Development and usability of a new subcutaneous auto-injector device to administer hydroxyprogesterone caproate to reduce the risk of recurrent preterm birth

Abstract

Background

Current administration of hydroxyprogesterone caproate (HPC) by intramuscular injection is associated with limitations, including the potential for human error and contamination, patient anxiety, and increased risk of needlestick injury.

Objective

To describe the design of an auto-injector for subcutaneous (SC) administration of HPC and the results of studies that evaluated the target user’s understanding of the proper use of this device.

Materials and methods

A single-use, prefilled, fixed-dose, disposable auto-injector intended for the SC administration of HPC was developed, and its usability by health care providers was evaluated in 3 formative (N=32, 64 injections) and 3 validation studies (N=45, 90 injections). These studies consisted of one-on-one testing sessions performed in a simulated home environment. Analyses were based on observed use error or use difficulty during the performance of specific tasks, including those considered critical (associated with high severity harms).

Results

In the formative studies, the majority of participants correctly administered an injection with the auto-injector, but prior training improved performance. Specific errors were noted, including holding the device at the injection site for a period inconsistent with its instructions for use (IFU). The IFU was modified to reduce potential occurrence of these errors. Use errors were subsequently observed on critical tasks in the first and second validation studies, including hold-time errors that were attributed to using visual cues rather than counting seconds. For the third validation study, the IFU was modified to focus on visual cues and all users were able to successfully perform the injection per the IFU.

Conclusion

An auto-injector device for SC administration of HPC for reduction in risk of recurrent preterm birth was successfully developed through iterative design and validation testing. The device design provides high usability and acceptance of this device by health care professionals.

Keywords:

• hydroxyprogesterone caproate
• 17P
• auto-injector
• subcutaneous injection
• usability
• human factors
• combination device

Acknowledgments

All studies described in this report were funded by AMAG Pharmaceuticals, Inc. Under the direction of the authors, E Jay Bienen, PhD, of The Curry Rockefeller Group, LLC, provided editorial assistance, which was funded by AMAG Pharmaceuticals, Inc.

Disclosure

MNT is employed by Antares Pharma, which designed the Makena auto-injector tested in these human factors studies. BC is employed by Design Science, which conducted the human factors testing on this drug-device combination product. MJJ and KBH are employed by AMAG Pharmaceuticals, Inc., which markets Makena (hydroxyprogesterone caproate injection), and WSS was an employee of AMAG at the time of the study. The authors report no other conflicts of interest in this work.