In the Face of New Challenges;Effective Human Factors Engineering for Software as Medical Device Products

Abstract

This paper tackles challenges facing human factors professionals when transitioning into working with Software as Medical Device products. Specifically, it outlines the challenges Novo Nordisk A/S has faced when it comes to applying human factors considerations when developing Software as Medical Device products and ensuring regulatory compliance. It showcases the efforts Novo Nordisk A/S has implemented to meet these challenges and conclude on the learnings Novo Nordisk A/S has had with the proposed solutions.

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References

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Center for Devices and Radiological Health Office of Device Evaluation (2016), Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Food and Drug Administration, U.S. Department of Health and Human Services. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices

Human Interface Guideline (n.d.), Controls. Apple Inc. Retrieved January 4th, 2022, from https://developer.apple.com/design/human-interface-guidelines/ios/controls/pickers/

Association for the Advancement of Medical Instrumentation (2009), Human factors engineering – Design of medical devices (pp. 16) https://webstore.ansi.org/Standards/AAMI/ANSIAAMIHE752009R2018?gclid=EAIaIQobChMI143OuNeu9QIVE-J3Ch2u_wwuEAAYASAAEgKTkvD_BwE