This can, and has, damaged the reputation of the domain, with nightmarish consequences. Up-and-coming solutions produced by companies in the field can suffer from years of setbacks to their progress, as financial resources and talent flock to other, more lucrative sectors. Moreover, the regulatory and reimbursement bodies may become more stringent in their standards, while consumers may dismiss rigorous reproducible neuroscience research with blanket statements.

Such events send shockwaves through the investor community. Due diligence processes become more invasive and capital scarcer, even for promising startups in the same vertical, sowing investor doubt in the broader neuroscience startup space. This can lead to reduced funding for an extended period, stifling innovation and growth and resulting in slower growth until the sector can achieve both the technological maturity and venture confidence needed to build and commercialize in the space.

A key aspect of the advancement of BCIs will be investigating the incorporation of new materials with enhanced capabilities. One such example is graphene, which presents a promising alternative to silicon-based electrodes due to its superior conductivity, flexibility and charge capacity. It is also considerably thinner than silicon, potentially reducing the pressure on brain tissue and the risk of trauma.

However, being a relatively novel material, it will take significantly longer to navigate the approval processes for its use with implanted medical devices. A champion of the material will need to bear the burden – and cost – of demonstrating its safety and efficacy for chronic implantation. For instance, INBRAIN Neuroelectronics has already secured US Food and Drug Administration (FDA) Breakthrough Device Designation for its graphene-based solution for treating Parkinson’s disease, offering the industry a glimpse of what might be possible when integrating new materials into devices.

Similar pioneering efforts will be needed to prove the suitability of additional emerging materials that will further the use of BCI technologies.

At first glance, the regulatory process for neurotech startups appears unnecessarily exhaustive, taking around five-to-six years from the first FDA meeting until a device is granted clearance. However, rather than a bureaucratic obstacle, this is essential to ensure the safety and efficacy of emergent BCI technologies.

The last thing anyone wants is for a therapy or drug to get to market, only to be pulled due to lack of efficacy – or worse, potential danger to patients. This is especially true for the neurotechnology space. So, while the old mantra to “move fast and break things”may have worked in the traditional tech space, when dealing with the human brain it is essential to be intentional and cautious.

The recent Neuralink revelation has highlighted the need for rigorous approvals to ensure the efficacy of new technologies, but this should not detract from the long-term expectations for BCI adoption. It should be emphasized that this was an issue of data capture, rather than a safety concern, and the novel thread system is unique to Neuralink’s approach. Other companies are utilizing alternative methods, such as Synchron using an endovascular approach, while Motif Neurotech is pioneering minimally invasive techniques that do not penetrate the dura of the brain.

Nevertheless, the regulatory journey serves as an essential gatekeeper that, while time-consuming, is essential to establish the foundational groundwork for safe and effective deployment that will pave the path to widespread adoption.

While lengthy approval processes must remain, regulators are taking a more collaborative approach towards innovation. Last year (2023), the FDA launched its Total Product Life Cycle Advisory Program (TAP) to facilitate faster development and deployment of safe and effective medical devices. This is achieved by fostering closer relationships between the regulatory body and developers that have demonstrated strong safety and efficacy in conjunction with novel or superior approaches. In October 2023, the FDA announced the expansion of the TAP pilot to include devices reviewed in the Office of Neurological and Physical Medicine Devices.

This more collaborative approach to oversight, moving away from the perceived adversarial relationships of the past towards strategic partnerships with innovative companies, will help accelerate the pace of innovation and expedite some approval timelines while maintaining the necessarily rigorous standards of safety and efficacy. In the end, patients will win.

While waiting for the longer approval times for implanted neural technologies, increased investment in non-invasive (wearable) BCI solutions will propel the market forward. These solutions are primarily based on electroencephalograms, ultrasounds and magnetic stimulation, such as Magnus Medical, which uses transcranial magnetic stimulation to affect the neural circuits involved in major depressive disorder.

Wearable devices, providing non-invasive brain interfacing, will see earlier and perhaps wider adoption. However, their inability to penetrate deeper into the brain will mean they can only access top-level neural signals, limiting their depth of insight and neuromodulation capabilities.

As such, implanted devices – without the skull as a barrier – will be required to penetrate deeper into the brain to access and transmit neural data with greater depth and specificity. While being invasive may pose greater procedural risks and regulatory hurdles, implanted BCIs will eventually be able to reach deeper and access the cerebral sulci to address a greater number of disease states.

In the continuum of BCI development, wearables and implanted solutions represent complementary approaches to the same goals of greater efficacy, accessibility, and ultimately patient benefit. We are seeing this with companies such as ONWARD Medical running simultaneous external and implantable development programs.

As the technology continues to advance, demonstrating solutions’ long-term efficacy represents a key challenge, as BCI devices must be implanted in people’s brains for 5–10 years to establish their safety, which cannot be artificially accelerated.

Given the complexities involved with neuromodulation, it can be tempting to hold devices to a higher standard. While understandable, we should not impose excessive requirements, which are not required by alternative solutions and may hold back the commercialization of these technologies.

This is especially true for cases where devices have the potential to become first-line care, such as with spinal cord injuries or neuropsychiatric disorders. Some models can validate devices for chronic implementation by simulating the body’s response over time, and standards for certificating devices are already stringent. While these should be maintained to establish efficacy and minimize risk, we should not look to establish new performance standards that exceed requirements and stymie innovation.

Continually pushing the boundaries of science and creating stronger starting positions following each discovery will help to propel the industry. Every new iteration, research or commercial project, will allow the industry to learn more and progress. This could help to further shorten timeframes, while working within existing safety protocols.

As BCI-focused innovation reaches a tipping point, the rapid pace of innovation must be tempered by a commitment to ethical principles. Issues relating to privacy, consent and societal impact all demand careful consideration. This is our one chance to get it right and, dealing with the human brain and people’s neurological wellbeing, we must ensure we proceed in an ethically sound way.

Prudens qui patiens – the prudent man is patient.

We have the opportunity to learn from past endeavors and proceed guided by ethical principles that can best serve all people. If that means going slower to do it, whether through regulatory oversight or strict adherence to ethics, it is the right thing to do.