Updated: 7th July 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
Why Usability Engineering Matters
Medical devices are designed to improve patient outcomes, support healthcare professionals and deliver safe, effective treatments. However, even a technically perfect device can create significant safety risks if users cannot operate it correctly.
Many adverse events involving medical devices are not caused by equipment failure, but by the way people interact with the device. Confusing instructions, poorly designed user interfaces, unclear labelling or complex operating procedures can all contribute to use errors that place patients at risk.
Usability engineering seeks to minimise these risks by placing users at the centre of the design and development process. Rather than assuming that users will always operate a device exactly as intended, manufacturers must consider how different people interact with their products in real-world environments.
Healthcare professionals may use devices under pressure in busy clinical settings, while patients may rely on them at home with little or no formal training. Differences in experience, age, physical ability, environmental conditions and stress levels can all influence how safely and effectively a medical device is used.
IEC 62366-1 provides manufacturers with a structured framework for identifying, evaluating and reducing use-related risks throughout the product lifecycle. By applying usability engineering from the earliest stages of development, manufacturers can improve patient safety, reduce use errors and demonstrate compliance with international regulatory expectations.
Today, usability engineering is considered an essential part of medical device development and applies to a wide range of products, including:
- Active medical devices
- Non-active medical devices
- In vitro diagnostic medical devices (IVDs)
- Software as a Medical Device (SaMD)
- Combination products
- Home-use medical devices
- Implantable medical devices
- Wearable medical technologies
Regardless of device complexity, effective usability engineering helps ensure that products are safe, intuitive and appropriate for their intended users and environments.
What Is Usability Engineering?
Usability engineering is the systematic process of designing medical devices so they can be used safely, effectively and efficiently by their intended users within their intended environments.
Rather than focusing solely on the technical performance of a device, usability engineering considers how people interact with the product during normal use, reasonably foreseeable misuse and unexpected situations.
The objective is to identify potential use-related hazards early in development and implement design solutions that reduce the likelihood of user error while improving overall safety and user experience.
Effective usability engineering considers a wide range of factors, including:
- Intended users
- Intended medical purpose
- User interface design
- Physical ergonomics
- Cognitive workload
- Environmental conditions
- Training requirements
- Labelling and Instructions for Use (IFU)
- User feedback
- Human limitations
Importantly, usability engineering is not about making products more attractive or aesthetically pleasing. Its primary objective is to ensure that users can operate medical devices correctly and safely under real-world conditions.
This requires manufacturers to understand how people think, behave and respond when interacting with medical technologies throughout the product lifecycle.
Human Factors Engineering vs Usability Engineering
The terms human factors engineering and usability engineering are often used interchangeably, but they describe closely related concepts rather than being identical.
Human factors engineering is the broader scientific discipline that studies how people interact with products, systems and environments. It considers physical, cognitive and organisational factors that influence human performance and safety.
Usability engineering applies these human factors principles specifically to the design and development of medical devices.
In practice, both disciplines share the same objective: reducing use-related risks while improving safety, effectiveness and user satisfaction.
Within the medical device industry, IEC 62366-1 provides the internationally recognised framework for applying usability engineering principles throughout device development.
What Is IEC 62366-1?
IEC 62366-1 is the internationally recognised standard for applying usability engineering to medical devices. It provides manufacturers with a structured process for identifying, evaluating and reducing use-related risks throughout the design and development of a medical device.
Rather than prescribing how a device should look or function, the standard focuses on ensuring that intended users can operate the device safely and effectively within its intended environment.
The standard recognises that medical devices are used by a wide variety of people with different levels of experience, physical abilities and clinical knowledge. These may include healthcare professionals working in busy hospital environments, laboratory staff performing diagnostic testing or patients using medical devices independently at home.
IEC 62366-1 helps manufacturers understand how these different users interact with a device, identify potential use-related hazards and implement design solutions that reduce the likelihood of user error.
Ultimately, the objective is to improve patient safety by ensuring that the design of the device supports safe and effective use under real-world conditions.
Why Was IEC 62366-1 Developed?
Historically, many medical device incidents were attributed to “user error.”
However, investigations increasingly demonstrated that these incidents were often influenced by the design of the device itself rather than simply the actions of the user.
Examples included:
- Confusing controls
- Poorly designed user interfaces
- Ambiguous labelling
- Complex operating procedures
- Inadequate instructions for use
- Alarm fatigue
- Similar-looking connectors or accessories
Rather than placing responsibility solely on the user, regulators recognised that manufacturers should proactively design devices that minimise the likelihood of foreseeable use errors.
IEC 62366-1 was developed to provide manufacturers with a consistent methodology for applying usability engineering throughout the product lifecycle, ensuring that human factors are considered from the earliest stages of design rather than being assessed only after development has been completed.
Which Medical Devices Does IEC 62366-1 Apply To?
One of the strengths of IEC 62366-1 is its broad applicability.
The principles of usability engineering can be applied to almost every type of medical device, regardless of its complexity or intended purpose.
Examples include:
- Surgical instruments
- Infusion pumps
- Ventilators
- Patient monitors
- Diagnostic imaging equipment
- Blood glucose meters
- Pregnancy tests
- Laboratory analysers
- In vitro diagnostic medical devices
- Implantable medical devices
- Wearable medical technologies
- Home-use medical devices
- Software as a Medical Device (SaMD)
Although the usability activities may vary depending on the device, the underlying objective remains the same: ensuring that users can operate the product safely and effectively.
The Relationship Between IEC 62366-1 and ISO 14971
Usability engineering and risk management are closely linked.
IEC 62366-1 focuses specifically on identifying and reducing use-related risks, while ISO 14971 provides the broader framework for managing all risks associated with a medical device throughout its lifecycle.
During usability engineering, manufacturers identify potential use errors, evaluate the associated risks and implement design changes or other risk control measures where necessary.
These activities support the overall risk management process by helping ensure that risks arising from user interaction are systematically identified and appropriately controlled.
Rather than operating as separate processes, usability engineering and risk management should work together throughout device development.
Usability Engineering and Risk Management Go Hand in Hand
IEC 62366-1 focuses on identifying and reducing use-related risks, while ISO 14971 provides the framework for medical device risk management. Together, these standards help manufacturers identify hazards, implement effective risk controls and demonstrate that medical devices are safe throughout their lifecycle.
The Relationship Between IEC 62366-1 and ISO 13485
While IEC 62366-1 describes the usability engineering process itself, ISO 13485 provides the quality management framework within which these activities are performed.
Manufacturers operating an ISO 13485 quality management system should integrate usability engineering into their established design and development processes.
This helps ensure that usability activities are:
- Planned
- Documented
- Reviewed
- Verified
- Maintained throughout the product lifecycle
Integrating usability engineering within the quality management system also improves traceability and supports regulatory submissions.
Usability Engineering Should Be Embedded Within Your QMS
IEC 62366-1 is most effective when integrated into a robust Quality Management System. Discover how ISO 13485 helps manufacturers incorporate usability engineering, design controls, risk management and continuous improvement throughout the medical device lifecycle.
The Relationship Between IEC 62366-1 and IEC 62304
Many modern medical devices rely on software, and where software forms part of the medical device, usability engineering remains just as important.
IEC 62304 focuses on the software development lifecycle, including software planning, implementation, verification and maintenance. IEC 62366-1 complements this by ensuring that users can interact safely and effectively with the software interface.
For software-driven devices, the two standards work together to support both robust software development and safe user interaction.
Manufacturers developing Software as a Medical Device (SaMD) or software-controlled medical devices should therefore consider both standards as part of an integrated development process.
Developing Medical Device Software?
Many modern medical devices incorporate embedded software or Software as a Medical Device (SaMD). While IEC 62366-1 focuses on safe user interaction, IEC 62304 defines the software lifecycle requirements, including software planning, development, verification, validation and maintenance. Together, these standards help manufacturers develop software that is both technically robust and safe for users.
Why Regulators Expect Usability Engineering
Regulatory authorities increasingly expect manufacturers to demonstrate that medical devices have been designed with the intended user in mind.
Rather than relying solely on training or warnings to prevent errors, manufacturers should show that they have systematically identified foreseeable use errors and reduced associated risks through good design wherever possible.
Effective usability engineering supports:
- Patient safety
- Clinical effectiveness
- Reduced use errors
- Improved user confidence
- Better product acceptance
- More efficient healthcare delivery
It also provides valuable evidence during conformity assessment by demonstrating that user interaction has been considered throughout device development.
The Medical Device Usability Engineering Process
Usability engineering is not a single test performed at the end of product development. Instead, it is a structured, iterative process that begins during the earliest stages of design and continues throughout the development lifecycle.
IEC 62366-1 encourages manufacturers to consider how users will interact with a device from the outset, allowing potential use-related risks to be identified and addressed before the device reaches the market.
By integrating usability engineering into product development, manufacturers can improve patient safety, reduce costly design changes later in the project and generate objective evidence demonstrating that the device can be used safely and effectively.
Although the complexity of the process will vary depending on the type of medical device, the overall approach remains consistent.
Free Download: IEC 62366-1 Usability Engineering Checklist
Applying IEC 62366-1 to medical device design and development? Download Patient Guard's printable IEC 62366-1 Usability Engineering Checklist to help review intended users, use specification, use-related risks, formative evaluation, summative validation, the Usability Engineering File and post-market feedback.
Define the Intended Medical Purpose
Every usability engineering process begins with a clear understanding of what the medical device is intended to do.
Manufacturers should define the intended medical purpose before usability activities begin, as this influences every subsequent stage of development.
A well-defined intended purpose helps establish:
- The clinical application of the device.
- The intended patient population.
- The expected users.
- The operating environment.
- The foreseeable use scenarios.
- Regulatory classification.
Without a clearly defined intended purpose, it becomes difficult to determine whether a device can be used safely under real-world conditions.
Identify the Intended Users
Different users have different capabilities, expectations and training.
A consultant surgeon, a laboratory technician and a patient using a home medical device all interact with medical technology in very different ways.
Manufacturers should therefore identify all intended user groups, which may include:
- Surgeons
- Nurses
- General practitioners
- Laboratory personnel
- Emergency responders
- Biomedical engineers
- Caregivers
- Patients
- Lay users
Understanding the characteristics of each user group allows manufacturers to design interfaces, instructions and workflows that better support safe operation.
Define the Context of Use
Medical devices are used in many different environments, each presenting unique challenges.
Examples include:
- Operating theatres
- Intensive care units
- Emergency departments
- General wards
- Clinical laboratories
- Ambulances
- Community healthcare settings
- Patients’ homes
Environmental conditions such as lighting, noise, interruptions, protective clothing, time pressure and available training may all influence how safely a device can be used.
By carefully considering the context of use, manufacturers can identify usability challenges that may not be apparent during laboratory testing.
Identify Use-Related Hazards
Unlike traditional risk management, which considers hazards associated with the device itself, usability engineering focuses specifically on hazards arising from user interaction.
Manufacturers should identify situations where users could unintentionally operate the device incorrectly, misunderstand information or fail to complete essential tasks.
Examples include:
- Selecting the wrong treatment mode.
- Misinterpreting displayed information.
- Connecting accessories incorrectly.
- Entering incorrect patient information.
- Misreading measurement units.
- Skipping critical preparation steps.
- Incorrect specimen handling for IVDs.
- Using the device outside its intended environment.
Identifying these hazards early enables manufacturers to develop effective risk control measures before the device reaches clinical use.
Clear Labelling Helps Prevent Use Errors
Effective medical device labelling plays a vital role in usability engineering by helping users understand how to identify, prepare and operate devices safely. Learn more about medical device labelling requirements, including regulatory expectations, symbols, warnings and best practices for supporting safe device use.
Develop the User Interface
The user interface includes every aspect of the device that allows users to interact with it.
This extends far beyond screens and software and may include:
- Buttons
- Touchscreens
- Displays
- Controls
- Connectors
- Packaging
- Labelling
- Instructions for Use (IFU)
- Audible alarms
- Visual indicators
An effective user interface should support intuitive operation, minimise confusion and help users complete critical tasks safely, even under challenging conditions.
Good interface design often reduces the need for extensive user training by making correct operation the natural outcome.
Conduct Formative Evaluations
Formative evaluations are performed throughout product development.
Their purpose is to identify usability issues early, allowing manufacturers to improve the design before final validation takes place.
Typical formative activities include:
- User interviews.
- Observation studies.
- Prototype evaluations.
- Simulated clinical scenarios.
- Task analysis.
- Expert reviews.
- Heuristic evaluations.
Because formative evaluations are iterative, findings are used to refine the design before further testing is undertaken.
This continuous improvement process helps eliminate usability issues before they become embedded within the final product.
Implement Risk Control Measures
Where usability problems are identified, manufacturers should implement appropriate risk control measures.
Design improvements are generally preferable to relying solely on warnings or user training.
Examples include:
- Simplifying controls.
- Improving display readability.
- Redesigning connectors.
- Introducing physical safeguards.
- Improving alarms.
- Clarifying Instructions for Use.
- Reducing unnecessary complexity.
- Improving workflow.
The objective is to reduce the likelihood of use-related errors through good design wherever reasonably practicable.
Conduct Summative Evaluation
Summative evaluation represents the final validation of the usability engineering process.
Unlike formative evaluations, which improve the design, summative evaluations demonstrate that the completed device can be used safely by representative users under realistic conditions.
These evaluations typically involve:
- Representative users.
- Realistic environments.
- Critical clinical tasks.
- Defined success criteria.
- Objective observations.
- Structured data collection.
Manufacturers use the results to demonstrate that the final design adequately addresses identified use-related risks.
Summative evaluation provides important evidence supporting regulatory submissions and conformity assessments.
Prepare the Usability Engineering File
Throughout the usability engineering process, manufacturers should maintain a Usability Engineering File (UEF).
The UEF documents how usability activities have been planned, performed and evaluated throughout development.
Typical contents include:
- Usability engineering plan.
- Intended users.
- Intended use.
- Context of use.
- Hazard identification.
- User interface specifications.
- Formative evaluation reports.
- Risk control measures.
- Summative evaluation report.
- Traceability records.
- Design changes resulting from usability activities.
The Usability Engineering File demonstrates that usability engineering has been applied systematically and provides objective evidence to support regulatory submissions.
Usability Engineering Is an Ongoing Process
Usability engineering does not end once a medical device is placed on the market.
Post-market surveillance provides valuable information about how devices perform in real clinical environments and may identify previously unrecognised use-related issues.
Manufacturers should review information from:
- Customer complaints.
- Incident reports.
- Trend analysis.
- Clinical feedback.
- Service records.
- Literature.
- User surveys.
- Corrective and preventive actions (CAPA).
This information can be used to improve future device generations, update Instructions for Use and strengthen overall risk management activities.
By treating usability engineering as a continuous lifecycle process rather than a one-time regulatory exercise, manufacturers can continue improving patient safety long after a device has entered clinical use.
Understanding Human Factors Engineering
Human factors engineering is the scientific discipline concerned with understanding how people interact with products, systems and their surrounding environment. Within the medical device industry, it plays a vital role in reducing use-related risks and ensuring that devices can be operated safely by their intended users.
Every medical device is ultimately designed for people. Whether it is used by a consultant surgeon during a complex procedure, a laboratory technician analysing patient samples or an individual managing a chronic condition at home, the success of the device depends on how well it supports safe human interaction.
Human factors engineering recognises that people have limitations. They may become distracted, fatigued, stressed or overwhelmed. They may have reduced vision, limited dexterity or varying levels of clinical knowledge. Rather than expecting users to adapt to poorly designed devices, manufacturers should design products that accommodate these human characteristics wherever reasonably practicable.
By understanding how people behave in real-world environments, manufacturers can reduce the likelihood of use errors and improve both safety and user confidence.
Physical Human Factors
Physical human factors relate to the interaction between the user and the physical characteristics of a medical device.
Manufacturers should consider whether the design supports comfortable, safe and intuitive operation for all intended users.
Examples include:
- Device size and weight.
- Handle design.
- Button size and spacing.
- Touchscreen responsiveness.
- Grip and ergonomics.
- Connector design.
- Display visibility.
- Device portability.
- Packaging design.
Even relatively small design decisions can significantly influence whether users operate a device correctly under routine clinical conditions.
For example, poorly positioned controls or connectors that appear similar may increase the likelihood of incorrect operation, particularly during stressful situations.
Cognitive Human Factors
Medical devices should also be designed to support the way people think, process information and make decisions.
Cognitive human factors consider how users understand information, interpret instructions and respond to changing clinical situations.
Manufacturers should evaluate whether the device:
- Presents information clearly.
- Supports logical workflows.
- Minimises unnecessary complexity.
- Reduces cognitive workload.
- Uses consistent terminology.
- Provides meaningful feedback.
- Prioritises critical information.
- Helps prevent avoidable mistakes.
Devices that overload users with unnecessary information or require complex operating procedures may increase the likelihood of use-related errors.
Good usability engineering aims to make correct operation as intuitive as possible.
Environmental Factors
Medical devices are rarely used under ideal laboratory conditions.
Healthcare environments can vary considerably depending on the intended use of the device.
Examples include:
- Busy operating theatres.
- Emergency departments.
- Intensive care units.
- Ambulances.
- Clinical laboratories.
- Community healthcare settings.
- Patients’ homes.
Environmental conditions may influence usability through:
- Poor lighting.
- Background noise.
- Time pressure.
- Interruptions.
- Personal protective equipment (PPE).
- Limited working space.
- Multiple users operating simultaneously.
Manufacturers should evaluate how these factors may influence user behaviour during normal and reasonably foreseeable use.
Designing for Different Types of Users
One of the most important principles of IEC 62366-1 is recognising that not all users have the same knowledge, experience or physical capabilities.
Medical devices may be used by:
Healthcare Professionals
Experienced clinicians often operate devices in fast-paced environments where rapid decision-making is essential.
Although professionally trained, they may still experience fatigue, distractions and high workloads that increase the risk of use errors.
Laboratory Personnel
IVD devices are frequently operated by laboratory scientists and technicians who require clear workflows, intuitive interfaces and reliable specimen handling procedures.
Even small usability issues may affect testing efficiency or increase the likelihood of processing errors.
Patients
Patients using medical devices at home often have little or no clinical training.
Manufacturers should therefore ensure devices are simple to understand, easy to operate and supported by clear Instructions for Use.
This is particularly important for devices intended for long-term self-management, such as insulin delivery systems, blood pressure monitors and respiratory devices.
Caregivers
Family members and carers frequently assist patients with medical devices despite having no formal healthcare training.
Usability engineering should consider whether caregivers can safely prepare, operate and maintain the device under realistic conditions.
Lay Users
Some medical devices are intended to be used entirely by members of the general public.
Examples include home pregnancy tests, self-testing IVDs and certain over-the-counter healthcare products.
Designing for lay users requires particular attention to intuitive operation, simple instructions and effective risk reduction measures.
Foreseeable Misuse
Not every use error results from carelessness.
IEC 62366-1 encourages manufacturers to consider reasonably foreseeable misuse during device development.
Foreseeable misuse refers to situations where users operate a device in ways that are not intended but can reasonably be anticipated.
Examples include:
- Skipping preparation steps.
- Selecting the wrong operating mode.
- Using incorrect accessories.
- Misinterpreting displayed information.
- Incorrect specimen collection for IVDs.
- Failing to perform routine maintenance.
- Ignoring warning messages.
- Using the device outside its intended environment.
By identifying foreseeable misuse during development, manufacturers can introduce design improvements that reduce associated risks before the product reaches the market.
Accessibility and Inclusive Design
Modern medical devices should be designed for the widest practical range of users.
Accessibility is becoming increasingly important as healthcare systems support ageing populations and greater home use of medical technologies.
Manufacturers should consider users who may have:
- Reduced vision.
- Hearing impairments.
- Limited dexterity.
- Cognitive impairments.
- Language barriers.
- Reduced digital confidence.
Simple design improvements such as larger text, clearer symbols, colour contrast, tactile controls and intuitive workflows can significantly improve both safety and usability.
Inclusive design not only benefits vulnerable users but often improves the overall user experience for everyone.
Usability Begins During Medical Device Design
Effective usability engineering starts long before validation testing. Discover how medical device design and development integrates user needs, design controls, verification, validation and risk management to create safer, more intuitive medical devices from concept through to commercialisation.
Human Factors Continue Beyond Product Development
Human factors engineering does not end when a device is launched.
Real-world experience provides valuable information about how users interact with medical devices in clinical practice.
Manufacturers should continuously review:
- Customer complaints.
- User feedback.
- Clinical observations.
- Incident reports.
- Service records.
- Post-market surveillance data.
- Training feedback.
- CAPA investigations.
This information helps identify opportunities to improve future device designs, refine Instructions for Use and strengthen the overall usability engineering process.
By continuously learning from real-world use, manufacturers can improve patient safety while ensuring devices remain intuitive and effective throughout their lifecycle.
Understanding Use Errors
A fundamental objective of IEC 62366-1 is reducing the likelihood of use errors that could compromise patient safety or device performance.
Historically, incidents involving medical devices were often attributed simply to “user error.” However, modern usability engineering recognises that many of these incidents are influenced by the design of the medical device itself rather than the actions of the individual user.
Poor interface design, unclear labelling, confusing instructions or complex operating procedures can all contribute to mistakes, even when users are appropriately trained and acting in good faith.
By identifying situations where use errors may occur, manufacturers can improve the design of the device and reduce associated risks before the product reaches the market.
What Is a Use Error?
A use error occurs when the outcome of a user’s action differs from what was intended, resulting in a potentially hazardous situation or an incorrect outcome.
Importantly, a use error does not necessarily mean that the user acted carelessly or ignored instructions.
Instead, it often reflects a mismatch between the design of the medical device and the way people naturally interact with it under real-world conditions.
Examples of use errors include:
- Selecting the wrong operating mode.
- Entering incorrect patient information.
- Misinterpreting information displayed on a screen.
- Connecting accessories incorrectly.
- Administering an incorrect dose.
- Performing device setup incorrectly.
- Mishandling an IVD specimen.
- Misreading measurement units.
Each of these situations may have significant clinical consequences, even when the device itself is functioning exactly as intended.
Use Error vs Device Failure
One of the key principles of usability engineering is distinguishing between a use error and a device failure.
A device failure occurs when the medical device does not perform as intended because of a fault or malfunction.
Examples include:
- Mechanical failure.
- Electrical failure.
- Software malfunction.
- Component failure.
- Battery failure.
- Manufacturing defects.
In contrast, a use error occurs when the device functions correctly, but the interaction between the user and the device leads to an unintended outcome.
Understanding this distinction helps manufacturers identify whether improvements should focus on product design or technical performance.
Use Error vs Abnormal Use
IEC 62366-1 also distinguishes between use error and abnormal use.
Abnormal use refers to situations where a device is intentionally used in a manner that falls outside its intended purpose or clearly disregards the manufacturer’s instructions.
Examples may include:
- Deliberately bypassing safety mechanisms.
- Using the device for an unintended medical purpose.
- Modifying the device without authorisation.
- Ignoring explicit safety warnings.
Although abnormal use may not always be preventable through design, manufacturers should still consider reasonably foreseeable misuse during the usability engineering process.
The goal is to identify behaviours that are likely to occur in practice and reduce associated risks wherever possible.
Critical Tasks
Not every interaction with a medical device carries the same level of risk.
IEC 62366-1 places particular emphasis on identifying critical tasks.
Critical tasks are user actions that, if performed incorrectly or omitted, could result in harm to the patient, user or another individual.
Examples include:
- Programming an infusion pump.
- Confirming patient identity.
- Selecting treatment parameters.
- Preparing an implant before surgery.
- Performing calibration procedures.
- Collecting patient specimens.
- Reading diagnostic test results.
- Administering medication.
These tasks should receive particular attention during usability evaluations because they have the greatest potential to affect patient safety.
Hazard-Related Use Scenarios
Manufacturers should also develop realistic scenarios that explore how users interact with the device during activities associated with potential hazards.
These hazard-related use scenarios help evaluate whether users can safely perform critical tasks under representative conditions.
Examples may include:
- Responding to device alarms.
- Changing treatment settings.
- Connecting disposable accessories.
- Performing emergency procedures.
- Interpreting diagnostic results.
- Recovering from user mistakes.
Testing these scenarios during usability evaluations provides valuable evidence that the device supports safe operation under realistic conditions.
Real-World Examples of Use Errors
Use-related risks exist across almost every category of medical device.
Infusion Pumps
Users may accidentally select the wrong infusion rate or drug concentration if the interface is confusing or similar options appear together.
Surgical Instruments
Instruments with similar appearance may be selected incorrectly during surgery, increasing the likelihood of procedural errors.
In Vitro Diagnostic Medical Devices
Incorrect specimen preparation, sample identification or interpretation of results may affect diagnostic accuracy.
Home Healthcare Devices
Patients may misunderstand operating instructions, omit important preparation steps or fail to recognise warning messages.
Wearable Medical Devices
Incorrect placement of sensors or misunderstanding device alerts may reduce monitoring accuracy.
Medical Device Software
Users may enter incorrect information, misunderstand displayed data or navigate software workflows incorrectly if interfaces are poorly designed.
Reducing Use Errors Through Good Design
The most effective way to reduce use-related risks is through thoughtful design rather than relying solely on training or warnings.
Examples of good usability design include:
- Clear and consistent user interfaces.
- Logical workflows.
- Readable displays.
- Intuitive controls.
- Effective alarm systems.
- Well-designed packaging.
- Clear Instructions for Use.
- Physical safeguards that prevent incorrect assembly.
- Colour coding where appropriate.
- Confirmation prompts for high-risk actions.
By making correct operation easier and incorrect operation more difficult, manufacturers can significantly improve patient safety while reducing the likelihood of foreseeable use errors.
Learning from Post-Market Experience
Even the most comprehensive usability programme cannot predict every possible interaction between users and a medical device.
Once a product is placed on the market, manufacturers should continue monitoring real-world performance to identify emerging usability issues.
Useful sources of information include:
- Customer complaints.
- Incident reports.
- Customer support enquiries.
- User surveys.
- Clinical feedback.
- Literature reviews.
- Post-market surveillance activities.
This information can identify previously unrecognised use errors and provide valuable opportunities for continuous improvement.
By integrating post-market experience back into the usability engineering process, manufacturers can strengthen future product designs while maintaining a strong focus on patient safety.
Post-Market Surveillance Improves Usability Over Time
Usability engineering continues long after a medical device reaches the market. Discover how Post-Market Surveillance (PMS) helps manufacturers monitor real-world use, identify use-related issues, evaluate customer feedback and continuously improve device safety and usability throughout the product lifecycle.
Formative and Summative Evaluation
One of the core principles of IEC 62366-1 is demonstrating that a medical device can be used safely by its intended users. This is achieved through a combination of formative and summative usability evaluations.
Although both involve observing users interacting with a medical device, they have different objectives and are performed at different stages of development.
Formative evaluations help improve the design, while summative evaluations provide objective evidence that the final device can be used safely and effectively under realistic conditions.
Together, these activities form the foundation of usability validation.
What Is Formative Evaluation?
Formative evaluation is an iterative process used throughout product development to identify usability issues before the design is finalised.
Rather than validating the finished device, formative evaluations help manufacturers understand how users interact with prototypes, identify potential use-related problems and make improvements before significant resources are committed to production.
The emphasis is on learning and continuous improvement.
Manufacturers may conduct multiple formative evaluations during development as the design evolves.
Typical formative evaluation activities include:
- User interviews.
- Prototype testing.
- Task analysis.
- Simulated use sessions.
- Expert usability reviews.
- Heuristic evaluations.
- Observation studies.
- Early interface assessments.
Each evaluation provides valuable feedback that can be incorporated into the next design iteration.
Why Formative Evaluation Is Important
Identifying usability issues early is considerably more efficient than correcting problems once development has been completed.
Early evaluation helps manufacturers:
- Improve user interface design.
- Simplify workflows.
- Reduce user confusion.
- Improve device ergonomics.
- Clarify Instructions for Use.
- Refine training materials.
- Reduce use-related risks.
- Avoid costly redesigns later in development.
Formative evaluation also provides confidence that the device is progressing towards successful summative validation.
Designing Effective Formative Studies
There is no single prescribed method for conducting formative evaluations.
The approach should be appropriate for the complexity of the medical device, its intended users and the associated risks.
Manufacturers should ensure that studies:
- Involve representative users.
- Reflect realistic use environments.
- Include important user tasks.
- Encourage honest user feedback.
- Document observations objectively.
- Record design improvements arising from the evaluation.
The objective is not to prove that the device is perfect, but to identify opportunities for improvement.
What Is Summative Evaluation?
Summative evaluation is the final usability validation performed before the medical device is placed on the market.
Unlike formative evaluations, which are intended to improve the design, summative evaluations demonstrate that the completed device can be used safely by representative users without unacceptable use-related risks.
The design should already be substantially complete before summative evaluation begins.
The results provide objective evidence that usability engineering has achieved its intended objectives.
Why Summative Evaluation Is Required
Medical devices may appear intuitive during development but behave very differently when used by representative users in realistic environments.
Summative evaluation confirms that users can successfully perform critical tasks without introducing unacceptable risks.
This provides important evidence supporting:
- Regulatory submissions.
- Technical documentation.
- Risk management activities.
- Design validation.
- Clinical confidence.
- Product safety.
It also demonstrates that usability engineering has been systematically applied throughout development.
Selecting Representative Users
One of the most important aspects of summative evaluation is selecting users who accurately represent those expected to operate the device once it reaches the market.
Depending on the intended purpose, this may include:
- Surgeons.
- Nurses.
- Laboratory scientists.
- Biomedical engineers.
- Patients.
- Caregivers.
- Lay users.
- Community healthcare professionals.
Manufacturers should ensure that participant selection reflects the intended user population as closely as reasonably possible.
Testing only experienced engineers or internal staff is unlikely to provide meaningful evidence of real-world usability.
Simulated Use Environments
Usability evaluations should be performed under conditions that closely resemble actual clinical use.
Realistic environments help identify usability issues that may not become apparent during laboratory testing.
Examples include:
- Simulated operating theatres.
- Hospital wards.
- Clinical laboratories.
- Ambulance settings.
- Home healthcare environments.
- Community clinics.
Environmental factors such as lighting, noise, interruptions and time pressure should also be considered where appropriate.
The closer the evaluation reflects real-world use, the more valuable the resulting evidence becomes.
Critical Tasks During Evaluation
Summative evaluations focus particularly on critical tasks identified during the usability engineering process.
These tasks are observed carefully to determine whether users can complete them successfully without introducing unacceptable risk.
Examples may include:
- Preparing the device for use.
- Programming treatment parameters.
- Interpreting displayed information.
- Collecting patient samples.
- Responding to alarms.
- Administering therapy.
- Cleaning and maintaining the device.
- Shutting the device down safely.
Performance during these tasks provides valuable evidence that the final design adequately supports safe operation.
Recording Objective Evidence
Usability evaluations should generate objective, well-documented evidence rather than subjective opinions.
Manufacturers typically record:
- Task completion success.
- Observed use errors.
- User feedback.
- Time required to complete tasks.
- Requests for assistance.
- Deviations from expected workflows.
- Root causes of usability issues.
- Corrective actions where appropriate.
This information supports the Usability Engineering File and demonstrates traceability throughout the development process.
Formative vs Summative Evaluation
Although both involve observing users interacting with a device, their objectives are fundamentally different.
| Formative Evaluation | Summative Evaluation |
|---|---|
| Conducted during development | Conducted after design completion |
| Improves the design | Validates the final design |
| Multiple iterations | Usually one final validation study |
| Identifies usability issues | Demonstrates safe use |
| Supports continuous improvement | Supports regulatory submissions |
| Flexible approach | Structured validation protocol |
Rather than viewing these activities as separate exercises, manufacturers should consider them complementary stages within a continuous usability engineering programme.
Usability Evaluation Supports Continuous Improvement
Successful usability engineering does not end after summative evaluation.
Information gathered through post-market surveillance, customer feedback, complaints and incident investigations can all provide valuable insights into how users interact with the device in everyday clinical practice.
Manufacturers should periodically review this information to determine whether additional usability improvements are required.
By continuously learning from real-world experience, organisations can refine future product designs, strengthen risk management activities and further improve patient safety throughout the product lifecycle.
The Usability Engineering File (UEF)
The Usability Engineering File (UEF) is the central record demonstrating how usability engineering has been applied throughout the development of a medical device.
Rather than being a single report created at the end of a project, the UEF is a collection of documents and objective evidence that shows how use-related risks have been identified, evaluated and reduced through the design process.
The file provides traceability from the earliest usability activities through to the final summative evaluation, allowing manufacturers and regulatory authorities to understand how usability considerations have influenced the finished product.
Maintaining a well-structured Usability Engineering File is an important part of demonstrating compliance with IEC 62366-1 and supporting regulatory submissions.
Why Is the Usability Engineering File Important?
The purpose of the UEF is to demonstrate that usability engineering has been performed systematically rather than as an isolated design activity.
It provides objective evidence that the manufacturer has:
- Considered the intended users.
- Evaluated the intended use environment.
- Identified use-related hazards.
- Assessed potential use errors.
- Implemented appropriate design improvements.
- Validated the final user interface.
- Reduced use-related risks as far as reasonably practicable.
By documenting these activities, manufacturers can demonstrate that patient safety has been considered throughout the development lifecycle.
The UEF also provides valuable information for future product improvements, design changes and post-market surveillance activities.
What Should Be Included in the Usability Engineering File?
The exact contents of the UEF will depend on the complexity of the medical device, but a comprehensive file typically includes documentation covering every stage of the usability engineering process.
Examples include:
- Usability Engineering Plan
- Intended medical purpose
- Intended users
- Intended use environments
- User profiles
- User interface specification
- Identification of critical tasks
- Hazard-related use scenarios
- Use-related risk analysis
- Formative evaluation reports
- Design changes resulting from usability testing
- Summative evaluation protocol
- Summative evaluation report
- Residual use-related risk assessment
- Traceability records
The file should clearly demonstrate how usability findings have influenced the design of the medical device.
Maintaining Traceability
One of the most important characteristics of a well-prepared UEF is traceability.
Regulators and Notified Bodies should be able to follow the complete usability engineering process from the identification of a potential use-related hazard through to the implementation and verification of appropriate risk control measures.
For example, a single usability issue might be traced through:
- Identification during user research.
- Assessment as a potential use-related hazard.
- Inclusion within the risk management process.
- Design modification.
- Formative evaluation.
- Further design refinement.
- Successful summative evaluation.
- Inclusion within the final technical documentation.
This level of traceability provides confidence that usability engineering has been applied consistently and effectively.
How the UEF Supports Technical Documentation
For manufacturers placing medical devices on the UK, EU or other regulated markets, the Usability Engineering File forms part of the wider body of technical documentation.
While the exact structure of technical documentation varies depending on the applicable regulations, usability engineering evidence often supports sections relating to:
- Device description.
- Design and development.
- Risk management.
- Verification and validation.
- Clinical evaluation.
- Labelling.
- Instructions for Use.
- Benefit-risk analysis.
Rather than existing in isolation, the UEF complements these documents by providing evidence that user interaction has been systematically considered during product development.
Relationship Between the UEF and Risk Management
The Usability Engineering File should not be developed independently of the manufacturer’s risk management activities.
Many use-related hazards identified during usability engineering will also appear within the ISO 14971 risk management file.
Maintaining consistency between these documents improves traceability and demonstrates that use-related risks have been appropriately evaluated alongside other device risks.
Examples include:
- Incorrect device operation.
- Misinterpretation of displayed information.
- Incorrect assembly.
- Failure to respond to alarms.
- Incorrect specimen handling.
- Device misuse.
- Inadequate cleaning or maintenance.
Coordinating usability engineering and risk management activities reduces duplication while strengthening the overall design process.
Usability Engineering Supports the Entire Device Lifecycle
Usability engineering begins during product design but continues throughout the medical device lifecycle. Discover how risk management throughout the device lifecycle helps manufacturers identify emerging risks, evaluate post-market information and continuously improve the safety and performance of their medical devices.
Keeping the UEF Up to Date
The Usability Engineering File should be treated as a live document.
Whenever significant design changes occur, manufacturers should consider whether additional usability activities are required and update the file accordingly.
Examples include:
- Changes to the user interface.
- New intended users.
- Additional clinical applications.
- Updated Instructions for Use.
- New accessories.
- Software updates affecting user interaction.
- Changes arising from post-market surveillance.
- Corrective and preventive actions (CAPA).
Regularly reviewing the UEF helps ensure it remains an accurate reflection of the current design and continues to support ongoing regulatory compliance.
Common Documentation Mistakes
One of the most common issues identified during regulatory reviews is insufficient or poorly organised usability documentation.
Manufacturers should avoid:
- Creating the UEF only at the end of development.
- Missing traceability between identified hazards and design changes.
- Incomplete evaluation reports.
- Failing to document design decisions.
- Limited justification for user selection.
- Poor linkage to the risk management file.
- Inadequate records of formative evaluations.
- Not updating the UEF following significant design changes.
A well-maintained Usability Engineering File provides confidence that usability engineering has been integrated throughout the design process rather than treated as a one-off compliance exercise.
Organise Your Technical File for Regulatory Success
The Usability Engineering File forms an important part of your wider Technical Documentation. Learn how to structure a medical device Technical File in line with EU MDR Annex II and Annex III, creating a clear, traceable and audit-ready submission for Notified Bodies and regulatory authorities.
Common Usability Engineering Mistakes Manufacturers Should Avoid
Usability engineering is far more than a regulatory requirement. When applied effectively, it helps manufacturers develop medical devices that are safer, easier to use and better suited to their intended users.
However, many organisations make similar mistakes during development, often resulting in avoidable design changes, delayed regulatory submissions or increased use-related risks.
Understanding these common pitfalls can help manufacturers establish a more robust usability engineering process while improving patient safety and regulatory compliance.
Leaving Usability Engineering Until the End of Development
One of the most common mistakes is treating usability engineering as a final validation activity rather than integrating it throughout the design and development process.
If usability issues are only identified shortly before regulatory submission, manufacturers may be forced to redesign the user interface, update technical documentation or repeat verification and validation activities.
Integrating usability engineering from the earliest design stages allows issues to be identified and resolved while changes remain relatively simple and cost-effective.
Selecting the Wrong Participants
Usability evaluations are only meaningful if they involve representative users.
Manufacturers sometimes rely solely on internal engineers, experienced employees or clinical specialists who already understand the device.
While these individuals can provide valuable technical feedback, they may not represent the knowledge, experience or behaviours of the intended user population.
For example:
- A laboratory scientist may interact with an IVD very differently from a home user.
- A consultant surgeon may have different expectations than a general ward nurse.
- An experienced biomedical engineer may overlook usability challenges that patients immediately encounter.
Selecting participants who genuinely represent intended users produces more reliable and meaningful usability evidence.
Relying Too Heavily on Training
Training can improve user competence, but it should not be used as a substitute for good design.
If a device requires extensive training simply to perform routine tasks safely, manufacturers should consider whether the user interface itself could be improved.
Where reasonably practicable, design changes should reduce the likelihood of use errors before relying on:
- Additional training.
- Warning labels.
- User reminders.
- Procedural controls.
A well-designed medical device should naturally guide users towards safe operation.
Ignoring the Real-World Environment
Medical devices are often evaluated under ideal laboratory conditions that do not accurately reflect everyday clinical practice.
Real-world healthcare environments can include:
- Time pressure.
- Noise.
- Interruptions.
- Low lighting.
- Emergency situations.
- Personal protective equipment (PPE).
- High workloads.
- Multiple users operating simultaneously.
Failing to consider these factors may result in usability issues only becoming apparent after the device has been placed on the market.
Where appropriate, usability evaluations should simulate realistic conditions as closely as possible.
Confusing Usability with Appearance
An attractive product is not necessarily a usable product.
Usability engineering focuses on safety, effectiveness and ease of use rather than aesthetics.
Manufacturers should avoid prioritising visual appearance over practical considerations such as:
- Readability.
- Logical workflows.
- Clear controls.
- Intuitive navigation.
- Effective feedback.
- Ergonomic design.
A simple interface that supports safe operation is generally preferable to a visually impressive interface that increases cognitive workload.
Poor Documentation and Traceability
Even where excellent usability engineering has been performed, poor documentation can make it difficult to demonstrate compliance.
Common documentation issues include:
- Missing evaluation records.
- Incomplete hazard analysis.
- Weak justification for user selection.
- Poor traceability between identified hazards and design changes.
- Missing evidence of design improvements.
- Inadequate usability validation reports.
Maintaining comprehensive records throughout development makes regulatory reviews significantly easier and demonstrates that usability engineering has been applied systematically.
Usability Engineering Strengthens Your Technical File
Evidence generated through IEC 62366-1 forms an important part of your medical device Technical Documentation. Learn how to build a strong MDR Technical File by linking usability engineering, risk management, verification, validation and post-market evidence into a clear, audit-ready submission for Notified Bodies.
Failing to Learn from Post-Market Experience
Usability engineering should continue after a device has been placed on the market.
Customer complaints, incident reports and post-market surveillance activities often identify usability issues that were not evident during development.
Manufacturers should regularly review:
- Customer complaints.
- Vigilance reports.
- Service records.
- User feedback.
- Clinical observations.
- Trend analysis.
- Corrective and preventive actions (CAPA).
This information provides valuable opportunities to improve future product designs while reducing recurring use-related risks.
Overlooking Instructions for Use and Labelling
Even an intuitive medical device relies on clear supporting information.
Poorly written Instructions for Use (IFU), confusing symbols or unclear labelling can undermine an otherwise well-designed product.
Manufacturers should ensure that:
- Instructions are written for the intended users.
- Safety information is clearly presented.
- Symbols are appropriate and consistently used.
- Maintenance procedures are easy to follow.
- Warnings are understandable and proportionate.
Usability engineering should evaluate not only the device itself but also the information supplied with it.
Treating Usability Engineering as a Regulatory Checkbox
Perhaps the biggest mistake is viewing usability engineering purely as a documentation exercise undertaken to satisfy regulatory requirements.
In reality, effective usability engineering delivers significant business and clinical benefits.
Well-designed medical devices can:
- Improve patient safety.
- Increase user confidence.
- Reduce training requirements.
- Improve clinical efficiency.
- Reduce customer support requests.
- Strengthen regulatory submissions.
- Enhance market acceptance.
- Reduce the likelihood of costly post-market design changes.
Manufacturers that embed usability engineering within their design culture often develop products that are not only safer but also more successful commercially.
Usability Engineering as Part of Continuous Improvement
Successful manufacturers recognise that usability engineering is never truly complete.
As healthcare environments evolve, user expectations change and new technologies emerge, opportunities for improving usability continue throughout the product lifecycle.
By integrating lessons learned from development, regulatory reviews and post-market experience, organisations can continuously refine their products while maintaining a strong focus on patient safety and user-centred design.
The Future of Medical Device Usability Engineering
Medical technology is evolving rapidly. Artificial intelligence, connected healthcare, wearable technologies and home-use medical devices are changing how patients and healthcare professionals interact with medical products.
As devices become more sophisticated, usability engineering is becoming increasingly important. Rather than simply ensuring compliance with IEC 62366-1, manufacturers are expected to design products that remain safe, intuitive and effective throughout increasingly complex healthcare environments.
The future of usability engineering is likely to place even greater emphasis on understanding user behaviour, reducing cognitive workload and designing devices that support confident decision-making across a wide range of clinical settings.
Designing for Home Healthcare
Healthcare is increasingly moving beyond hospitals into patients’ homes.
Many medical devices that were once operated exclusively by trained healthcare professionals are now routinely used by patients, family members and caregivers with limited clinical experience.
Examples include:
- Blood glucose monitoring systems.
- Blood pressure monitors.
- Home dialysis equipment.
- CPAP devices.
- Wearable cardiac monitors.
- Insulin delivery systems.
- Home diagnostic tests.
These users often receive significantly less training than hospital staff, making intuitive design and clear Instructions for Use even more important.
Future usability engineering activities are expected to place increasing emphasis on designing products that can be used safely in non-clinical environments.
Artificial Intelligence and Human Oversight
Artificial intelligence is introducing new usability challenges for medical device manufacturers.
As AI systems become increasingly capable of supporting diagnosis, treatment planning and clinical decision-making, users must be able to understand when and how to rely on AI-generated outputs.
Usability engineering therefore extends beyond the physical interface to include how information is presented, explained and acted upon.
Manufacturers should consider whether users can:
- Understand AI-generated recommendations.
- Recognise system limitations.
- Identify when clinical judgement remains necessary.
- Respond appropriately to alerts and recommendations.
- Maintain appropriate human oversight.
Designing interfaces that support informed decision-making will become increasingly important as AI adoption continues to grow.
Human Factors Are Essential for AI Medical Devices
Artificial intelligence can support diagnosis, clinical decision-making and patient monitoring, but it must be designed with people in mind. Discover how artificial intelligence in medical devices is transforming healthcare while highlighting the importance of usability engineering, human oversight and intuitive user interfaces.
Accessibility and Inclusive Design
Healthcare serves an increasingly diverse population.
Manufacturers should consider users with varying:
- Physical abilities.
- Cognitive abilities.
- Vision.
- Hearing.
- Language skills.
- Digital literacy.
- Clinical knowledge.
Future medical devices are likely to place greater emphasis on inclusive design principles that make products accessible to the widest practical range of users.
Examples may include:
- Larger, high-contrast displays.
- Improved colour accessibility.
- Voice-guided interfaces.
- Simplified workflows.
- Tactile controls.
- Adjustable display settings.
- Plain language instructions.
Inclusive design benefits not only vulnerable users but also improves usability for the broader patient population.
Digital Health and Connected Medical Devices
The growth of digital health technologies is creating new opportunities and new usability considerations.
Many modern devices now communicate with:
- Mobile applications.
- Hospital information systems.
- Cloud platforms.
- Electronic health records.
- Remote monitoring services.
As connected healthcare continues to expand, usability engineering must consider the complete user journey rather than the medical device alone.
Manufacturers should evaluate how users interact with connected systems, ensuring that information is presented consistently and that workflows remain intuitive across multiple platforms.
Connected Medical Devices Need Intuitive User Interfaces
As connected healthcare continues to evolve, usability engineering is becoming increasingly important. Discover how the Internet of Medical Things (IoMT) is transforming patient care through connected medical devices, remote patient monitoring and digital healthcare, while highlighting the need for intuitive user interfaces and safe human interaction.
Personalised Healthcare
Medical devices are increasingly supporting personalised treatment based on individual patient characteristics.
Future usability engineering may need to consider adaptive interfaces that present different information depending on the user, clinical context or treatment pathway.
For example, devices may offer:
- Different interface modes for clinicians and patients.
- Customisable dashboards.
- Personalised alerts.
- Individual treatment recommendations.
- Tailored educational content.
These developments have the potential to improve usability while supporting safer and more effective healthcare delivery.
Continuous Learning Through Real-World Data
Modern medical devices generate increasing amounts of post-market information.
Manufacturers can use this data to better understand how devices are used in everyday clinical practice and identify opportunities for continuous improvement.
Examples include:
- Complaint trends.
- User feedback.
- Service records.
- Clinical observations.
- Usability-related incidents.
- Customer support enquiries.
Analysing this information allows organisations to refine future device designs while strengthening their overall usability engineering process.
Regulatory Expectations
Although usability engineering is defined by IEC 62366-1, regulators increasingly expect manufacturers to demonstrate that human factors have been considered throughout the design and development process.
For manufacturers placing medical devices on international markets, usability engineering supports compliance with a range of regulatory requirements and standards.
Rather than treating usability as a standalone activity, manufacturers should integrate it within their wider quality management system, design controls and risk management processes.
European Union (EU MDR)
Under the Medical Device Regulation (EU) 2017/745, manufacturers must demonstrate that devices achieve their intended performance while reducing risks associated with normal use and reasonably foreseeable misuse.
Usability engineering supports these objectives by providing evidence that user interaction has been considered throughout the design process.
New to the EU MDR?
IEC 62366-1 is just one part of the wider European regulatory framework for medical devices. If you're looking for a complete introduction to the Medical Device Regulation, including device classification, General Safety and Performance Requirements (GSPRs), Technical Documentation, Clinical Evaluation, Risk Management, CE marking and Post-Market Surveillance, read our EU MDR for Beginners: Complete Compliance Guide.
United Kingdom (UK MDR)
Manufacturers placing medical devices on the UK market should similarly consider usability throughout the product lifecycle.
Although the UK regulatory framework continues to evolve, designing devices that minimise use-related risks remains a fundamental expectation.
Placing Medical Devices on the UK Market?
Usability engineering plays an important role in demonstrating that medical devices are safe and suitable for their intended users. If you're planning to place a device on the Great Britain market, read our guide to regulating medical devices in the UK, covering UK MDR requirements, MHRA registration, UK Responsible Persons, conformity assessment and post-market obligations.
In Vitro Diagnostic Medical Devices (IVDR)
Usability engineering is equally important for in vitro diagnostic medical devices.
Laboratory professionals, healthcare workers and patients all interact with IVDs in different ways, and poor usability may affect specimen handling, test performance or interpretation of results.
Manufacturers should therefore ensure usability engineering reflects the intended users and environments for each diagnostic device.
Developing an In Vitro Diagnostic (IVD)?
Usability engineering is just as important for IVDs as it is for medical devices, helping ensure users can safely collect specimens, perform tests and interpret results. If you're looking for a complete introduction to the In Vitro Diagnostic Regulation, including device classification, Performance Evaluation, Technical Documentation, GSPRs, PMPF and CE marking, read our IVDR for Beginners: Complete Guide to Regulation (EU) 2017/746.
United States FDA
The U.S. Food and Drug Administration (FDA) places significant emphasis on human factors engineering for many medical devices.
Manufacturers are expected to demonstrate that intended users can safely perform critical tasks under representative conditions before products are placed on the market.
Although terminology may differ, the underlying objectives closely align with the principles of IEC 62366-1.
Why Usability Engineering Continues to Evolve
Medical technology will continue to become more connected, intelligent and personalised.
Despite these technological advances, the fundamental objective of usability engineering will remain unchanged: ensuring that medical devices can be used safely, effectively and confidently by the people who rely on them.
Manufacturers that integrate usability engineering throughout the product lifecycle are better positioned to improve patient safety, strengthen regulatory submissions and develop products that meet the needs of both healthcare professionals and patients.
How Patient Guard Can Help
Developing a medical device that complies with IEC 62366-1 requires more than simply completing usability testing. Manufacturers must demonstrate that usability engineering has been integrated throughout the design and development process, from identifying intended users and use-related hazards through to validation and post-market surveillance.
At Patient Guard, we help medical device and IVD manufacturers implement practical usability engineering processes that support regulatory compliance while improving patient safety and user confidence.
Whether you are developing a novel medical device, updating an existing product or preparing for regulatory submission, our experienced regulatory consultants can provide support throughout the product lifecycle.
Our usability engineering services include:
- IEC 62366-1 gap assessments
- Usability engineering planning
- Human factors reviews
- Use-related risk identification
- Formative evaluation planning
- Summative usability validation support
- Usability Engineering File (UEF) preparation and review
- Technical Documentation support
- ISO 14971 risk management integration
- Design and development consultancy
- Regulatory strategy for UK, EU and international markets
We work with manufacturers of:
- Medical devices
- In vitro diagnostic medical devices (IVDs)
- Active medical devices
- Implantable medical devices
- Home-use medical devices
- Digital health technologies
- Connected medical devices
- Software as a Medical Device (SaMD)
By integrating usability engineering into the wider design, risk management and quality management processes, manufacturers can strengthen regulatory submissions while developing safer, more intuitive medical devices.
If you require support with IEC 62366-1, human factors engineering or medical device regulatory compliance, our team is here to help.
Free Download: IEC 62366-1 Usability Engineering Checklist
Applying IEC 62366-1 to medical device design and development? Download Patient Guard's printable IEC 62366-1 Usability Engineering Checklist to help review intended users, use specification, use-related risks, formative evaluation, summative validation, the Usability Engineering File and post-market feedback.
IEC 62366-1 Usability Engineering FAQ
IEC 62366-1 is the international standard that specifies the process for applying usability engineering to medical devices. Its objective is to reduce use-related risks by ensuring devices are designed for safe and effective interaction with their intended users.
Usability engineering is the systematic process of designing medical devices so they can be used safely, effectively and efficiently by their intended users within their intended environments.
IEC 62366-1 can be applied to a wide range of medical devices, including active and non-active devices, IVDs, implantable devices, home-use products and Software as a Medical Device (SaMD). The extent of the usability engineering activities should be appropriate to the device and its associated risks.
Human factors engineering is the broader scientific discipline that studies how people interact with products and systems. Usability engineering applies these human factors principles specifically to the design and development of medical devices.
A use error occurs when a user's action or omission results in an unintended outcome that may lead to a hazardous situation. Many use errors arise from design issues rather than carelessness or inadequate training.
Formative evaluations are performed during development to identify and resolve usability issues. Summative evaluations validate that the final medical device can be used safely and effectively by representative users under realistic conditions.
The Usability Engineering File is the collection of documents demonstrating how usability engineering has been applied throughout the design and development process. It includes plans, evaluations, risk assessments, design changes and validation evidence.
IEC 62366-1 focuses on identifying and reducing use-related risks, while ISO 14971 provides the overall framework for medical device risk management. The two standards complement each other and are typically implemented together.
Yes. Usability engineering is equally important for in vitro diagnostic medical devices, particularly where specimen handling, result interpretation or user interaction may influence diagnostic performance and patient safety.
Yes. Home-use medical devices often require particularly careful usability engineering because they may be operated by patients or caregivers with limited medical training.
Yes. Software interfaces used within medical devices and Software as a Medical Device (SaMD) should also be considered during usability engineering to ensure users can safely interpret information and complete critical tasks.
Usability engineering should begin during the earliest stages of device design and continue throughout development, validation and post-market surveillance. Leaving usability activities until the end of development often results in unnecessary redesign and increased project costs.
Summary
Usability engineering is an essential component of modern medical device development. By placing intended users at the centre of the design process, manufacturers can reduce use-related risks, improve patient safety and develop products that are intuitive, effective and fit for purpose.
IEC 62366-1 provides a structured framework for applying usability engineering throughout the medical device lifecycle, from defining intended users and identifying use-related hazards to conducting formative and summative evaluations and maintaining a comprehensive Usability Engineering File.
Rather than being viewed solely as a regulatory requirement, effective usability engineering supports better product design, stronger regulatory submissions and greater confidence among healthcare professionals, patients and regulatory authorities alike.
As medical devices continue to evolve through digital health, connected technologies and artificial intelligence, understanding how people interact with these products will become increasingly important. Manufacturers that integrate usability engineering into their quality management systems and development processes will be well positioned to deliver safer, more user-centred medical technologies.
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