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Usability Studies

Medical Device Usability Testing

For decades, Sterling has been helping hundreds of clients bring their devices to market faster, streamline the regulatory process, minimize risk, and cut costs. With advanced expertise in medical device usability testing, we know what it takes to ensure the device you build works as intended for the consumer while meeting the ISO 62366-2015 and IEC 60601-2022 standards and FDA Guidance for Applying Human Factors and Usability Engineering to Medical Devices.  

What is Medical Device Usability Testing? 

Human factors or usability testing validates the safe and effective use of a medical device, including mitigation of use related hazards to ensure error-free use of the device. A crucial part of your design controls process, medical device usability testing captures critical insights about how critical use errors can occur while using the product. Usability testing must involve anyone who operates the device—not just the patients and the clinicians, but also technicians, the people who set up the device, and others—to ensure all users can safely use the device. 

Why do you need Medical Device Usability Testing? 

FDA data shows that >33% of medical device incidents involve use errors and >50% of device recalls for design problems involve the user interface. Manufacturers must demonstrate that their device enables users to perform tasks with little or no chance of an error that could cause harm to patients or themselves (IEC 60601-1-6). Evidence of usability testing must be provided to electrical safety lab prior to standards testing. Medical device usability testing is necessary to obtain FDA approval to market Class II or III medical devices. 

Human Factors Testing of Your Medical Device Ensures Compliance  

Conducting usability testing of your medical device is crucial in supporting human factors engineering as you design and develop a device that is safe, effective, and performs as intended without use errors as required by ISO 62366-2015, IEC 60601-2022, and the FDA Guidance for Applying Human Factors and Usability Engineering to Medical Devices.  Key areas of focus must include the physical interface, software interface, the instructions for use and other labeling, and any required training.  

A Multi-Dimensional Approach to Medical Device Usability Testing 

At Sterling, we recognize the importance of applying usability testing throughout your entire product development lifecycle—starting at the beginning of the design and development process. If you wait until the validation phase to explore usability, you run the very real risk of discovering critical flaws that warrant a redesign, which will not only result in costly delays that affect your bottom line, but it could also lead to a more difficult regulatory submission process. By finding issues earlier in the process, you can more easily make changes to the design without impacting timelines or budgets.  

With the goal of understanding device users and use errors as you design and develop your product, we follow a multi-dimensional approach for usability testing that includes comprehensive formative and summative evaluations. 

  • Formative testing: Formative testing lets you learn more about the products through the lens of the end users. This ensures your design matches user requirements and identifies potential design weaknesses. At Sterling, we incorporate formative testing at various points throughout the development process to allow for iterative improvements as needed before the product is fully developed. By letting users interact with and respond to a proposed concept or prototype early and often, you can mitigate use related hazards to ensure error-free use of the device and tailor your device to user requirements. Designs or design requirements can be modified in response to the findings of formative testing. 
  • Summative testing: Summative testing validates that the final product is the device can be used by the intended users, under the expected use conditions, without serious use errors or problems. At Sterling, we follow a quantitative testing approach that ensures the device meets user requirements before the product is put to market and is designed in accordance with ISO 62366-2015, IEC 60601-2022, and the FDA Guidance for Applying Human Factors and Usability Engineering to Medical Devices. After we complete the summative study on your medical device, we consolidate and analyze the test data and detail the findings in a summative test report, which will become part of the usability file for your FDA submission.  

Medical device usability testing is a crucial component of a medical device’s lifecycle and the FDA/CE submission process. Regardless of where you are in your medical device’s lifecycle, Sterling can help you create customized testing plans to support a smooth, cost-effective product design and development process that ensures your devices are safe for users and meet required standards. Beyond the medical device usability testing itself, our team of medical device experts can work with you to analyze the post-market performance of your device and make any required adjustments. 

Deliverables may include: 

  • Usability plan 
  • Use specifications 
  • Risk analysis and uFMEA 
  • Formative human factors testing 
  • Summative (validation) human factors testing 
  • Human factors/usability file for regulatory submission 
  • Instructions for use (IFU) design 
  • In-depth interviews 
  • Contextual inquiry/clinical observations 
  • Concept feedback sessions 
  • Gap analysis for human factors standards compliance 
  • Human factors/usability file remediation 

For more information about how Sterling can help you facilitate medical device usability testing, contact us here.


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