Neuroprosthetics and the science of patient input

Abstract

Safe and effective neuroprosthetic systems are of great interest to both DARPA and CDRH, due to their innovative nature and their potential to aid severely disabled populations. By expanding what is possible in human-device interaction, these devices introduce new potential benefits and risks. Therefore patient input, which is increasingly important in weighing benefits and risks, is particularly relevant for this class of devices. FDA has been a significant contributor to an ongoing stakeholder conversation about the inclusion of the patient voice, working collaboratively to create a new framework for a patient-centered approach to medical device development. This framework is evolving through open dialogue with researcher and patient communities, investment in the science of patient input, and policymaking that is responsive to patient-centered data throughout the total product life cycle. In this commentary, we will discuss recent developments in patient-centered benefit-risk assessment and their relevance to the development of neural prosthetic systems.

Assessing the Benefit-Risk Profile for Pediatric Implantable Auditory Prostheses

“…Patient and family perspectives have become an important factor in regulatory and third-party payer decision making. 2,5,[99][100][101] The extent of the family's risk tolerance 2 for selecting the CI or the ABI has not been well characterized. Some insight into a family's willingness to obtain an ABI for their child is evidenced in the numbers who travel outside the US for the procedure.…”

<italic>In Vivo</italic> Impedance Characterization of Cortical Recording Electrodes Shows Dependence on Electrode Location and Size

“…N EURAL prostheses have improved the lives of many people worldwide by restoring lost sensory function, such as vision and hearing, and alleviating the neurological symptoms of movement disorders, such as Parkinson's disease [1]- [5]. In addition to neural stimulation, neural recording is also playing a major role in returning independence to sufferers of neurological diseases and trauma [6]- [8].…”

On the Use of Subdermal Electrical Stimulation for Restoration of Sensory Feedback

“…This clinical acceptance may improve if the prosthesis provides intuitive sensory feedback (improvement in accuracy), in terms of the prosthesis being light, comfortable, and convenient for daily use (Biddiss & Chau, 2007). As stated by (Benz & Civillico, 2017), users wish to have lightweight prostheses to decrease fatigue of the arm, shoulder, and back. The difficulty in performing precise hand or finger movements is also becoming a concern (Benz & Civillico, 2017).…”

“…As stated by (Benz & Civillico, 2017), users wish to have lightweight prostheses to decrease fatigue of the arm, shoulder, and back. The difficulty in performing precise hand or finger movements is also becoming a concern (Benz & Civillico, 2017). In addition to fatigue, power consumption should be considered in the case of transradial prostheses, as enough power should be available for a whole day's use without any recharge (Cipriani et al, 2010).…”