R&D Expert Explains Medical Device D&D Process | Pressure Tested

Hi, my name’s Rich Timbrell. I’m the head of R&D and commercial product for a medical technology company based in the UK, specialising in decontamination solutions for healthcare and life science applications, and I’m going to be pressure tested. My background spans around 10 years of product development covering functional neurosurgery, orthopedics, and then finally into my current role. I’m going to talk about medical device development processes, front-end innovation, and general good practice for developing new medical devices.

What is product development?

So product development is utilisation of technologies and concepts to come and address a need in a marketplace. So in my experience, which is very heavily in medical devices, it typically has this sort of fuzzy front end where you can go and generate concepts, do ideation, create prototypes really quickly. And then it tends to move into a much more sort of regulated route of development that will take you through understanding your user’s requirements, building some quantitative metrics around to really understand and to define those user needs, and then going and creating something that addresses those. And then moving into a process of design verification to show that the thing that you’ve made meets those quantitative measures, and then finally getting that device out into the hands of users and showing that it does truly address the need in the market.

So how is product development different from regulated product development?

So working within a regulated industry, there is usually a pretty well-defined path that takes you through coming from kind of an early concept and moving that through various stages of maturity to get through to a final on-market product. And it’s a lot about defining what you want the device to achieve, rationalising why the device needs to be made that way, creating things associated with that product, and then demonstrating that the thing that you have made is appropriate for meeting the need. I guess, in comparison to sort of less formal and regulated medical device development, the real challenges are traceability, are documentation, and are really proving that the thing that you intended to make has been made correctly. In kind of unregulated development, there’s a lot less focus on traceability. There’s a lot more focus on kind of the backend testing and showing that it does something and meets a need beyond defining what those needs are early.

So what is front-end innovation?

So front-end innovation is typically a phase of product development that happens before you move into kind of your regulated, compliant medical device framework. And it’s a really good opportunity to go out into the market and go and understand your market, understand your customer pain points, talk to users, float early concepts with them, and understand how it might fit into their workflows. Get really informal feedback to really try and understand what the customer is looking for and how the technologies that you’ve got and the innovations that you might have could be used to address that.

What is a prototype?

So typically when I talk about prototypes, I talk about two different types of prototype. I talk about feature prototypes, and I talk about form models. And feature prototypes are something that it can be used to demonstrate a concept. They often work like, but they don’t look like, the final solution. So if we take a hydrogen peroxide fogging system, for sake of argument, it might just be a really rudimentary box with some outlets, but we might be trying to prove the principle of injection, for sake of argument. So that injection module might work like the final thing but not look like it. And we can go and demonstrate that we can get the right levels of efficacy. We can go and demonstrate we might get the right levels of validation and reporting out of that. But you’d never go and sell that to a customer. It’s not going to be accepted into the marketplace. And then form models are things that look like but don’t work like. And these are much more sort of visual demonstrators of what the final product might look like, how the user might interact with it. And that can be used to really understand how the user feels about their level of interaction within the device. And the nice thing about splitting these two things out into feature prototypes and into form models is that then the final stage of product development is to really bring those two things together so that you end up with this lovely product to go and sell. And then you obviously take that through various levels of design for manufacture, assembly, design for test, inspection, and various other things to get your final medical device.

What is the design and development process I follow?

So my team has a front-end innovation process whereby we understand the market, we understand the user need within the market, and then we decide that we want to go and develop a product or develop a technology to go and address a need. And we’ll go into a front-end innovation process whereby one of the team will own that whole process, and it’s a really good opportunity for them to get overarching product ownership. That front-end innovation process will have objectives and deliverables within it, and that’s largely centred around developing feature prototypes and proving that they work and developing some form models of what the device could look like. Once we’ve been through that process, it then goes to a business review where we say, “Okay, well, we’ve proven this concept, and this is what we think we want the final product to look like, and do we have a business case to support it?” And assuming that we do, we take it into a five-stage gate development process where we go out and we conduct usability to understand user needs in the market. We then use a development matrix to develop some design inputs that have a source of specification that address that user need. We then go and finalise and lock our design outputs, and it’s at that point we hit design freeze. And then we move into a process of verification, so going through and testing quantitative measures, so things like the flow rate are correct, it’s the right dimensions, those type of things. And then finally, onto our final stage, which design validation, which is to get the product out into the environment and demonstrate that it can go and meet those user needs. And typically, the more time and effort that we spend in the front-end innovation process, the easier and more streamlined that regulated product development process is. And each of those stage gates is split up with a design review where we look at the design principles, the design maturity through the course of the project, the manufacturing principles, as well as staying aligned to our regulatory and quality requirements. And alongside that, we also have a business review where we’re looking at, is the project on budget? Can we still sell the device? Has the market changed substantially? And lots of other factors that build the commercial case for the product as well.

What are technology readiness levels?

So, technology readiness levels are a way of defining how mature a technology is as you move from an idea at the start to a fully validated in the market technology at the end. And my personal opinion is that I don’t really use them. I don’t really believe that they are an accurate representation of product. And I much prefer to look at a product from a perspective of, does it meet the need vendor? Can it follow through a regulated framework? And then can I demonstrate that the device meets the needs in the market? We do have a rough kind of view through product development of what technology readiness level we would be at, but we definitely don’t stick to any hard and fast rules around that.

How long does it take to develop a medical device?

Well, that’s entirely dependent on the medical device that you’re designing. It entirely depends on how well you understand your market, how well you define the user need is, and what existing products there are on market as well. And all of that dictates the direction that you take with medical device development. So if I’m developing something like an iterative product that might be a new version of something on market, I can define that relatively well because I know what the steps will be, I know what the testing requirements are, and I know how to go and test it in the field with users at the end. If I’m designing a groundbreaking technology that’s to address a major problem in the market that maybe doesn’t have anything else that already addresses that need, then it’s a much longer development process because I might have to go and fully understand that need. I might not have ways of quantifying how to actually address that need. It might be a whole new technology. It might need to go through clinical trials. It might need to go through pre-clinical trials as well. So there is no direct answer on how long it takes to develop a medical device. It’s entirely dependent on the medical device you’re making. I think the really important thing is, for whatever device that you’re developing, have a plan, have a regulatory strategy, and understand your requirements as you go through the project.

Who do you need in the R&D team?

So again, this kind of depends on what product that you’re trying to develop. But for me, there’s two things I look for when I’m trying to hire new people into R&D, and that is attitude and application. And attitude I’m a really big believer in. I believe you can go and teach skills to people that have got the right attitude. They want to learn, they want to grow, they want to get better, and they want to go and tackle the big challenges. You can have all the skills in the world, but if you don’t want to go and apply them, and you don’t want to grow, and you don’t want to get better, then you’re always up against it. So I would rather take an engineer that’s really hungry and wants to go and learn and wants to grow than I would take somebody that’s really established that just wants to kind of sit where they are. But that’s personal preference, and that won’t necessarily fit for everybody. Beyond that, I then talk about application quite a lot, and what I mean by that is I want people that can go and take a concept that they either really understand or maybe one that they just need a bit of education around and then apply it to a problem. And I have a favourite interview question, and I might need to rethink this interview question now that I’ve put it out there. But I will lay out a very simple model for design control. So user needs, design inputs, outputs, verification, validation. And I’ll ask the individual to talk through those steps and their understandings of them. And to be honest, I don’t really care too much about how much they know about them. They might absolutely nail it. They might also not have any idea, and I’ll bring them up to speed on what that is. And then I’ll put a really simple medical device in front of them, something like a Calpol syringe, and ask them to retrospectively apply each of those steps. And I think from that kind of five, 10-minute exercise, I can learn everything about the qualities of that individual and how they can take a concept and apply it to a real-world solution. And if they can do that, and they’ve got the baseline level of skills and a really good attitude, then they’ve got a place in my R&D team.

How do you decide which emerging technologies are worth investing R&D resources in and which are not?

So I think the first thing to address is you need to understand your market. You need to understand the trends in your market. You need to understand the customer personas in your market. You need to understand the things that they really like, the things they do as kind of standard practice, and the things that they don’t. You need to understand the resistance. And once you understand your market, you can then understand your user pain points and your user needs in the market. And from that, you can then develop product to meet those needs, integrating emerging technologies. But look, emerging technology is being discovered all the time. And the real skill in an innovation-led business is working out which emerging technologies to back and which ones not to. And there’s genuinely no hard and fast rules around this. But from my perspective, I’m looking at technical feasibility to start with. So does the technology give potential for a substantial improvement on something that’s already in the market. And then can that be done at the scale that you want it to? So something that might work in a half-meter by a half-meter box might not work in a room, for sake of argument. So trying to understand the limitations of that technology is really important. But for me, it’s all about looking at how that technology could integrate into a product, what the regulatory requirements might be around that, what the limitations from a quality perspective would be, and how you might prove that technology does actually do what it says it’s going to do. I think the other piece is that there’s loads of really cool technologies, and just because a technology is really cool, doesn’t mean that you should back it into every product. Additive manufacture would be a really good example of this. It absolutely has a place in somewhere like orthopedics, and it’s made a really big breakthrough in helping develop osseointegrating hip implants, for sake of argument. But if you were to push that technology, maybe plastic additive manufacturing into sort of reusable medical devices or something like that, it doesn’t mark a substantial improvement, that technology, for the user. So it’s all about understanding what the user wants, what the user’s willing to receive, and whether that technology can genuinely improve their life or improve their process. And then the final bit is around kind of the workflows that people go through. Some technologies will slot into existing workflows and improve outcomes. Other technologies will have to try and change the workflow, and it’s about really understanding whether there is appetite in your market for that technology to come in and change the way that a workflow is used.

What characteristics distinguish successful medical device innovations from those that fail to gain traction?

So in my opinion, the best medical devices are really simple devices, so simple to manufacture, simple to assemble, and simple to use, that address a real clinical or user need in the marketplace. So if it doesn’t address those three needs, then it is unlikely to be a successful medical device. And I’ve seen so many medical devices fail in the market because they either try to address a clinical need or a user need that doesn’t really exist or that they don’t fully understand, or to push a technology that just either isn’t appropriate or isn’t ready to be accepted into the marketplace. So I think for me, the best medical devices and the ones that are successful are simple, easy to use, intuitive to use, and address a real need for the user.

How do you balance breakthrough innovation with incremental product improvements?

So there’s always going to be a requirement to maintain existing on-market products. There’s going to be regulatory changes. There’s going to be failures of products in the field. There’s going to be changes in requirements. There’s going to be different use scenarios. So there’s always going to be a list of sort of mandatory changes that you have to go and address. That’s kind of the bare minimum that you need to do. I think beyond that, it becomes a question of risk versus reward. So do I back a team to go and take an existing on-market product and maybe add some features to it, speed up the way the device is manufactured, used, assembled, or give some improved quality outcomes? And that’s typically kind of the low risk, low reward outcome. What you tend to do is put very little financial investment into that by comparison, and probably not get a huge amount out of it at the end. There’s then the other side, which is do you go and heavily invest into R&D and develop new products, and that’s typically a much higher risk strategy, but a much higher reward at the end. It’s typically a higher financial investment. It’s typically a longer development process, and there’s no guarantee of success because you’re making a new on-market product. So they’re kind of the two strategies, and I think for me it’s all about balance. It’s about showing that the R&D function or design development function, whatever you want to call it, can go and maintain existing on-market products and can go and deliver new products to market. And that’s to spread the risk profile across the company, but also to demonstrate to stakeholders that you can operate in different environments and react to different needs.

What are the biggest challenges facing R&D leaders in the medical device industry today?

So there’s a very political and there’s a non-political answer to this, and I guess I’ll address both of them. But to start with, it’s really tough for businesses in the UK at the moment, but particularly for UK-based research, design development, and manufacturing. And we seem to have pushed ourselves to a position whereby we’re removing incentives for people to really, really heavily go and invest in new talent and in new R&D. And when companies feel under financial and regulatory pressure, they tend to close up. So I know a lot of people are either removing, slimming, or completely redirecting their R&D functions. So that’s a real challenge for R&D leaders because all R&D leaders want to be pushing for the really big next thing, and I’d love to see us relax a little bit around some regulation and to give much better financial incentives for businesses to go and invest heavily into R&D. And I’m really lucky that the role that I’m in at the moment, we are doing that. We’re investing into new R&D, with a view to what that looks like in revenue in three to five years’ time. But a lot of businesses won’t be doing that, and we need to find a way to encourage them. Beyond that, the really big challenge for R&D leaders is the speed at which technology’s moving So, years ago, you used to be able to develop a product and it used the state-of-the-art today, and it would still be the state-of-the-art in maybe 5, 10, 15, 20 years’ time. But the speed at which technology’s moving at the moment, makes it really difficult for R&D leaders to say that I’m going to build this product, and I’m going to go through a new product development path for it, and I’m going to create a state-of-the-art product. Because by the time I get to the end of that, in some circumstances, that technology might have been superseded by something else. So, trying to work out which technologies are worth backing and which technologies have longevity is a real challenge for R&D leaders at the moment.

What factors are most critical when moving a concept from the laboratory into a commercially viable product?

So, when moving from a laboratory environment into a commercially viable product, the biggest challenges tend to be around design for principles. So, when you’re working in a laboratory, you tend to have quite heavy designer influence, quite heavy engineering influence, and you tend to be able to just put things together and just be able to test it with that kind of expert in the field, sort of hand-holding through the whole process. And obviously, that’s not possible when you’re in a commercial environment. So, design for principles cover design for manufacture. So as I move from the laboratory into a commercially viable product, how do I manufacture it correctly? How do I manufacture it repeatably? And how do I manufacture it at the scale required? Then design for inspection. So, how do I ensure that the thing that I’ve made is, I can verify that it is meeting the specification every time. Design for assembly. So, how can I ease production so that it doesn’t take heavy engineering involvement every time to make a really complicated device, and it can fit into an existing or a new production line? And then finally, design for test and/or design for use. So, how do I make this so simple that I can put it through a repeatable test program and when it goes out into the field, that I have high success rates across all of my products all of the time?

What are some common mistakes that organisations make during the development process?

Well, the one that I always talk about is entering into design control too early. So, there is something in medical device development called development change control, and that says once you lock your design inputs, that you have to go through a process of assessing the impact of change on your device. And I’ve seen lots and lots of medical device companies go in and lock their inputs really early with a pretty heavy and substantial bit of R&D to still do. And then they end up getting swamped in paperwork and rationales as to why they’re changing things when they don’t even necessarily have a concept at that point. So, spending enough time in the front-end innovation process to really refine your concept, really understand how your user views that concept, to really understand any of your user pain points, to understand the market, to understand how the device will be used, and to get opinions from the market, and to go through lots and lots of iterations very quickly, is really important.

How do you measure the success of an R&D program beyond product launch?

So, there’s a few different perspectives to consider here. So from an R&D perspective, I’m looking at when my product is out in the marketplace, what’s my first-time success rate? What’s the burden on the business to go and support it from an ongoing servicing or maintenance perspective? How often do I have to replace components? And those type of things. From a customer perspective, I’m then looking at, have I got improved outcomes as a result of my medical device? So in this infection technologies, that might be, have I got improved efficacy? Have I got reduced process time? Have I got quick turnaround time on my room or on my device? And then from a business perspective, there always needs to be that business angle. And what I’m probably looking at is my return on my investment, and that could be measured in various different forms, and different businesses will define it in different ways. That might be my annual turnover. That might be my five-year ROI. That might be the reduction in the amount of expenditure I have to make to maintain that product on market versus the previous iteration. So, it’s really those three pillars. The R&D perspective, the customer outcomes, and then the effect on the business from a financial and support perspective.

What lessons have you learned from products or projects that did not meet expectations?

Some products will fail, and that’s absolutely fine. But it’s better to fail early in the development process than it is to fail late. And the biggest lesson that I’ve learnt from a product development perspective is if you are going to fail, fail as early as possible and pivot because you build risk in, you build time in, and you build cost in as you get through the development process. A really good example, and I won’t talk specifics about it, is we pushed a technology and got right through to design validation and went and tested it to do some sort of summative usability at the end, and everybody hated it and couldn’t actually see a tangible improvement on the device that existed. And actually, the real push for that technology was because it was easier for the business and it was lower cost, and not actually considering whether there was actually any want to adopt that technology and adopt that innovation into the market.

How do regulatory requirements influence innovation decisions within your R&D function?

So, I think there’s a bit of misconception that regulatory requirements are kind of this gatekeeper to R&D or provide a series of unnecessary hurdles for R&D to jump through. And my perception is slightly different to that, and I think a well-defined regulatory process with a really strong regulatory strategy that’s reviewed throughout the course of a project And that’s aligned with R&D early, supported by a strong R&D and a strong regulatory team can be a real asset because it gives you a framework in which to develop product with a really clear goal at the end, and a really clear set of regulatory requirements that you can design against, as well as your functional and your user requirements.

How early should regulatory and quality teams be involved in the innovation process?

So the standard answer for this is as early as possible, and I’m a really big advocate of having quality regs and other functions involved early on. But for me, it’s about having the right level of involvement at the right stage of the project. So from a regulatory perspective, really early definition of what the strategy is. From a quality perspective, what our quality management system looks like, how we’re going to address various different elements of quality throughout the project. It’s also really important that there’s real clarity on who owns what decision-making throughout the project. I’ve worked in organisations before where R&D think that they own everything, and I’ve worked in organisations where quality and regulatory can sometimes overstep their boundaries, and that causes friction. So I think involvement really early on, but having a real clear understanding of who owns what, whose decision is what early on, is the best way to work between R&D regs and quality.

How do you encourage creativity and risk-taking while maintaining accountability?

So depending on where you are at in the development of a product or a project depends on the level of risk that you’re willing to take on within that project. And it’s one of the reasons that I believe in a single R&D team that addresses development across the entire design life cycle, right from front-end innovation, which is a space that you can take much higher risk in because it’s typically task-based, it’s typically not bounded by quality or regulatory concerns, and you can go and experiment and try things. And that’s a really, really good area for taking risks and seeing if they pay off. The individuals then also work through your regulated product development. And again, you can take risks early on until you’re at the point where you’re hitting design freeze, and then you want to be lowering your risk profile through the project. And then also with supporting existing on-market product, and that’s really where you don’t want to be taking any risks. You have a medical device that’s on market, you want to maintain it, and the chances are that you’re probably addressing something on that device to meet a change in regulations or a quality concern. So that’s where you want to be really low risk. On the subject of accountability, I think it’s about defining who owns what, and ultimately they’re responsible for that project, and then the overarching manager of the program, in which in my company that’s me, is accountable for making sure that we deliver continuous improvement activities as well as addressing our existing product pipeline.

What leadership lessons have had the greatest impact on your career in R&D?

So I guess first of all, I’ve had some really good mentors. I’ve still got some really good mentors. I’ve had some really good managers. I’ve had some really good peers, and I’ve had some really, really good collaboration partners as well. And you’re constantly learning. You’re never fixed. You’ve never become the best at anything. There’s always scope to go and learn. But I guess the one leadership lesson that really sticks with me is be comfortable not being the smartest person in the room. And there’s a real skill in that, and it’s really uncomfortable. But if I walk into a design review and I’ve got an absolute expert in chemical formulations and an absolute expert in embedded software, there’s a real skill in acknowledging that they are the experts in that and being able to sit back and not try and push your ideas, not try and push your solutions. But just to sit there, to absorb, to listen, to process that information, and then provide really clear direction on the recommendations and on the outcomes that you are looking for.

How do you foster collaboration between R&D, manufacturing, commercial, and clinical needs?

So there’s probably three tiers of this. So at a senior management level, at a functional lead level, it’s about understanding what the objectives and what the deliverables are for each of those functions. And sometimes they can counter each other. So R&D’s objective might be to go and develop new product and take it to market as quickly as possible. And if you look at that in isolation, then the effect on manufacturing is just not considered. Manufacturing’s objective might be to have 100% first-time pass through manufacturing with no faults. Your commercial team might be to go and sell all your product for a particular price, and your clinical need might be to address a particular need in the marketplace. But if you look as silos at what your function wants to do without consideration of what the other functions need to do, then you almost certainly get into a clash. And you just don’t need to. So if you’re developing new product with an eye for manufacturing in mind and early involvement with the manufacturing engineers, then that can foster real collaboration. Again, ultimately, all businesses exist to go and make money. So tying your R&D really closely with your commercial is probably the most important thing that you can do. Because if R&D left to their own devices, will just go and develop product. They’ll just go and develop really cool things. But ultimately, it’s got to be sold in the marketplace at the end. So getting really close alignment between R&D and commercial and constant feedback from the market, constant feedback on pricing, both where the cost price is and where the target sale price is, is a really good way to foster that collaboration

Which technologies or trends do you believe will have the greatest impact on medical devices over the next decade?

So the really easy answer to this is AI, because AI’s moving really quickly. But I think for me, it’s more about transitioning products towards preventative, predictive, and early intervention with medical devices. AI will clearly have a part to play in that, but I think there’s a lot of products that just retrospectively address a problem, and I think the trend will move towards predicting that problem occurring and preventing it occurring, rather than just retrospectively treating it. I guess in infection control, a really good example of this would be, at the moment, we might do a high-level disinfection of a room because somebody’s identified MRSA in the room, for sake of argument. So we wheel in a UVC system or a hydrogen peroxide fogging system, and we go and high-level decontaminate that room. And I think the market’s going to move much more towards predictive. So how do we predict that that room is at high risk of infection? How do we use patient data? How do we use usage monitoring to predict that that room is going to be subject to acquiring an infection? And how do we go and prevent that from occurring and instigate a clean before we get to that point?

How are advances in areas such as AI, automation, connectivity, or sustainability influencing your innovation strategy?

So to tick those off in order, AI has a place in R&D and in innovation, but I see it as a tool to be used by really competent, really strong engineers. And the way that we use it is to get us maybe 90% of the way towards a mathematical model or towards an industrial design that might take a long time and a lot of heavy investment historically from an individual, and then use the really talented individual to put the high-level input into the AI software, and then to go and validate that the outcome is actually what we want and that there is value in that model or in that design. So from an automation perspective, I think it sort of ties back into monitoring and preventive maintenance or preventive addressing of concerns or clinical challenges. And it’s about trying to remove the user from that interaction with that device as much as possible so that the user interaction becomes as simple as possible. Now, there are clearly challenges associated with the more automation you have, the more validation or verification you’ve also got to do, particularly if that involves high levels of software. It ties in lots of software risk management, lifecycle management, and other factors as well. But that’s kind of how I see automation influencing medical devices. From a connectivity point of view, I think it’s no longer good enough to just make a product that goes and does a thing, but it’s about how do you consistently demonstrate that that product is doing what you’re doing? How do you validate it? How do you report it? And how do you show to the customer that you’ve had successful implementation of that solution? So from a disinfection perspective, it’s no longer good enough to wheel a UVC system into a room and hit go and then take it out at the end and say the room is decontaminated. It’s about moving that device in, independently verifying that the device has done what it’s said it is going to do, generating a report, showing that to the customer and demonstrating it so that they have real confidence that the system has done what it says it’s going to do. And then finally, from a sustainability point of view, I think the main effect on innovation strategies is around single-use versus reusable medical devices. And depending on where you are in the world, there is different views on this at the moment, and there are certain markets that see it as more sustainable, largely from an investment in processing perspective and time, cost, energy to have single-use devices. I think there’s then ownership on how those single-use devices are made, whether they can be recycled, whether they can be reused, and making sure that they just don’t go into an incinerator at the end. And then there’s other bits of the world that are moving towards reprocess solutions. And I think the challenge here with innovation is making sure that the reprocessing is low energy, is low intensity, doesn’t degrade the material over time, and that you get the maximum length of time out of your reusable product as possible.

If you could solve one major unmet need in healthcare through technology, what would that be and why?

So I would love to see that when a patient goes into any element of the healthcare system, they have zero risk of coming out of the healthcare system in a worse state than they went into. So in my current role, which is centred around infection prevention, infection control, I would love to see a patient go and never get a hospital-acquired infection of any sort. I think I read a paper that said in 2025, there were 814,000 hospital-acquired infections through MRSA, C. diff, E. coli, and others. And that’s an outrageous number of hospital-acquired infections, and it should never be the position that an individual goes into a healthcare system, into a healthcare setting to go and have a routine operation or be seen and be able to come out in a condition that is either worse or exasperated from the condition that they went in.

Software versus hardware. Why is there a fight?

So I think it comes down to what you can tangibly see and what you can tangibly feel, and some of the regulation around software and some of the regulation around hardware. So there’s a real comfort in being able to go and physically hold a device and physically see something happen. And as mechanical engineers, we all love being able to go and see a mechanism working that has a manual input, and you can see the process happen. I think part of the fight comes from software isn’t. You can see some code and you can interrogate some code, but it’s much harder to see tangibly what that software is doing. It’s one of the really nice things about embedded systems is that that software interacts with hardware, and that gives you a tangible outcome that you can measure. I guess, around the regulation for it, it’s much easier to regulate hardware, in my experience, than it is to go and regulate software, particularly things that have a high risk, because you need to put so many controls around that. And the risk of a software bug materialising or a software failure occurring is never zero. But from a mechanical perspective, you could design out that failure mode.

How do you deal with sales going out and selling the future and over-promising?

So I think the first thing is that alignment between sales, marketing, and R&D is really important because there will always be a requirement for products ahead of launch to be pushed out into the marketplace to understand what the commercial opportunity is around it, to understand how the user feels about it. I think it’s a really tight balancing act between showing the right level of product development so that everybody in the business, including sales, knows that actual R&D is happening, and then also not showing your hand so much that they go and oversell untested technologies or unproven technologies. So it’s a really fine balancing act, but I think getting really close alignment with your sales team and your R&D team is really important for fostering that relationship. I think it’s also about the two functions pushing each other. So if R&D have really cool new technologies that they think can significantly advance the field, there’s an onus on R&D to push sales to go and really test the marketplace with that. Likewise, there’s also the feedback from sales that says, “If you can give me this,” or, “You can achieve this,” or, “You can shorten a process time,” or, “You can achieve this level of efficacy, then I can get X outcome from that from a commercial perspective.” So I guess the pushing of technology pushes the sales team to go and try and understand what the customer will accept, and then the sales team can push R&D on what they can actually deliver based on what the customer is asking. 40% of products that hit the market fail because they have no need. These are tough odds.

How do you design in that environment?

So first of all, that number does not surprise me at all, and I think this comes down to how you understand the market that you play in and that you design in, and how well you try to understand the needs, how good the product is, and also making sure that the product addresses a really specific need. So the best products that I’ve seen, and the most successful ones, understand their market. They narrow down onto a particular area of the market that they want to go and play in, and then they understand what the needs are and what the workflows are for that need, and then they go and design product. The devices that I’ve seen fail and the products that I’ve seen fail either don’t understand their market, or they understand the market and they try and play in too broad a subsection of that market. And some of them understand all of that, but then don’t ask the right questions. They don’t go and watch users in the environment to understand how the user actually operates in that environment. They just ask a question from a tick box exercise around maybe a usability process and say, “Okay, well, how do you use this device?” And then they go and design something, and that thing can be the best thing on the market, but if it isn’t accepted or doesn’t actually achieve the requirement or meet the need of the customer, then you’re never going to go and sell that device. So for me, it’s really about understanding your market, understanding your subsection of the market, understanding your user needs, understanding your workflows, looking at your technologies, and then building your product. And if you go too product-focused too early without understanding those things, then you’re always going to run into a position whereby you just don’t have a clinical need to go and address.

So that’s me pressure-tested. Here’s my final thoughts for the day. So the UK historically has been a really, really good place for innovation. We’ve developed some amazing products, not just across healthcare, but across all sectors as well. And that has come from investment into R&D. It’s come from pushing the boundaries of what is technologically possible and from really understanding pain points across the market to develop really cool, innovative products that go into the marketplace and make a real difference. And I guess my final thoughts, having gone through all of these questions today and given my thoughts around them, my reflection is we need to keep doing that, and we need to find a way to do that. And we need UK businesses to take the risk and to go and have a go at developing the next thing to really push the boundaries of what’s possible to make real differences in the medical device market.