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Quantifying Patient Capabilities and Setting the Stage for Future Development: Insights from a Sensor-Augmented

Jakob Lange1, Andreas E Schneider1, Christoph Jordi1

  • 1Ypsomed AG, Burgdorf, Switzerland.

Medical Devices (Auckland, N.Z.)
|August 5, 2024
PubMed
Summary

Sensor-augmented studies quantified user handling forces for pen injectors. Results show force exertion varies with user dexterity and device design, informing future self-injection device development.

Keywords:
force sensorhandling forcepen injectorsimulated usesubcutaneous drug deliverytorque sensoruser capabilityuser impairment

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Area of Science:

  • Biomedical Engineering
  • Human Factors Engineering
  • Medical Device Design

Background:

  • Traditional usability testing may not fully capture user limitations in device interaction.
  • Understanding user force capabilities is crucial for safe and effective self-injection devices.

Purpose of the Study:

  • To quantify user handling forces during pen injector use.
  • To investigate the impact of user characteristics and device geometry on force exertion.

Main Methods:

  • 46 participants (healthy and dexterity-impaired) performed simulated pen injector handling tasks.
  • Non-functional devices with force/torque sensors were used.
  • Participants applied comfortable and maximum forces for each step.

Main Results:

  • Significant differences in comfortable and maximum forces were observed between healthy and impaired groups.
  • Force exertion decreased with age and increased dexterity impairment.
  • Applied forces were influenced by device geometry and grip.

Conclusions:

  • Sensor-augmented simulated use studies provide quantitative data on user force capabilities.
  • Findings inform performance requirements for improved self-injection device design.
  • This research supports the advancement of user-centered injection devices.