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Formative usability evaluation of a fixed-dose pen-injector platform device.

Jakob Lange1, Tobias Nemeth1

  • 1Ypsomed AG, Burgdorf, Switzerland.

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Summary

This study found a new fixed-dose pen injector safe and effective for self-administering biopharmaceuticals. Users, including novices, successfully used the device with clear instructions, highlighting its user-friendly design and feedback mechanisms.

Keywords:
FixPenhandling studyhuman-factor engineeringinstructions for usepen injectoruser error

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Area of Science:

  • Biopharmaceutical delivery devices
  • Human factors engineering
  • Usability testing

Background:

  • Formative usability study of a novel fixed-dose pen injector for subcutaneous biopharmaceutical delivery.
  • Focus on patient self-administration across diverse age groups and user experience levels.
  • Evaluation of device safety, effectiveness, and user feedback compared to a market-established benchmark injector.

Purpose of the Study:

  • Assess user ability to safely and effectively operate the pen injector using provided instructions for use (IFU).
  • Benchmark the new device against a competitor for usability and performance.
  • Identify and document usability issues and gather subjective user ratings.

Main Methods:

  • 20 participants, divided into three groups, reviewed the IFU.
  • Participants performed simulated subcutaneous injections using the pen injector device on an injection pad.

Main Results:

  • All participants successfully utilized the pen injector.
  • High user satisfaction reported, with over 90% positive scores for handling forces and device feedback.
  • 85% or more users rated device fit and grip favorably.
  • Audible and visible feedback mechanisms for dose loading and injection completion were noted as significant improvements.

Conclusions:

  • The pen injector platform and its IFU are suitable for safe and efficient use by all tested user groups.
  • Findings suggest the device and IFU are well-prepared for future summative usability testing in specific applications.