Context of use

Dr.-Ing. Benedikt JannySenior Usability Engineer | Managing Partner
Last updated: October 2026
Short definition

The context of use (German: Nutzungskontext) describes the users, goals, tasks, resources, and environmental conditions under which a product is used. Context analysis (German: Kontextanalyse) refers to the systematic collection and analysis of these conditions.

In usability engineering for medical devices, it serves to understand the actual or intended use thoroughly enough that relevant findings can feed into the use specification, the use-related risk analysis, the design of the user interface, and the planning of usability evaluations. The context of use therefore covers much more than the physical place where a medical device is used. It also considers workflows, organizational conditions, collaboration, time pressure, interruptions, available aids, and the abilities and limitations of the users.

On this page

Role in the usability engineering process

Context analysis is one of the early activities of the usability engineering process. It provides important information for creating and refining the use specification. On this basis, the following elements in particular can be described or developed further:

  • User groups and user profiles
  • Intended patient populations
  • Use goals
  • Tasks and workflows
  • Use environments
  • Required resources and aids
  • Typical and safety-relevant use scenarios
  • Foreseeable use errors
  • Hazard-related use scenarios
  • User interface requirements
  • Conditions for formative and summative evaluations

IEC 62366-1 does not prescribe a standalone activity called "context analysis." It does, however, require the creation of a use specification and the subsequent identification of safety-related characteristics of the user interface, foreseeable use errors, hazards, and hazard-related use scenarios. A robust context analysis supplies important empirical foundations for this.

Without an adequate context analysis, there is a risk that development decisions rest on simplified or inaccurate assumptions. As a result, relevant user groups, tasks, or conditions of use can be overlooked. An incomplete context analysis can, for example, have the effect that:

  • Safety-relevant tasks are not identified
  • Use-related risks are assessed incompletely
  • User interface requirements are missing
  • Formative evaluations are conducted unrealistically
  • The summative evaluation does not reflect relevant conditions
  • Problems are recognized only after the product is placed on the market.

Context analysis should therefore not be understood as an activity that is completed once. Its results must be reviewed during development and updated when new findings emerge from risk management, user research, evaluations, or post-market surveillance.

Components of the context of use

According to ISO 9241-11, the context of use comprises in particular users, goals, tasks, resources, and environment. Usability is therefore always tied to specific users, specific goals, and specific conditions of use.

Users

All persons who interact directly or indirectly with the medical device or its user interface must be considered. These can include:

  • Physicians
  • Nursing staff
  • Therapists
  • Medical technical staff
  • Patients
  • Relatives and informal caregivers
  • Cleaning staff
  • Reprocessing staff
  • Service technicians
  • Installation staff
  • Administrators
  • Transport and logistics staff

Relevant user characteristics can include, for example: education and expertise, experience with the product or comparable products, physical abilities, sensory abilities, cognitive prerequisites, language skills, health literacy, technical background, medical limitations, as well as stress, fatigue, or emotional strain.

The FDA regards the intended users, the use environments, and the user interface as the three central components of the device-user system. In doing so, it explicitly refers to physical, sensory, cognitive, linguistic, and experience-related characteristics of the users.

Goals

Use goals describe what outcome users want or need to achieve by using the product. Examples are: making a diagnosis, administering a medication dose, monitoring a physiological value, assessing an alarm, preparing a product for the next use, configuring a therapy, or documenting the course of treatment.

Not only the primary medical goals need to be considered. Supporting goals such as cleaning, setup, maintenance, data transfer, or handover to other persons can also be safety-relevant.

Tasks

Tasks describe the activities users perform to reach their goals. These include not only the central operating steps but the complete lifecycle of use, for example:

  • Transport and storage
  • Preparation
  • Installation and setup
  • Assembly
  • Entry of patient or therapy data
  • Actual use
  • Monitoring
  • Response to alarms and error messages
  • Ending the use
  • Cleaning and disinfection
  • Reprocessing
  • Maintenance and service
  • Disposal

Tasks should not be considered in isolation. In practice, they are often part of complex workflows that involve several people, products, and organizational units.

Resources

Resources are all means that users need or can draw on during use. These can include:

  • Accessories and consumables
  • Personal protective equipment
  • Instructions for use
  • Quick reference guides
  • Training
  • Software and IT systems
  • Hospital information systems
  • Power supply and network connections
  • Spatial and technical infrastructure
  • Colleagues and other supporting persons
  • Customer support and technical service
  • Available time and staffing resources

Resources can support safe use, but they can also create new dependencies and risks. For example, a network interruption can delay information, or missing accessories can lead to improvised ways of working.

Environment

The environment comprises more than the geographic or spatial place of use. Relevant environmental conditions can include:

  • Lighting and reflections
  • Noise level
  • Temperature and humidity
  • Space available
  • Movement and vibration
  • Electromagnetic influences
  • Hygienic conditions
  • Wearing gloves or protective clothing
  • Interruptions and distractions
  • Time pressure
  • Emergency situations
  • Parallel tasks
  • Presence of other persons
  • Organizational requirements and responsibilities

The physical, social, and technical environment and the organizational conditions should be considered together. A medical device can, for example, function technically in an operating room, in an intensive care unit, and in an ambulance. The requirements for perception, operation, alarming, and error tolerance can, however, differ considerably across these contexts.

Methods of context analysis

A robust context analysis often combines several methods. Suitable methods include, for example:

  • Contextual inquiry
  • Field observations
  • Shadowing
  • Stakeholder interviews
  • Focus groups
  • Workplace analyses
  • Workflow analyses
  • Task analysis
  • Cognitive task analysis
  • Ethnographic studies
  • Document analyses
  • Analysis of training materials
  • Analysis of complaints and vigilance data
  • Analysis of comparable products
  • Formative usability evaluations

Interviews are particularly suitable for capturing experiences, goals, expectations, and subjectively perceived difficulties. However, they are often not sufficient to understand the actual context of use completely. Users can often describe routine activities, informal shortcuts, or situational adaptations only incompletely. In addition, described and actually performed workflows can differ.

Field observations, by contrast, make it possible to capture real workflows, interruptions, spatial conditions, team interactions, and the use of additional aids directly. A good context analysis therefore combines, where possible, statements from users, observable behavior, existing process and product documentation, and findings from risk and market data.

The choice of methods should be risk-based. The more novel the product, the less familiar the context of use, and the more severe the possible use-related harm, the more important direct empirical investigation becomes.

The terms context analysis, context of use, use environment, use specification, and task analysis are often mixed up.

Context analysis and context of use

Context analysis is the methodical activity for investigating use. The context of use is the resulting understanding, or the documented description, of the users, goals, tasks, resources, and environments.

Context of use and use environment

The use environment is one component of the context of use. The context of use additionally comprises users, goals, tasks, and resources. A description such as "use in hospitals" is therefore not yet a complete description of the context of use.

Context analysis and use specification

The use specification is a normative output of the usability engineering process according to IEC 62366-1. Context analysis supplies data and findings with which relevant content of the use specification can be empirically substantiated and made more concrete. The use specification includes in particular the medical indication, the intended patient population, the intended part of the body or type of tissue, user profiles, use environments, and the operating principle of the product. The context of use can additionally contain detailed information on goals, tasks, workflows, resources, and organizational conditions.

Context analysis and task analysis

Task analysis examines activities, action steps, decisions, information requirements, and possible errors within a workflow. Context analysis is broader. It additionally considers the users involved, their goals, the available resources, and physical, social, technical, and organizational conditions.

Context analysis and user research

User research is an umbrella term for the systematic study of users, needs, behavior, and use situations. Context analysis is a specific objective within user research: It is meant to capture and document the context of use that is relevant for development, risk management, and evaluation.

Context analysis is an important basis for identifying and assessing use-related risks. A use error does not arise solely from a property of the user or of the product. It often results from the interaction between user characteristics, task, user interface, environment, available resources, and organizational conditions. Examples:

  • An alarm is recognized in a quiet test environment but is masked by other alarms in the actual clinical setting.
  • A display is legible under normal lighting conditions but causes misinterpretations in direct sunlight.
  • A work step is comprehensible to experienced professionals but is forgotten by occasional users.
  • A function can be operated correctly from a technical standpoint but does not fit the real clinical workflow.
  • A handover between two user groups causes relevant information to be lost.
  • Instructions for use are available but cannot practically be used during a time-critical task.

For the use-related risk analysis, not only individual operating actions but also the conditions under which these actions are performed should therefore be analyzed. Among other things, the following can be derived from the context analysis:

  • Foreseeable use errors
  • Typical and safety-relevant use scenarios
  • Hazard-related use scenarios
  • Contributing environmental factors
  • Use situations with increased strain
  • User interface requirements
  • Requirements for training and accompanying documentation
  • Conditions for formative and summative evaluations

IEC 62366-1 links the analysis of the user interface and its use with the control of risks arising from correct use and from use errors within normal use.

Typical weaknesses in practice

A frequent mistake is to document the context of use solely as a list of physical environmental conditions. Further typical weaknesses are:

  • Equating context analysis with the use specification
  • Describing the environment without considering user, task, and resources
  • User groups that are too general, such as "medical professionals"
  • Purely demographic rather than task-related user profiles
  • Relying exclusively on interviews
  • No observation of real workflows
  • Limiting the analysis to the primary medical application
  • Neglecting preparation, cleaning, reprocessing, and maintenance
  • No consideration of team communication and handovers
  • No consideration of interruptions and multitasking
  • Neglecting rare but safety-relevant situations
  • No consideration of time pressure and emergencies
  • Insufficient analysis of home-use scenarios
  • No consideration of accessories and third-party systems
  • Assumptions without a traceable rationale
  • No link to the use-related risk analysis
  • No translation into user interface requirements
  • No updating when new findings emerge

Descriptions of context such as "use by physicians," "use in hospitals," "use by trained personnel," or "use in the home environment" are also problematic. Statements like these are too general on their own. They describe neither concrete tasks nor relevant user characteristics, resources, or conditions of use.

The assumption that real users always act according to official processes or instructions for use can also lead to gaps. A context analysis should therefore take into account how tasks are actually performed and which foreseeable deviations occur in normal use.

Regulatory reference

ISO 9241-11:2018 defines usability as the outcome of the use of a system, product, or service by specified users to achieve specified goals in a specified context of use. The components of the context of use include users, goals, tasks, resources, and environment. The standard thus describes a general frame of reference but does not prescribe a specific method for carrying out a context analysis.

IEC 62366-1 does not require a standalone document titled "context analysis." It does, however, require a use specification with information on, among other things, user profiles and use environments. This information forms a basis for the further steps of the usability engineering process. In addition, safety-related characteristics of the user interface, known or foreseeable use errors, hazards, hazardous situations, and hazard-related use scenarios must be identified. Without an adequate understanding of the context of use, these activities can be carried out in a robust way only to a limited extent.

When identifying hazards and foreseeable sequences of events, ISO 14971 requires consideration of the intended use and reasonably foreseeable misuse. Findings from context analysis can therefore be important inputs to risk management.

The FDA likewise regards intended users, use environments, and the user interface as central components of the device-user system and treats these components, together with preparatory analyses and evaluations, as the basis for identifying and controlling use-related risks. For FDA submissions, changes to intended users, use environments, training, or labeling are also explicitly relevant to the risk-based determination of the required scope of human factors documentation.

In brief

The context of use describes: users + goals + tasks + resources + environment. Context analysis is the systematic investigation of these factors. It creates the empirical basis for developing a medical device not for an abstract "user" but for real users, tasks, workflows, and conditions of use.

A robust context analysis connects: user research → use specification → use-related risk analysis → requirements → evaluation. Those who describe the context of use too generally risk overlooking relevant tasks, use errors, and safety-critical conditions.

Frequently asked questions (FAQ)

Is the context of use the same as the use environment?

No. The use environment is only one component of the context of use. The context of use additionally includes users, goals, tasks, and resources. A complete description of the context also considers organizational, social, and technical conditions.

Is a context analysis mandatory under IEC 62366-1?

IEC 62366-1 does not require a standalone activity or a document titled "context analysis." It does, however, require information that can hardly be produced robustly without an adequate analysis of the context of use, in particular user profiles, use environments, foreseeable use errors, and hazard-related use scenarios.

Are interviews sufficient for a context analysis?

In many cases, no. Interviews provide important information about experiences, expectations, and perceived problems. However, they often capture actual workflows, unconscious routines, interruptions, and informal adaptations only incompletely. Especially for safety-critical applications, interviews should, where possible, be supplemented by field observations, workflow analyses, or other empirical methods.

Does a context analysis have to be carried out on site?

Not every activity necessarily has to take place at the planned site of use. However, where environmental conditions, collaboration, workflows, or organizational factors are safety-relevant, an investigation in the real or a comparable context of use is particularly valuable. If an on-site investigation is not possible, the substitute sources used and the remaining uncertainties should be documented.

How detailed does the context of use need to be described?

The required level of detail depends on the product, the user groups, the complexity of the tasks, and the possible harms. The description should be concrete enough that relevant use-related risks, user interface requirements, and conditions for evaluations can be derived from it. A statement such as "use in hospitals" is usually not sufficient for this.

Does the context of use have to be updated during development?

Yes. New findings from user research, risk management, formative evaluations, complaints, or post-market surveillance can make an update necessary. The effects on the use specification, user profiles, use-related risk analysis, design inputs, and evaluation planning should also be reviewed.

Do you want to investigate the context of use of your medical device systematically and carry the results over traceably into the use specification, the use-related risk analysis, and the evaluation planning? We support you with field studies, contextual inquiry, workflow and task analyses, and other human factors methods.

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