Case Study Spotlight
Aquablation System
with Procept BioRobotics
Since 2018, LHF has provided Human Factors support to Procept BioRobotics on their AQUABEAM Robotic system. The system is the first and only image-guided, heat-free robotic therapy for the rapid removal of prostate tissue.
We developed a robust UE strategy, conducted a gap analysis of Procept's usability documents, and ensured their HF/UE SOP and other documents aligned with the requirements of IEC 62366-1. As part of the latter, our team drafted multiple reports to document Procept's usability efforts, ensuring they would meet the FDA's (USA) regulatory expectations. Later, we assisted with the UFMEA development process before conducting a formative study of their system.
The AQUABEAM system is now commercially used by urologists internationally, and we continue to support Procept BioRobotics with their ongoing HF needs.
Additional Case Studies
Due to NDAs and MSAs, LHF is not able to provide full case studies for every project we've completed. The following case studies may have generalized device or company information, stock pictures, and/or media of prior generation products to avoid revealing proprietary details.
Surgical Navigation App
with BoltNav
Services:
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Gap Analysis
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URRA
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UE Plan
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Formative & Summative Studies for Aseptic Presentation & Labeling Comprehension
Laser Vision Correction
with Zeiss
Services:
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Gap Analysis
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URRA
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UE Plan
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Formative & Summative Studies for Aseptic Presentation & Labeling Comprehension
Past Projects
Due to NDAs and MSAs, LHF is not able to provide full case studies for every project we've completed. However, you can find details about some of our projects that can be partially revealed below.
Ventilator
Vapotherm
Services:
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URRA development and refinement
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Formative study
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Protocol development
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Study execution
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Data analysis & reporting
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Blood Gas Analyzer
Siemens Healthineers
Services:
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URRA refinement
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Known Problems Analysis
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Summative study
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Protocol development
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Study execution
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Data analysis & reporting
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Robotic Surgical System
Vicarious Surgical
Services:
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3 formative studies to evaluate multiple early-stage designs
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Protocol development
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Study execution
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Data analysis and reporting
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Cervical Surgery Device
Cognito Therapeutics
Services:
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Formative study
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Protocol development
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Study execution
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Data analysis & reporting
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Sound System
Sonos
Services:
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Benchmark evaluation study of two designs from multiple user groups
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User feedback analysis
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Report
Autonomous Robo-Taxi
Motional
Services:
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Protocol development and execution of a hardware testing study
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User research study
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Data analysis and reporting
RFID Localization System
Hologic
Services:
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Summative study to evaluate design changes to an FDA-approved system (re-validation
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Protocol development
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Study execution
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Data analysis & reporting
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Drug Delivery Device
AcelRx Pharmaceuticals
Services:
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HF/UE report
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Summative study
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Protocol development
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Study execution
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Data analysis & reporting
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