Roundup of 2025 part 2: Selling to the NHS

Charlotte Lewis: Hello, and welcome to Talking digital health, a podcast by law firm Mills & Reeve, hosted by health and tech lawyers Sophie Burton-Jones and Charlotte Lewis. Our aim is to discuss key topics of interest to those procuring tech in the NHS and those selling tech to the NHS. If you like this podcast, then please follow or subscribe and even maybe leave a review. It really helps with reach. I'm Charlotte Lewis.

Sophie Burton-Jones: And I'm Sophie Burton-Jones, and we're your hosts for this episode. Now, we launched this podcast back in January, and now it's December, so we thought we'd finish the year with a round-up of some key bits and pieces from our guests and episodes from 2025.

Part one was released last week, and that was about our NHS digital transformation episodes, and this part two is going to focus more on our selling to the NHS episodes, so if you're a health tech company, this is the one for you. So we're starting right back at the first episode we ever released, where we talked to Nadia Kadhim about the compliance and assurance requirements that healthtech companies need to have in place to sell to the NHS, and at what point in their life cycle of getting ready to sell they should be putting them in place.

Clip one begins

Nadia Kadhim: But across the board, no matter what compliance requirement you're trying to go through and what kind of compliance you need, start early. Starting your compliance journey early is just the key, because if you begin this process later, for instance, after developing your solution, you may need to change your documentation, or you may need to change your product based on the compliance requirements.

You may face delays, and revisiting and reworking aspects of your product, compliance posture just takes time, which costs money. And although starting from scratch might initially feel like it's slowing you down because you feel like you're navigating this red tape, when all you want to do is innovate and build and, and go to market as soon as possible, it definitely will be worth it in the end.

And if we think about time and timelines and how long does it take, it's also important to note and to remember always that compliance isn't a one-time thing. It isn't a one-and-done deal. It isn't a tick box exercise. Once you've met the initial requirements, it's always an ongoing process.

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Sophie Burton-Jones: So I think there's some really great messages in there from Nadia, and it's obviously really important to get ahead of the game when it comes to compliance and not leave it to the last minute. But I think a really big takeaway is that there's often a rush to try and get everything sorted to go to market in the first place, and then the kind of regular review and updating process sometimes gets forgotten because then you're starting to focus more on customers and customer relationships.

But really, you need to have that ongoing level of compliance and refresh and update to be able to meet the customer's requirements and meet the checks to continue operating. So I think that was a really important message coming through there.

Charlotte Lewis: Definitely. And actually something that we see in contracts, that ongoing compliance is a requirement, it's a contractual requirement, so not to be forgotten about for sure. Obviously there are products out there that can help you with that ongoing compliance, It’s useful to be aware of. We were then joined by our colleague, the lovely Steph Caird, to talk about medical device regulation and the requirements for UKCA/CA marking of digital products and how long that process can take.

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Stephanie Caird: Generally requirements around needing to apply a UKCA or CE marking to your product and being registered with the MHRA, both in terms of the product and as a manufacturer are before the devices are placed on the market. Now, depending on what classification your device has, you might be able to self-certify and apply the marking yourself.

The riskier the product is, or more invasive the technology is, you'll need to get a notified body involved to do an assessment of your documentation. If you need to involve a notified body, you'll need to factor that in both from a time and money perspective, because they sometimes have backlogs in reviewing paperwork, and at one point the backlog was about six to eight months long, and you won't be able to submit your registration paperwork to the MHRA until you have that assessment.

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Sophie Burton-Jones: So it's really clear coming from the conversation with Steph that not only is medical device regulation a pretty complex area, but it's also changing as we speak as regulators try to get a grip on how to ensure technology and AI is certified in a healthcare environment. There's been lots of announcements and things about that since we first spoke to her at the beginning of the year. So we got Steph back again for another episode. Thank you very much, Steph. And she gave us an update on what's been happening since we first spoke in, in this sphere.

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Stephanie Caird: So from a medical device regulatory standpoint, if the AI tool is part of an investigation, so you're trying it out with the patients to see how it works, ie the product is still in development, it could be lawfully made available without a CE or a UKCA mark, provided that the manufacturer has met the other conditions within the regulations. If the product is something that is already being marketed and sold as a medical device by the manufacturer, in that case, we would expect it to require a UKCA or a CE mark, and the manufacturer to be registered with the MHRA before that product can be used by the NHS.

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Sophie Burton-Jones: I think when I hear medical device regulations, even as a lawyer, I kind of sit back and go, "Ooh, this makes me nervous," so I can totally get how people who are setting up and trying to get their business going might think, "Oh, this is a real headache. How do we approach this?" It is complex, but there are lots of specialist expert advisors out there who can help with it, and I think it's one of those ones where you really do need to be having a conversation with the appropriate people early on, because that can really help steer you as to what you do need to do and when you need to worry about it.

They might shortcut some of those processes or thoughts that you're going to have to go through something that you might not necessarily have to. But I think it's equally clear that it's a space that is going to continue changing as AI changes and increases. So it's also, again, that theme of keeping an eye on it, looking and checking it regularly in terms of announcements coming from the MHRA and others as to what you need to be doing. And, you know, having a great quality contact that you can pick up the phone to and say, "What's the latest? I've seen this, it's worrying me. Do I need to worry about it?"

Charlotte Lewis: I think we all have our skill set, and I'm sure all of those listening, if you're building a healthtech business, I'm sure that you have a great number of skills. But if this isn't one of your areas of expertise, then it's certainly an area where we would recommend bringing experts in, because it's not the sort of thing you can fudge, unfortunately. That's the main message. It's come loud and clear from Steph, and it’s being reiterated by us.

It was then our turn to talk to each other about some of our favourite topics. Obviously these were the most popular episodes.

Sophie Burton-Jones: We like to think.

Charlotte Lewis: Yeah, I know. It's just because we're so sad, and we just love what we do. We talked about the terms and conditions to use when contracting with the NHS, and how to hopefully limit down negotiation time if your terms are already written in a way that works for NHS customers.

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Sophie Burton-Jones: When a supplier's trying to break into the NHS or the wider public sector, this can be heightened because NHS customers expect to see various compliance commitment and what we'd call good supplier terms that are typically more detailed than you'd see in the private sector, and which in our experience can catch people out. So Charlotte, what in your view are the key contractual provisions NHS organisations would expect to see in a supplier's standard terms?

Charlotte Lewis: As you've said, Sophie, NHS customers and the wider public sector, for that matter, will expect to see certain terms in contracts, and in some cases, internal governance processes will mean that such customers will not even sign contracts unless those terms are included.

Some terms are mandatory, but the sorts of non-mandatory terms that they would expect to cover include things like a reference to freedom of information, modern slavery, human rights and equality, health and safety law, environmental law, and social value.

Sophie Burton-Jones: There's quite a lot there which people may or may not be familiar with. I think it's fair to say that when we list all of those, there's also a scale of how long or short provisions for each of those could be as well. For example, we could see a freedom of information clause that's only about three sentences, but equally we can see one that's half a page, a page long.

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Sophie Burton-Jones: Obviously, it's a topic that we could talk about forever because we do it day in, day out. But I think one of the key kind of takeaways, if you're just listening to this snippet and thinking, "What's the key takeaway here?" Well, it's two things. One, if you're going to go and sell to the NHS or the public sector more generally, there are certain terms and conditions that you're going to need to have in your contract documents.

If you can tackle those up front and draft them in a way that actually aligns with your product or service offering, it's far, far better to do that than be silent on it and then the customer or potential customer comes and tries to impose some standardised, really lengthy terms and conditions dealing with certain points that just don't fit or don't work, because you'll end up with more time on negotiation, when you're really quite desperate to get that signature on the contract and actually move forward with the relationship.

I think it's also worth flagging, as we did in the clip, that, for example, if you say, "Right, we need to have a freedom of information clause," or, "We need to have an AI clause in our contract," there's a multitude of ways that that can play out. Just because you need a clause dealing with that, it doesn't mean that clause needs to be three pages long. Some circumstances it will be really important and you will need to have quite lengthy provisions on it. Sometimes it's just a simple three-line clause that needs to cover it off. So again, somebody going through their checklist of what isn't in the contract can say, "Yes, that's been appropriately dealt with. Yes, that's there," rather than raising alarm bells that it hasn't been considered, and maybe that then makes them look more closely at the contract and worry about lots of things that aren't in there, when from your perspective there's a good reason that they're not in there or there's a good reason they've been dealt with in the way that they've been dealt with.

Charlotte Lewis: Yeah, I think for me, there's something here about… It builds trust if you are upfront and honest about these things, knowing that there's a good chance they're going to be required of you anyway. I think it’s far better to include them because otherwise you end up, as you say, in negotiations about a whole load of other things that you really didn't want to include.

And the other thing is it also builds a furthering on that trust point. It demonstrates awareness that you understand the market that you're selling to because you understand what their needs are, and you're prepared to just include that in your standard terms. It really sets off that relationship on the right foot from the off. It isn't a point worth scoring, basically. You're going to end up having to put them in, so just do it and everybody's happier at the outset is what I would say.

Sophie Burton-Jones: Yeah, and also another thing that I talk to clients about sometimes, which I think goes down really well, is if there are key positions that you're going to take which look a little bit unusual or different to maybe what you might see in a standard contract released by the NHS, having some form of FAQ readymade answer to explain why you've done it that way and show that you've gone through the thought process, that can really help shortcut some of those conversations as well.

Charlotte Lewis: Yeah, absolutely. And yeah, and if there are things that you've included because they're really important to your organisation, then that's a really helpful way of articulating that again, so you've already explained it. Interestingly, this conversation came up recently in the context of working with the NHS and pharma working together, and there are certain things that pharmaceutical companies have to include for a variety of reasons, and that often NHS organisations might feel a bit disgruntled about. Our message to that was, to said pharma companies is, state that at the beginning that these are things you have to do, and this is why you have to do them, and this is why it makes sense to do it. And actually, straight away the relationship will be on a better footing because the other party doesn't feel like you're trying to screw them over, basically, and they understand the thought object. So yeah, I think communication, it makes such a difference.

So after doing that (and you can tell that this is our area of expertise because we've spoken the most about it in this podcast) we then had a great conversation with our other lovely colleague, Gayle Curry, about pilots and how from a supplier perspective you can make sure you get the right outcomes.

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Charlotte Lewis: So if you're running a pilot, then how would you set one up for success? And I guess it depends on what you deem by success, but how would you go about doing that with those eyes wide open?

Gayle Curry: I think that's a really important point, Charlotte. You have to work out, what is your objective, first of all, and what does success look like? And you work back from that point. So you have to build a relationship with the NHS partner you're going to be working with during the pilot. Try to become a helpful member of their team, recognise that they're busy, they're pulled in lots of different directions. Yours is probably not the only pilot they're running.

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Sophie Burton-Jones: One of the points coming out of the conversation with Gayle that we've got there, but also in one of the other episode that we did on the NHS side and how they feel about pilots, is that quite often it's just a kind of “Let's run a pilot!” and nobody's really clear on what they're trying to achieve, that it's not time-bound. They don't know what the outcomes are.

How can you say that something's been successful or not if you're not really clear on that? In this case, people are busy, they've got lots of things on. It's not their sole focus. There's a risk that it slips, and then I think you can kind of get to the end of a pilot, and there's a kind of, disgruntled might be too strong, but a feeling of “what have we actually achieved here?” I think if you've set out that really clearly and stayed on track, you're less likely to have that at the end of it because there's lots of conversations about whether pilots are worth it at all. And I think what we're trying to say is in certain circumstances, as long as they're clear, they can be really valuable both for the customer organisations, but also for the suppliers trying to tweak and understand what is and isn't needed.

But there's an awful lot of pilots that run that there isn't really much need for them, and you could do them in a better way, and that frees up time, frees up money, and all of that good stuff. So I think, I don't want it to sound like we're sitting on the fence, but pilots can sometimes be good and sometimes be bad, and you just want to make sure if you're going to go and do them, that yours are falling on the good side. Otherwise you just get a bit disheartened, and you really want to be able to move your product and offering onto the next stage where you're getting your revenue-bearing contracts in, rather than just getting stuck in an endless loop of pilots.

Charlotte Lewis: I think that my message about pilots would be that, and I think that historically, it's been a sort of assumption that it's a part of every process, and it's something that either has to or should be done in order to prove something. And I think you make a really good point, is actually to challenge your thinking on that and think, "Do I need to run a pilot to prove my outcomes or to prove my product, or is there a different way of doing it that doesn't require a pilot within an NHS trust?"

Because it might not be the right solution for you. If it is, then that's great, and being really clear about why you're doing it and what you're trying to achieve from it will be instrumental, and that's exactly the point that Gayle's really making in that clip. We're not anti-pilots, to be absolutely clear, but I think as with a lot of people nowadays, our kind of position is in the right place at the right time, they could be a really great thing. But let's all just have a think about whether that is an appropriate use of NHS resource, or whether there's a different and better way of doing things.

Sophie Burton-Jones: Well, not just NHS resource, the company's resource because if you're a growing company, you've also got limited money that you've got to make stretch to lots of different things. So don't waste your money on that if you don't need to.

Charlotte Lewis: Absolutely, and we can't really talk about pilots without talking about what happens next, and I think that's the thing that we're really quite keen. It's what you get out of it that's the important thing. So we brought back our procurement colleague, Nathalia Perera, to give some advice on moving from pilot to bidding for a contract, and what you can do as an SME to achieve the best outcome during that bidding process.

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Sophie Burton-Jones: If you've worked with a customer before, for example, on a pilot or a trial or something like that, are you still going to have to potentially put forward a full bid for an opportunity?

Nathalia Perera: Well, usually yes. The main thing is it really does depend on the instructions in your tender documents that that authority's published, so make sure if you're a supplier that you do read those very carefully. But the best approach to take is to assume that the evaluator who's going to be marking your bid has no knowledge of you and has no knowledge of your product or your service, and just go into that almost like you're answering an exam question when you're writing your bid.

Charlotte Lewis: It can often feel, and that's quite a good example, that bid processes are better suited for larger and more well-established suppliers. If you're a digital health startup, is there anything specific you can do to improve your chances?

Nathalia Perera: That’s a really good question. It is quite tricky, and I've got a lot of sympathy for kind of those smaller or startup companies. There's actually a really good link which the government's published, called “How to bid for government contracts as an SME effectively”, which I would really recommend to any kind of entity, not just kind of digital tech entities. Generally, there's a few different things you can do at different points in the tendering cycle.

To begin with, if your future customer is carrying out any market engagement, then definitely get involved, take part in that. If they're sending out questionnaires or having supplier days or bidder days, make sure that you get involved in those, because that's really your opportunity to potentially influence the process in a fair way, because other suppliers are also able to do that. So that is one really good thing to do to get a bit of an edge and to also get an understanding of how these processes work.

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Sophie Burton-Jones: There's some interesting stuff from Nathalia there where I think the perception is, and I think it's fair, that it can be really hard for people trying to break into the market to actually be successful in a procurement process because the whole mechanism is arguably geared better to those that have specialist bid teams, who have prior experience that they can set out in their tender, and if you're trying to break through, it can feel like an impossible task. I guess we want to try and end on a positive note rather than all doom and gloom, but Nathalia was talking about resources that are available, that you can use as a smaller tech company that's trying to grow, and how you can get involved and how you can get your voice heard in a process to set you up in the best way possible to get some success.

However, it's procurement. You're not going to win them all, but do you need to win them all? Probably not. As you're growing, that might be too much. So really focus on the opportunities that you think are really going to suit you and what you're offering, and get fully involved in the process to improve your chances there.

Charlotte Lewis: Yeah, definitely. That's it for our first year discussing what healthtech or digital health companies need to know when selling to the NHS. But never fear, shifting from analogue to digital features front and centre in the NHS 10 year plan, so that means there's still lots more to discuss when we're back next year, and many more episodes to come. We've already got lots of great guests planned, but in the meantime, we hope everyone has a great Christmas and New Year, and we'll see you in 2026.

Hopefully it goes without saying, but we will anyway, that at Mills & Reeve, we're very happy to discuss any legal queries you might have, whether you're buying or selling healthtech. Our individual contact details are available on our website, mills-reeve.com. Thank you very much for joining this episode of Talking digital health by law firm Mills & Reeve.

Sophie Burton-Jones: And Happy New Year.