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Aquablation System
With Procept BioRobotics
Since 2018, LHF has provided Human Factors support to Procept BioRobotics on their next generation robotic Aquablation system. Aquablation therapy is the first and only image-guided, heat-free robotic therapy for the rapid removal of prostate tissue.
Procept was looking for Human Factor experts who could help guide their strategy as they developed their usability processes for new product introductions. With our help, Procept created robust usability engineering processes and templates aligned with IEC 62366-1 and FDA regulations. Our relationship with the Head of Product Design at Procept goes back decades and has expanded to include support in the creation of Procept’s entire UE file from planning through validation.
Aquablation therapy is now commercially used by urologists internationally, and we continue to support Procept BioRobotics with their ongoing Human Factors needs.
Industry: Medical Device
Device:
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Surgical robot
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Ablation system
Services Provided:
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UE strategy and documentation (UE Plan, SOP, and reports)
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IEC 62366-1 audit
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Gap analysis
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User specification
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Task analysis, uFMEA, and risk amangement
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Formative and summative studies
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HF/UE Report for the FDA
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 HQ in San Jose, CA
As part of a long-term strategic partnership, Procept sought to partner with our team to help develop Usability Engineering processes and templates starting with their 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.
PROCEPT BioRobotics's very first patients treated with Aquablation delivered through HYDROS at UNC Health Pardee
Rahul Mehan performing his first Aquablation case with HYDROS at Dignity Health
The partnership with Procept continued with the usability engineering activities needed during the development of their HYDROS system. Together, we helped them plot a course of action for the entire UE process as documented in a UE Plan. The project work continued with Use Specifications, task analyses, risk documents, test planning and reporting. We supported their multiple formative and summative studies including protocols, facilitation, root cause and residual risk analyses and FDA reporting.
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
The Hydros Robotic System launched mid-2024 to delighted hospitals and urologists. According to Mark Baerenrodt, Head of Product and responsible for usability at Procept, the partnership with our team was “wildly successful” citing zero FDA issues with the UE submission.
We’ve had a great time working with Procept and enjoyed supporting their usability improvements over the years and launch of HYDROS. What started as a documentation and strategy consultation has grown into a true partnership as we continue to collaborate on new Procept projects and support their Human Factors efforts.
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