Bridging bench to bedside with aneurotechnology cross-development platform

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.

Grant Number: 5I01RX004250-03
NIH Institute/Center: VA
Principal Investigator: David Borton