Citation:

Yashwanth Teja Donga, 2026. "Bridging Usability Engineering and Risk Analysis in Medical Device Design", ESP Journal of Engineering & Technology Advancements  6(2): 13-22.

Abstract:

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.

References:

[1] A.P. Gurses, A.A. Ozok and P.J. Pronovost, Time to accelerate integration of human factors and ergonomics in patient safety, BMJ Quality & Safety. 21(4) (2012) 347-351.

[2] World Health Organization, Medical devices: Managing the mismatch: An outcome of the Priority Medical Devices project, WHO Press. (2017) 1-200.

[3] H. Patel, B. Lo and G.Z. Yang, Medical cyber-physical systems: A survey of security vulnerabilities, risks, and controls, IEEE Access. 8 (2020) 147402-147420.

[4] International Electrotechnical Commission, IEC 62366-1: Medical devices – Application of usability engineering to medical devices, IEC Standard. (2015) 1-100.

[5] International Organization for Standardization, ISO 14971: Medical devices – Application of risk management to medical devices, ISO Standard. (2019) 1-120.

[6] J. Zhang, T.R. Johnson and V.L. Patel, A cognitive taxonomy of medical errors, Journal of Biomedical Informatics. 36(3) (2003) 194-204.

[7] B. Kirwan and L.K. Ainsworth, A guide to task analysis, Taylor & Francis. (1992) 1-300.

[8] U.S. Food and Drug Administration, Applying human factors and usability engineering to medical devices: Guidance for industry and Food and Drug Administration staff, FDA Report. (2016) 1-50.

[9] European Union, Regulation (EU) 2017/745 on medical devices, Official Journal of the European Union. (2017) 1-175.

[10] C.J. Vincent, Y. Li and A. Blandford, Integration of human factors and ergonomics during medical device design and development: It’s all about communication, Applied Ergonomics. 45(3) (2014) 413-419.

[11] P. Carayon, T.B. Wetterneck and A.J. Rivera-Rodriguez, Human factors systems approach to healthcare quality and patient safety, Applied Ergonomics. 45(1) (2014) 14-25.

[12] J. Zhang, M. Walji and T.R. Johnson, Integrating human factors and risk management in medical device design, Journal of Biomedical Informatics. 43(5) (2010) 772-781.

[13] T. Zayas-Cabán and R.S. Valdez, A human factors approach to medical device design for home healthcare, Information Technology & People. 24(4) (2011) 363-381.

[14] J.L. Martin, B.J. Norris, E. Murphy and J.A. Crowe, Barriers to the integration of usability engineering into the medical device development process, Journal of Biomedical Informatics. 47 (2014) 291-302.

[15] A.P. Gurses and P. Carayon, The role of human factors in improving patient safety in the ICU, Critical Care Clinics. 29(1) (2013) 63-80.

[16] J. Kuchenbecker, M. Krüger and H. Hofmann, Incorporating user-centred design into risk management for medical devices, Biomedical Engineering. 62(3) (2017) 305-314.

[17] R.N. Keers, S.D. Williams, J. Cooke and D.M. Ashcroft, The impact of poor UI design on infusion pump errors, BMJ Quality & Safety. 29(6) (2020) 502-510.

[18] R.M. Ratwani, R.J. Fairbanks, A.Z. Hettinger and N.C. Benda, Challenges in applying human factors engineering in health IT, Journal of the American Medical Association. 320(10) (2018) 1032-1033.

[19] L. Lin, K.J. Vicente and D.J. Doyle, Mapping human factors design issues to risk categories in medical devices, Human Factors. 64(5) (2022) 855-870.

[20] G.Z. Yang, J. Cambias and K. Cleary, Human-centred risk assessment in medical robotics, Science Robotics. 6(53) (2021) eabf6589.

[21] B.D. Franklin and K. O’Grady, Usability as a regulatory requirement, International Journal for Quality in Health Care. 31(8) (2019) 595-602.

[22] R.J. Holden and B.T. Karsh, The technology acceptance model in healthcare, Journal of Biomedical Informatics. 43(1) (2010) 159-172.

[23] M.E. Wiklund, J. Kendler and A.Y. Strochlic, Usability testing of medical devices, CRC Press. (2016) 1-250.

[24] C.M. Johnson, T.R. Johnson and J. Zhang, A user-centred framework for redesigning health care interfaces, Journal of Biomedical Informatics. 38(1) (2005) 75-87.

[25] N.A. Stanton, P.M. Salmon and L.A. Rafferty, Human factors methods: A practical guide for engineering and design, CRC Press.(2013) 1-400.

[26] M. Wu, R. Feyen and R. Small, Simulation-based usability evaluation of infusion pumps, Human Factors and Ergonomics Society Annual Meeting. 48(17) (2004) 1992-1996.

[27] S. Wilson and S. Sharples, Evaluation of human factors interventions in health care, Ergonomics. 58(1) (2015) 56-68.

[28] D. Embrey, SHERPA: A systematic human error reduction and prediction approach, Human Factors Conference Proceedings. (1986) 1-10.

[29] J.S. Ancker, A. Edwards and S. Nosal, Effects of workload and alerts on clinical decision systems, BMC Medical Informatics and Decision Making. 17(1) (2017) 36.

[30] E. Liljegren, Usability in a medical technology context, International Journal of Industrial Ergonomics. 36(4) (2006) 345-352.

[31] D. Imbeau and I. Deniaud, Verification and validation of ergonomic interventions in design, Work. 41(1) (2012) 5156-5162.

[32] M. Hägglund, I. Scandurra and D. Moström, Integrating usability and risk management in design process, Studies in Health Technology and Informatics. 160 (2010) 246-250.

[33] E.J. Topol, High-performance medicine: Human and AI convergence, Nature Medicine. 25(1) (2019) 44-56.

[34] R. Lin, B. Green and M. Keane, Evaluating usability-centred risk mitigation strategies, International Journal of Human Computer Interaction. 37(12) (2021) 1156-1172.

[35] E. Coiera and F. Magrabi, Usability design impact on medical device safety, Journal of the American Medical Informatics Association. 27(3) (2020) 400-408.

[36] V. Blijleven, K. Koelemeijer and M. Jaspers, Usability and risk management in ICU procurement, BMJ Innovations. 5(2) (2019) 72-80.

[37] K.J. Vicente, J.D. Lee and S. Narayanan, Eye-tracking evaluation of usability-integrated systems, Human Factors. 63(3) (2021) 451-465.

[38] M.M. Walker, J. Gerhart and D. Hoffman, Survey of human factors integration practices, Medical Device Industry Journal. 42(9) (2020) 58-65.

[39] C. Nemeth, M. O’Connor and P.A. Klock, Integrating usability and risk assessment models, Applied Ergonomics. 60 (2017) 134-144.

[40] A. Dubey and L.D. Riek, Predicting use-errors using deep learning models, Human-Computer Interaction. 36(4) (2021) 289-312.

[41] D.W. Meeks, A. Takian and D.F. Sittig, Sociotechnical aspects of patient safety and EHR design, Journal of the American Medical Informatics Association. 21 (2014) e28-e34.

[42] B.T. Karsh, P. Waterson and R.J. Holden, Human factors in healthcare and patient safety, Human Factors. 56(5) (2014) 727-733.

[43] E.J. Topol and S.R. Steinhubl, Digital medicine: Empowering patients and clinicians, JAMA. 321(4) (2019) 339-340.

[44] C.D. Wickens and J.G. Hollands, Engineering psychology and human performance, Psychology Press. (2015) 1-350.

Keywords:

Device Regulations, Human-Computer Interaction, Human Factors, IEC 62366, ISO 14971, Medical Device Design, Patient Safety, Risk Analysis, Usability Engineering, Use Errors.