Abstract
This second chapter will enter the main purpose of this book: explain how to build the BCI of the future. The road from concept to patient is more complex than what is usually anticipated. This chapter will expose the discipline and rigor required to carry a development project all the way to the final goal: human use. Before trying to understand the targets of our technologies and the limitations induced by the human body, we will describe the general methodology leading to successful developments in the field of neuroactive medical devices. We will also point out that BCI and neuro-technologies are evolving in a special environment which must first be well understood. Important nontechnical notions, like user’s needs, product approval, and reimbursement, will be exposed to set the frame in a holistic approach.
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References
https://en.wikipedia.org/wiki/International_Telecommunication_Union
https://en.wikipedia.org/wiki/Federal_Communications_Commission
https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631844.htm
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm631786.pdf
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Clément, C. (2019). From Concept to Patient. In: Brain-Computer Interface Technologies. Springer, Cham. https://doi.org/10.1007/978-3-030-27852-6_2
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DOI: https://doi.org/10.1007/978-3-030-27852-6_2
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Publisher Name: Springer, Cham
Print ISBN: 978-3-030-27851-9
Online ISBN: 978-3-030-27852-6
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