Enabled by the RTO grant from UK Edge Innovate UK Business Growth, Health Tech Enterprise has collaborated with the team at Capa Valve to carry out a rigorous usability study to evaluate how intended users interacted with two versions of the Capa Valve PFS-LS-RD (Pre-Filled-Syringe, Liquid Solid, Reconstitution & Delivery) syringe. The data from the study would be used to further refine the design of the device and prove its utility as an alternative solution for drug delivery.
The Challenge
The traditional preparation of medications requiring reconstitution is often a multi-step, cumbersome process involving multiple vials, syringes, and needles. This complexity in preparation introduces several clinical risks such as contamination, dosing errors and even injury. The team at Capa Valve have developed an innovative two stage pre-filled syringe technology, designed specifically for safe, effective and rapid drug reconstitution and delivery. As a new technology looking to provide an alternative to a well-established approach, good quality usability data is vital to establish its validity.
Our Approach
HTE conducted a rigorous usability study of behalf of the Capa Valve team, working with them to agree the target user groups, clinical scenarios on test and the methodology of assessment.
Target User Groups: The study involved both community health nurses (Vaccine Study) and hospital-based neonatal nurses (Antibiotic Study). Two independent sites were chosen for the assessment.
Clinical Scenarios: Participants performed step-by-step simulations reflecting real-world preparation procedures of an analogue vaccine (Priorix MMR) and analogue antibiotics (such as benzylpenicillin). These were done in comparison with the same preparation completed with the PFS-LS-RD.
Methodology: The team assessed participant performance against a task analysis grid, specifically tracking “Successes,” “Close Calls,” “Use Difficulties,” and “Use Errors”. All interactions with the Capa Valve device and the analogue kits were video recorded for review and questions sets used to obtain qualitative data.
The Outcomes
The study achieved all its objectives, providing critical insights into the device’s performance with intended users, verifying satisfaction with the device and identifying clear pathways for further design optimization. Some of the key positives were:
- The highly intuitive design, all participants could interact with the device without overreliance on the instructions for use,
- The reduced waste and less cluttered work environment, with nurses praising the all-in-one nature of the device.
- Increased safety, removing the need for recapping or removal of syringe needles as part of the reconstitution process reduces the risk of needle stick injuries and the all-in-one style of the device removes dilution and preparation error.
- A common human interaction error was identified in the study enabling a simple design change at an early stage
The Impact
By identifying these “real-world” use errors early in the development cycle, HTE enabled the Capa Valve team to focus on high-impact refinements of the device. The study confirmed that the device significantly reduces the risk of needle-stick injuries and contamination, positioning it as a safer, more efficient alternative to standard manual reconstitution kits.
The work completed by Health tech Enterprise was comprehensive and thorough. The detailed report we received confirmed some of the things we already suspected and gave us a clear steer on some simple steps to improve our product. The process has been really valuable, and we will be seeking to do more usability testing on our other designs in the future. Kevin Abbott Managing Director Capa Valve.
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