"The best way to predict the future is to create it."

Peter Drucker

Workplan:

BiopsyPen methodology aims at meeting the three objectives set up in the project. Product development will be handled in WP2 to WP5 to converge on WP6 and be tested in WP7. Clinical and regulatory objectives will also be included in WP6 and WP7. Two demonstrators are planned to be developed within the project. All further research and development will be produced within WP2 to WP5, addressing the objectives for the involved technologies regarding the progress of the state-of-art described above. WP6 will take advantage of all outcomes released in the latter workpackages in order to be able to integrate all technologies and proceed with the assembly, packaging and manufacturing of demonstrators 1 and 2. Finally, WP7 will contribute to the assessment of the main features of BiopsyPen and to its marketing approval.

WP1 and WP8 – Management & Dissemination

WP1 leader: MedLumics;
WP8: MedLumics.
Partners involved: P1 to P7.

WP1 will be dedicated to the management of the Consortium in support of the coordinator and the members of the Steering Committee. In WP8, dissemination activities will be developed in order to ensure the appropriate dissemination of project results and to define an exploitation plan of the project results, especially focused on the companies involved in the project

WP2 – Light Source

Leader: EXALOS.
Partners involved: P1, P2, P3.

Within WP2 new broadband and highpower SLED chips, suitable for hybrid flip-chip integration on silicon motherboards, will be developed. Furthermore, new ultracompact swept sources at 1300 nm with 20 kHz sweep rate and at least 5 mm imaging depth (10 mm coherence length) including credit card-sized drive electronics will be developed.

WP3 – Photonic Chip

Leader: VTT.
Partners involved: P1, P2, P3, P4, P7.

The aim of this work package will be the design of photonic chips, the fabrication and related process development for the passive waveguide circuits, the development of implanted heaters, current injection modulators and monolithically integrated photodiodes, and the testing of the fabricated chips. The final outcome of this workpackage will be fabricated and tested OCT chips.

WP4 – Mems actuators design and integration

Leader: TUD.
Partners involved: P1, P2 P3, P7.

The workpackage will focus on designing fabricating and testing 1D and 2D MEMS actuators for two new generation of OCT handheld BiopsyPen. Special attention in the design phase will be paid to system assembly (WP6) and to the integration capabilities of the newly develop actuators with the SOI photonic platform.

WP5- Signal and Image Processing

Leader UPM.
Partners involved: P1, P2.

The following issues will be developed: a) Image enhancement and analysis, b) B-scan reconstruction and c) Imaging system integration and validation.
Two versions of signal and image processing software one for each demonstrator will be released in this WP. Reduction in exploration time and image quality improvement to ensure better diagnostic capabilities.

WP6 – System Architecture , design and integration

Leader: MED.
Partners involved: P2 to P7.

This WP is the core of the proposal (together with WP7) as it will contribute to bring BiopsyPen device to real settings. Two demonstrators will be integrated and developed, with the second one relying on the inputs obtained with the former. A system validation plan will be designed and implemented. All electronics, firmware and software will be reading from the optical instrumentation; the design and manufacture of optical delivery system will be tackled together with assembly issues. The integration, manufacturing and verification of the all system as a whole will be the final outcome of this work package.

WP7 – Preclinical Validation

Leader: MUW.
Partners involved: P1 and P6.

The two new generations of handheld BiopsyPen will enable step-changes in performance of point-of-care dermatologic imaging. The detection of skincancer will be used as a surrogate for other epithelial cancers, e.g. oral cancer, colonoscopy and head and neck cancer. Closelinks with leading clinical users exist within the consortium, enabling preclinical validation in dermatology and oncology.