The Importance of Technology Readiness Levels (TRLs) in Product Development & Diagnostic Development

How to Reduce Problems During the Product Development Process

Have you ever wondered why some great ideas never make it to a fully commercialised product? In our experience, great diagnostics don’t fail because of bad ideas – they fail because they scale too soon. And what separates breakthrough diagnostics from expensive dead ends is usually a clear path to readiness. And how do you make sure this is done properly? With Technology Readiness Levels (TRLs).

What Are Technology Readiness Levels?

TRLs give diagnostics teams a framework to validate technology, communicate maturity, and make smarter development decisions at every stage, providing the structure innovators need to move from lab discovery to clinical adoption with confidence.

TRLs help medical innovators reduce risk, validate performance, and move confidently from concept to commercialisation. They are essential for medical device and diagnostics teams navigating R&D, regulatory expectations, and investor confidence.

In healthcare, “almost ready” isn’t ready enough. The path from breakthrough science to clinical reality is full of risk.
That’s why smart innovators rely on Technology Readiness Levels to guide product maturity, reduce uncertainty, and strengthen clinical confidence before launch.

The Medtechtomarket Podcast -The Importance of TRLS

Dr Jack Fitzpatrick and John Storton sat down to record our first ever podcast episode to discuss TRLs and how every stage of readiness brings us closer to better healthcare.

Key topics:

• What are Technology Readiness Levels
• How do TRLs reduce or mitigate risk in product development?
• What are the origins of TRLs
• Are there any mainstream examples of products not getting to full commercialisation?
• What happens at each stage of diagnostic development?
• When do Regulators and investors get involved in product development?
• At which stage should you partner with a CDMO?

Full transcript:

John Storton Why do so many breakthrough technologies never become successful products? If you’ve ever worked in R&D, startups, corporate innovation, or deep tech, you’ve probably seen this happen. Often the issue isn’t the idea itself, it’s maturity. Today we’ll be talking about technology readiness levels, where they came from and why they matter, and why understanding them might be the difference between a prototype and a viable product. We have our business development manager, Jack Fitzpatrick, with us today. Good afternoon, Jack. We use technology readiness levels, or TRLs, as they’re known, as part of our product development process here at Medtechtomarket. So can you tell us what they are and why they’re important please?

Dr Jack Fitzpatrick Yes, so TRLs are essentially a framework to ensure that a product is developed with the end goal in mind. And so there’s nine, and they’re broken into three distinct stages. Stage one is sort of the research and development proof of concept stage. The middle stage is then validating that technology within a regulated environment in a lab. And then the third stage is actually demonstrating that technology in a real-world application to prove that it actually does what it says and has been developed properly.

John Storton So it’s a risk management tool, essentially then?

Dr Jack Fitzpatrick It’s a way of de-risking technologies or understanding how de-risked they are. So TRLs one to three. It’s sort of early-stage science. It’s not really become a product at that point or, you know, it’s not really been demonstrated in a productized form. At TRL nine, that’s ready to be on the market ready to be sold and regulated.

John Storton So in TRL one to three or the early stages, the uncertainty and the risk is massively greater than at the final stages?

Dr Jack Fitzpatrick Absolutely. So what we tend to see is, you know, TRL one to three, that’s a high risk technology where there’s still many areas that it could go wrong. So the appetite for adopting those technologies can be quite low because especially large corporations at this point, they see that as a liability really. Whereas at TRL nine, it’s sort of got everything but the sticker on it, it’s ready to be on the market by whoever wants to adopt that technology.

John Storton When I was doing my research, I found a phrase that seemed to fit this situation: “innovation loves a good demo”. So I presume that’s where somebody had an idea. Technically it might work or it has worked once or twice, but “it works” isn’t really the same in product development as something that is constant in the real world environment, and almost perfect.

Dr Jack Fitzpatrick Yeah, exactly. And sort of consistency and repeatability are a key factor of that. So, you know, something might have been demonstrated in the lab, but can you convert that into a product which every single version of that product has to work the exact same. You can’t have one of them failing or one of them, overestimating something, underestimating something. And so TRLs are really about progressing through that from that early stage, the science works, to now we’ve got a product and that works and it’s safe and effective for use.

John Storton Right, okay. So you mentioned three stages before, but you can also cut it in half and say there’s science and research and then more of a product development stage afterwards.

Dr Jack Fitzpatrick Yeah, absolutely. And that’s where we help out is that a lot of the science and research may have already been done on some of the projects we work at, especially the university projects. But we then take that science which is robust and productise it. And, you know, that comes with its own challenges really.

John Storton And you said it’s a framework. I presume it’s across the board used by everybody. Is it a case of if you don’t pass the requirements at stage one, you don’t get to stage two? Or is that a mistake that a lot of people make where they skip ahead a few, or they jump ahead?

Dr Jack Fitzpatrick Following the TRLs religiously is what a lot of people struggle with. And people have a tendency to maybe skip ahead or believe they’ve reached a certain TRL. But if you’ve missed out any of those levels, you’re actually back at that point. You know, you can’t go to TRL seven if you’ve not done three, that kind of thing. So some people might believe they’re further ahead than they are. Um, if they’ve not been following them methodically.

John Storton Right. So you can see quite easily how things go wrong and [perhaps] the feasibility test might have been fine. And then it doesn’t actually make sense in the real world. You can see how easily that could happen if stages haven’t been followed properly.

Dr Jack Fitzpatrick Yeah, exactly. And so actually a key issue we sometimes see is people might carry out clinical studies based on a technology. So if a technology hasn’t been productised and it hasn’t been through manufacturing validation, any clinical work done on that is then not valid for a technical file submission for regulatory bodies. So we sometimes get people thinking they’re at a certain stage because they’ve done clinical studies. But if that technology is still lab based and not productised, then unfortunately they’re further behind than they think.

John Storton Yeah. And I suppose that can have knock on effects for investment and various other things, which I suppose we can touch on a bit later on when we go through the TRLs in a bit more detail. Yeah. Um, I actually looked at some famous examples of this kind of thing where tests have been done, but actually it doesn’t work in the real world. One of the earliest, well, one of the more sort of mainstream examples I found was PVC piping. So they did the durability test. It worked just as well as copper, metal, whatever was used before. It was cheaper to make and was going to revolutionise the plumbing industry. But apparently the supply chain and the actual end users, the plumbers themselves just didn’t want to use it because they thought – just like us saying, “AI is going to take our jobs” – Back in the nineteen fifties, plumbers were like, well, this will make my job quicker and easier, so I can’t charge as much. And so apparently it took fifteen years for that to be adopted and to be accepted as useful in a real-world working environment.

Dr Jack Fitzpatrick Yeah. Well, exactly. Yeah. We see a lot of that as well in diagnostics and medtech, where things work really well in the lab. But getting them into practice is, is a whole, a whole different beast. So yeah.

John Storton So you’ve got different examples where it might not be the end user, it might be someone in the supply chain, but somewhere along the line, something that’s not been considered in the lab stages. There’s a lot of things that can go wrong really aren’t there?

Dr Jack Fitzpatrick Yeah, absolutely. Definitely. And yeah, I think it is, you know, it’s used globally in all industries. But I think especially in regulated industries like medtech and diagnostics, there’s also that layer of you can go along theTRLs and think you’re really close, and the regulators can turn around and say, you’re missing this key bit of information that you should have done back at TRL three. And you know, you’ve got to go back and do it. So it’s definitely important in our industry as well.

John Storton Well that’s it. Depending on what you are creating, there’s a sort of a necessity for safety or otherwise. Which brings me nicely on to the origins of the TRLs.

Dr Jack Fitzpatrick Yeah, I think I heard it was NASA, was it, that came up with them?

John Storton It was indeed. Quiz points for Jack. Um, yeah. I mean, similar to medical diagnostics, if you get it wrong with a NASA piece of equipment, it may be the consequences are mission failure, loss of life… billions of dollars. So in our industry as well, it’s almost equally as important that we get it right. You can’t just sort of gloss over a few of them, can you?

Dr Jack Fitzpatrick Well, exactly. Yeah, you can imagine. Space travel again, highly complex and well-regulated for safety. So yeah, glad that it trickled down to other industries.

John Storton So you mentioned earlier, Jack, that there are nine TRLs in product development, or diagnostics development in our case. So what we’re talking about here is product maturity, isn’t it? It’s how ready it is to go to market. So if we start right at the beginning, then at TRL one, what does that look like?

Dr Jack Fitzpatrick Yeah. So TRL one is essentially the basic scientific concepts of that idea or product have been observed. So it’s, you know, it’s a feasible option. Um, and then TRL two sort of identifies an application for that, for those principles. So you sort of think where it might be used, what the product might look like, and you’ve got an idea, it’s sort of coming together. And then TRL three is actually some form of data to back up that idea. So you’ve got early proof of concept feasibility. And you know, this can be quite basic and, and doesn’t have to be necessarily on the product. It can just be on the underlying technology.

John Storton Lovely. It’s still very much sort of curiosity phase at this stage though, isn’t it? The technology is kind of fragile. It’s still more of a concept than a product isn’t it.

Dr Jack Fitzpatrick Well, yeah. So obviously then you’d move on to TRL four and five. With TRL four it’s meant to be tested in laboratory conditions. So not really reflecting the real world, but a controlled environment. And then TRL five is sort of a little bit closer to the real-world setting. Obviously in our industry that would probably be a laboratory anyway or similar. So some of the TRLs merge into each other a little bit. Then TRL six would be you’ve actually got quite a robust prototype operating in conditions that are as close to the real world as you can get whilst still being in a, in a sort of laboratory based environment. So you’re not actually out in the real world, but you’re as close as you can get to an artificial version of that, essentially.

John Storton And TRLs is four to six are also known as the ‘Valley of Death’ in terms of development stages, where, as we’ve mentioned previously, the idea is great. It works in a lab, but something goes wrong. And why do you think that is at this stage of the development? Is it because of a change of location? Is it because you’re testing more robustly or are you just do you need more data? What is it that makes it more difficult?

Dr Jack Fitzpatrick Essentially, you know, getting proof of concept data and getting one experiment to work or getting an indication something might work. That can be, I would never say simple, but that could be easier than the TRL four to six stages, getting that real kind of robust repeatability and also trying to understand, you know, if the variability is too great, then that’s not a reliable diagnostic, for example, in our industry. Um, and so it’s really that next level of scientific scrutiny. And I think that’s where things can get a bit more difficult, really.

John Storton And as we mentioned before, funding can get a bit hazy at this stage, can’t it? Because investors want to make sure that it’s going to get to market quickly and make loads of money, I presume. And If it’s not quite ready, they might be reluctant to start pumping money into it. So there’s a lot of complexity.

Dr Jack Fitzpatrick Yeah. Also I think one of the big problems with, as you said, Valley of death is that the early stages are well funded with academic grants and academic funding and sort of Universities. Um, and then the latter stages when the technology is very reliable and there’s good confidence in it, then obviously that’s when investors or VCs would step in. And I think that mid stage is definitely the there’s less appetite for the bluesky academic funding, but there is no interest from VCs because it’s still too risky. So unfortunately, no one’s kind of willing to step in and carry things through that valley. Um, and obviously, you know, we help out and that’s where we support people. But again, the funding unfortunately is still a bit sparse at the moment. So, you know, hopefully that’s something that maybe a government could look into, uh, you know, sort of creating a setup for that, really.

John Storton Yeah. A policy reform that perhaps we don’t have time to go into detail on this episode!

Dr Jack Fitzpatrick We’re not politicians, unfortunately.

John Storton Okay, so we’re out of the difficult TRL stages four to six. Is this when we start to get serious and have an actual product on our hands?

Dr Jack Fitzpatrick Yeah, absolutely. So, you know, TRL seven to nine, the product’s kind of been developed. It’s been, you know, tested in a lab and people are confident it works. And then it’s sending it out into the real world. You know, it works in a lab with someone with a pipette or whatever. But can that work in a clinic? Can it work at home use, um, you know who’s the intended user of that device, rather than a trained scientist who’s been doing the experiments, you know, every day for the past month. Um, and so yeah, that’s the critical stage to prove the real-world effectiveness of that product really.

John Storton But it’s still testing at this stage, isn’t it? And as we said before, risk management. As we get closer to stage nine, you’re mitigating or eliminating all of that risk aren’t you?

Dr Jack Fitzpatrick Yeah, exactly. So stage nine is effectively a fully de-risked product. Um, and stage seven to eight is mostly de-risked and there’s a good confidence in the product. Um, but there’s still that final bit of data that needs collecting.

John Storton We have heard quite an interesting analogy about TRLs. Do you want to explain how our founder, Matt Pearce describes how TRLs should be approached?

Dr Jack Fitzpatrick So his favourite analogy is actually “it’s like baking a cake”. So essentially you can have all the ingredients to make a cake, but the order in which you combine those ingredients and the steps you take are fundamental to getting the end result of a tasty cake. If you add them all in at once, chuck everything in the oven and don’t do anything, you’re probably not going to get a very tasty cake. You know, it’s important the steps you take and they must be done in an exact order. And that’s very similar to TRLs.

John Storton So we’ve mentioned that investors will start to get involved around the valley of death. Regulatory bodies might be involved at a similar stage. There are also kind of implications for internal team members, R&D teams, etc., aren’t there? Because they won’t be ready to push things forward until they’re satisfied that their particular TRL is done properly. Will they?

Dr Jack Fitzpatrick Yeah, I mean exactly. That’s obviously where things like in regulated product development, we operate a QMS, a quality management system. And although it’s not directly aligned to TRLs, they are very closely aligned systems in terms of we must ensure that certain conditions are met before we’re able to move on to following milestones. Um, and that’s exactly how TRLs need to be approached. And that’s why a lot of the work we do aligns to the TRL system. So we can take products from TRL one through to TRL nine. But actually most commonly people might come to us around TRL three, where the fundamental science has been proven and they’ve got the proof of concept data, but then they’re ready to take it through regulated product development, and we’re able to then take that and collaborate with them to take it to a market ready product with full confidence that the data is there and the regulators have approved it.

John Storton So it sounds like quite a scary process for, you know, an academic researcher that’s just wants to do good in the world. So how do you convince them that getting involved or partnering up with Medtechtomarket is actually a good thing?

Dr Jack Fitzpatrick So this is the thing is that some people can maybe think that productisation is all about making money, but actually it’s also about things being safe and regulated. So for example, the ISO 13485 quality management system, which is a requirement of IVDs and medtech devices, you know, it’s very, very strict, very stringent requirements. And if that was imposed on a university lab, they wouldn’t be able to do any of their normal research because they’d be too busy calibrating every single pipette every day, you know, and so we help them get a regulated product onto the market so that bodies know that it’s safe and effective, which helps it get to the patients that need it the most. It’s not just about selling a product to make money. It’s about having a safe and effective product that does what it says and what it needs to help patients.

John Storton So like we said before, it’s about technology maturity and mitigating risk rather than just getting something ready and selling it as fast as you can.

Dr Jack Fitzpatrick Yeah, absolutely. In fact, it’s almost the opposite of selling it as fast as you can. But it takes quite a while. And some people would prefer to sell it faster, but it’s important to go through the TRLs and as they align with regulations to ensure that everything is safe and effective and you’re not selling something that you know is actually endangering patients and not doing its job.

John Storton Good old NASA. They got it right, making sure it was ordered properly.

Dr Jack Fitzpatrick Exactly.

John Storton Final thought then you mentioned that Medtechtomarket normally get involved after the academic research has been done. I suppose it could work the other way around where someone’s right near the end and might want just a little help over the precipice, so to speak. What’s the preferred method for Medtechtomarket, to do the whole thing or just to help out where we can?

Dr Jack Fitzpatrick It’s honestly both. We’re very flexible and we’re happy to help projects at any stage essentially. So although we can do the full project from TRL one, you know, people can come to us with a concept or an idea and we could take that all the way through to TRL nine and market launch. Some people have been through V and V, and then they may be looking for some regulatory help and manufacturing. So they’ve got the product approved, but they need manufacturing help. And we also offer services like that. So we help out wherever it’s needed essentially.

John Storton Great stuff. Well, I think we’ve covered a lot about the basic strategy or structure of TRLs today. So wherever you fit in the innovation ecosystem, the question isn’t just, is it a good idea? It’s how ready it is. Um, Jack, thanks for joining me today, and thanks for listening. If you found this useful, share it with someone that you know, that’s building funding or scaling a new technology and we’ll see you next time.