Medical device human factors validation testing requires strict procedures following the Guidelines issued by FDA and IEC to validate the safe and effective use of medical devices. UX Firm has a proven track record of delivering effective test protocols for FDA review, high quality formative and summative usability evaluations, and highly detailed reports to be used in pre-submissions to FDA for 510K submissions.
The big companies charge very big bucks for these services. Because we are a boutique consultancy, we can be highly competitive in pricing and highly effective in working directly with you to produce the research results you require.
Contact us to start the conversation.
IEC 62366, ISO 14971, & ANSI/AAMI HE75 Require Human Factors Usability Testing
“IEC 62366 specifies a process for a manufacturer to analyze, specify, develop, and validate the usability of a medical device as it relates to safety. . . . Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process.
It strengthens links to ISO 14971. . . . Part 2 [offers] more detailed descriptions of usability engineering methods that can be applied generally to medical devices.”
ANSI/AAMI HE75 Human Factors Engineering—Design of Medical Devices—provides comprehensive guidance on designing to accommodate user characteristics, managing the risk of use error, and undergoing usability testing to confirm the safety and effectiveness of the design. This document complements ANSI/AAMI/IEC 62366.
FDA issues guidance for Applying Human Factors and Usability Engineering to Medical Devices
The most recent guidance was issued on February 3, 2016.
“FDA has developed this guidance document 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.”
UX Firm ensures compliance in Medical Device Human Factors Validation Testing
UX Firm is uniquely qualified to conduct usability testing of medical devices to ensure compliance with all regulations and guidelines. The experience of the partners, coupled with our hands-on approach to every research engagement, provides a complete testing process to produce actionable outcomes for product development teams.
For every phase of your planning and development process, we provide the right set of tools from our UX toolkit to gain insights into your users’ goals and context of use, building knowledge of user experience into all stages of product development from requirements gathering to the documentation of findings and recommendations against established criteria of safety, ease of use, and effectiveness of the design.
UX Firm has in-depth experience in user research with medical devices, which also extends to software used for insurance claims processing for physicians and recipients, studies around accessibility and universal design, and leading edge research using eye-tracking and fMRI.
As part of our engagement with clients, we can do any or all of the following tasks:
- Write the test plan
- Prepare IRB approval documents (when required)
- Manage participant recruitment
- Conduct formative and summative/human factors validation testing
- Write a comprehensive report to include root cause analysis of errors
For insights into our experience working with participants in medical usability studies, check out our blog.
Case Study Example
Gain insights into user experience of multiple product design prototypes to determine preferences, success/failure rates, and safety of use by caregiver, clinician, and patient populations.
Structure a comparative usability evaluation of five prototypes with representative users from three population groups, using all versions of the prototype (in varied order) to determine human factors issues including safety and reliability as measured against a specific set of criteria.
A sample page from the report shows the results of one aspect of this testing. Two prototypes were determined to be the most successful and acceptable to the three user groups, with features from a third prototype reflecting some interest and acceptance from study participants. Recommendation was accepted to continue design and development of two prototypes to include the best features identified from this evaluation.
Retest took place in an iterative design process to determine improvements in success/acceptance in usability testing of more advanced models.
“[Our company] engaged UX Firm to conduct usability testing on our product in development. The study involved numerous concepts with different user groups and environments. UX Firm did an outstanding job conducting the study and analyzing the results in a timely fashion. They made relevant suggestions for device and labeling design changes to enhance user experience and safety. Their final presentation and report was professional and thorough.”
–Human Factors Evaluation Leader, R&D
Contact us to start the conversation about how we can help with your medical device compliance requirements.