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

Abstract

Objectives: A redesigned pen injector for administration of follitropin alfa (follitropin α) has been developed for use in fertility treatment cycles. Pre-summative and summative usability testing was undertaken to assess the risk of dosing errors compared with the existing follitropin α pen. The study also assessed proper use of and dose selection with the redesigned pen.

Methods: Infertile women who were trying to conceive and specialist nurses were recruited from four cities in Germany. Usability goals relating to proper use of the pen device were defined from a risk assessment and further categorized as critical and functional operational goals. Individual, non-interventional, standardized, usability tests were performed with patients and nurses by four experienced research professionals using questionnaires that also included ease-of-use ratings. A non-standardized qualitative analysis of nurse–patient training sessions was performed in the presence of a research professional; reasons for confidence, safety, possible misunderstandings and risks when handling the pen were noted.

Results: The overall risk of dosing errors with the redesigned pen was not higher than with the existing pen. No unexpected operational risks and no major concerns regarding the risk of misuse or dosing errors were identified.

Conclusions: The study provides useful practical information on the redesigned pen from both patient and nurse perspectives.

Keywords:

• follitropin α
• human factors
• in vitro fertilization
• infertility
• injection device
• pen injector
• recombinant human follicle-stimulating hormone
• usability testing

Acknowledgements

The authors would like to thank M Christen (Merck Serono S.A., Geneva, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany) for conducting the risk assessment review, and for collaboration on the design and implementation of the pre-summative and summative usability testing, and M Hagen and M Beekmann for performing the nurse and patient interviews. They also thank J Davies, H Wills and C Kidd of Caudex Medical Ltd, Oxford, UK (supported by Merck Serono S.A., Geneva, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany), for their assistance in the preparation of this manuscript.

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