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Formative Study on the Wearability and Usability of a Large-Volume Patch Injector.

Jakob Lange1, Andreas Schneider1, Christoph Jordi1

  • 1Ypsomed Delivery Systems, Ypsomed AG, Burgdorf, Switzerland.

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|November 24, 2021
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Summary

This study shows a novel 10 mL large-volume patch injector is user-friendly for subcutaneous biologic delivery. Patients and healthcare professionals found the device acceptable for self-administration.

Keywords:
bolus dosedrug deliverylarge-volume injectionmedical devicesself-medicationsubcutaneous injectionusability

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Area of Science:

  • Biotechnology
  • Drug Delivery Systems
  • Medical Device Design

Background:

  • Subcutaneous self-administration of biologics requires novel large-volume patch injectors.
  • Usability and wearability of these on-body devices are underexplored.
  • A formative simulated use experiment evaluated a 10 mL large-volume patch injector platform.

Purpose of the Study:

  • To assess the handling and acceptability of a novel 10 mL large-volume patch injector.
  • To investigate user perceptions of the device's size and weight.
  • To evaluate the usability and wearability of the patch injector platform.

Main Methods:

  • Twenty-three participants (patients and healthcare professionals) simulated injections with the patch injector.
  • Participants performed predefined movements and activities during the 17-minute simulated injections.
  • Usability and wearability were assessed via observation and participant feedback (Likert scales, interviews).

Main Results:

  • All participants successfully completed the simulated injections.
  • Only minor, non-serious usability issues were identified.
  • High ratings were given for device acceptability, wearability, and usability.

Conclusions:

  • The novel prefilled large-volume patch injector facilitates safe and effective subcutaneous delivery of up to 10 mL biologics.
  • The device demonstrated successful use across diverse patient demographics.
  • The 15-minute injection duration was well-tolerated, suggesting suitability for self-administration.