Human factors engineering and design validation for the redesigned follitropin alfa pen injection device

Abstract

Objectives: To demonstrate, using human factors engineering (HFE), that a redesigned, pre-filled, ready-to-use, pre-asembled follitropin alfa pen can be used to administer prescribed follitropin alfa doses safely and accurately.

Methods: A failure modes and effects analysis identified hazards and harms potentially caused by use errors; risk-control measures were implemented to ensure acceptable device use risk management. Participants were women with infertility, their significant others, and fertility nurse (FN) professionals. Preliminary testing included ‘Instructions for Use’ (IFU) and pre-validation studies. Validation studies used simulated injections in a representative use environment; participants received prior training on pen use.

Results: User performance in preliminary testing led to IFU revisions and a change to outer needle cap design to mitigate needle stick potential. In the first validation study (49 users, 343 simulated injections), in the FN group, one observed critical use error resulted in a device design modification and another in an IFU change. A second validation study tested the mitigation strategies; previously reported use errors were not repeated.

Conclusions: Through an iterative process involving a series of studies, modifications were made to the pen design and IFU. Simulated-use testing demonstrated that the redesigned pen can be used to administer follitropin alfa effectively and safely.

Keywords:

• failure modes and effects analysis
• follitropin alfa pen
• human factors engineering
• usability
• validation testing

Acknowledgments

The authors thank Jane Davies of Caudex Medical, Oxford, UK, and Michele Springer of Caudex Medical, New York, NY, USA (supported by EMD Serono, Inc., Rockland, MA, USA, a subsidiary of Merck KGaA, Darmstadt, Germany) for their assistance in the preparation of this manuscript, and Deborah Rice, RN and Gladys Lopez, RN for consultant advice on medical training practices and review of the Instructions for Use. The authors would also like to thank the following centers for recruiting participants to the study: Boston IVF, Waltham, MA, USA; Fertility Centers of Illinois, Chicago, IL, USA; San Diego Fertility Center, San Diego, CA, USA; and Texas Fertility Center, Austin, TX, USA.

Declaration of interest

MC Mahony, B Hayward, and D Green are employees of EMD Serono, Inc., Rockland, MA, USA (a subsidiary of Merck KGaA, Darmstadt, Germany). P Patterson is an employee of Agilis Consulting Group, LLC, Cave Creek, AZ, USA. R North is an employee of Human Centered Strategies, LLC, Colorado Springs, CO, USA. This study was sponsored by EMD Serono, Inc., Rockland, MA, USA, a subsidiary of Merck KGaA, Darmstadt, Germany. EMD Serono contracted with Agilis Consulting Group, LLC, who designed and performed the study, monitored and analyzed the data, and wrote the study report.

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