During the Paralympic Games in Paris, a woman born with a cerebral motor disability took part in the torch relay by controlling an exoskeleton arm, using only the power of her mind. While the achievement made headlines, it is one of dozens of recent advances in the field of neurotechnology empowering individuals to control devices directly from their brain.
BCIs connect the brain to external devices with the potential to restore motor function in patients, improve cognitive abilities, and even achieve deeper human-machine interactions for sufferers of neurological conditions ranging from Parkinson’s disease to depression. The potential for commercialization has piqued investor interest. A funding round last December saw one startup raise over USD 100 million, valuing it at USD 500 million. Within a decade, the market for BCIs could be worth USD 1,5 billion in the US alone.
Companies and academic researchers operating in this space share the same goal: to capture enough information from the brain’s neural signals to decipher the user’s intention. Routes to achieve this differ and are categorized by their invasiveness. While some techniques require surgery to implant chips close to the cortex, others rely on external sensors. There’s an inherent trade-off. As the Massachusetts Institute of Technology (MIT) puts it, the deeper the electrodes go, the more invasive the surgery required to plant them, and the greater the risks. But going deeper also puts the electrodes closer to the brain activity, which means the device can capture information with higher fidelity.
Medical applications, both surgical and non-surgical
The initial market for BCIs is medical, notably to aid communications for people who can’t easily move or speak, either by helping them navigate a computer cursor or by translating their brain activity into speech or text. A clinical trial led by researchers at UC Davis claimed a breakthrough last August from a neuro prosthesis device implanted into the brain of a man with severely impaired speech due to amyotrophic lateral sclerosis. Four microelectrode arrays were attached to the left precentral gyrus of the patient, a brain region responsible for coordinating speech. The man was able to communicate speech with 97% accuracy “better than many commercially available smartphone applications that try to interpret a person’s voice”, according to the neurosurgeon behind the study.
Another approach, termed functional neuro intervention, is designed to tap the brain’s signals without intracranial surgery. A neurotech startup backed by Microsoft co-founder Bill Gates and Amazon founder Jeff Bezos has patented a stent-like device that can be inserted through a patient’s jugular vein and delivered to the blood vessel that rests on the surface of the brain’s motor cortex. The company has also built a chat feature that generates prompts patients can use while texting. Results from a handful of trial implants in the US and Australia are encouraging.
Consumer wearable neurotech
Some BCIs do not require any surgical intervention. A number of these are designed to aid mental wellness, for example by enhancing sleep using audio therapy to track brain activity. Some work through bone-conduction speakers, others use a combination of headsets and electrodes applied to the head which deliver an electrical pulse to stimulate nerves that indirectly influence the body’s hypothalamus and circadian rhythm.
Ten million people in the US have been identified as candidates for BCI treatment (both invasive and non-invasive) but the market for non-medical applications is expected to be much larger. Several companies showcased examples at the CES as part of an emerging category of wearable neurotech which could also, in time, enable direct brainwave interaction with video games, drones and other electronic devices.
The CEO of one company aims to create an “everyday brain-computer interface” that can help people struggling with burnout, fatigue and productivity. Its smart headphones are like “a Fitbit for your brain” and could be the first in a new line of consumer-friendly brain-reading wearables. Combining AI and sensors, the smart headphones translate the electric activity of the brain into usable information for the wearer.
Where the IEC can help
The IEC has set up a Systems Committee on Active Assisted Living (SyC AAL), which focuses on the standardization of AAL products, services and systems to enable independent living for elderly or disabled users. It also enables cross-vendor interoperability of AAL systems, services, products and components. AAL systems and products may include alarm systems, wearables and even, if they ever become ubiquitous, BCIs.
The joint IEC and ISO technical committee which prepares standards for information technology, ISO/IEC JTC 1, oversees a subcommittee specifically set up to standardize BCIs. It cannot standardize brain implants or medical devices but should be able to look at wearable devices. IEC TC 47 publishes key standards for the design, use and reuse of sensors, enabling users to measure their performance. Focusing on wearables, IEC TC 124 publishes standards for technologies which include patchable, ingestible and implantable materials and devices and electronic textile materials and devices. IEC TC 62 prepares standards for medical equipment, software and systems. Its work is focusing more and more on the use of AI in medical applications and digital health, enabling the patient to control his health by using wearables at home. AI tech is standardized by JTC 1/SC 42, which is cooperating with IEC TC 62 on several of these standards.
On the conformity assessment side, IECEE offers testing and certification for the safety, reliability, efficiency and overall performance of electrical equipment for medical use to IEC International Standards. In addition, IECQ enables assessment of sensor manufacturers and associated service providers to see if they comply with the agreed international standards.
The future of BCI tech and risks ahead
Standards will obviously help in making sure the tech brought to market is both safe and efficient. They should also favour the lowering of prices in the medium term, by ensuring a level playing field for all the companies involved in this very exciting space.
The CEO of one BCI developer with a market leading cap of USD 5 billion thinks brain implants could soon cost as little as USD 1 000 – 2 000. It completed its first surgical implant on a human in January 2024, reporting in May that the patient, a quadriplegic, had since managed to control his laptop, play online computer games with friends and browse the internet, “all by controlling a cursor with his mind. He has even played Mario Kart on a Nintendo Switch console — something he had not been able to do since his spinal cord injury.”
Advances in artificial intelligence (AI) mean that the decoding and translations of brainwaves into actions will become even more accessible. As of today, only a handful of BCIs have been implanted in humans and while trials are being ramped up, no invasive BCI technologies have received national approval to commercialize. Given the risks of brain surgery from most surgical brain implants, the need to ensure the safety and effectiveness of devices and medical procedure is paramount. The BCI implant of the same patient mentioned was also reported as having become slightly detached from the brain following the procedure. While not life threatening, the company had to modify its algorithms for the BCI to continue to function.
In addition, the popularization of BCI technology will create ethical and privacy issues. The company working with OpenAI deemed it necessary to state it does not share the user’s brain data with the tech giant. As with the wider AI market, these issues will need only be solved with the joint efforts of standards organizations, regulatory agencies, tech companies and the academic community.
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