Presentation
Integrating Human Factors Feedback into Clinical Studies: A Case Study of the Port Delivery System with Ranibizumab and Novel Laser Application
SessionPoster Session 1
DescriptionTraditionally, clinical studies and human factors (HF) activities in the development of combination products and medical devices are carried out as distinct efforts. However, adapting HF tools for integration into clinical studies offers a valuable opportunity to gather user feedback during early investigational phases, particularly for novel devices or techniques. By embedding these activities, teams can drive iterative improvements in device usability and adoption, optimizing both clinical outcomes and development efficiency through a more cohesive approach.
This presentation will showcase a case study on embedding continuous user feedback into a clinical study involving a complex system of devices. The clinical study evaluated an alternative surgical approach for Genentech’s Port Delivery System (PDS) with ranibizumab implant, incorporating a novel application of the Iridex laser system for transscleral pars plana ablation. This innovative technique holds potential to streamline the PDS implantation procedure, reducing surgical complexity while maintaining efficacy.1
To capture real-world insights, user interviews with retinal surgeons were conducted immediately after use of the devices in the clinical study. Facilitated by human factors engineers alongside clinical study representatives, these interviews identified critical technique modifications and usability challenges. The findings significantly influenced subsequent iterations of the IFU, optimized clinical training materials, and contributed to procedural refinements for future studies.
This case study highlights the value of integrating human factors practices into clinical studies. Attendees will leave with actionable insights into how user feedback can bridge clinical and HF activities, drive continuous innovation, and improve device usability during early investigational stages.
1Shelton A, Schutten M, Fuji RN, Boyd R, Stevenson V, Leahy M, Knupp L, Lieng J, Thompson D, Tam T, LaMarche K, Barteselli G, Malhotra V, Bantseev V. TRANSSCLERAL PARS PLANA CHOROID ABLATION USING THE IRIDEX LASER SYSTEM YIELDS IMPROVEMENTS FOR SURGICAL INSERTION OF THE PORT DELIVERY IMPLANT IN A MINIPIG MODEL. Retina. 2025 May 1;45(5):996-1005. doi: 10.1097/IAE.0000000000004385. PMID: 39778117.
This presentation will showcase a case study on embedding continuous user feedback into a clinical study involving a complex system of devices. The clinical study evaluated an alternative surgical approach for Genentech’s Port Delivery System (PDS) with ranibizumab implant, incorporating a novel application of the Iridex laser system for transscleral pars plana ablation. This innovative technique holds potential to streamline the PDS implantation procedure, reducing surgical complexity while maintaining efficacy.1
To capture real-world insights, user interviews with retinal surgeons were conducted immediately after use of the devices in the clinical study. Facilitated by human factors engineers alongside clinical study representatives, these interviews identified critical technique modifications and usability challenges. The findings significantly influenced subsequent iterations of the IFU, optimized clinical training materials, and contributed to procedural refinements for future studies.
This case study highlights the value of integrating human factors practices into clinical studies. Attendees will leave with actionable insights into how user feedback can bridge clinical and HF activities, drive continuous innovation, and improve device usability during early investigational stages.
1Shelton A, Schutten M, Fuji RN, Boyd R, Stevenson V, Leahy M, Knupp L, Lieng J, Thompson D, Tam T, LaMarche K, Barteselli G, Malhotra V, Bantseev V. TRANSSCLERAL PARS PLANA CHOROID ABLATION USING THE IRIDEX LASER SYSTEM YIELDS IMPROVEMENTS FOR SURGICAL INSERTION OF THE PORT DELIVERY IMPLANT IN A MINIPIG MODEL. Retina. 2025 May 1;45(5):996-1005. doi: 10.1097/IAE.0000000000004385. PMID: 39778117.
Event Type
Poster Presentation
TimeMonday, March 234:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices