Innovating Neurotech with Abandon, but without Abandonment
Innovating Neurotech with Abandon, but without Abandonment
Commercial Success is a Responsibility, Not a Right
In 1954, at the age of 23, my late grandfather—Pastor Paul P. Pluimer—was paralyzed from the waist down. He was attending to a mechanical issue underneath his work truck when the newly minted electronic emergency brake faultily disengaged, causing the truck to roll off the wheel chocks and onto his back, severing his spine.
For the remaining 58 years of his life, he was unable to locomote without the support of either braces, crutches, or a wheelchair. Growing up in the early 2000s, I longed for sufficiently advanced (or “magic”) technologies that would allow him, and other paraplegics, to walk again. At the time though, such machines were sequestered to the realm of science fiction movies. Incredibly, just a couple of decades later, groups like Blackrock Neurotech, ONWARD, and NeuroRestore have brought this once fantastical dream into reality.
In 2016, Blackrock Neurotech published their seminal report outlining how implantation of its Utah Array into the left primary motor cortex of Ian Burkart’s allowed for the patient to regain control of his hand through a computer interface. NeuroRestore and ONWARD followed closely behind, publishing their own restorative brain-spine interfaces in 2018 and 2023, respectively. These revitalizing apparatuses allow paralyzed patients to walk, and even swim again, building upon principles first described in 2006 where computer devices transcribe neural impulses into basic computer functions such as a mouse click (Hochberg et al., 2006; Santhanam et al., 2006).
The neurotech market has since widened its scope both in target and methodology. Expanding its portfolio beyond mind-control of computer systems, Neuralink’s recently FDA-breakthrough-designated Blindsight device promises to restore vision through stimulation of the visual cortex. Synchron routes its StentrodeTM through the brain’s largest dural sinus – allowing for thought-controlled computer manipulation. Abbott and Boston Scientific use Deep Brain Stimulation for treatment of neuropathic pain and Parkinson’s tremors.
Motif recently showcased their “Digitally programmable Over-brain Therapeutic”, a pea-sized, minimally-invasive magneticoelectric implant that rests atop the dura (the protective outer-cover of the brain) which, given its tiny size, could potentially allow for treatment of non-motor ailments like depression and addiction. Forest Neurotech is developing a non-invasive ultrasound neurofeedback system that rests atop a surgically introduced clear window of the skull.
These revolutionary devices make up a fraction of an accelerating market that is poised to shape the future of neurobiological research and, if demonstrably commercially viable, civilization itself. Optimistically, if the current trajectory holds, we could very well see BCIs introduced for most neurological conditions within the next few decades. Assuming researchers continue to overcome formidable technical hurdles, the major bottleneck facing the neurotech industry is no longer technical, but ethical.
With Great Power Comes Great Responsibility
The morals of implantable Brain Computer Interfaces (iBCIs) have been pointedly debated since their invention in the 1960s. José Manuel Rodríguez Delgado, the first BCI neurosurgeon, manipulated the behavior of a female criminal as an alternative to the individual serving a prison sentence. His observations led Delgado to envision a “psychocivilized” society where careful technological manipulation of the brain could remedy some of humanity’s undesirable and violent behaviors, thus allowing humans to flourish into a more enlightened era. However, as Delgado’s contemporary Elliot Valenstein astutely argued, “we would be in serious trouble if a number of influential people became convinced that violence is mainly a product of a diseased brain rather than a diseased society.”
Despite momentous scientific advancements, the conversation surrounding neuroethics has progressed only marginally since the 60s. Most modern discussions operate under the assumption that these technologies will function as intended, focusing on four main concerns: privacy, augmentation, bias, and agency. However, there’s another critical, red elephant-sized consideration that tends to remain in shadow because it hinges on the pessimistic possibility of company failure: the issue of abandonment. Put simply, abandonment arises when a person receives an implant, but the company becomes unable to support them due to various issues, namely economical and strategic.
These dystopian situations are not merely hypothetical; they have arrived. Consider the case of Automatic Technologies in San Francisco. In 2013, Markus Möllmann-Bohle received a facial electrode implant for chronic pain, dramatically improving his everyday life. But, when the company collapsed in 2019, Markus’ implant was left unattended, forcing him to personally reconfigure his own parts as a means to keep his system operating, ala Tony Stark.
A similar situation occurred with Second Sight where retinal implants were left to decay in patients’ eyes after the company decided its Argus II model was no longer viable. Imagine losing your eyesight, then regaining it, only to lose it once again due to, not biological, but budgetary restrictions. More recently, the paralysis-focused company Lifeward refused to fix the battery of an exoskeleton that was allowing a paralyzed man to walk again because the technology was outdated. And the list goes on. In 2019, the spinal-cord stimulation company Nuvectra filed for bankruptcy after implanting their pain-management device in 3000 patients, as did its competitor Florida-based Stimwave.
Even BCI Pioneer Ian Burkhart’s implant was explanted after 7.5 years due in large part to the research team running out of funding: “ ‘It was probably around the five-year mark that we started running into some issues with funding’…When the team did manage to secure funding, it was only for six to eight months. At one point, Burkhart says, he was told to have the implant removed, but assured that he could have it put back in once funding had come through. ‘That’s not the way to handle it,’ he says. ‘It’s a big risk to have the device removed, and then to put one back in right away.’ ”
Beyond funding-related challenges, deep-brain stimulation devices offer numerous examples of commercial responsibilities related to battery life, “reversability,” and how to facilitate device upgrades in-vivo.
These grim circumstances raise pressing questions about the long-term obligations of researchers, industry, and funding agencies to participants who wish to retain their implanted devices—especially when manufacturers discontinue support or cease operations (Drew, 2022; Patrick-Krueger et al., 2024). Even if a device passes clinical trials, commercial hurdles can lead to abandonment; a device proven effective may fail to reach practical use due to stakeholder agendas, a situation known as “shelving.”
While manufacturers have been encouraged to incorporate long-term care responsibilities into their business models or implement healthcare-as-a-service strategies for sustained revenue, no definitive solutions have been implemented. When makers of implanted devices go under, the implants are typically left in place because removal surgery is often too expensive, risky, or unnecessary. However, without ongoing technical support from the manufacturer, it is only a matter of time before programming needs, malfunctioning wires, or depleted batteries render the implant unusable.
Where Do We Go From Here?
First, there needs to be clear consensus for what constitutes abandonment in neurotechnology. Earlier this year, Okun and colleagues undertook this task by convening an expert consensus group of physicians, scientists, ethicists, and stakeholders.
They proposed that neurological device abandonment occurs when there is a “failure to provide fundamental aspects of patient consent; fulfill reasonable responsibility for medical, technical, or financial support prior to the end of the device's labeled lifetime; and address any or all immediate needs that may result in safety concerns or device ineffectiveness and that the definition of abandonment associated with the failure of a research trial should be contingent on specific circumstances.”
Furthermore, the NIH BRAIN Initiative Neuroethics Working Group (NEWG) has recommended two key principles: first, that post-trial needs should be anticipated and participants adequately informed; second, that all professional parties involved in trials—researchers, institutions, device manufacturers, and funders (collectively referred to as “involved parties”)—share a limited responsibility to take reasonable steps to ensure participants continue to have access to beneficial devices. At the very least, neurotech must implement standardization, enhance financial safeguards, and incorporate non-abandonable elements when possible.
Implement Standardization
The lack of neurotech standardization is plaguing the industry. When a patient needs a replacement for a simple part, there ought to be multiple avenues for repair beyond the parent company. A similar approach was taken within cardiology in the early 1990s when pacemaker manufacturers voluntarily adopted industry-wide standards, allowing power supplies from any company to be compatible with pacemakers from any other manufacturer.
Ideally, there will also be adoption of standards for performance assessment, data representation, storage, sharing, user needs, sensor technology, and end effectors. Defining unified terminology and establishing standardized functional models are essential for a baseline understanding across the field. Working groups like the IEEE Brain Standard Association are already attempting to address these deficiencies.
Provide Institutional Support and Financial Safeguards
The National Institutes of Health (NIH) and the Center for Medicaid and Medicare Services (CMS) are constrained by legal limitations that prevent them from offering continued support or coverage for participants after clinical trials conclude, while the potential solution of conducting long-term follow-up studies to provide post-trial care and gather valuable data is hampered by the unreliability of securing future grant funding, creating a significant gap in the continuity of care and research for trial participants.
Thus, enhancing standards to minimize gaps in post-trial care is imperative. This would involve distributing obligations among organizations to reduce the burden on any single entity and ensuring that those who benefit financially or reputationally contribute fairly. For post-trial needs reliant on specific parties, those groups should bear additional responsibility.
For financial support not tied to a specific party, two models are suggested:
Pre-agreed Distribution of Costs: Involved parties agree in advance on how to share responsibilities and costs, such as manufacturers donating replacement parts while institutions waive procedure fees.
Insurance Policies or Funds: Contributions to an insurance policy or a fund can spread financial risk evenly and provide upfront certainty for patient support. These could be managed by impartial entities with clear coverage criteria, whether on a study-specific basis or as part of a broader program.
Develop Better, Non-Abandonable Technology
Ultimately, researchers could also implement technology that effectively cannot be abandoned. This would involve developing devices that are biodegradable or self-sustaining, reducing long-term risks associated with maintenance and support. An example is the recently reported biodegradable and self-deployable electronic tent electrode for brain cortex interfacing. Implementation of such innovations as a fail-safe would minimize dependency on manufacturer support and lessen the potential for patients to be left with obsolete or non-functional implants.
Slow and Steady Wins the Race
By 2026, the market for neurotechnology is predicted to grow to $17B. As commercial investment grows, so too does the likelihood of abandonment. Moving forward requires a careful and balanced approach: standardizing industry practices, strengthening institutional support, creating financial safeguards, and developing more sustainable technologies. This necessitates collaboration between researchers, policymakers, ethicists, and the public that go beyond pursuit of academic publications and elite global gatherings that characterize too many neuroethicists’ career goals. By focusing on responsible innovation and long-term patient care, we can harness the power of neurotechnology to improve lives while upholding our ethical obligations to the people who matter most.
References
Drew, L. (2022). Abandoned: The human cost of neurotechnology failure. Nature. https://doi.org/10.1038/d41586-022-03810-5
Hochberg, L. R., Serruya, M. D., Friehs, G. M., Mukand, J. A., Saleh, M., Caplan, A. H., Branner, A., Chen, D., Penn, R. D., & Donoghue, J. P. (2006). Neuronal ensemble control of prosthetic devices by a human with tetraplegia. Nature, 442(7099), 164–171. https://doi.org/10.1038/nature04970
Patrick-Krueger, K. M., Burkhart, I., & Contreras-Vidal, J. L. (2024). The state of clinical trials of implantable brain–computer interfaces. Nature Reviews Bioengineering. https://doi.org/10.1038/s44222-024-00239-5
Santhanam, G., Ryu, S. I., Yu, B. M., Afshar, A., & Shenoy, K. V. (2006). A high-performance brain–computer interface. Nature, 442(7099), 195–198. https://doi.org/10.1038/nature04968
Author Contributions
Brock Pluimer, PhD researched and wrote this article. Brock is an interdisciplinary neuroscientist, currently working as a postdoctoral scholar at the University of California, Irvine where he researches the basic and clinical applications of altered states of consciousness.
Naveen Rao edited and wrestled with GPT to generate the image. He is not sure who won.
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