Patient-Centric Regulation: Usability, Human Factors, and Labeling in 2025

Medical devices are only as safe and effective as their users’ ability to operate them correctly. Even the most advanced technology can fail if patients or healthcare professionals misunderstand instructions, misuse the device, or encounter confusing interfaces. Regulators now recognize usability and human factors as central to patient safety.

In 2025, both FDA and EU regulators are emphasizing patient-centric design, usability validation, and clear labeling. These expectations reflect a growing commitment to designing devices that are intuitive, accessible, and aligned with real-world use conditions. For manufacturers, this means human factors and labeling are not optional extras, but integral parts of regulatory submissions and post-market compliance.

This blog explores regulatory expectations for usability, common pitfalls, and strategies companies can use to embed patient-centric principles into development and compliance.

Regulatory Context

United States

FDA’s guidance, Applying Human Factors and Usability Engineering to Medical Devices, requires manufacturers to demonstrate that devices can be used safely and effectively by intended users in intended environments. Key expectations include:

• Identifying user groups (patients, caregivers, clinicians) and critical tasks.

  
  

• Conducting formative usability studies to identify and correct design issues.

  
  

• Performing summative (validation) testing with representative users.

  
  

• Documenting design changes driven by human factors findings.

  
  

Labeling and Instructions for Use (IFUs) must support safe use, but FDA stresses that labeling cannot substitute for poor design. Devices must be inherently intuitive.

European Union

Under MDR, Annex I requires manufacturers to minimize risks related to use errors. Usability and labeling are explicitly tied to General Safety and Performance Requirements (GSPRs). Notified Bodies now scrutinize:

• Usability engineering files documenting the design process.

  
  

• Results of summative usability validation studies.

  
  

• Labeling that is clear, comprehensive, and consistent with design.

  
  

Labeling must also comply with language and formatting requirements across Member States, adding complexity for global manufacturers.

Global Trends

Regulators in Canada, Japan, and Australia are aligning with IMDRF human factors principles. Globally, usability and labeling are being harmonized as core safety considerations.

Why Patient-Centric Design Matters

Patient-centric design is not only a regulatory expectation, it is also a strategic advantage:

• Safety: Reduces adverse events caused by user error.

  
  

• Compliance: Meets FDA, EU, and global regulatory requirements.

  
  

• Market Acceptance: Devices that are easy to use gain faster adoption and better adherence.

  
  

• Reputation: Demonstrates a commitment to patient safety and accessibility.

  
  

Common Pitfalls

1. Late Human Factors Testing: Many companies delay usability studies until late in development. This makes it difficult to fix design flaws without costly rework.

   
   

2. Non-Representative Users: Testing only with ideal users fails to capture real-world risks. Regulators expect representative user groups, including elderly patients, children, or those with disabilities.

   
   

3. Incomplete Documentation: Failure to maintain a usability engineering file is a frequent finding in EU audits.

   
   

4. Over-Reliance on Labeling: Some manufacturers attempt to compensate for poor design with complex instructions. Regulators reject this approach.

   
   

5. Global Labeling Gaps: Failure to adapt IFUs for different languages or cultural contexts can delay approvals in international markets.

   
   

Case Examples

• Autoinjector Misuse: A pharmaceutical company submitted an autoinjector without robust usability data. FDA reviewers found that patients misfired doses in simulated use, delaying approval until redesign and new testing were completed.

  
  

• Successful Formative Testing: A device start-up conducted formative studies early, discovering that patients struggled with button placement. By redesigning the interface before summative testing, the company avoided costly delays and achieved rapid clearance.

  
  

• Labeling Noncompliance: A European manufacturer failed to provide multilingual IFUs consistent with MDR Annex I. Its Notified Body issued a major nonconformity, delaying certification.

  
  

Practical Steps for Manufacturers

1. Integrate Human Factors Early: Build usability into the design process from the beginning, not as a final step.

   
   

2. Identify Critical Tasks: Map out the steps where errors could harm patients. Design these tasks to be intuitive and error-resistant.

   
   

3. Conduct Formative Studies: Test prototypes with real users in realistic environments. Use findings to refine design.

   
   

4. Perform Summative Validation: Conduct final usability validation with representative users, documenting safe and effective use.

   
   

5. Maintain a Usability Engineering File: Record all human factors activities, decisions, and outcomes. Regulators expect this file in submissions.

   
   

6. Design Clear Labeling: Develop IFUs and labeling that complement intuitive design. Use plain language, diagrams, and consistent terminology.

   
   

7. Plan for Global Labeling Requirements: Translate and adapt IFUs to meet MDR and local requirements in all markets.

   
   

Strategic Implications for Executives

For CEOs

Patient-centric design strengthens brand reputation and market success. CEOs should position usability and labeling as strategic priorities, not compliance afterthoughts.

For QA/RA Leaders

QA/RA teams must ensure usability files and labeling are complete and consistent with regulatory requirements. They must also coordinate global labeling strategies to meet diverse requirements.

For Product and R&D Leaders

Product teams must design with the patient in mind. Usability findings should drive design choices, and labeling should be integrated with interface design.

For Commercial Leaders

Easy-to-use devices with clear labeling gain faster adoption by hospitals, payers, and patients. Commercial teams should leverage usability as a differentiator in the market.

Conclusion

In 2025, regulators expect medical devices to be patient-centric. Human factors, usability, and labeling are not optional, they are core to safety and compliance. Manufacturers that embed usability early and invest in clear, accessible labeling will not only satisfy regulators but also build trust with patients and healthcare providers.

How PRP Compliance Can Help: We help companies design usability programs, conduct formative and summative studies, and prepare human factors documentation for FDA and EU submissions. Contact PRP Compliance to ensure your devices are intuitive, safe, and compliant in every market.