WP8 System Integration and Benchmarking
The FUTURA platform is a complete highly complex, innovative robotic system. Considering the components that this platform comprises, e.g. robots, transducers, hardware connection interfaces, sensors, internal control mechanisms, and human communication interfaces, it is evident that designing and implementing such a system is a daunting task. Above all, integration of each component into a serviceable, high performance platform is a very critical and delicate task. The key to meet this goal is to choose an appropriate co-development methodology for the hardware and software components of the robotic system that will be developed in FUTURA. The aim of this WP is to develop and maintain, during the overall duration of the project, both software and hardware integration platforms which all partners can integrate with, based also on robot simulation. This last is essential to produce the various simulation/emulation modules that will be plugged into the
co-development structure until real components become available. To ensure that no incompatible development of different components occurs during the project, and to facilitate the integration phase, WP8 cannot be restricted to the final stages of the project. Development of preliminary prototypes will help to define the system integration process step by step and extensive set of bench tests will be performed with each sub-module of the platform before integration. These results will be used as reference for the bench testing, after integration, of the overall platform. The test-benching of different sub-modules (e.g., the custom transducer with the robot-patient interface) is expected to considerably reduce the time for the final integration, thus speeding-up the testing of the whole system. After integration and testing has been carried out
and a first version of the system is available, scenario-based experiments and benchmarking protocols will be carried out as defined in Task 8.3.
Within WP8, all the medical constraints must also be considered, e.g. safety issues and biocompatibility and both robotic and medical standard safety protocols and certification have to be taken into account for the overall duration of the project.
DESCRIPTION OF WORK
T8.1 Hardware and Software co-development and simulation - Primary goal of Task 8.1 is to choose an appropriate co-development methodology for hardware and software components of the robotic platform. In order to avoid incompatible development both for hardware and software components among partner it will be of high importance to develop an integrated platform since from the initial stage of the project. To reach this aim, preliminary prototype of platform components will be bench test before the integration and some simulation and emulation software will be exploited to be plugged in the co-development structure until real components become available. The integration and test of the system as a whole will be started whenever all platform components reach a certain development stage. Overall robotic platform will be simulated in a virtual scenario before real integration, by embedding software developed in WP3, collision avoidance and obstacle perception
algorithms, and control strategies from WP4 and WP5.
The possibility of integrating medical simulation software, both diagnostic and therapeutic, will be evaluated during this Task by medical/cognitive Partners.
T8.2 Experiments and benchmarking protocols - Verification and benchmarking experiments will be performed at stages throughout the project. The first phase will be devoted to data collection, while final months will be addressed to experiments. This Task will allow all partners sharing, reporting and analyzing results and data from across the project, thus enabling closer coordination of work and objectives. Similarly, benchmarking experiments will be required to evaluate the final output of the project and demonstrate the usefulness of the developments platform. Task 8.2 will thus define these essential benchmarking steps and scenarios to be used both on individual components and on the integrated system. Clinical targets for the FUTURA platform will be in three phases:
- benign tumors in non moving organs: Uterine Fibroma/Myoma and breast fibroadenoma;
- static solid tumors with easy acoustical path: bone tumors (mostly metastasis), lymphomas, pancreas;
- solid malignant tumors in moving organs: liver, kidney.
Benchmarking will cover:
- the targeting accuracy on static targets, the feedback control on volume ablation on in-vitro phantom and then on perfused organs;
- the targeting accuracy, motion detection and compensation and tracking ability of the device on moving organs both on in-vitro phantoms and then perfused organs.
The FUTURA system and components will be compared to MRgFUS ExAblate and robotic positioning by INNOMOTION (IBSMM). The benchmark criteria will include mainly target precision and accuracy of the focal spot of the applications listed before. Other criteria will be assessment of safety and time required for each procedure. The efficacy and user ergonomics by analyzing, modeling and simulation of the work flow will also be considered. Equal and better performance of FUTURA will be seen as a success. The results will be quantified where possible. The work will be done according to ISO 13485 Quality management system at IMSaT under the WP leadership of IBSMM.
T8.3 Validation of safety standards and procedures - Verification of the standard safety protocol either in medical al robotic field are essential step for the development of FUTURA platform. Both IBSMM and UNIVDUN are working according to ISO 13485 QMS standards to assure that the FUTURA system is prepared for regulatory approval and first in human clinical trial. These protocols had to be taken into account for the overall duration of the project.