Business Reasons to Prioritize Human Factors in Medical Device Design

Evidence suggests that many medical device manufacturers are reluctant to conduct elective human factors activities or user research of any kind until they are compelled to do so by regulatory requirements. This reportedly stems from a communication gap between human factors practitioners and other disciplines regarding whether and how adopting a user-centered design approach benefits the broader corporate agenda. The goal of this article is to help bridge this gap by highlighting entirely practical business reasons to prioritize human factors throughout the medical device design process. This contribution thus supports internal advocacy efforts and promotes best practices across the industry.

Authors

Publication Details

Journal
Journal of Clinical Engineering
Published
2025-09-16
DOI
https://doi.org/10.1097/jce.0000000000000729
Primary Topic
Quality and Safety in Healthcare
Type
article
Field-Weighted Citation Impact
0.00
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article

Business Reasons to Prioritize Human Factors in Medical Device Design

Joseph R. Pauszek
Journal of Clinical Engineering
Quality and Safety in Healthcare
article

Business Reasons to Prioritize Human Factors in Medical Device Design

Joseph R. Pauszek
article en

Abstract

Evidence suggests that many medical device manufacturers are reluctant to conduct elective human factors activities or user research of any kind until they are compelled to do so by regulatory requirements. This reportedly stems from a communication gap between human factors practitioners and other disciplines regarding whether and how adopting a user-centered design approach benefits the broader corporate agenda. The goal of this article is to help bridge this gap by highlighting entirely practical business reasons to prioritize human factors throughout the medical device design process. This contribution thus supports internal advocacy efforts and promotes best practices across the industry.

Journal of Clinical EngineeringVol. 50(4)
Openalex Percentile: Top 54%
Quality and Safety in Healthcare
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