Project Management
Work Package 1

WP1 will survey and coordinate activities of the project, guarantee a smooth flow of information, develop and manage reporting strategies among project partners and towards the European Commission (EC). The Coordinator, ICFO, will be responsible for all coordinator core tasks including coordination of the interface between the project and the EC. EIBIR will be in charge of the overall project management including the daily management of work and logistics, provide meeting support and follow-up, ensure the observance of the project work plan, and monitor its implementation by following project management and quality control procedures. All deliverables and reports will mention the name(s) of its author(s). The results and work described in these documents will refer to the results of efforts pertaining to the project and any external sources will be properly referenced.

The overall WP1 objectives are to

• Monitor and coordinate the overall project progress and to ensure quality assessment and control of the project;
• Ensure the consortium internal communication process and communication towards the European Commission;
• Day-to-day administrative and logistics tasks, coordination of reporting procedures in close collaboration with all partners, budget management, financial monitoring, administration of payments, preparation of annual reports, and administration of contracts;
• Establish the management structure and organize meetings of the LUCA General Assembly, Steering Committee and Medical Advisory Board;
• Ensure IPR, data and publication policy management working with WP6 and WP7.

Development of components and sub-systems
Work Package 2

The objective of this WP is the development of innovative components and sub-systems to reach the clinically expected specifications (accuracy, precision) while being a low-cost system appropriate for point-of-care deployment. Specifically, it will develop: (i) two photonic sub-systems based on new light sources, detectors and micro-electronics, (ii) a software suite, (iii) the subsystem for integration with the ultrasound system, and, (iv) a joint optical and Ultrasound probe.

In more detail, WP2 aims to

• Develop sub-systems of light sources including lasers, drivers, housing and fiber coupling, sub-systems of photodetectors including photo-diodes, housing and fiber coupling, digital micro-electronics for time-to-digital convertors and other components for TRS that are cost-effective and robust;
• Develop sub-systems of light sources including lasers, drivers, housing and fiber coupling, sub-systems of photodetectors including photo-diodes, housing and fiber coupling and a hardware correlator for DCS that are cost-effective and robust;
• Develop an input/output module for integration into specific and general Ultrasound systems and to peripherals such as remote control unit.
• Develop an ultrasound probe with optical fibers in place;
• Develop a software-suite for control, display and communication;
• Develop a software-suite for data analysis with ultrasound priors.

Development of a demonstrator
Work Package 3

The objective of this WP is the development of a novel demonstrator that integrates the sub-systems developed in WP2 into a system that could be tested in the real-settings, i.e. in the clinics. It will focus on usability, medical standards, future commercial exploitation and industrial design concepts.

More specifically, WP3 will

• Integrate and adapt the TRS and DCS sub-systems for inclusion in an integrated device.
• Integrate the two optical sub-systems including the optical-ultrasound combined probe interface.
• Introduce the communication and integration of the optical system with the ultrasound system.
• Build the fully functional LUCA system

Ex vivo, phantom validation and standardization
Work Package 4

The main objective of WP 4 is to perform validation of the proposed components, sub-systems and the integrated “LUCA system” in laboratory settings following specific protocols for performance assessment.

The tasks of WP4 include

• The development and provision of TRS-DCS phantoms, optical-ultrasound phantoms;
• The validation of the operation and the performances of components;
• The validation of the operation and the performance of sub-systems;
• The validation of the operation and the performance of the integrated system.

Validation in real-settings
Work Package 5

The objective of this WP is to develop clinical protocols, obtain ethical approvals and test the demonstrator in real settings first, in terms of its usability and integration into the clinical and radiologist work-flow in the endocrinology unit for screening of the thyroid nodules, and then carry out a pilot study to demonstrate it on real healthy thyroid and on thyroids with nodules.

More specifically, WP5 will:

• Develop a clinical protocol to evaluate the potential of LUCA for the screening of thyroid nodules;
• Obtain ethical approvals for studies on both healthy subjects and subjects diagnosed with thyroid nodules;
• Test procedures, evaluate and provide feedback on the usability of LUCA and its potential integration into the clinical work-flow;
• Carry out a pilot feasibility study on healthy volunteers;
• Carry out a pilot feasibility study on a small group of subjects with thyroid nodules;
• Analyze data and assess of the future potential of LUCA from a clinical end-user viewpoint.

Dissemination
Work Package 6

The main objective of this WP is to develop and pursue the overall external project communication and dissemination activities to raise awareness of the project’s new innovative tools to be used in future and will demonstrate the benefits for all end-users. Input to this horizontal WP will be required from all scientific partners. It will promote wider acceptance of the proposed solutions by disseminating the results of the project by communication targeting the professional end-user communities, the appropriate public authorities, other relevant stakeholders as well as the general public.

The overall objectives of WP6 are to

• Develop and update the content of the LUCA website;
• Disseminate the results generated in LUCA, to reach the professional end-user communities in radiological and endocrinology specializations, public authorities and all the stakeholders to pave the way towards the up-take of the LUCA solution;
• Increase the awareness of the potential of solutions based on biophotonics in the health care sector;
• Increase the awareness of the general public on biomedical optics and its potential socio-economic impact;
• Provide educational outreach opportunities to promote the youth and the life-long learning participation in this area of research and development.

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Exploitation
Work Package 7

The main objective of the work package is to develop an exploitation strategy for the results of the project with the ultimate goal of facilitating the introduction into the market of the proposed solution. At the same time, efforts will be made in order to prepare the transfer of the project results into the real world for the advantage of all the actors of the LUCA consortium and ecosystem, encompassing final users, manufacturers and other players in the value chain, as well as all the stake-holders and citizens.

The tasks of WP7 are wide-ranging:

• Analysis of the market structure and identification of current and potential business models for the commercial exploitation of the LUCA solution, including investigations on the potential impact on the different roles in the value chain as well as on stake-holders;
• Identification of the IP related to the LUCA solution, define exploitation strategies and guidelines for consistent IPR management;
• Product and service profiling. The aim is to gather desired properties of the innovative solution to create feasible product(s) specification(s) and to demonstrate the technical, organizational and legal feasibility of the LUCA solution;
• Business strategy and exploitation plans. Analysis of the market and demand for the proposed solution, value and cost chains. The aim is to understand the existing market, the potential client base for the proposed solution, to identify the competitors and providers and formulate a strategy for a feasible marketing and business plan that takes into account acquisition of appropriate regulations from the intended countries.
• Enable and foster the up-take of the LUCA solution by appropriate standardization activities.