This initial phase, conducted from (April 1st 2015 to Sept. 30th 2015) enabled to transition from a TRL 4 to a TRL 6 thanks to technical feasibility assessment, which consisted of scaling-up the technology by demonstrating the prototype in a relevant preclinical environment, and to establish and validate a pre-industrialized device for clinical trials.
Pre-clinical tests: The first action was to demonstrate the technology in a relevant preclinical environment. The TRL 4 imagery prototype has then been tested through preclinical tests: first, images of a large variety of skin diseases have been performed thanks to collaborations with histopathology laboratories and allowed calibrating the technology (TRL 5). Then, the prototype has been applied on several human skin tumors, in particular basal-cell carcinoma and melanoma (TRL 6). After the clinical examination, the tumor was removed by the dermatologist and immediately imaged to keep the in vivo structure of the tissue. Those tests have been carried out in close collaboration with the Dermatology Department of Saint-Étienne Hospital, which is a French leader of non-invasive dermatological imaging research. This preclinical demonstration allowed to periodically adjust the technical developments on more tangible clinical criteria in order to converge towards an optimized technology according to the dermatologists’ feedback.
Feasibility study: The second action was to carry out a conception and industrialization feasibility study. From the general functional decomposition of the DERMAE medical device, we defined 13 essential functions which were then translated into 12 use-cases in order to specify the technical requirements in the design of the device. Then, the regulatory framework (EU directive and standards) of the project has been analyzed to define the performance and safety requirements of developing a medical device.
Design and development of prototype: The third action was to design and develop a prototype of the pre-industrialized device by taking into account all the constraints and requirements defined in the previous feasibility study. Here is the specification we have made: the device was designed as a microscope which can be rotated as required from vertical to horizontal position.
• In vertical mode, it can be used on biological tissue samples (ex vivo) or for small animals imaging (in vivo) for the study of skin pathologies in situ during preclinical research in the cosmetic or pharmaceutic industry.
• In horizontal mode, it can be used on patients (in vivo) for the non-invasive study of skin lesions during dermatology clinical trials.
First, a design study has been carried out, including in the conception the aesthetic creation of the device and the design of the protective housing in which the optical technology will be integrated, and its support. Then, a mechanical feasibility study has been performed to define the technical solutions for providing an ergonomic kinematics for the moving parts: the rotation, the translation and the precise setting of the optical unit.
Finally, an industrialization feasibility study has been made to anticipate the industrialization and large-scale production issues from the conception. For example, an analysis of the volume of the future series and the cost structures of the device allowed to define the most relevant materials and manufacturing tools and processes to use. After having achieved those studies, a prototype of the pre-industrialized device has been developed, validated and manufactured.
Market evaluation: In addition, a feasibility study of market access strategy has also been carried out. This market study consisted of identifying and interviewing worldwide key opinion leaders (Europe, USA & APAC) to challenge the targeted markets specificity and to analyze competitors’ business model, clinical development strategy and outcomes. This study has confirmed the complete relevance of the DERMAE intended market and the economic viability of the innovation.
