US human factors engineering evaluation of an updated follitropin alfa pen injector (GONAL-f® RFF Redi-ject®) and instructions for use

ABSTRACT

Objectives: The multi-dose, pre-filled GONAL-f® RFF Redi-ject® (follitropin alfa injection) pen injector was updated following feedback on user experience and pen functionality, as part of a continuous assessment program. Human-factors engineering (HFE) evaluations were conducted to confirm that the updated pen injector could be used by intended users to safely and effectively perform critical tasks identified by the risk-management plan.

Methods: Five rounds of formative evaluation and a simulated-use summative evaluation of the pen injector, instructions for use (IFU), and training video were conducted by HFE specialists or the intended users of the pen injector.

Results: The IFU and training video were revised following formative evaluations. Summative evaluation of simulated-use involved 60 participants, each of whom performed six use-scenarios related to potential hazards, selected on the basis of the risk-management plan. Overall, participants found the pen injector easy to use and the IFU clear and effective.

Conclusions: Through an iterative process involving a series of HFE evaluations, modifications were made to the injection mechanism, the dose display, the IFU and the training video. Summative evaluation confirmed that the updated pen injector and associated user materials can be used safely and effectively to perform critical tasks identified through the risk-management plan.

KEYWORDS:

• Human factors engineering
• GONAL-f RFF Redi-ject
• follitropin alfa
• pen injector
• instructions for use
• usability testing

Acknowledgments

The authors would like to thank participants, investigators, co-investigators, and the study teams at each of the US fertility centers and at Merck KGaA, Darmstadt, Germany.

Declaration of interest

M Mahony is an employee of EMD Serono, Inc., Rockland, M USA, a business of Merck KGaA, Darmstadt, Germany. A Dwyer, R Barkume and A Strochlic are employees of UL-Wiklund (a UL LLC Company). F Jeannerot and T Studeli are employees of Merck, Coinsins, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discusses in the manuscript apart from those disclosed. Medical writing support in the preparation of this manuscript was provided by Alexander Jones and Steven Goodrick of in Science Communications, Springer Healthcare. This support was funded by Merck KGaA, Darmstadt, Germany. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This study was funded by Merck KGaA, Darmstadt, Germany.