Taking healthcare out of the hospital – how medical device design can empower users

The medical devices democratising healthcare

Creating medical technologies that can enable healthcare to be conducted outside of clinical settings often involves a certain degree of up-skilling non-specialist users. The idea is that by putting the right technology and support in the hands of more healthcare professionals (HCPs) and providers, patient access to care can be increased, a phenomenon known as the democratisation of healthcare.

There are many examples of devices being used to help democratise healthcare. Wearable devices are empowering users to track and better understand their health, providing a wealth of digital biomarkers that can be used to better inform health decisions. Meanwhile, point of care diagnostics are providing lab comparable results in minutes, enabling faster diagnosis and greater access for patients. The following are two examples of medical innovations developed with Team Consulting, which are helping to democratise healthcare.

An all-in-one hearing health assessment system

One highly successful device which is furthering the democratisation of healthcare is the Tympa System, a smartphone enabled otoscope. Developed by TympaHealth, a company founded by an ENT surgeon from the NHS, the Tympa System is designed to help improve the care pathway for receiving diagnosis and treatment for hearing loss, which can be both disjointed and relatively inaccessible. According to TympaHealth, the average waiting time for patients to receive treatment pre-Covid was 12-16 weeks, which grew substantially during the pandemic and carries significant risk of patient drop-out. To compound the problem, GPs in the UK have also stopped offering wax removal as a service, which has had a significant impact on access for patients who may need this procedure before an ear examination can be undertaken.

The Tympa System provides a means of conducting ear wax removal, a hearing check and digital ear examination all in a single 30-minute appointment. The device makes use of a smartphone camera with integrated optics and illumination to capture high-definition images and video of the ear, which can be shared with ENT specialists and audiologists if a referral is required. It also includes a micro suction device for removing wax.

Importantly, this device is designed to enable both specialist and non-specialist users to provide hearing assessments outside of a clinical environment – for example in a high street pharmacy. Today, there remains an apparent reluctance among people to attend appointments in a clinic, especially for conditions that can carry a stigma such as hearing loss. This device is a good example of a technology which democratises healthcare, increasing accessibility for patients and reducing the number of hospital and GP appointments required.

A cloud-connected point-of-care diagnostics system

A second example of a technology enabling healthcare outside of clinical settings is a point-of-care diagnostics device developed by LumiraDx with support from Team Consulting. Traditionally, diagnostic tests for markers such as D-Dimer, CRP and INR would be conducted in a centralised lab on a variety of different instruments. This would require patient samples to be ferried to the lab from hospitals and GP surgeries, where they are processed by skilled technicians before returning a result. We can all remember the anxiety we faced taking a Covid test early on in the pandemic and then waiting for the result to come through on your phone from the central lab. That anxiety multiplies when it’s a complex health condition where decisions need to be made very quickly.

The LumiraDx Platform provides a wide variety of lab-quality diagnostic tests at the point of care – be it the patient’s bedside, in a high street pharmacy, in the home or in a resource-poor setting. This enables users to make faster, more accurate decisions on diagnosis and treatment.

In combination with things like wearable monitoring devices, technologies such as this are bringing us ever closer to the concept of the ‘virtual ward’ – the idea that patients could be provided with acute care, monitoring and treatment at home, rather than in the hospital. This is desirable as it has been shown that patients recover better in their own homes and remain more connected with their carers and communities.

Healthcare at home – the challenge of training patients

While the previous two examples have focused on medical devices designed for use by clinicians and healthcare professionals (HCPs), there are also occasions when we require patients to self-train and administer therapies which would otherwise be carried out by an HCP in a clinical setting.

Take for example home auto-injection systems for a condition like rheumatoid arthritis. Traditionally, a patient would be instructed in first use of an auto-injector by an HCP during a face-to-face meeting, who would be able to support the patient with challenges such as injection anxiety and how to rotate the injection site. Increasingly, patients are now expected to self-train in the use of auto-injectors, sometimes having to rely solely on instructions for use (IFUs) to learn how to use their device.

In reality, many people either don’t read instructions fully or don’t follow the use steps correctly. This has been a significant driving factor in the simplification of use steps in recent years, with many modern auto-injectors now following a simple two-step process of ‘remove cap’ and ‘hold against skin’. Whilst this has reduced the opportunity for user error, it has also come at the expense of device complexity.

Even something as simple as an asthma inhaler poses significant challenges in terms of self-training and adherence for patients, as delivery technique is critical. With pressurised metred dose inhalers (pMDIs), users often struggle with coordinating the button press with inhalation, the result being that most of the drug is deposited on the back of the throat, which can lead to further complications. Inhaler spacers, which are plastic tubes that are attached to the mouthpiece, go some way to addressing the coordination challenge, but they are bulky and require cleaning. This has driven innovations in inhaler design such as breath actuation, where the plume of drug is not released until the user starts inhaling. The challenge here again is that this comes at the price of increased device complexity.

When you factor in all the additional support previously provided to a patient by an HCP, device manufacturers are therefore asking much more of their users and requiring more effective user-centred design. This has pushed companies to look beyond the device itself, to other elements of the design ecosystem such as the packaging and quick reference guides.

Digital tools to support users

The benefits of using smart devices go beyond training. Sensors enable the recording of usage data, which can be shared with HCPs to ensure patients are adhering to their treatment, or with device manufacturers to make improvements to their product offering. Patients can also access more general information and support around managing their condition.

Another area where smart devices are proving to be useful is in the decentralisation of clinical trials. As the name suggests these would typically be conducted in a clinical setting which may therefore limit the number and type of participants that pharma companies can engage with. Additionally, a clinical setting can influence the behaviour of a participant.

Smart devices are now enabling clinical trials to be conducted over longer periods of time, in the participant’s home environment. This gives pharma companies much greater access to patients – especially more vulnerable cohorts who would previously have been excluded from attending clinical settings, such as cystic fibrosis patients. It also provides more confidence that the data collected is representative of reality. In short, smart devices in clinical trials allow for higher quantities of more targeted data, which can help to promote safer and more effective treatments.

While these digital solutions may seem like an obvious benefit for both users and pharma companies, the system design needs to work hard to engage and motivate patients, particularly if additional user steps are required such as downloading an app or sharing personal data. Designing solutions to prompt and motivate users to adopt a digital solution requires a deep understand of their desires and un-met needs. This comes down to performing good contextual research from the outset and testing ideas, often with the target user group.

Ensuring user-centred design in a development

Taking healthcare out of the hospital and clinical settings has the potential to improve access, enable faster, more accurate diagnosis, reduce burden on the healthcare system and ultimately create better health outcomes. However, doing so places greater burden on both the devices enabling this and the users themselves. It is therefore important to think carefully about what is being lost by taking a task out of the hands of an experienced HCP. Achieving the right balance involves developing devices which people can and want to use, which are simple, intuitive and safe. This is easier said than done. The following are some of the key steps that can be employed in a device’s development to achieve successful, user-centred design.

Contextual research

The key to effective design is understanding the underlying behaviours, beliefs and unmet needs of your users, followed by a cycle of developing and prototyping solutions and testing them frequently with stakeholders along the way. This process should ideally begin with conducting contextual research. When developing a diagnostics device for example, it can be useful to visit labs, GP surgeries, hospitals and pharmacies, ideally in different locations. This ensures that regional differences are captured and insights gathered from a sample of relevant stakeholders, which may include patients, carers, HCPs, buyers and regulators.

User journey mapping

Once a contextual understanding of the user and environment of use has been developed, a useful next step is creating a user journey map. The aim is to map the different use steps and highlight pain points in a user’s journey – the areas of friction where improvements can be made. If there are multiple stakeholders involved, this is also where conflicting requirements can be identified.

From here, key design challenges can be identified and prioritised, which can then be expressed as “how might we?” statements, such as “how might we reduce the number of use steps required to set up a test?”. These insights can then be used to inform the concept generation phase.

Testing early and often

Getting something into the hands of the target users early and often is essential to allow effective testing and iteration of device designs. This can range from simple foam handling models to functional demonstrators. Creating something physical is a valuable way of identifying potential usability issues and design flaws that are often difficult to foresee. This may involve simple ergonomic issues such as how a user naturally holds the device, or functional problems involving the position of different features. By creating quick and dirty prototypes, device manufacturers can work through a cycle of prototyping, testing and iterating the design, until converging on a few suitable options to take forward.

Human factors studies

As the development team begins to converge on a suitable design, it is a good idea to start conducting more formal human factors observational studies. This provides the opportunity to explore specific aspects of the device’s use in more detail, to understand the root causes of any issues. This applies to both physical and digital aspects of the design. To support digital prototyping, there are a number of tools available for smartphones and tablets that allow development teams to quickly and cheaply prototype a workflow for a user study. Recording these interactions allows a review of what the user focuses on at different moments of time, if they are experiencing an issue.

In medical device development, the process of learning from target users is often continuous and should occur throughout the development. The above steps should come together to provide a rich picture of user expectations and their comprehension of the system. This allows design decisions to be based on first-hand evidence.

The design ecosystem

Sometimes, a complicated challenge can’t be solved through device design alone and requires looking at the packaging and information design, digital design and even service design to achieve a desired outcome.

One of the common challenges with designing medical devices is how to deal with the existing mental models of a user. This might range from perceived ways to administer an injection dose, to applying a sample off-instrument for a diagnostic device. To tackle any preconceived mental models, designers can utilise the various parts of the design ecosystem to nudge and guide the user towards a desired behaviour, from the packaging and instructions for use, to the design of the device itself.