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- W3204707059 abstract "Academic researchers concentrate on the scientific and technological feasibility of novel treatments. Investors and commercial partners, however, understand that success depends even more on strategies for regulatory approval, reimbursement, marketing, intellectual property protection and risk management. These considerations are critical for technologically complex and highly invasive treatments that entail substantial costs and risks in small and heterogeneous patient populations. Most implanted neural prosthetic devices for novel applications will be in FDA Device Class III, for which guidance documents have been issued recently. Less invasive devices may be eligible for the recently simplified de novo submission routes. We discuss typical timelines and strategies for integrating the regulatory path with approval for reimbursement, securing intellectual property and funding the enterprise, particularly as they might apply to implantable brain-computer interfaces for sensorimotor disabilities that do not yet have a track record of approved products." @default.
- W3204707059 created "2021-10-11" @default.
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- W3204707059 date "2021-09-29" @default.
- W3204707059 modified "2023-09-26" @default.
- W3204707059 title "Turning Neural Prosthetics Into Viable Products" @default.
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- W3204707059 doi "https://doi.org/10.3389/frobt.2021.754114" @default.
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