The project description is aimed at presenting, in form of abstract or executive summary, the context and medical need and the medical device project aimed at solving the detected need. For clarity purposes we propose developers to add also a representative image of the project concept from the very beginning, which can be updated as the project evolves. In this way, findability and easy interaction of possible co-creators is supported.
UBORA showcases a comprehensive collection of open-source medical devices linked to all areas of medical practice and to all purposes of medical technology, hence being the most comprehensive wiki available for the co-creation of medical devices. With the objective of easening the interaction of users with the e-infrastructure for finding projects of interest and at the establishment of collaboration with colleagues working in similar projects, together with the project description, it is important to use some medical tags acting as "keywords" representative for each project. A list of suggested keywords for indexing the projects is also provided, on the basis of identified clinical need (e.g. rehabilitation, prevention, etc.), clinical area (e.g. cardiology, neurosurgery, etc.) and technology (e.g. mobile-based, ergonomic support, active medical device etc.): this scheme is one of the implemented strategies to have a FAIR data management to ensure findability, accessibility, interoperability, and reusability of data.
The project management section is opened to users to design medical devices under the coordination of expert mentors. It is a medical device oriented project management environment, including a repository, available for free download of project blueprints which have completed the development and compliance phase. This section provides a meta-structure composed of 6 work packages (WPs), as a way of supporting a methodic approach to medical device development and homogeneity among projects within the UBORA e-infrastructure. The meta-structure includes the following work packages, which are in accordance with the overall structure proposed by systematic development methodologies (i.e. conceive-design-implement-operate cycle, the VDI 2206) and with the ISO13485:2016 framework for medical device development.
- WP1: Medical need and product specification
WP1 or “medical need and product specification” work package is designed to specify the clinical need and the scope of the medical device and to identify the main product requirements, as well as clinical area related to the technology. Moreover, in WP1, the risk class and applicable standards for the specific design are identified. The device classification, structured through a checklist, follows the rules described in Annex VIII of MDR 2017/745. In order to improve usability and minimize human error, the rules are arranged as a decision tree, which leads the designer(s) through a flow of simple (mainly yes/no) questions. Regarding the applicable standards to the device, UBORA provides a list of questions concerning the medical technology, in order to select the basic safety standards (also known as horizontal standards), which are usually difficult to identify through keywords in a search engine.
-WP2: Conceptual design
After specification and planning, the design starts: WP2 or “conceptual design” work package leads the designer in the development of different embodiments/ideas of the same medical device, which are analysed and ranked in a polling section, on the basis of feasibility, performance, usability and safety aspects.
- WP3: Design and prototyping
Through the WP3 or “design and prototyping” work package, the designer prepares documents related to the medical device concept proposed in WP2: the project management system suggests the organization in subsections related to mechanical components, electronics/firmware, software, and their integration. We propose developers to share all the relevant design and prototyping information and results, including files for helping with the replicability of the devices, if possible using widespread and editable file formats.
- WP4: Implementation
Once WP3 is concluded, the WP4 or “implementation” work package leads the developers in the testing phase, so as to demonstrate compliance with relevant standards.
- WP5: Operation
WP5 or “operation” work package is aimed at completing the technical documentation of the device, in order to publish the project for downloading, and provides a lean business model canvas, customized for OSMDs, to help the potential transfer of the technology to industry.
- WP6: Project closure
Finally, WP6 or “project closure” work package guides the developers in creating promotional videos and brochures, toward crowdfunding campaigns and commercialization after adequate certification, for which the completely documented process provided by UBORA in form of dossier is essential.
The repository contains all the files (including blueprints, pictures, selected datasheets, ... ), useful to document the project. It is divided in five different folders:
- electronics and firmware;
- system integration;
- project documentation.
You can use the latter folder to store the figures to be included in various textboxes of the project management.
The assignments section allows to assign/request/communicate with the other team members, keeping track of the different tasks. You need to provide the title, a description and the assignee.
The "History" page keeps track of all the activities performed during the project development, indicating the "author", the "action", and the "date".