At the frontier of scientific exploration, few fields captivate the imagination like neurotechnology. With its promise to decode the mysteries of the nervous system, neurotech holds the potential to revolutionize how we treat disease, enhance human capabilities, and better understand ourselves. Achieving these breakthroughs is not about taking small steps, but daring to leap and embarking on moonshots that challenge deeply held assumptions to push the boundaries of possibility. However, we must be mindful of the human tendency for old ideas to lead to confirmation bias. This can limit our ability to see beyond current assumptions in creating better applications.
It’s a dogma-eat-dogma world
The history of neuroscience is replete with examples of long-held beliefs that were eventually overturned. Examples include the “single neurotransmitter dogma” that each neuron produces only one type of neurotransmitter, or the “static adult brain myth” that adult brains do not grow new neurons. These serve as reminders of the importance to challenge established beliefs and remain open to new possibilities. To achieve moonshot breakthroughs in neurotechnology, we must question the very foundations of knowledge. Current paradigms, no matter how established, should be scrutinized with a critical eye.
Strategies to facilitate disruptive innovation
1. Create a space open to new ideas
To foster truly innovative moonshots in neurotechnology, we must create intellectual and experimental spaces for new ideas to flourish. This requires a willingness to challenge current limitations and question beliefs or assumptions that may be preventing exploration of new avenues. For example, are we overly focused on neuron-centric models at the expense of understanding the role of glial cells in cognition? And, if so, are we using the understanding of different types of neurons to develop more precise and effective treatment options? Keeping these nuances of cells in mind may enable more seamless integration with the nervous system while keeping it in balance.
We must also embrace complexity and recognize that biological systems, especially the human brain, operate in intricate and nonlinear ways. This calls for interdisciplinary approaches that can capture this complexity, such as integrating insights from chaos theory, network science, or quantum biology.
Researchers must also be open to exploring alternative paradigms and actively pursue other explanations or mechanisms for observed phenomena. For example, whether consciousness can arise from quantum effects in microtubules within neurons, as proposed by Hameroff and Penrose’s Orch-OR theory.
2. Hold onto ideas, but not too hard
It is crucial to cultivate a mindset of intellectual humility and flexibility, in order to avoid the pitfalls of confirmation bias and dogma. Constantly questioning our own assumptions and probing potential flaws in our theories, can identify blind spots in our thinking and open new avenues for exploration. At the same time, encouraging constructive skepticism can foster a research culture that values and rewards thoughtful criticism and alternative viewpoints, rather than confirmatory results.
We must also be open to considering multiple hypotheses and actively explore alternative explanations or mechanisms, no matter how unlikely they may seem at first. This approach, the method of multiple working hypotheses, can lead to unexpected insights and breakthroughs. One example is in neuroplasticity. Despite the Hebbian rule of “cells that fire together wire together,” staying open to the possibility of other forms of plasticity has allowed people to find that there are other plasticity rules, such as anti-Hebbian and homeostatic plasticity. With multiple ways for the nervous system to undergo changes, these mechanisms might be leveraged for therapeutic development.
3. Embrace an integrative approach inside and out
Embracing an integrative approach to neurotech can open a new frontier of innovation and the introduction of groundbreaking solutions to address neurological disorders and advance human health. By recognizing the intricate connections between the brain and other bodily systems, such as the gut-brain axis and neuroimmune interactions, we can develop more holistic and effective interventions.
This approach, leveraging insights from bioelectricity, the autonomic nervous system and neurocardiology, can create comprehensive solutions that address the complex interplay between neural and physiological processes. This presents an unprecedented opportunity for neurotech innovators and entrepreneurs to tap into previously unexplored markets, positioning their organizations at the forefront of a transformative wave in medical technology and human augmentation.
Neurotechnology is inherently interdisciplinary, encompassing a wide range of disciplines, including biomedical engineering, computation, and interaction design. Many discoveries and innovations in neuroscience came about through bringing perspectives from other fields. For example, Sonera and NeuroBionics are both leveraging advances in materials science, specifically magnetic resonance imaging (MRI) to improve neural interfaces. While MRI developments did not begin in neuroscience, its origins in physics, engineering, and radiology have helped to chart the nervous system.
Daring to question deeply held beliefs and dreaming big can pave the way for extraordinary advancements – moonshots for those willing to break from conventional thinking and chart new paths into the unexplored territories of the human mind and brain.
Charting the course for moonshots
The next great leap in neurotechnology may not come from incremental improvements to existing approaches, but a paradigm shift that completely reframes how we think about the brain and mind. These strategies offer a framework to push the boundaries of possibility. Challenging ourselves to question assumptions, explore alternative explanations, and collaborate across disciplines in unprecedented ways can open up the possibility of new breakthroughs. These moonshots may revolutionize our understanding of the brain, leading to transformative treatments for a range of neurological and psychiatric conditions.
This article was originally published on February 2nd, 2025, via DotMed
Neuralink’s first successful human brain implantation earlier this year brought brain-computer interfaces (BCIs) back into the spotlight, capturing people’s imaginations with the possibilities – and potential pitfalls – of implanting neuromodulation devices into a human brain.
Despite the recent revelation regarding the retraction of some of its connecting threads, Neuralink nevertheless serves as one example of how the neurotechnology industry is advancing solutions that create direct communication pathways with the human brain. A range of factors, including technological breakthroughs, regulatory issues and strategic shifts, have converged to make 2024 the pivotal year for the growth of BCIs.
Pioneering novel materials spurs advancement
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.
The regulatory landscape: long timelines are essential
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.
Collaborative regulation helps expedite approvals
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.
Joint development of wearable and implanted solutions maintains momentum
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.
Overcoming the challenge of demonstrating long-term efficacy
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.
A point of ethics
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.
This article was originally published in Technology Networks on July 11, 2024.