The MIRACLE structure combines horizontal activities (ethics, management, communication, dissemination, exploitation) and vertical activities (knowledge breakthrough, components development, prototyping, validation, demonstration, development of market strategies).
During the 36 months of MIRACLE project a substantial amount of effort has been devoted to:
• Kick-start the project and starting to address the main technical challenges by active communication among the clinical and technical teams.
• Put in place all the necessary project committees and management structure.
• Create a Project Quality Handbook establishing practical guidance to ensure high quality of project, which is regularly updated.
• Document all the technical requirements and specifications related to the clinical applicability of the medical device to be developed.
• Request the ethical approval.
• Develop the clinical protocols for the use of the device.
• Establish the visual identity of the project and the communication channels for project dissemination.
• Launch and update the MIRACLE website (
http://miracleproject.eu/(si apre in una nuova finestra)).
• Take part in relevant events to disseminate the project.
• Perfom Intellectual Properties Rights (IPR) analysis to ensure freedom of operate and patentablity of the results.
• Identify the relevant standards related to MIRACLE development.
Currently, MIRACLE project faces a 6 months delay in the technical development and subsequent tasks due to the COVID19 outbreak. Yet, the following achievements have been successfully delivered:
• Spectra from 150 samples (including bovine, equine and human tissues) were measured using MIR spectrometer and analysed allowing the consortium to identify together with the medical team the relevant spectrum peaks that are directly related to the assessment of cartilage quality.
• Tailored QCLs corresponding to the identified relevant clinical peaks were developed and the prototypes were delivered.
• Unforeseen QCL adaptors for facilitate effective coupling were designed and manufactured.
• Three different strategies for iBEAM combiner for efficient radiation coupling have been explored, prototyped and tested.
• Simulations on the MIR probe design according to the surgeon’s requirements have been performed and a decision on the two most promising designs was made.
• A hook shaped MIR test probe has been prototyped for the surgeons to test if the design is suitable for arthroscopy procedure, receiving positive feedback.
• A prototype for the MIR straight probe has been delivered for pre-validation studies and is now in optimization phase.
• 2 generations of the hook shaped ATR diamond probe were prototyped, tested and delivered.
• Unforeseen fiber loop probe is under development.
• The assembling of the main unit system combining all the prototyped components was achieved.
• Pre-validation studies (i.e. establish correlation between the relevant clinical wavenumbers and OA grading) have been performed using three different commercial MIR spectrometers.
• A systematic study was performed using bovine samples (72 samples) with controlled mechanical or enzymatic degradation (something that cannot be achieved with human samples).
• Pre-validation studies have been delivered including 377 human samples and 242+648 equine samples.
• First version for the end user software is implemented in the main unit.
