Bridging Usability Engineering and Risk Analysis in Medical Device Design

Skip to main Communities My dashboard Log in Sign up Published April 4, 2026 | Version v1 Journal Open Bridging Usability Engineering and Risk Analysis in Medical Device Design Authors/Creators Yashwanth Teja Donga Description Medical equipment is becoming more complex and requires not only technological sophistication but also careful alignment with human cognitive and physical capabilities. Although both risk analysis and usability engineering are important in terms of safety and efficacy of the device, the two fields have been historically considered separately. Recent sources suggest that inefficiencies, adverse events that can be prevented, and regulatory issues can take place due to not integrating usability processes and risk management. This review discusses the existing methods of integrating usability engineering and risk analysis in the design of medical devices, assesses the existing empirical evidence, and puts forward a theoretical model of integration. Among the notable challenges, it is possible to distinguish such issues as methodological fragmentation, slow usability feedback, and inadequate industry implementation of integrated practices. The importance of integrating human factors engineering and risk management principles early and systematically is supported by experimental studies and real-life data on a regular basis. Future trends indicate the need for standardized instrumentation, cross-functional design procedures and better standards of regulation to promote secure, convenient, and reliable medical apparatuses. Files JETA-V6I2P102.pdf Files (1.3 MB) Name Size Download all JETA-V6I2P102.pdf md5:880204401a507cc79c813b5f2daef9ae 1.3 MB Preview Download Additional details Dates Submitted 2026-03-06 Updated 2026-03-15 Accepted 2026-04-04 Software Repository URL https://www.espjeta.org/jeta-v6i2p102 Development Status Active 44 Views 27 Downloads Show more details All versions This version Views Total views 44 44 Downloads Total downloads 27 27 Data volume Total data volume 35.9 MB 35.9 MB More info on how stats are collected.... Versions External resources Indexed in OpenAIRE Communities Keywords and subjects Keywords Device Regulations Human-Computer Interaction Human Factors IEC 62366 ISO 14971 Medical Device Design Patient Safety Risk Analysis Usability Engineering Use Errors Details DOI DOI Badge DOI 10.5281/zenodo.19639320 Markdown [](https://doi.org/10.5281/zenodo.19639320) reStructuredText .. image:: https://zenodo.org/badge/DOI/10.5281/zenodo.19639320.svg :target: https://doi.org/10.5281/zenodo.19639320 HTML <a href="https://doi.org/10.5281/zenodo.19639320"><img src="https://zenodo.org/badge/DOI/10.5281/zenodo.19639320.svg" alt="DOI"></a> Image URL https://zenodo.org/badge/DOI/10.5281/zenodo.19639320.svg Target URL https://doi.org/10.5281/zenodo.19639320 Resource type Journal Publisher ESP Journal of Engineering & Technology Advancements Published in ESP Journal of Engineering & Technology Advancements, 6(2), 08-12, ISSN: 2583-2646, 2026. Languages English Citation Export Technical metadata Created April 18, 2026 Modified April 19, 2026 Jump up About About Policies Infrastructure Principles Projects Roadmap Contact Blog Blog Support Help FAQ Developers REST API OAI-PMH Contribute GitHub Donate Funded by Powered by CERN Data Centre & InvenioRDM Status Privacy policy Cookie policy Terms of Use This site uses cookies. Find out more on how we use cookies Accept all cookies Accept only essential cookies

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