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Spinal Navigation System
Navigation System for Spinal Surgery
with Bolt
From 2020 to 2021, LHF provided complete human factors support to a start up device company called Bolt® Navigation (Bolt). From HF strategy and risk documentation to IFU design and usability testing, our team provided it all for Bolt’s one-of-a-kind spinal navigation system for the placement of pedicle screws. With our help, Bolt was able to develop a safe and usable system that improves accuracy and efficiency for surgeons and the surgical staff. The Bolt Navigation System received FDA market approval in December 2023.
Industry: Medical Device
Device:
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Software as a Medical Device (SaMD)
Services Provided:
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UE strategy and documentation (UE Plan, Use Specification, and UI Requirements)
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Task Analysis
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Workshop on UFMEA & Risk Management
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UFMEA Development
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Pre-Formative Contextual Use Interviews
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Formative Usability Evaluation
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IFU Design and Development
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Summative Usability Evaluation
In early 2020, Bolt approached LHF seeking human factors support for an innovative surgical navigation system called the Bolt Navigation System. The system was designed by an spine surgeon who saw the need for a more efficient method for accurately placing fixation devices in the spine. The Bolt system’s main component is a program (app) that runs on a standard iOS (Apple®) device. This was in stark contrast to the much larger CT-based navigation solutions on the market, which many hospitals can’t afford. The Bolt system enables surgeons to take pre-operative images of each level of the spine to be operated on, plan implant placement on these images and then leveraging the system’s gyroscope technology, allow for accurate visualization guidance for the placement of pedicle screws.
The Bolt Navigation System in use at posterior fusion procedures.
While innovative and exciting, the initial version of the app was early in its development, lacked a comprehensive set of user interface requirements, and user interface and experience issues that the company sought to iron out. As a start-up company they also required assistance developing their design history file (DHF) and risk management file (RMF). As part of our collaboration on the program, our team (in conjunction with Sunrise Labs) provided the expertise necessary for Bolt’s success.
This included performing a comprehensive task and use-related risk analysis to better understand and document the expected workflow and identify potential safety issues associated with using Bolt. In addition, we authored all the relevant documentation for Bolt’s usability engineering file (a subset of the DHF).
We then embarked on an iterative evaluation process, conducting contextual interviews and voice-of-the-customer (VOC) feedback sessions with surgeons in the EU to gather design inputs and further refine the user interface requirements.
As higher fidelity prototypes became available during the height of the COVID-19 pandemic, we coordinated and conducted a formative usability evaluation with U.S. and EU-based surgeons, leveraging a remote platform. Due to the digital nature of the user experience, the team was fortunate to obtain rich sets of data, which led to additional recommendations for design refinement and usability/safety mitigations.
As Bolt’s partner throughout the development process, LHF also participated in multiple design brainstorm sessions and created GUI mockups to explore potential solutions aimed at addressing the usability findings.
Two sequential mock-ups our team developed as we explored the best method to address a usability concern found in the formative study
Once the system included the modifications based on this feedback, LHF coordinated and moderated the summative HF validation study, which was conducted with a mix of neurosurgeons and orthopedic surgeons who received training in a saw bones lab then performed simulated use in a cadaver lab. An added benefit of conducting the validation with cadavers was that it enabled Bolt to obtain accuracy data that was used in the 510(k) submission.
We later assisted Bolt with their final regulatory submission, summarizing the human factors efforts conducted throughout the robust development process, and presenting the final validation data in the FDA’s desired format.
In December 2023, we were thrilled when Bolt announced it had received FDA approval for its thesystem to be used commercially on the U.S. market. The first U.S. procedure with the Bolt system was conducted shortly afterwards. Since then, Bolt has been recognized at various events and conferences, and was acknowledged as one of the “Future Stars of Spine 2023” in December 2023. We look forward to seeing how much more BoltNav and their system has to offer to the medical field.
Another procedure completed with the Bolt Navigation System
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