The redesigned follitropin alfa pen injector: results of the patient and nurse human factors usability testing

This paper describes why and how human factors practitioners should employ a combination of research methods for user data collection, rather than relying on only one or two such as heuristic evaluation and laboratory testing. The paper presents three case studies of multiple-method usability research projects: alternating usability testing with ethnographic interviews in a longitudinal study of a clinical information system; two parallel usability research efforts for a small company with a limited budget; and contextual inquiries followed by group interviews of experts, then by usability testing. The authors believe that combining research methods is more likely to increase the strategic penetration of human factors within organizations.

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Human factors/ergonomics to support the design and testing of rapidly manufactured ventilators in the UK during the COVID-19 pandemic

International Journal for Quality in Health Care ◽

10.1093/intqhc/mzaa089 ◽

2020 ◽

Author(s):

Sue Hignett ◽

Janette Edmonds ◽

Tracey Herlihey ◽

Laura Pickup ◽

Richard Bye ◽

...

Keyword(s):

Human Factors ◽

Design Procedure ◽

Usability Testing ◽

Rapid Response ◽

Design Development ◽

Detailed Design ◽

Safety Standards ◽

The Uk ◽

Design And Testing

Abstract Background This paper describes a rapid response project from the Chartered Institute of Ergonomics & Human Factors (CIEHF) to support the design, development, usability testing and operation of new ventilators as part of the UK response during the COVID-19 pandemic. Method A five-step approach was taken to (1) assess the COVID-19 situation and decide to formulate a response; (2) mobilise and coordinate Human Factors/Ergonomics (HFE) specialists; (3) ideate, with HFE specialists collaborating to identify, analyse the issues and opportunities, and develop strategies, plans and processes; (4) generate outputs and solutions; and (5) respond to the COVID-19 situation via targeted support and guidance. Results The response for the rapidly manufactured ventilator systems (RMVS) has been used to influence both strategy and practice to address concerns about changing safety standards and the detailed design procedure with RMVS manufacturers. Conclusion The documents are part of a wider collection of HFE advice which is available on the CIEHF COVID-19 website (https://covid19.ergonomics.org.uk/).

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The recombinant human chorionic gonadotropin prefilled pen: results of patient and nurse human factors usability testing

Expert Opinion on Drug Delivery ◽

10.1517/17425247.2012.698607 ◽

2012 ◽

Vol 9 (8) ◽

pp. 893-900 ◽

Cited By ~ 3

Author(s):

Helen Saunders ◽

Joan C Schertz ◽

Clara Hecker ◽

Barbara Lang ◽

Pablo Arriagada

Keyword(s):

Human Factors ◽

Chorionic Gonadotropin ◽

Human Chorionic Gonadotropin ◽

Usability Testing

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Clinical Actual Use Human Factors Testing

Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care ◽

10.1177/2327857918071039 ◽

2018 ◽

Vol 7 (1) ◽

pp. 152-154

Author(s):

Shannon Clark ◽

P.E., Denise Forkey

Keyword(s):

Human Factors ◽

Best Practice ◽

Usability Testing ◽

Clinical Testing ◽

Medical Products ◽

Practice Recommendations ◽

Actual Use ◽

Guidance Documents ◽

Time Savings ◽

Validation Testing

Due to perceived cost and time savings, medical device and combination product manufacturers frequently consider the option to combine human factors testing with clinical studies. There are some scenarios in which human factors and clinical testing of medical products can be combined to save time and resources. While guidance documents published by the Food and Drug Administration (FDA) emphasize that most human factors validation testing can fully evaluate use-related safety via simulated use usability testing, there are some cases in which clinical actual use usability testing is needed to fully evaluate use-related safety. This paper suggests synergies between clinical testing and human factors testing, presents challenges faced by human factors practitioners when the two types of testing are combined, and offers best practice recommendations to maximize the chance of successfully evaluating the human factors endpoints.

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