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Putting into context: CI for medical device design

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Sean Hӓgen, principal, founder, director of research & synthesis, BlackHӓgen Design explains why contextual inquiry (CI) is beneficial in medical device design.

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With the rapid expansion of advanced technologies to enhance medical device designs for both in-home and clinical environments, it’s more important than ever to involve proven methodologies to ensure user and regulatory acceptance of new or improved devices.

One such method is contextual inquiry (CI), a structured observational approach to gaining valuable insights into behaviours between end users and the products they interact with. Trained observers view, in real-time, what users typically do, day to day, revealing exactly how they interact with the devices and systems being considered for redesign or reinvention.

A sub-set of the human factors engineering (HFE) process, CI is most valuable when deployed early on in the development cycle. The knowledge gained from this research is subjected to rigorous data analysis to identify user patterns and behaviours. Insights from CI research provide the foundational guidance to inform the design of a final product that meets the criteria for safety, usability, market strategies, and regulatory approvals.

Expectations for a CI research process

CI provides a deeper and richer understanding of the potential use of the new or re-engineered device in the environment where it normally will be used. This means considering environmental constraints or disruptions like crowded rooms, noise, multitasking, or other potential distractions.

Direct observation, identifying problems, characterising them, and user interactions that influence these scenarios reveal opportunities for a new device design. It’s a “show me, don’t tell me” approach where the observer views what the users are actually doing and what they need versus their recollection of what they are doing or think they need; in other words, filtering out biases that would occur with an interview or survey.

Specific expectations for the desired outcome of a CI study keep a project on target. Certain deliverables should be specified:

Creating a contextual inquiry project

A CI project includes planning and logistics, fieldwork scenarios, data visualisation and analysis, and finally, translation of the information learned. 

Sample size may vary but as the methodology studies behaviour and not opinion, it can often be a small set of observations. Assuming the participant types are homogenous in nature and represent appropriate use scenarios, a pattern or trend in behaviour can be realised in samples as small as six, though more often it is closer to 12. For example, if researching a device used in both private hospitals and teaching hospitals, observations are going to require an additional sample of the same size for each type of hospital. This is because the context of care between these two types of hospitals is different, and the nature of the clinical teams varies greatly between these two types of clinical environments. 

Once the data has been analysed, workflow maps can be generated reflecting metrics imperative to product development:

All interrelationships of the interaction points are recorded as well as those of the user experience. The recordings may be written/logged and/or demonstrated on video. This information provides a proven foundation for generating specific recommendations for design or re-design.

Advantages and disadvantages of a CI approach

Some medical device development teams consider themselves ‘experts’ in device use and design parameters. But over time, when perspectives on how users interact with devices evolve, design teams may not consider how users have created workarounds to overcome design discrepancies.

Therefore, the “why” the device is being used in a non-prescribed way is not always communicated to the manufacturer. Most design projects start with the “what” is going to be designed and not the “why.” This is when a CI approach is valuable as it specifically provides the “why” basis for the need and an understanding of real-world behaviour with direct observation and interaction with the prospective end users. It’s the “show me, don’t tell me,” advantage.

A CI study can add cost to a project depending on the team size and the scope of the project, i.e., domestic or global. CI may not be the best approach if there is limited time and budget, or if there is very high confidence that only a limited set of specific details need to be captured from the context of use.

The case for CI

However, there is a strong case for a CI methodology, particularly as it relates to discovering unmet needs related to the efficacy and safety of a product design. The aim of any product design program is to ensure that the device is useful and commercially viable. A proven methodology in the HFE process, CI ensures that developers are gaining the knowledge of human behaviours and the ‘why-behind-the-what’ that will assure the value and safety of the final product.  

In fact, regulatory agencies worldwide encourage these types of contextual immersion studies throughout the feasibility and discovery phases. CI studies can determine the benefits to the end user which leads to market acceptance and the foundation for regulatory approvals.

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