COVID-19 has had a dramatic impact on almost all aspects of the way we work and live our lives. What’s more, most estimates suggest that there will be restrictions on the way we work, travel, and meet-up for many months to come and the knock-on socio-economic impact will undoubtedly be felt for even longer. Many people have found the pandemic has encouraged a moment of reflection. The deviation from ‘normal behaviour’ has encouraged lots of us to pause and take stock – to question the routines in our lives and consider if there is a better way of doing things.

In some new product developments, companies have chosen to pause indefinitely, while waiting to see what the ‘new normal’ means, and how this influences the underlying product proposition. However, in many other cases, the need for the product remains very clear and perhaps even more pressing. For example, important new therapies are waiting to come to market that are reliant on the next generation of drug delivery devices. Furthermore, the recent pandemic has highlighted the lack of resilience in the healthcare systems around the world. New medical devices have a critical role to play in strengthening this resilience by improving the efficiency of care and allowing patients to be treated at home rather than within clinical settings.

In a highly regulated market, such as medical device development, it can be tempting to follow the well-trodden path when it comes to some processes and ways of working. This often represents the safe bet, with the lowest level of risk. However, developing medical device in an environment with restrictions on movement poses a significant challenge. Activities like simulated use studies (also referred to as human factors or usability studies), the cornerstone of demonstrating that a device is safe and effective, are made far more complicated in light of the virus and evolving expectations on physical interactions.

There are four key questions to answer when planning simulated use trials, which were relevant before the pandemic, but are ever more so today.

1. Is it legal – In many countries or regions, face-to-face interviews and observations may be prohibited.
2. Is it ethical – Where it is legally possible, a difficult ethical challenge is faced, particularly where participants have complex medical conditions.
3. Is it deliverable – Where studies are legal and ethical, a third challenge exists in terms of recruiting representative participants in appropriate numbers.
4. Could alternative research approaches provide similar answers.

There is no simple prescription for the best way forward. The optimum solution is likely to be different for each project, as this will be informed by project timelines, the stage in the design process, the level of work already completed, the target population, and the device being designed.

Ostensibly, remote research is a very attractive proposition, as it allows for complete social distancing. However, it also throws up several challenges around access to physical stimulus and technology. We have been delivering remote research studies for clients long before the start of the pandemic and have developed rigorous processes to ensure our client’s research programs are both safe and effective.

In some cases, it may be possible to move to remote research without any form of introduced physical stimulus – we can learn a lot about patients and their needs by discussing their current therapies and the devices that they already have in their homes. In these cases, we adopt approaches such as remote diaries, online focus groups, and one-to-one video interviews. These approaches hold great benefits over typical face-to-face research as we gain an intimate window into people in their own homes surrounded by their belongings. These techniques have great value at the start of projects in generating insight to inspire the product development process. Alternatively, if we want to reach a bigger audience and have some clear questions in mind, questionnaires can be another way to gain insight.

Later on in the design process, we can manufacture and ship early prototypes or simple block models and watch people interacting with these over webcams. While this seems an obvious solution, it takes a good deal of planning to ensure the best results and it’s critical that stimuli is well packed and presented to ensure that the order of presentation is controlled as well as any peeking before the study starts! Where it is not feasible to make a number of prototypes, there is value in using animations or videos of the prototypes in use to describe the concept to users.

In other cases, there is no real substitute for having the participant in the same facility. Sometimes it is important that we can observe user interactions very closely to identify how users behave and where they might be having difficulty, especially if safety is critical to the project. Through a combination of engineered safeguards and safe working practices the risk of viral transmission can be controlled allowing this to happen.

More than just user testing

Fortunately, good human factors is much more than just user testing. As highlighted in EN 62366-1 and the related MHRA guidance, it involves using a range of modelling approaches to understand:

• Who will be using the product
• How different capabilities will shape the way the product is use
• What the user-related risks are with legacy and similar products

In the early stages of the design, much can be learned from studying feedback from existing products, and from theoretically exploring the potential changes to the product. These activities are not impacted by COVID-19 restrictions and can be fundamental to a successful product development.

A range of different formative studies are required to be conducted as development progresses to complement early modelling. Some of these will be formal, detailed and comprehensive (like summative studies), while others will be far more exploratory perhaps focusing on a specific area. Although remote research has always been a possibility for such studies, recent circumstances have made it more of a mainstream need and talking point. We have been adapting our working practices, which have been developed and refined over many years, to ensure that we can continue to include users appropriately and valuably in the design process in these changing and unusual new times.

Some of our key insights from running a range of remote research studies to date, from differing stages of development, are outlined below, in no particular order of importance.

• Recruitment screeners should take into account the person’s access to and/or familiarity with the planned technology to be used (e.g. do they have laptop with webcam, internet access etc.), however, care must be taken to ensure that the sample population remains representative.
• Recruitment screeners should take into account the person’s willingness to receive samples in a time of social distancing and timing plans allow for sample quarantine if required or desired.
• Consideration should be made to provide technology to enable certain people to access the study if required in order to maintain appropriate sample representation.
• The type of technology and methods used should be carefully considered to answer the research questions. Options can range from telephone interviews and video calls, to online focus groups or diary studies.
• Interview schedules may not follow traditional sequential slots due to changed working patterns and so should be considered in project timelines.
• Logistics – planning availability, preparation and delivery of samples via couriers, and their return and cleaning as needed.
• Logistics – participant compensation: payment arrangements when not meeting face-face.
• Remote studies can provide appropriate, and valuable, evidence and information to support development and be suitable as formative studies.
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Ultimately, the optimum solution and approach for user evaluations will be specific to a project and its requirements. Our medical sector specialists would be very happy to support you in navigating this to enable your projects to move forwards in the most safe, ethical and efficient way, whilst providing the level of feedback and evidence needed to support key decisions in the development of devices for the future.

 

If you would like to discuss how we could help you in planning or reviewing your approach to human factors and usability, please do not hesitate to contact us through the details below.

 

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