MedTech - A Clinicians Perspective

In the Beginning…

When I graduated from medical school in 1999, the MedTech as a term was not widely recognised. We simply used the term "medical devices" or "devices," to capture all products we used to diagnose, monitor or treat patients. Most of us were not tech-minded; our goal was patients, and devices were there to support that mission. We were shown which devices to use for specific procedures or diagnoses based on what was in use at the time. We became aware of their limitations either because we were told or discovered through trial and error.

Fast forward twenty years, and we now live in a different world. The MedTech evolution is here, a multi-billion dollar industry where technology advances at an exponential rate. Software developments are expanding what devices can do and clinicians need to adapt to a changing world and changing practice. Medtech exists to advance clinical care through faster, more reliable diagnoses, better treatment, improved monitoring, and prevention. Clearly, any advancement that positively impacts human health is advantageous. However, we must not lose sight of the bigger picture: the patient, who is supposed to be the ultimate beneficiary of that advancement.

I say "supposed to be" because MedTech organisations are not charities. They are commercial entities that primarily exist to make money. Their goal is to get novel products to market as quickly as possible, before a competitor does, in order to maximise profitability. We certainly do not want to miss out on technological advances that could lead to better patient care, but this must be managed carefully, as the drive for profit and the assurance of device quality can sometimes be opposing goals.

Healthcare standards have improved significantly over the past century, for many reasons. Medical discoveries have allowed us to determine predisposition to disease, enable early detection, and develop pharmaceutical advances. There have also been advances in training and in technology. There is no question that progress in medical technology has positively influenced healthcare, yet it remains just one of many factors driving improvements in clinical practice and patient care, all of which are inextricably linked.

At the risk of stating the obvious: for devices to fulfil their intended use, they must be used, and used correctly. Developers need to know who their users are and the settings in which devices will be used. This generally falls into two categories: home use and professional use. Home use devices are typically low-risk and are used by patients or carers for monitoring, prevention, or mild treatment (e.g., an inhaler). If an abnormality or concerning result is detected, it is usually up to the user or patient to seek professional help for further interpretation or to act as previously directed by a clinician. Professional devices are generally more complex to operate, requiring an assumed level of competence and knowledge. They are also typically higher-risk and require interpretation of results so that the most appropriate next steps in care can be determined.

Throughout my career as a professional user I have used hundreds of different types of devices, some good, some terrible. Clinicians generally give little to no thought to how devices came into clinical use, who designed them, who approved them, or who decided to procure them. The exception is when things go wrong, then we want answers. Most often, we simply work with what we are given or what we have become accustomed to using. This is not to say we are uninterested in MedTech or developments in the field, we are, but our primary focus remains the wellbeing of the patient, ensuring they leave our care in a better state than when they entered. Devices are one link in that chain.

Many elements differentiate a good device from a bad one, and in my experience they can be broken down into three main areas:

1. Clinical performance and patient safety
2. Usability and integration
3. Reliability and Durability

Although listed separately, all three are inextricably linked in practice. Notably absent from this list is cost. While we know devices are not cheap, and that more expensive devices are probably better, product cost, both upfront and ongoing, is not something most clinicians become aware of unless specifically brought to our attention. Further attention will now be paid to these three key areas.

Clinical Performance and Patient Safety

As stated above, my goal as a clinician is to ensure patient wellbeing. Devices are simply the tools that enable us to achieve that. We choose the right tool for the right job to deliver the desired outcome. There is an underlying assumption that devices placed on the market are fit for purpose and that the regulatory systems in place are rigorous enough to safeguard against harm. In truth, very few clinicians know much about the regulatory framework surrounding MedTech. We know it exists, and we largely assume it functions as intended. However, there is a belief that devices are not regulated to the same extent as pharmaceuticals, and therefore we need to remain vigilant.

We have all had experiences with bad devices and have seen some that we believe are unsafe and should never have been allowed onto the market, gynaecological mesh being a prime example. While I have witnessed products being recalled due to safety concerns, there are also devices I currently use that I consider unsafe because of the way they can be used or misused. Where an alternative exists, I will choose that instead. I have seen products with labels or notes written by in-house staff, instructing users to "do this," "don't do that," "use here, not there," and so on. We should not need to add such labels to equipment, having to do so is indicative of a failure of the manufacturer to consider the use and use environment.

We accept that some degree of risk is inherent to all devices, but in some cases, the risk is simply too high. We are regularly involved in pharmaceutical clinical trials, yet far less often in device trials. I believe that many of these risks could be alleviated if device companies simply talked to us. This is especially important when it comes to device usability.

Usability and integration

It is important to distinguish between products that are fundamentally unsafe, i.e. those with inherent flaws in the technology and those that are simply difficult to use, which in practice can also make them unsafe. Even if a device is built on proven technology, it can only fulfil its intended purpose if it is used correctly. To be blunt, your device is one of many in the clinical space and our priority is always the patient. The time we have to operate any given device is not as generous as you might imagine, and it is entirely possible that our full attention will not be on the device at the moment of use. Simply put, a device that demands more user input and concentration leaves more room for error, or if it is too complicated we simply wont use it.

Let me give you an example. By chance, I once visited a company that had prototyped a diagnostic device for use in an intensive care unit (ITU). It was all ready for manufacture and all systems go. The employees were proud of their work and eagerly showed me how it functioned. The device features man knobs, levers, and buttons. I started pressing some buttons and twisting knobs, and I could see the employee's face change colour as I inadvertently did things I wasn't supposed to. I had accidentally initiated a calibration process, a process that in itself was extremely manual, clunky, and laborious. The core concept was excellent, and the underlying technology worked, but the user interface and operation required to make the technology function did not. I politely explained that pressing the wrong buttons and twisting the wrong levers at the wrong time was exactly what would happen in a real clinical environment, especially in ITU. I asked how many of the developers had been in an ITU? The answer, none. The calibration process, critical for ensuring sensitivity and specificity, was far from user-friendly. It looked impressive to those inside the organisation, but they had become so familiar with the device that operation was second nature to them, they could not see the forest for the trees. They knew what to press, what to twist, and in what order to make it 'work'. Although the company had a clinical resource, their input had been limited to the core technology and concept, which was proven, not the operation. Further usability assessments confirmed the same concerns, leading to a costly major redesign ultimately costing the company millions and contributing to its eventual collapse.

When considering usability, it is also vital to account for variation across the spectrum of users. What does 'for professional use only' actually mean? A doctor? A nurse? An Operating Department Practitioner? Each group may have different expectations, competencies, nuances and physical attributes. As a petite female surgeon, I struggle with many surgical instruments that are clearly designed for people with larger hands than mine, predominantly men. Different clinicians also vary in how quickly they adapt to the latest technology,  some love it, others much less so. Some of my colleagues prefer different devices for the same procedure based on personal preference. Using devices is often like riding a bicycle, the more you do it, the more competent you become. However, given their shaky start learners are excellent at exposing device flaws, whereas familiarity tends to normalise or embed quirks and risky areas of operation. Those risks, once identified, can and should be fed back to the manufacturer so they can be addressed.

Primarily, devices need to be intuitive in operation. The reality is that very few clinicians read the instructions that come with products. While we often receive training for more complex devices, that knowledge only stays fresh for so long. Eventually, use becomes second nature, or we rely on intuition. The best products are those you can walk up and use because you have used something similar before, or for more complex systems, the user interface provides clear prompts on what to do. When an alarm sounds due to a device fault or patient alert, the nature of the fault needs to be immediately clear to the user. Alarms that sound constantly for minor issues lead to alarm fatigue and missed critical events.

Alongside usability is adaptability. Unless your product is a true game-changer that completely transforms a given process, it will need to integrate into existing practice and the current operating environment. For example, if your device must connect to a hospital IT network and requires additional infrastructure for functionality or cybersecurity, the chances of adoption drop significantly. If your device requires cords or cables to run across workspace floors, that creates additional hazards and may raise eyebrows from Heath and Safety. Returning to the ITU device mentioned earlier, if a product demands so much attention or concentration to operate such that other necessary tasks are neglected, it will not fit well into the use environment. Careful consideration of the use environment and integration with current practice is essential. Your ideal operating environment may not exist or may simply be unrealistic. Speaking to actual users in the early stages of development is absolutely critical to address these issues and increase chances of adoption.

Reliability and Durability

It should come as no surprise that we expect devices to operate as intended, consistently. Clinicians want tools that make their jobs easier. That said, we are also creatures of habit, so getting us to adopt a new procedure or device can be challenging. While I am more than happy to try a new device, I do so with caution. If it breaks down, gives a clearly erroneous result, or proves temperamental, my confidence in it diminishes. I will give it a second chance, but if it fails again, there will not be a third. We accept that products can occasionally fail, but repeated failures lead to a rapid loss of trust.

We expect downtime to be kept to an absolute minimum. Devices that are frequently unavailable due to constant calibration or maintenance are of limited practical use. Maintenance and calibration schedules should be clear and simple. Likewise, any faults that require user intervention should be straightforward to remedy.

Products must also withstand the realities of the clinical environment, realities that often surprise device designers. As mentioned, healthcare settings can be chaotic. Your device may not be handled as you expect. It may be knocked or dropped, intentionally or unintentionally misused, have liquids spilled on it, or be exposed to aggressive cleaning or disinfecting solutions. If it is portable, can it be moved freely? When moved, it will inevitably bump into things, will that damage critical components, and will the user be aware? While I cannot claim to be a software or cybersecurity expert, I have seen patients try to log into hospital equipment so can only imagine what the threats are in cyberspace. Will your device be adequately protected against threats and unintentional access?

Device developers need to be clear about the intended use environment and aware of its realities. I have seen many products that break too easily, claim to be portable yet cannot be moved by smaller-staff members, create trip hazards with multiple cords and cables, or have displays that become unreadable under certain lighting or direct sunlight. These examples are far from exhaustive. Understanding the use environment is essential, and that understanding can only be gained through direct exposure either by device developers immersing themselves in clinical settings, or by drawing on the experience of those who work there.

Summary

There is no question that advances in MedTech have improved clinical outcomes for patients and made healthcare delivery more efficient. However, as technology evolves at an unprecedented pace we must not lose sight of the bigger picture, the people at the heart of MedTech —patients.

While great ideas backed by technology are plentiful, we must be cautious of the “solution in search of a problem” scenario. Innovation in MedTech must be driven by real clinical needs, not the other way around. Devices should have a clearly defined clinical purpose and be safe, reliable, and intuitive. Although clinicians recognise the need for innovation, they are generally creatures of habit and resist change unless there is a clear, demonstrable benefit. We want devices that reduce burden, not add to it, while still improving clinical outcomes.

Even though we largely trust the technology and regulatory systems designed to protect patients and users, my decades of clinical experience have shown that many companies fail to appreciate the importance of device usability and overlook the dynamics of the clinical environment. These failures introduce risks to both users and patients. If your device is intended for use by clinicians, involve them from the early stages. They are well positioned to identify risks that developers might overlook and to offer feedback on known risks. If you have a device that addresses a specific clinical need or even if you’re unsure, talk to us. We are more than happy to help develop products that make our lives easier and improve clinical outcomes.



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