Preliminary Minimum Reporting Requirements for In-Vivo Neural Interface Research: I. Implantable Neural Interfaces

Eiber, Calvin D.; Delbeke, Jean; Cardoso, Jorge; Neeling, Martijn de; John, Sam E.; Lee, Chang Won; Skefos, Jerry; Sun, Argus; Prodanov, Dimiter; McKinney, Zach

doi:10.1109/ojemb.2021.3060919

Cited by 7 publications

(3 citation statements)

References 56 publications

(42 reference statements)

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“…Reviewing existing PNIs provides insights into design considerations and could accelerate the design of new PNIs. The authors of several review articles (Ghafoor et al, 2017;Giagka and Serdijn, 2018;Russell et al, 2019;Wu and Peng, 2019;Cho et al, 2020;Larson and Meng, 2020;Wu and Guo, 2020;Yildiz et al, 2020;del Valle et al, 2021;Eiber et al, 2021;Farina et al, 2021;Paggi et al, 2021;Selim et al, 2021) provide different perspectives but a convergent view on primary design requirements for PNI. The three primary requirements are identifying the target nerve for interfacing, choosing the electrode type for interfacing, and determining the electronic hardware to stimulate or record neural activity.…”

Section: Design Processmentioning

confidence: 99%

Accelerating neurotechnology development using an Agile methodology

Thota,

Jung

2024

Front. Neurosci.

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Novel bioelectronic medical devices that target neural control of visceral organs (e.g., liver, gut, spleen) or inflammatory reflex pathways are innovative class III medical devices like implantable cardiac pacemakers that are lifesaving and life-sustaining medical devices. Bringing innovative neurotechnologies early into the market and the hands of treatment providers would benefit a large population of patients inflicted with autonomic and chronic immune disorders. Medical device manufacturers and software developers widely use the Waterfall methodology to implement design controls through verification and validation. In the Waterfall methodology, after identifying user needs, a functional unit is fabricated following the verification loop (design, build, and verify) and then validated against user needs. Considerable time can lapse in building, verifying, and validating the product because this methodology has limitations for adjusting to unanticipated changes. The time lost in device development can cause significant delays in final production, increase costs, and may even result in the abandonment of the device development. Software developers have successfully implemented an Agile methodology that overcomes these limitations in developing medical software. However, Agile methodology is not routinely used to develop medical devices with implantable hardware because of the increased regulatory burden of the need to conduct animal and human studies. Here, we provide the pros and cons of the Waterfall methodology and make a case for adopting the Agile methodology in developing medical devices with physical components. We utilize a peripheral nerve interface as an example device to illustrate the use of the Agile approach to develop neurotechnologies.

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Section: Design Processmentioning

confidence: 99%

Accelerating neurotechnology development using an Agile methodology

Thota,

Jung

2024

Front. Neurosci.

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“…It may also be based on the chronicity of the disease and whether the implant was the only potentially effective intervention or one of last resort for a severe motor or cognitive disorder. In addition, there should be reporting requirements for investigators conducting research with implantable neural interfaces (Eiber et al 2021). Access may be based on whether agencies like the US FDA determined that they were in patients' best interests (Johnston et al 2020).…”

Section: Fairness In Access To Neural Prostheticsmentioning

confidence: 99%

Ethical and social aspects of neural prosthetics

Glannon

2021

Prog. Biomed. Eng.

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Neural prosthetics are devices or systems that bypass, modulate, supplement, or replace regions of the brain and its connections to the body that are damaged and dysfunctional from congenital abnormalities, brain and spinal cord injuries, limb loss, and neuropsychiatric disorders. Some prosthetics are implanted in the brain. Others consist of implants and systems outside the brain to which they are connected. Still others are completely external to the brain. But they all send inputs to and receive outputs from neural networks to modulate or improve connections between the brain and body. As artificial systems, neural prosthetics can improve but not completely restore natural sensory, motor and cognitive functions. This review examines the main ethical and social issues generated by experimental and therapeutic uses of seven types of neural prosthetics: auditory and visual prosthetics for deafness and blindness; deep brain stimulation for prolonged disorders of consciousness; brain-computer and brain-to-brain interfaces to restore movement and communication; memory prosthetics to encode and retrieve information; and optogenetics to modulate or restore neural function. The review analyzes and discusses how recipients of neural prosthetics can benefit from them in restoring autonomous agency, how they can be harmed by trying and failing to use or adapt to them, how these systems affect their identities, how to protect people with prosthetics from external interference, and how to ensure fair access to them. The review concludes by emphasizing the control these systems provide for people and a brief exploration of the future of neural prosthetics.

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“…Accordingly, the second paper of the present NT-BMI series formalizes a “Functional Model for Unified Brain-Computer Interface Terminology” [14] . In complement, the third paper in the series presents a set of “Preliminary Minimum Reporting Requirements for in-vivo Neural Interface Research” for implantable neural interfaces [15] .…”

mentioning

confidence: 99%