Defining and addressing medical device user needs
The FDA specifies, “Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient.”
To meet this requirement and align with EU MDR and FDA human-factors guidance—which urges manufacturers to “maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and use environments”—manufacturers must replace assumptions with systematic user research.
In this article, we’ll cover concepts for identifying and addressing medical device user needs, common barriers to accurate capture, and six steps to document and validate these requirements throughout development.
Understanding medical device user needs
User needs define the fundamental requirements and expectations of end-users that a device must fulfill in its intended context of use. Generally, development teams capture these user-driven requirements early in the design and development process. They form the basis for design inputs and serve as benchmarks to verify and validate that the finished product meets its intended purpose.
Regulatory design control frameworks require design validation that confirms a device meets defined user needs and intended uses. Developers who misunderstand or overlook user needs risk producing a device that is difficult to use or prone to errors. They also risk increasing safety and efficacy risks.
Yet, manufacturers face structural barriers when identifying and addressing user needs. Resource constraints—limited time and budget, in particular—commonly impede early user research and involvement. Plus, internal silos and poor cross-functional communication cause teams to rely on unverified assumptions about user requirements, rather than direct user input.
Limited prescriptive detail on documenting user needs compounds these challenges and leads to an industry-wide lack of standardization. Medical device companies and relevant regulatory bodies actively explore, refine, and promote standardized practices to address these challenges.
6 steps to identify and document user needs
The following six steps help medical device manufacturers mitigate challenges in accurately capturing, documenting, and validating user needs. These steps, while established, evolve as design methodologies advance.
1. Define the device’s intended use and user profile
Clearly define the device’s intended use and profile of its users—and document it. This entails developers articulating what the device must do and identifying who will operate it. The user profile should also factor in the use environment and user capabilities, including training requirements, dexterity, and experience level.
These factors ensure the design process reflects the real contexts and limitations of device use.
2. Capture user insights through direct research
After defining the intended use and user profile, next capture user insights through direct research. Relying on assumptions or second-hand information often leads to incomplete or biased user needs. First-hand research helps uncover explicit needs that users can readily articulate and latent needs that surface only through observation.
Primary direct research methods include in-depth interviews, focus groups, contextual inquiry, and ethnographic observation—yet teams must tailor methodologies to the device’s risk class, complexity, and development phase.
This effort also satisfies FDA human-factors guidance, which aims to “assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and use environments.”
3. Convert research findings into clear user need statements
Translate raw user research data into concise, high-level user need statements. In sifting through qualitative and quantitative data, identify recurrent user challenges and goals. Each need statement should explicitly capture what the user wants to achieve or avoid, using the user’s perspective and language.
Avoid implying a specific design solution—focus on the underlying need or benefit, not the device feature that might deliver it. Well-crafted user need statements are precise, actionable, and testable.
4. Document and trace user needs in design inputs
Document all user needs and maintain a clear mapping of each need to specific design input requirements. Assign each need a unique identifier and link it to one or more measurable design inputs that specify how the device will fulfill that need.
Teams often use a requirements traceability matrix to connect user needs to their corresponding design inputs. This matrix also links to design outputs, verification, and validation.
5. Validate that the final design meets user needs
For the finished device, design validation confirms that the final product meets the needs of clinicians in its intended use scenario. Quality system regulations require validating the design under real or simulated use conditions with production-equivalent units.
An essential part of these use conditions is the onboarding process, in which the end-user is trained on how to use the device in the best possible way. A well-designed educational methodology can support device adoption and reduce errors in the use of the device.
In practice, this means performing comprehensive tests with representative users—supported by appropriate training protocols—to ensure the device is safe, effective, and user-friendly in its intended environment. Validation essentially asks, “Did we design the right device?” by demonstrating that the final design addresses each user's needs.
6. Adopt relevant feedback loops
After launch, manufacturers must implement robust feedback loops to ensure the device continues to fulfill user needs over time. Quality systems require establishing processes to proactively capture and analyze user feedback—i.e., complaints and user observations—once the device is in the field.
Simulation-based training modules, such as those from LeQuest, log detailed user-interaction metrics and competency scores, creating a track record of proven competence that feeds post-market feedback loops and highlights use-error patterns
LeQuest, your partner in medical device application training
LeQuest works in parallel with device development, building FDA-aligned simulation modules that support application training, increase device adoption, and uncover residual usability risks. These modules deliver launch-day training and create a track record of proven competence for regulatory review.
Its immersive, scenario-based learning empowers clinicians to master new technology quickly and safely, long before the first device ships.
LeQuest is the today and tomorrow of medical device mastery. Learn how LeQuest can help you address user needs.