The intended user (German: vorgesehener Benutzer) is the person or group of people whom the manufacturer designates to interact with the medical device, for example as operating professionals, as patients in self-use, or as technical personnel for maintenance, installation, or cleaning. A product can have several intended user groups. The delimitation is important: The intended user describes who is meant to use the product; which characteristics this person brings is the subject of the user profile.
Why the intended user matters
Defining the intended users is one of the first steps in the usability engineering process and part of the use specification according to IEC 62366-1. Depending on the product, this can include healthcare professionals, patients, caregivers, and installation, transport, maintenance, or other persons who operate or handle the medical device. It largely determines the design of the user interface: A product for trained professionals may contain more complex operating logic and technical terminology than a product for lay users in self-use. It is also a prerequisite for correct participant selection in usability tests. The FDA Human Factors Guidance explicitly requires that test participants represent the actual intended users; otherwise the validation is not considered meaningful. If intended user groups are overlooked, such as maintenance technicians or family caregivers, there is no systematic safeguard through usability engineering and risk management for these groups.
Regulatory reference
According to IEC 62366-1, defining the intended users is part of the use specification, alongside medical indication, patient group, use environment, and the part of the body involved. The FDA Human Factors Guidance explicitly names healthcare professionals, technical personnel for maintenance and cleaning, and lay users, patients, and their family members as intended user groups. The HFE/UE report must describe the intended users, uses, and use environments. The MDR requires the intended users to be stated as part of the general device description in the technical documentation. ISO 14971 counts the user profile among the elements of the intended use. Different user groups with different prior knowledge lead to different hazard profiles, which must be considered separately in risk management.
Delimitation from the user profile
This is the distinction most frequently confused in usability engineering for medical devices. The intended user answers the question of who uses the product as intended: a categorization of roles such as "anesthesiologist," "nurse," or "patient in home self-use," derived directly from the intended use. The user profile, by contrast, answers the question of which characteristics this user group brings: level of education, professional experience, physical or cognitive limitations, language skills, technical affinity, working conditions. A team that names only the user group "nursing staff" without developing a profile, for example with regard to shift-related fatigue, different experience levels, or time pressure in emergency situations, makes design decisions without a reliable basis. The two terms belong together but must be clearly separated analytically: first who, then which characteristics.
| Intended user | User profile | |
|---|---|---|
| Guiding question | Who uses the product as intended? | Which characteristics does this user group bring? |
| Content | Categorization of roles such as "anesthesiologist," "nurse," or "patient in home self-use," derived directly from the intended use | Level of education, professional experience, physical or cognitive limitations, language skills, technical affinity, working conditions |
Practical examples
An insulin pump typically has several intended users: the patient in self-use, possibly a caregiver, and trained professionals for the initial setup in the clinic: three groups, each with its own user profile. For a ventilator for intensive care units, the intended users are exclusively trained intensive care nurses and physicians, and lay users are explicitly excluded; in addition, there is a separate user group "service technician" with an entirely different interaction profile, without patient contact but with access to technical configuration menus. For a blood glucose meter for home use, the range of intended users extends from younger to older people with diabetes, with limited fine motor skills or eyesight, as well as family caregivers.
Connection with use specification and task analysis
The intended user is a core element of the use specification and is derived directly from the intended use (in MDR terms, the intended purpose). The same intended user can also act in different environments, for example a nurse in a hospital versus a home care nurse in a domestic setting, which in turn influences the user profile and the task analysis. Only once the intended user and the user profile are established can one realistically analyze which tasks are carried out by whom under which conditions and where critical tasks with an increased risk of error lie.
The intended user answers the question "who," the user profile the question "which characteristics." The two belong together but are often confused in practice, or one of them is simply skipped.
Overlooked user groups such as maintenance personnel or family caregivers remain without systematic safeguards through usability engineering and risk management.
Frequently asked questions (FAQ)
What is the difference between intended user and user profile?
The intended user specifies which role or group is meant to operate the product as intended. The user profile then describes the relevant characteristics of this group. Without an intended user there is no object for a user profile; without a user profile, the intended user remains a mere categorization without design-relevant substance.
Can a medical device have several intended users?
Yes, for more complex products this is even the rule, for example professionals for initial commissioning, patients for daily self-use, and service technicians for maintenance, all at the same time. Each group needs its own consideration in the use specification, user profile, task analysis, and risk assessment.
Do maintenance or cleaning personnel also have to be considered intended users?
Yes. The FDA guidance explicitly names technical personnel for maintenance, installation, and cleaning as a separate user group in the human factors process. Even without direct patient contact, operating errors during maintenance or cleaning can indirectly lead to patient harm.
Do you want to make sure that all intended user groups of your product are fully captured? We support you with the use specification and user analysis.
More about our usability engineeringSources
- IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
- ISO 14971:2019, Medical devices, Application of risk management to medical devices
- Regulation (EU) 2017/745 on medical devices (MDR)
- FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices