aspects that you may want to take into that going forward. Or if you are anticipating a collection of data post market launch or at pilot studies for instance, it might influence what's the type of information in a more real world setting that you want to collect to fulfil any of those gaps in your current evidence set. Goes without saying, and obviously with Calum on the call, there's economic evaluations that you can do on the basis of the evidence you've identified. And I guess going through this process and you know, working with somebody who is experienced in conducting these evaluations, you can identify the best route, hopefully the META Tool gives you the foundation of the evidence that you have available to you and that would be most appropriate to use for your particular asset. But then you could use somebody else's knowledge to know what's the best modelling exercise appropriate for you to present for your product and what's the most resonating evaluation to present to your customer. Obviously you can validate the principles and assumptions in your strategy with external experts as many of you may know here at Mtech Access, we do have a various panels across the world as well as in the UK, of experts that we can work with. But also you may have your own panel of experts or people that you're partnering with and you can use this through interrogation of the evidence going forward. And then obviously as Sam's indicated, actually consider whether HTA is appropriate route for your reimbursement. Again, this may look different depending on the market that you are talking at, depending on the regulations. For instance, it's going through a HTA route, a prerequisite. And so you don't have any other option if you want to enter that market or is it more a consideration and obviously navigate through that process as you may have to engage HTAs at nearly stage to understand if they would evaluate your product or not. They may choose not to. Obviously as I indicated this, this is just the sort of top list that we come up with. And it really would depend on your particular asset and ultimately what the report said in terms of what potentially would be appropriate for you given forward. Can we move on Calum. So now we've reached a stage where we open the floor to some questions. Thank you to all of those who submitted some questions when they've registered for this webinar. And also thank you to those who have already started to provide us with some questions within the chat box. We'll work through as many of these as we possibly can given the time allowance, but please do be reassured that we will connect with and reach out to everybody regarding their questions after this call. We also encourage anybody after the call there will be a survey. Please do include any further questions there or feel free to reach out to any of us on the call today or use the information email for Mtech access here. We'd more than happy to follow up with any questions at a later date. So I'll get us started. And Sam, I think this is is one for you, is "How we at Mtech access can make it easier for our MedTech clients to navigate the META review process?"(Sam clearing throat) Yeah, great question. And I think it is really around trying to guide and steer developers through that process. And what we would propose is that before you even start filling out the synopsis form for the META Tool, we would have a call with you and try and establish sort of your objectives, what are you looking to achieve with your product, and then we can sort of guide you a little bit on how to fill out the synopsis and obviously that will steer you into that. The facilitation section of the process is a process that we would spend quite a lot of time on with you, just really trying to understand the information that you've put in the form, trying to pull out anything that may have possibly not been filled completely or just understanding fully all of the data you have, what other trials you have planned or other activities. And then obviously after the report what we would propose is a follow-up meeting, some kind of workshop ideally so that we can steer you through and we can go through the sort of report and then provide guidance on next steps and how you can sort of fit in in some of those gaps. And then really think about for the individual developer, what is the best route reimbursement is HTA the right route for you? What are you trying to achieve? And just make sure your objectives and commercial objectives are kind of addressed as much as possible.- Thank you Sam, that was a great response. Calum, I've got one here for you if you don't mind. So.- Good.- I think I've alluded to at least my opinion on this question, but it'd be great to hear from yourself as well. So if NICE is not the objective, I guess you could extrapolate to any HTA is not the objective, what is the upside of going through the META Tool process in relation to implementing a market access plan for a healthcare service? So specifically the question mentions the NHS.- Okay. No, no thanks, thanks Hannah, and thank you for whoever submitted that really good question. I think what Hannah and I have presented as a payer already, and Sam's touched on this too, but I think so I hope this isn't too replicative, but you know, even if you're not directly aiming for NICE approval, the the NICE META Tool can and should be helpful really, I think for anyone who's developing a medical technology for the NHS market or indeed any other market with similarities in that regard. I mean, indeed, as we've previously covered the the META Tool process is extensively designed to be beneficial for developers intending to submit to NICE other HTA bodies or really any form of relevant payer centrally. What really underpins this is that most importantly it shows where you might be missing evidence, right? To what extent are you prepared, framed against the requirements that you face, the stakeholder requirements that you face. So both in a clinical and economic and actually stepping back from that a value story perspective, of course knowing this early on means that you can fix these issues before they become big problems. It's like having a roadmap so you don't get lost later on. Secondly, related to that extent, I mean, of course it should help ultimately to make your product development process and ultimately your product itself better, you know, by understanding what the NHS needs, which is inherent to ultimately to the NICE META Tool process and what it guides us through. You can then of course, tweak your technology in theory. And actually beyond that, I think very practically speaking to fit these needs, this of course with NHS would increase the chances that they'd want to use it ultimately. But actually a lot of the needs of the NHS will be reflected in similar markets around particularly monotonous payer markets around the world and certainly in the western world. And it helps I think also to essentially encourage smarter planning for how to get the product into the NHS market or indeed the market of interest. It start in a systematic way. It frames, it's a way of thinking, it's a way of collecting everything holistically, establishing that foundation and therefore, in a considered structured way, planning for the future. So the tool gives you that clearer picture of the landscape, perhaps the NHS landscape that you're interested in. Of course, this can be pretty complicated in of itself. So approaching this in a systematic structured way is probably a fairly sensible way to go. Lastly, I think what's inherent to all this, of course, is a really terrific learning experience going through this process. It should help you to understand the rules of the expectations of a market like the NHS or indeed most certainly the NHS that's going to be approach useful for any future products you develop. So I think in a nutshell, the META Tool is perhaps more than just a step, as you might say towards approval. It's not quite that specific. It's really more of a comprehensive guide objective of course, rather than normative in its nature. But that's going to help you. Ideally it's any stage that you see fit to interact and engage with it for making your product better insofar as convincing the right people that it's worth using for indeed the patients and the health systems that you're interested in reaching. It's essentially an incredibly healthy exercise that puts you in a far more confident and stable position, ideally, I think quite realistically than if they're not doing it. So NICE approval. The NICE being the target. I don't think that's necessary at all, really. It's sort of an ideal case if you're thinking about going to NICE but hardly required. Hannah, do you think that tackles the question? Is that okay?- I think that's perfect. It's just great to hear somebody else's opinion, Calum, so that's great.(indistinct overlapping chatter)- Can I add to that? Yeah, do you want to add to that Sam?- Yeah, yeah I was going to say, we've already alluded it to a little bit, but I think the other thing to think about in the META Tool is that, you know, there isn't a defined time to do this and it could be done more than twice for the same product. So there are instances where you might want to take it very early on in the product life cycle where you are thinking about what evidence do I need, what trial should I be planning? And then a little bit later on when you've got that first, I guess the first bit of evidence that you've collated, you could go through it again and find out is that likely to be enough or do I need to be thinking about additional activities to support sort of reimbursement as well.- Perfect, thank you both. I think we've just got time for a very practical question if you wouldn't mind taking it, Sam. So we've had a couple of questions in or around this, but people I guess are really interested in terms of how long, in terms of timelines would it take approximately to complete this exercise and do we have any idea around budget ranges?- Yep, I'll take this sort of the timelines first. So I think the process itself from when the first engagement and then the META Tool is probably about four weeks. That takes a four week period. I think in order to get the best benefit out of it, as I said, we would like to have a workshop afterwards to kind of collate all the evidence to talk the developer through that and then to think about recommendations for next steps. So I think ideally that would probably be about a week after the completion of the facilitation. So I would say around sort of five to six weeks. But that, you know, if you think about timelines for a lot of advice and lots of different things, that's relatively quick. So a fairly quick turnaround for something that is really very valuable in my opinion to give you sort of that fairly quick feedback in terms of what your gaps are and what you should be doing for next steps. And then in terms of cost, I think it depends a little bit on what level of engagement and sort of post the facilitation, but I would imagine, well it'll be between eight and 10,000 pounds. So again, relatively cost efficient, relatively timely, but could be extremely valuable.- Yeah, absolutely. I'd concur with that. I think that's for the basic process and it's whether you require, you know, the facilitator to provide the extra to support you as we all know, there's nothing worse than just a report that lands on your desk with very little context and very little follow up and then it gathers dust ultimately. So I think that's all the time we have for questions. As I say, we will follow up with anyone. I know some of the questions in the chat box of already been responded, but please I encourage anyone who's listening live or listening to recording, please do connect with us. We'd be more than willing to respond to the best of our abilities coming forward.- Great, and then I'm just sort of going to wrap up here. So in terms of next steps, really have a think is the META Tool right for you and we've talked about it as being a really valuable tool, whether you want to go to NICE or not, whether you're really early on in your developing journey or whether you are a little bit later, it really does give that comprehensive understanding of what the data gaps are. So I think it's incredibly valuable. So please do have a think about it. Is it right for you? Please do book a call with us. There's a sort of an email in that bottom band that you're welcome to get in touch or put a message in the chat and we can contact you, you know, we can speak to our experts as Hannah alluded to. We have a large network of NHS associates, both in sort of the clinical setting and as payers. So we can speak to them around some evidence strategy for key global markets and then we can help you identify next steps from there as well. And we are offering everybody who has attended the webinars of a complementary discovery session with our evidence strategy and HTA experts. So we're happy to discuss sort of your requirements with you. And then thinking again about your commercial launch, thinking about your value proposition, does that really resonate with healthcare decision makers? Are you launch ready? This is where Hannah and her team come in thinking about that commercial launch again and thinking about your value proposition and its fit for purpose. So yeah, it's been great to speak with you all this afternoon. Thank you for joining and listing. Hopefully you found it valuable. Please do message or email and yeah, that'll be great to get some feedback as well. So please do fill out the the survey as well. Thank you for watching. If you'd like to find out more about our work or how we could support your market access goals, please email info@mtechaccess.co.uk or visit our website at mtechaccess.co.uk.