Accelerating neurotechnology development using an Agile methodology
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 neuro...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-02-01
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| Series: | Frontiers in Neuroscience |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fnins.2024.1328540/full |
| _version_ | 1797305318832603136 |
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| author | Anil Kumar Thota Ranu Jung Ranu Jung |
| author_facet | Anil Kumar Thota Ranu Jung Ranu Jung |
| author_sort | Anil Kumar Thota |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T00:24:11Z |
| format | Article |
| id | doaj.art-c004e6b6a178418da09eb908053278d5 |
| institution | Directory Open Access Journal |
| issn | 1662-453X |
| language | English |
| last_indexed | 2024-03-08T00:24:11Z |
| publishDate | 2024-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neuroscience |
| spelling | doaj.art-c004e6b6a178418da09eb908053278d52024-02-16T04:18:50ZengFrontiers Media S.A.Frontiers in Neuroscience1662-453X2024-02-011810.3389/fnins.2024.13285401328540Accelerating neurotechnology development using an Agile methodologyAnil Kumar Thota0Ranu Jung1Ranu Jung2Adaptive Neural Systems Group, The Institute for Integrative and Innovative Research, University of Arkansas, Fayetteville, AR, United StatesAdaptive Neural Systems Group, The Institute for Integrative and Innovative Research, University of Arkansas, Fayetteville, AR, United StatesBiomedical Engineering Department, University of Arkansas, Fayetteville, AR, United StatesNovel 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.https://www.frontiersin.org/articles/10.3389/fnins.2024.1328540/fullmedical device developmentdesign controlsverification and validationwaterfallAgileneurotechnology |
| spellingShingle | Anil Kumar Thota Ranu Jung Ranu Jung Accelerating neurotechnology development using an Agile methodology Frontiers in Neuroscience medical device development design controls verification and validation waterfall Agile neurotechnology |
| title | Accelerating neurotechnology development using an Agile methodology |
| title_full | Accelerating neurotechnology development using an Agile methodology |
| title_fullStr | Accelerating neurotechnology development using an Agile methodology |
| title_full_unstemmed | Accelerating neurotechnology development using an Agile methodology |
| title_short | Accelerating neurotechnology development using an Agile methodology |
| title_sort | accelerating neurotechnology development using an agile methodology |
| topic | medical device development design controls verification and validation waterfall Agile neurotechnology |
| url | https://www.frontiersin.org/articles/10.3389/fnins.2024.1328540/full |
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