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Title: The development of neural stimulators: a review of preclinical safety and efficacy studies
Authors: Shepherd, Robert
Villalobos, Joel
Burns, Owen
Nayagam, David
Keywords: neural stimulator
neural prosthesis
preclinical evaluation
safety and efficacy
electrical stimulation
Issue Date: May-2018
Publisher: IOP Publishing
Citation: Shepherd, R. K., J. Villalobos, O. Burns, and D. Nayagam. 2018. The development of neural stimulators: a review of preclinical safety and efficacy studies. Journal of Neural Engineering. 15(4): 041004.
Abstract: OBJECTIVE: Given the rapid expansion of the field of neural stimulation and the rigorous regulatory approval requirements required before these devices can be applied clinically, it is important that there is clarity around conducting preclinical safety and efficacy studies required for the development of this technology. APPROACH: The present review examines basic design principles associated with the development of a safe neural stimulator and describes the suite of preclinical safety studies that need to be considered when taking a device to clinical trial. MAIN RESULTS: Neural stimulators are active implantable devices that provide therapeutic intervention, sensory feedback or improved motor control via electrical stimulation of neural or neuro-muscular tissue in response to trauma or disease. Because of their complexity, regulatory bodies classify these devices in the highest risk category (Class III), and they are therefore required to go through a rigorous regulatory approval process before progressing to market. The successful development of these devices is achieved through close collaboration across disciplines including engineers, scientists and a surgical/clinical team, and the adherence to clear design principles. Preclinical studies form one of several key components in the development pathway from concept to product release of neural stimulators. Importantly, these studies provide iterative feedback in order to optimise the final design of the device. Key components of any preclinical evaluation include: in vitro studies that are focussed on device reliability and include accelerated testing under highly controlled environments; in vivo studies using animal models of the disease or injury in order to assess safety and, given an appropriate animal model, the efficacy of the technology under both passive and electrically active conditions; and human cadaver and ex vivo studies designed to ensure the device's form factor conforms to human anatomy, to optimise the surgical approach and to develop any specialist surgical tooling required. SIGNIFICANCE: The pipeline from concept to commercialisation of these devices is long and expensive; careful attention to both device design and its preclinical evaluation will have significant impact on the duration and cost associated with taking a device through to commercialisation. Carefully controlled in vitro and in vivo studies together with ex vivo and human cadaver trials are key components of a thorough preclinical evaluation of any new neural stimulator.
URI: http://repository.bionicsinstitute.org:8080/handle/123456789/348
ISSN: 1741-2552
Appears in Collections:Neurobionics Research Publications

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