Bridging bench to bedside with aneurotechnology cross-development platform

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Advancements in neurotechnology are shaping the future of medical care for those suffering from neurological illness, disease, and injury. Unfortunately, it can take decades to bring such advances from the benchtop to the bedside in service of our Veterans. The development, evaluation, optimization, and deployment of each subcomponent of a medical device is complex, and combinations of technologies are required to address the complex needs of Veterans with, for example, traumatic brain and spinal cord injuries. In fact, the last major neurotechnology translational success was arguably the deep brain stimulator (DBS) developed in the 1980’s, delivering electrical neuromodulation to the brain to reduce Essential and Parkinson’s Disease-related tremor, but were not approved by the Food and Drug Administration until 2002. While impressive technologies are on the horizon, including those supported by the Department of Veterans Affairs, the time, money, and scientific divide between benchtop successes and bedside therapeutic application is exceptionally vast. Bioelectronics are hyped as an alternative to drug interventions, but the reality is that the translation timelines for medical devices—and their success rates as therapeutic tools—mirror the slow and costly development of new pharmaceuticals rather than mirroring the lean, accelerated development of new electronics for the consumer market. This issue matters because the socioeconomic burden of neurological injury and disorders is significant. Spinal cord injuries (SCIs) alone are estimated to affect between 249,000 and 363,000 Americans (NSCISC), and roughly 42,000 people with SCIs are Veterans, an estimated $5M/patient over their lifetime in health care costs. Nearly half of all SCIs occur in people between the ages of 16 and 30, leaving many to live with the injuries for decades. The inefficiency of bringing new drugs to market is dubbed “Eroom’s” law, given the exponentially increasing cost of drug release—in contrast to Moore’s law, originally referring to the number of transistors on a microchip doubling every 2 years though the cost of computers is halved, but more generally illustrating the exponential growth for technologies over time. From a translational perspective, the efficiency of medical device innovation still has much more in common with pharmacological research and development (R&D) than it does with Moore’s law and consumer electronics. We propose the development of a hardware and software accelerator platform (“cross-development”, or xDev) for electrophysiology research and neurotechnology creation. Development of this platform would enable new research into spinal cord stimulation for sensorimotor restoration in SCI, as well as for continued investigation of spinal electrophysiology in closed-loop devices for chronic pain. The new tool will be used to accelerate design, development and deployment of neurotechnology by smoothing the transition between design phases, allowing rapid redesign and re-verification of neurotechnology components. The xDev platform maximizes the ability of neurotechnology device developers to test their tools with versatile interfaces, algorithms, and underlying chipsets, improving compatibility, cross-functionality, and inspiring new collaborations between technology developers. Strategic platform organization protects neurotechnology developers’ intellectual property, while improving modularity with tools from other manufacturers. Leveraging the xDev platform, we will demonstrate a new neurotechnology enabling chronic recording of spinal electrophysiology and fill a neuroscientific knowledge gap, connecting the fields of Restorative Neurology and therapeutic spinal cord neuromodulation.