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Aquablation System 
Aquablation Setup.PNG
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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. 
Industry: Medical Device 
  • Surgical robot
  • Ablation system 
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Services Provided: 
  • UE strategy and documentation (UE Plan, SOP, and reports) 
  • IEC 62366-1 audit 
  • Gap analysis 
  • uFMEA 
  • Formative study 
Procept BioRobotics is a surgical robotics company in San Jose, California that develops innovative urology solutions. They are the manufacturers of the AQUABEAM Robotic System, which treats benign prostatic hyperplasia (BPH) in males suffering from lower urinary tract symptoms (LUTS). The system does so by using a combination of cystoscopic and ultrasound imaging with a high-velocity waterjet precisely controlled by automated robotic technology. Procept’s system is in fact the first and only image-guided, heat-free robotic therapy for the rapid removal of prostate tissue.  
Procept's New HQ in San Jose, CA
Procept initially sought to partner with our team for help developing a UE Standard Operation Procedure (SOP) to integrate into their quality system. It was important that their procedures and templates aligned with IEC 62366-1 as well as FDA expectations, so we conducted a gap analysis and an audit of their existing usability documents. This culminated in the UE SOP, which we drafted and then helped finalize.  
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Procept also requested our support in developing the UE plan for their P1-G3 (Platform 1 – Generation 3) system, which was an updated version of the Platform 1 AQUABEAM System on the market at the time. To scope the usability activities needed to improve and eventually validate the system, we conducted another gap analysis of the usability documents for P1-G3 and reviewed the documentation and use-related complaint data from Platform 1.
Once we had drafted and finalized the UE plan in collaboration with Procept, we led the risk management efforts, which resulted in a UFMEA (use failure modes and effects analysis). This UFMEA indicated that the P1-G3 system did not require HF validation, but that a formative study to evaluate the impact of new GUI feature enhancements was warranted.   
Our team later conducted this formative study at the Procept global sales meeting in Atlanta, GA. We developed a protocol and moderator’s guide while Procept recruited six urologists. We collected feedback on the overall system architecture, GUI, and industrial design (including the surgical drapes) of P1-G3, all of which had been improved from Generation 1. This data was analyzed by our team before we prepared a formative test report in a format suitable for FDA submission.  
LHF team members discussing study findings to prepare for the report
One of the feature enhancements made to the P1-G3 GUI evaluated in the study
Our team also developed the HF/UE report for P1-G3, summarizing the usability activities conducted for the system, which included reviewing all the early-stage generative research Procept had done before we were contracted.   
The P1-G3 system was made available for commercial use by trained urologists and their surgical techs in 20XX.  
We had a great time working with Procept and enjoyed supporting their AQUABEAM usability improvements over the years. What started as a documentation and strategy consultation has grown into a true partnership as we continue to support other Procept projects.  
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