Is Neuralink the First Hook in a Neurobioeconomic – and Ethico-legal and Social - Chain Reaction?

In 2019, Elon Musk announced that his company, Neuralink would advance the clinical translation of a novel brain-machine-interface (BMI) that he claimed held “…promise for the restoration of sensory and motor function and the treatment of neurological disorders.” Now, following Neuralink receiving a Food and Drug Administration Investigational Device Exemption (FDA IDE), Musk has announced the first human implantation of this device; which he contends is a first step toward making the technology commercially available to anyone wishing to employ an indwelling BMI to run their computers and personal media devices, gain “better access” to the internet-of-things, and “better connections” to “the world, each other, and ourselves.”

Boastful and perhaps exaggerative claims, but there is veracity in his intent of making Neuralink technologies broadly available to the public. But at this point, a reflective – and responsive - pause is required: a number of questions, and concerns need to be posed – and addressed - before Neuralink, or any such technology is commercially offered directly to the public at-large. Musk explicitly states that while this technology is presently being implemented to treat identified neurological disorders or injury, the intended scope of its use is not solely limited to therapeutic applications. In this light, what conditions, characteristics, and/or desired outcomes will be considered as valid, and viable to justify the implantation of this BMI. Given that the advocated use is for optimizing human abilities, then it is likely that the lack of “medical necessity” would preclude insurance subsidy of the device, the neurosurgical procedures to implant it, and/or the costs to maintain (or update) the technology (as cost coverage of these aspects of current BMIs used for approved clinical therapeutics are consistently problematic). So, Neuralink will most probably foster a self-pay market. Thus, only a select few could acquire Neuralink devices; how then will society regard and treat those individuals who have – and do not have - an implant? Perhaps, we may look to fiction to pose possibilities, and Daniel H. Wilson’s excellent novel Amped, while published in 2012, now seems prescient in this regard.

Further, Musk has asserted that it’s his goal to make the procedure “… as simple and automated as LASIK”, through the employment of robotic surgery. What Neuralink and other BCI companies mean by “minimally invasive” deserves consideration. Even the use of a robotic surgical system will require medical oversight. And given current views of physicians, scientists, and scholars in the United States, Europe, Japan, and Australia regarding medical interventions intended for “non-therapeutic” (i.e., optimization/enhancement) purposes, it seems unlikely that physicians would approve implanting the Neuralink device for such ends. Still, let’s not be naïve: where there’s a will there’s a way, and where there’s demand there will be a market. But where? As we have noted, some nations cultural views, values, philosophies, and ethics may be more permissive, and would be more open - if not enthusiastic - to supporting and further providing Neuralink devices to those who want it – and can pay. This portends a shift in local and global neurobioeconomies, and the relative hegemony that could be gained by establishing such market presence and positioning.

While Neuralink technology is recognized to be not as sophisticated and/or capable as other, currently utilized BMIs, such distinction is of little relevance given Neuralink’s strong commercial “push” to bring BMI capability to a consumerist market. This could serve as both a “tipping point” and “tripping hazard” for the pace, scope - and emergence of safety and ethical issues - of direct-to-consumer (DTC) implantable neurotechnologies. The professional expertise (e.g., bio- and computational engineering, neurosurgery, etc.) required to further develop and provide these devices will not necessarily be impediments, as a number of nations already have neurotechnology programs that could serve as vectors for market influence, and these nations’ aforementioned differing values and ethical norms may promote faster uptake of these trends, and more viable locales and destinations for “boutique neurotech tourism”.

A DTC neurotech market is not new; as non-invasive neuromodulatory devices have been available, and proliferating the DTC milieu for well over a decade. By design, these devices are lower output than those employed in clinical therapeutics, and the Food and Drug Administration and Federal Trade Commission oversight and governance of these technologies are specifically contingent upon both these devices’ lesser power conductance and the constraint that they are not to be used to diagnose and/or treat a medical condition. While the Neuralink technology requires neurosurgical implantation, and has at least similar power output to those devices that are currently used in clinical care (e.g.- of movement disorders, neurotrauma; etc.), the noted “lesser capability” and intentional (re-)direction of application for “lifestyle” and “wellness” (inclusive of performance optimization) purposes might well be the “wrinkle” through which Neuralink appeals for – and could gain - regulatory approval for broadening public use.

Approval for DTC engagement is not a balm against the problematic. Even low output neurotechnologies, as offered in the DTC transcranial neuromodulation market, can incur problematic concerns. We have addressed these as germane to the variety of technologies available, the necessity for stringency in commercial manufacturing, advertising, and informational practices, and contingencies arising from widening patterns of consumer use (and potential misuse). To be sure, several of the same, and most probably additional concerns and issues will need to be defined and addressed if and as implantable neurotechnologies gain traction in public use markets. And while many of the technical, and ethico-legal and social issues focal to indwelling neuromodulation have been, and are being engaged in the literature, and multi-disciplinary venues (such as Neuromodec conferences; and the Annual Deep Brain Stimulation Think Tank, among others), Neuralink’s venture into this field, and the establishment of a novel, and volatile public use ecology will most certainly warrant more granular attention, further deliberation, and more detailed direction.

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