Human Factors: Beyond Risk Management


The last decade has seen the role of Human Factors (HF) gather significant attention and pace within the MedTech and Pharma world. A number of high profile key milestones define the progress HF has made, not least of all FDA’s HF Guidance, the revision of IEC 62366-1 and most recently for the UK, the release of MHRA’s own guidance focusing on Human Factors.

The identification of user needs and requirement for ensuring the “right product” has been designed (i.e. Design Validation) has been a critical component of Design Controls for medical devices since the introduction of FDA 21CFR 820.30 in 1990 as well as being part of the ISO Quality Management System for medical devices, ISO 13485. Nevertheless, the introduction of guidance focused on HF methodologies has brought without question a greater level of clarity as to how to incorporate HF into a device design.

Owing to the fact that FDA’s mission is to “…protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices” it stands to reason that from a regulatory perspective, the primary role of HF is to remove the potential for use-related risk. However, HF’s potential impact and return on investment extends far beyond being isolated as a risk management process.

Desire and Engagement

The consumer industry uses a plethora of methods and tools to attract consumers, encouraging the purchase of products which represent lifestyles, trends and aspirational visions of who people wish to become.  Consumer products are therefore marketed by highlighting the value and benefit they will have upon our lives; often in an aesthetically pleasing way.

The challenge in developing medical devices that people want to use, is that there is no ‘one sizes fits all’. Some users may want a device that looks clinical, professional and typically ‘medical’, whereas others would rather hide the fact they’re having to use medication and prefer the device to blend in: looking almost ‘consumerised’.

To illustrate these challenges, take the example of a daily injection device that patients can carry with them. Our past research - which has shown how different patients’ attitudes and desires can vary greatly – suggests that there are a range of user profiles. These can include but are not limited to: the hider, the embracer and the professional. The hider might not want to be reminded that this is medication; they want a discrete device that they can hide. The embracer on the other hand, acknowledges and actively embraces their condition. It’s part of their life that they want to make fun, even something they’re happy to show off. Finally, the professional. These patients want to be reassured that a medical product looks like a medical product; giving a sense of trust and comfort.

Developing and understanding the breadth and variety of users can seem daunting. However, performing formative studies can be a helpful way to navigate this landscape, and create tangible ways forward. Conversely, medical devices generally face a much tougher challenge creating a “consumer pull” since patients would in truth prefer to live without a specific disease or condition.

A traditional formative HF study could be utilised to help ensure the user interface is clear for the patient and not susceptible to potential use-related error or risk. However, in the context of real use, once combined with a drug which potentially has unpleasant side-effects, there is a very real risk that the patient will become reluctant to use the device, not because it is difficult to use, but because their overall experience is unpleasant. Whilst HF can do little to address unpleasant side effects patients may experience when undertaking this treatment, HF can help to understand patient barriers and motivators which in turn can be used to improve engagement and adoption during use. After all, a device which introduces a sense of stigma and embarrassment to the end user is ultimately far more ineffective in fulfilling the intended use than one which has a button which has a button that is slightly hard to depress.

By extending the focus of HF beyond a task-based risk reduction tool, it can help to deliver devices and experiences which address user needs on a richer level. The next time you think about planning a formative HF study, ask yourself, could we expect the same set of results if the user spent more than an hour using the device? What if they had to use it over a simulated duration akin to the intended use of the product?

Commercial Risk

In addition to helping support increasing desire and engagement within device design, HF tools such as Contextual Inquiry (CI) can add significant business value in helping to identify potential areas of commercial risk. CI traditionally generates a detailed model of the tasks specific users need to perform within a given environmental setting. CI draws upon observational techniques combined with opportunistic interview questions to help develop a deeper understanding behind peoples’ behaviours and actions. Traditionally, these task models are used to formulate the basis of a uFMEA through a Hierarchical Task Analysis and the definition of User Profiles within a use specification.

Our experiences of conducting CI in clinical and home-use settings has shown that the value extends further and can help to redefine the commercial pathway of a device programme that may follow. The semi-longitudinal nature of a CI study can help to undercover implicit decisions related to device use that are otherwise unobtainable through spoken discussion or interviews. Learnings which relate to motivations and behaviours can help to feed into marketing and positioning strategies, ensuring that the messaging behind a device reaches the correct persons who are most influential in the decision-making process for adopting a device for use.

Ian Culverhouse