3 steps to release Open Source Medical Devices — A visual guide for makers
We are very happy to share the infographic “Open Source Medical Devices — a visual guide for makers”. The guide has been developed during the last few months within the DSI4EU project, funded by EU Commission. We hope this visual guide will support makers, organisations and informal groups to understand a bit more how to deal with medical devices’ certification.
One of the barriers to the scalability of bottom-up technologies and solutions in the field of health and care can be mainly found in the certification procedure at the EU level. In order to place a medical device on the EU market, in fact, specific European Directives have to be met. Any health and care solution must be compliant with the regulations in order to reach to the market and the complexity of the certification process is often a barrier that prevents innovative low-cost projects from becoming real products. There is a lack of knowledge and competences within the ecosystem of makers and startups, but also among policymakers and health professionals.
As we identified exploring this sector, 3D additive manufacturing technologies and open-source licenses are the key enablers of the collaborative and commons-driven development of mass personalised solutions. But how can DSI communities leverage these technologies and open-source models to release personalised care devices that can really be used by people?
The guide aims to provide the DSI communities with an easy-to-use and step-by-step documentation on how to go from a prototype of an open care device to a product that can be compliant with regulations and, therefore, ready to get to the market.
The content of the guide is based on two main sources:
- the 6 work-packages process of the UBORA platform;
- the documentation shared during the webinar held (in Italian) by Carmelo De Maria and Licia Di Pietro, Università di Pisa within the series Digital Social Innovation Webinars.
The UBORA was funded within Horizon 2020 and aimed to create an e-Infrastructure for open source co-design of new solutions to face the current and future healthcare challenges of Europe and Africa.
The guide uses the 6 work packages taken from Ubora to generate an easy to use resource suitable for a dissemination within the DSI communities. The primary targets of the guide are European makerspaces and fablabs, namely the contexts where collaborative and open development based on 3D printing is practised and supported. The secondary targets are policy makers and healthcare professionals, in order to implement new certification processes and new care practices involving these types of devices.
The infographic is mostly based on visuals to help non-expert people understanding the key elements of EU regulations. The guide is not to be intended as a technical document, but rather as a resource for beginners: it has the goal to make the DSI community aware of the relevant steps to be considered during the development of a health and care approach.
Do you have any questions and comments? Write to us! dsi4eu (at) wemake.cc