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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.
Medical Devices (Auckland, N.Z.)
|November 24, 2021
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.
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.
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