The popular imagination of brain-computer interfaces tends toward the dramatic: a surgeon opening the skull, an electrode array positioned against cortical tissue, a patient gaining capabilities that medicine has never before been able to restore. That image is not wrong. The Utah Array, implanted in participants in the BrainGate consortium trials, allowed individuals with tetraplegia to control robotic arms and type using neural signals alone – outcomes published in Nature and The Lancet and widely cited as proof of the technology’s clinical potential. Some of the most significant advances in recent neurotechnology have followed precisely that path.
But as a model for how technology matures into a global health asset, surgical implantation has serious limitations, and the field’s accelerating investment in non-surgical implantable alternatives deserves to be understood as something more strategic than a concession to procedural caution.
The evidence velocity problem
The core issue is evidence velocity. Medical technology improves through clinical iteration: the accumulated experience of testing interventions in patients, learning from outcomes, and refining accordingly. Surgery, as a prerequisite for participation in that process, dramatically constrains the speed and breadth of learning. The first BrainGate2 trial, initiated in 2009, enrolled fewer than twenty participants over a decade. This was not because the science was uncompelling, but because the procedural burden made enrollment slow and repetition nearly impossible. Surgical (Brain-Computer Interface) BCI trials remain expensive to run, restricted to a small number of specialized centers, difficult to enroll, and nearly impossible to scale to the evidence thresholds that regulators, payors, and health systems require before broad deployment.
Non-surgical BCI: Beyond the risk-reduction frame
The more consequential development, however, goes beyond risk reduction. Non-surgical implantable BCI is now positioned to deliver the same clinical efficacy as surgical approaches and not as an aspirational target, but as an increasingly credible near-term thesis supported by the trajectory of the field. Synchron’s Stentrode, delivered endovascularly through the jugular vein and positioned in the motor cortex’s adjacent venous vasculature, has enabled ALS patients to operate computers, send messages, and conduct online banking without any craniotomy. A 2023 study published in JAMA Neurology (Mitchell et al.) reported that participants achieved meaningful communication rates and independent operation of digital devices using this approach, with a safety profile that bears no comparison to open neurosurgery. That changes the nature of the conversation entirely. The historical framing of non-surgical BCI as a lower-performance compromise for risk-averse patients is giving way to a more accurate description: a technology capable of equivalent outcomes, achieved through a development and deployment pathway that is faster, cheaper, and accessible to a substantially broader patient population.
A regulatory pathway that favors less-invasive innovation
In regulatory terms, the implications are direct. Approval agencies do not evaluate medical devices on efficacy alone but also, they conduct risk-benefit analysis, and for implanted BCIs requiring open neurosurgery, the risk side of that equation has been a persistent rate-limiter on timelines to approval and deployment. The FDA’s Breakthrough Device Designation, granted to Synchron in 2021, signals recognition of exactly this dynamic. Non-surgical implantable approaches that achieve equivalent efficacy at lower procedural risk do not carry that burden. And where efficacy equivalence is still being established, the precedent across device categories is instructive: subcutaneous implantable cardioverter-defibrillators were approved on favorable risk-benefit terms before demonstrated parity with transvenous devices. Deep brain stimulation systems with rechargeable batteries reached the market ahead of full comparative outcome data. Regulators have repeatedly demonstrated willingness to approve less invasive alternatives before full efficacy parity is established. There is no principled basis for neurotechnology to be treated differently.
A global health equity imperative
The global health equity dimension reinforces the case. Surgical BCI, by its nature, is a technology of the well-resourced: it requires tertiary care infrastructure, trained neurosurgeons, and post-operative support systems present in only a fraction of the world’s health systems. The Lancet Commission on Global Surgery estimates that 5 billion people lack access to safe, affordable surgical and anesthesia care. Against that backdrop, a BCI modality requiring craniotomy is not merely slower to scale and it is structurally excluded from most of the world’s neurological disease burden, which falls disproportionately on low- and middle-income countries. Non-surgical implantable approaches carry genuine potential to reach neurological patients in settings where surgical technologies will remain unavailable for the foreseeable future, expanding the addressable population not at the margins, but by orders of magnitude.
The strategic conclusion
None of this diminishes the importance of surgical BCI research. The scientific questions that high-resolution cortical interfaces can answer are not answerable any other way, and the field would be poorer without that work. But Neuralink’s first human trial (the PRIME Study), initiated in January 2024, enrolled a single participant and it is a meaningful milestone scientifically, but not a model for the evidence generation that health systems act on. The path from compelling science to broadly deployed health technology runs through clinical scale, regulatory feasibility, and patient accessibility. Non-surgical implantable BCI is increasingly capable of matching surgical performance while transforming the risk-benefit equation, and it is now the most credible path along all three dimensions simultaneously. For health policy, that is the position worth taking seriously.
Photo: Andreus, Getty Images
Michael Nketiah (MBA, RAC) serves as SVP of Regulatory and Clinical Affairs at Subsense Inc., where he leads regulatory strategy for non-surgical neurotechnology medical devices. He has more than 27 years of experience navigating FDA and global regulatory pathways for novel therapeutic technologies.
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