Neural electrodes for long-term tissue interfaces

Valle, Jaume del; Rodríguez-Meana, Bruno; Navarro, Xavier

doi:10.1016/b978-0-12-822828-9.00009-5

Cited by 2 publications

(1 citation statement)

References 124 publications

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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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