Abstract: PUB061
Formative Usability Evaluation of Moda-Flx Gen 2, a New Hemodiafiltration System
Session Information
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- D'Alessandri-Silva, Cynthia J., Diality, Inc, Irvine, California, United States
- Hoang, Caryn, Diality, Inc, Irvine, California, United States
- Hyun, Nicholas, Diality, Inc, Irvine, California, United States
Background
Moda-Flx Next Gen is being developed for hemodialysis (HD) and hemodiafiltration (HDF) via workflows intended to align with real-world practice. Consistent with consensus guidelines, formative usability evaluations help identify use-related risks analysis (URRA) and opportunities to improve workflow intuitiveness, reduce user burden, and support safe care delivery. This study evaluated if intended users could complete essential and critical tasks without formal training.
Methods
A simulated-use formative usability study conducted on 6 participants: dialysis nurse (n=2), clinical training (n=2), engineer (n=1) and marketer (n=1). All completed HD and HDF workflows (n=14) in the sequence expected during clinical care without prior device training. Participants worked independently on 86 critical tasks and 71 non-critical. All scenarios and associated tasks were able to be completed within 2 hours and scored Pass, Fail, or Close Call. MAUDE database review with product codes KDI (Dialyzer, High Permeability With or Without Sealed Dialysate System), ONW (Hemodialysis System for Home Use), FIP (Water Purification System), and FKJ (Filter, Blood Dialysis) from December 1, 2009 to April 1, 2026 to inform URRA and clinical use scenarios. Critical tasks were defined by the URRA.
Results
Of n= 157 tasks in n= 14 workflows there was 98% completion, without training. Multiple workflows achieved 100% success: UF and heparin pause, treatment parameter locking, rinseback procedures, treatment completion, HDF mode modification, and manual rinseback. HD initiation achieved a 98% success rate, with isolated failures related to dialysate line connections and hardware setup steps. HDF initiation achieved a 97% success rate, with isolated failures during substitution line connection.
Close calls were associated with confirmation steps, hardware connections, and parameter verification over core workflow navigation. Root cause analyses identified opportunities to improve visual differentiation, connector identification, workflow guidance, and interface prompts.
Conclusion
Moda-Flx Gen 2 system demonstrated strong usability with anticipated clinical workflows under simulated-use conditions. Findings support intuitive workflow and may reduce initial training burden and associated onboarding time. Gen 2 may further improve workflow clarity, reduce user burden, and enhance the user experience through human-centered design refinement.