Workpackage 1 : Project management and Quality assurance
The major objective of this WP will be to guarantee the successful realization and conclusion of the project including the project administration and control, risk management, problem handling and quality assurance on management levels. This WP makes sure, that the project runs to budget, is on time and the expected results are achieved. This goal will be reached by ensuring the correct and efficient collaboration between partners.
Workpackage 2 : Clinical and End-user requirements
WP2 basically focuses on the analysis of requirements from the point of view of patients and medical staff as well as on the current clinical practices’ shortcomings. This analysis will involve the requirements on i/ the patient’s monitoring; ii/ the clinical personnel’s practices of leg ulcer monitoring, decision and therapy and iii/ long-term monitoring and treatments of leg ulcer (construction of an administrative database based on a statistical analysis). Furthermore, WP2 will plan the validation performed in WP8.
Workpackage 3 : Complete system design
This WP aims to design the wound care product and the overall system in terms of architecture, size, spatial location of components, fluids management, power management and computing power for efficient data processing and device control, interconnections and interfaces. In this WP, User scenarios will be developed to drive the complete design and outline the technical requirements. All SWAN-iCARE components addressed in WP4, 5 and 6 as well as cartridge, interface materials, pump and battery will be designed in this WP.
Workpackage 4 : Development and/or selection of micro-sensors and micro-actuators
WP4 aims to deliver the micro-sensors and micro-actuators to be integrated into the SNPD and the stationary and ambulatory sensors complementary to the SNPD to monitor the parameters out of the wound. WP4 will be based on the specifications provided by WP2 and WP3. The most suitable technical approaches (colorimetric, electrochemical, electrical, optical sensors and actuators releasing bioactive molecules) will be developed and tested. The sensors will be evaluated in terms of performance, user-friendliness, costs and if needed, manufacturability.
Workpackage 5: Electronics, wireless connectivity developments and component integration
WP5 involves the development of the electronic boards. To limit the number of PCBs and so the risk of noise or ground loops, all sensors will be integrated into two boards, one for the sensors located outside of the SNPD and one for sensors inside the SNPD. A third board will contain the back-end electronics including the wireless communication module. A low power microcontroller will be used to collect the data from the sensors through a multi-channel analog to digital converter or digital interface, to control the actuators and will embed signal processing according to the needs. The user interface integrated in the SNPD will be simple since a complete GUI will be developed on the Smartphone. Finally, a secondary battery and power management strategy will be developed in order to reach the autonomy acceptable for the current application.
Workpackage 6 : Development of embedded software and wound healing applications
The first Activity in this WP6 will be the development of the embedded software framework. The work will consist of developing data fusion algorithms, SNPD Operating System and user application.
The second Activity will be the development of the patient’s application to interact with the SWAN-iCARE system and the development of the remote wound care clinical applications (decision support system, SWAN-iCARE Electronic Health Record and Clinical Workflows, administration application).
Workpackage 7 : System integration and prototyping
In this WP, all components (microsensors, microactuators, electronic parts, pump, battery) will be integrated into the smart cartridge and the smart disposable interface. ICT components (early prototypes) and a final wound care product prototype containing all ICT components will be manufactured and tested during in vitro assays (see WP9). Furthermore, the impact of sterilization on interface parts will be studied.
Finally, this WP will assemble the overall SWAN-iCARE system, including, the lab-scale version of the SNPD will developed in WP6 and the ICT tools at the care system level from WP7. A closed loop under human decision (manual closed loop) will be integrated.
Workpackage 8 : Verification and clinical validation
Iterative verification and validation of the prototypes will be carried out during the whole of the project, starting with single parts evaluation to in vitro tests and in vivo tests and evaluated in terms of sustainability and performances feeding back to further development if required. Furthermore, the final prototype will be by in vivo tests on patients under the guidelines of clinician’s and following ethical and certification protocols. Physicians and patients will be trained in this WP.
Workpackage 9 : Dissemination and exploitation
The impact on European economy is guaranteed by the planning and management of exploitation, the dissemination and the follow-up activities. Results will be made available to the research community and industry to let this technology take off, in the course of the project new areas for research and development will be identified. Moreover, this WP promotes project results dissemination and relationships with other EU and non-EU projects and creates appropriate liaisons with external bodies.
The SWAN-iCare system has been validated for its end to end connectivity in the five days meeting in Athens 8-12 May 2016