For every device that successfully reaches the market, there are about ten that are abandoned long before launch. Even among those that clear regulatory hurdles, a significant number fail to achieve commercial success. The reason often isn’t the quality of the solutions or a lack of expertise, but the absence of a clear go‑to‑market strategy and consideration of all stakeholders in the healthcare system. Clinicians involved in development often know what the market needs, but don’t know how to apply that knowledge correctly.
Dr. Paul Hercock, a former physician and now CEO of Mantra Systems, helped us analyze why promising innovations don’t become sustainable products, and what can be done to change that.
Andersen: Do you have data or insight into how many medical device startups fail at or shortly after the launch?
Dr. Hercock: The true perspective is that the majority of concepts don't get anywhere close to market launch. It’s easy to see how a go-to-market plan is relevant to traction once a product enters the market. But the other highly relevant area that it adds value to if done properly is in raising investment, because any well informed investor will be looking for a sensible and well constructed go to market plan. Without it, there's not going to be a return. Those that get into the market, there's a real tragedy there, because they've invested very, very heavily to navigate the regulatory requirements, only to find that they don't get the uptake and traction that they were expecting. So altogether, more than 90% of early stage companies in this space will fail before they get to market. Of those that actually enter the market, as many as 50% will see commercial traction well below their expectations, because they failed to plan for what is now a challenging reimbursement environment.
Andersen: What’s surprising is that the people who decide to develop medical devices are usually bright and intelligent. So how is it that they often don’t have a proper go-to-market plan?
Dr. Hercock: You're right, people in this space are extremely capable. They may come from several camps, and one of those is healthcare professionals who identify a clinical problem that isn’t being properly addressed by existing solutions.
These individuals tend to have an extremely detailed understanding of the problem itself. And they see, within their space, how a solution could address it. But they represent the perspective of just one stakeholder.
A proper go-to-market strategy needs to consider the perspectives of four groups: patient, healthcare professional, healthcare provider, and policymaker. Often, a professional working on a solution views it through the lens of fellow clinicians and patients but overlooks what policymakers may be thinking. Yet policymakers hold the purse strings, and without their support, there will be no commercial traction.
So it’s not a matter of intelligence. It’s that these innovators are deeply embedded in their own space and often lack the tools or perspective to step back and view a go-to-market plan more broadly. That’s where most fall short.
Andersen: In healthcare generally, we’re dealing with the same core stakeholders. These dynamics are taught in universities, and healthcare professionals should at least be aware of these groups.
Dr. Hercock: I was working in A&E. As someone who spent many years as a healthcare professional, I knew about NHS procurement systems. I knew that trusts were collaborating on purchasing decisions. I understood all of that. But there’s a big difference between knowing something and applying it properly.
What happens naturally, on a human level, is that people focus on identifying solutions, and that’s the exciting part. So time and resources go into developing the device or software, and then into raising investment – doing all the interesting bits. That often diverts attention from what may seem less relevant at an early stage. The mindset becomes: we’ll figure out how to sell it once it’s developed. That’s the wrong mindset. The real question is: are we solving the right problem in the right way? We need to stop fixating on the solution and instead focus on the problem, defined through the lens of all stakeholders. You’d be surprised just how much that shift can change the positioning and structure of the solution itself. And that’s the step many people fail to take.
Andersen: Are there specific features you've seen in a smart device that almost guaranteed unsafe use but was praised by investors as elegant or intuitive?
Dr. Hercock: I suppose unsafe use is one issue, but failure to gain uptake is another. I once developed a wound closure device and believed it was perfectly positioned.
I asked the nurses I was working with to test it on fake skin, just to get their impressions. Every single one of them held and used it in a way I hadn’t anticipated. Usability is often overlooked. A new innovation needs to integrate seamlessly with existing systems – and ideally, it should reduce the workload. I often hear, “Well, it only takes five seconds more than current solutions.” That won’t work. Multiply five seconds by tens or hundreds of thousands of healthcare workers every day – there simply aren’t resources for that.
Andersen: People want their problems to disappear. If your solution draws attention to itself, it’s not a solution.
Dr. Hercock: The other side of this is that some innovators do go part of the way – they reduce staff burden, which is great. They may even argue a compelling cost-saving case: “If you adopt our device, you’ll spend X today, but over the next two or three years, you’ll save 2X.” The problem with that line of reasoning is that it ignores how budgets are managed.
The issue may not be what happens in two or three years – it may be this quarter’s budget. So a longer-term saving might not get a company through procurement, because the person making the immediate purchasing decision is the one whose budget takes the hit. They may not be in a position to care that someone else’s future budget will benefit. And that’s where stakeholder management is often missing.
Andersen: That feels unfair.
Dr. Hercock: It's unfair and it's short-sighted, and it's a bigger problem because it's failing to seek overall improvements in healthcare, but it's a function of the way the system's currently set up. And UI and other innovators would rightly sit and talk about how unfair it is and how it's not optimized. And that's all true and valid, but it changes not one thing. Because if you want to get the product through approval, you have to work with the system as it is. You can't develop a device and change the system at the same time. That's not possible.
Andersen: Have you ever advised a team to kill their own product?
Dr. Hercock: Yes, I have. It’s unfortunate when it happens at a late stage, but I’ve done it quite often at an early one. People might assume the main reason I’d advise someone to abandon a product is because the market is already saturated with similar solutions. But that’s rarely the case. There’s usually room for another solution. The real reason I suggest killing an idea is when it’s unlikely to demonstrate a clear benefit or when it can’t be integrated seamlessly into existing care.
My own device that failed ten years ago is a good example of the former. I was developing a product to prevent the spread of infection via pulse oximeter clips, the ones that go on patients’ fingers. It’s a genuine issue: those clips are often far from clean. They’re used on over 100 patients a day, and anxious patients frequently put their fingers in their mouths – it’s a natural human reflex. That creates oral-to-oral transmission risks.
My device would have eliminated that route of spread. But how could I prove an overall reduction in infection spread as a result of my device? There are too many other variables in play, and a meaningful impact simply couldn’t be demonstrated. I couldn’t say, “You’ll prevent X infections and save Y money.” There would likely be a reduction in transmission, but it was impossible to quantify.
So I could speak to a clinician and say, “This is a real problem, and here’s a solution.” They might agree, but that would never be enough to get through procurement. If I were advising myself ten years ago, I’d probably suggest killing the product on that basis, because despite its potential, it would never gain commercial traction.
Andersen: Can you share an example where a device passed regulatory checks, but failed due to a predictable misuse or misunderstanding by frontline staff.
Dr. Hercock: There was a device, a variant of devices that measure blood glucose levels in hospitalised diabetic patients. The device is linked to electronic health record systems in the emergency rooms, but not integrated into the main patient record system. Which made it difficult to monitor trends over time. The idea behind this device was that it would record blood glucose from a finger prick in the same way as the traditional ones, but there was a requirement for nursing staff to enter patient details manually. These would then be sent to the cloud and go into the health record system.
In acute care, playing around with typing patient details in took far too long. And so these expensive new devices were sitting unused on the side, and the old devices would just continue to be used. And that wasn't the nursing staff being obstreperous. It was necessary in the time-constrained environment that they worked in. Of course, that device would never be reordered. It appealed to health care providers at an institutional level. That's why they bought it. But it did not appeal at all to health care professionals.
Andersen: We have so many technologies and so little integration into one system.
Dr. Hercock: So many solutions are for single problems; they just don't work together. And I think we collectively have a very rigid system now for both health care provision and health care procurement.
If we want to see more innovations in health care, there'll need to be some change to that rigidity. But that's not going to happen overnight. The UK government has just introduced a scheme of innovation passports.
The idea is you still need to get regulatory approval. But if the product is then approved for use in one hospital, it won't need to be comprehensively re-evaluated by other hospitals to save time. It remains to be seen whether that will be a success.
Andersen: I've heard that there are plans to create a unified health care platform.
Dr. Hercock: It's another HS2. I think this has been talked about for years, but where is it in terms of readiness? I'm always sceptical because the NHS needs a 25–30 year approach, but we change political parties and governments every five years. So, continuity of improvement is impacted just by the political system that we have.
I'm not here to offer solutions to that problem. But what I am here to do is advise innovators on how to best prepare for and navigate the system that we do have. And go-to-market planning is just a critical part of that, and must not be neglected in favour of the exciting bit, which is product development. It's almost not worth starting that until you've really sat back and thought about a proper go-to-market plan. And it begins on paper. And it can be done for free.
