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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

IMDRF SaMD Working Group (2013), Software as a Medical Device (SaMD): Key Definitions, International Medical Device Regulators Forum. Software as a Medical Device (SaMD): Key definitions (imdrf.org)

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

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

Abstract

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