Neuroimplants. Collapse of technology?
Adam Jensen's quote “I never asked for this” is extremely opposite to my views on the development of technology. And in the merging of the human mind with neuroimplants, I see almost evolutionary potential and the formation of a new species. But the most optimistic views of progress inevitably collide with reality. And this reality paints a very difficult picture.
While some people drink glycine and theanine so that “everything is fine in their head,” others would like to integrate a chip so that it can somehow take out this whole life. Nootropic drugs, the culture of biohacking, the difficulties of working with a regimen and lifestyle – all this is an excellent layer for moving towards something more than a person. But this path has its obstacles.
Brain neuroimplants. First problems
Technologies for installing implants in the brain have advanced significantly, at the same time making life easier for people with neurological diseases. But given the rapid development new generation neuroprostheses One unforeseen risk arises – what happens when the implants already installed become obsolete or their manufacturer goes bankrupt?
Current status of neuroprostheses
Tremendous advances in medical technology have led to increasingly sophisticated implantable neurological devices such as deep brain, vagus and spinal cord stimulators. Neuralink Elon Musk or interface man-brain-computer (BCI) remain the best known devices. China recently presented his own BCI implant. And it is quickly catching up with the United States in the field of neurotechnology.
Implanted devices have already improved the quality of life of people suffering from neurological diseases. But given the rate of development we are currently seeing, what happens when implants become obsolete? Or will they lose technical support from the manufacturer, similar to how Windows stops supporting outdated versions of the operating system? Will it be possible to remove the implant, and if so, who pays for it?
It all comes down to this: should there be safeguards in place to deal with such situations? Some people believe that the manufacturer must take responsibility for removing the chip. In a recently published research from the Norman Fixel Institute for Neurological Diseases in Florida, proposes a formal definition of “rejection of an implanted neurological device,” which researchers say is important for developing guidelines, policies and laws regarding neuroimplants.
Neurotech incident
In 2020 journal Nature Medicine released material about Australian Rita Leggett, who received an experimental brain implant to treat epilepsy. The device implanted as part of a clinical trial worked. Rita's seizures stopped. However, in the middle of the tests, the company NeuroVista, which created the device, closed down. The reason was investor distrust in the technology itself.
Since the company closed, no one monitored the device. In Rita Leggett's head there was literally a microcomputer with a working battery that would last for another three years. Rita's husband offered to buy the device from NeuroVista, but was refused due to the special components of the implant. The only way out of the situation was to remove the device.
Imagine that when you buy a smartphone, you agree in advance to give the same amount when you want to get rid of it. It makes no difference whether this happens due to its breakdown, or because you decided to simply “be without it.” Neurofeedback for prosthetics It is just as difficult to eradicate from oneself as it is to introduce it into the body.
According to Frederick Gilbert, an associate professor at the University of Tasmania who specializes in the ethics of neurotechnology and was interviewed for the Nature Medicine article, removing the device is tantamount to stopping treatment. The reason is that the devices seriously affect the patient's personality. The difficulty caused by device removal may be directly proportional to the effectiveness of the technology. Maybe the potential for technology development lies in symbiosis of EEG and neural networks.
Who is guilty?
The authors of the current study concluded that failure of the clinical trial would not be a failure of the neuroimplant. After all, failure will be a safety problem or lack of therapeutic effect. However, the authors have developed a system of criteria for how a manufacturer should behave in order to remain on the “right” side of the failure.
First, study participants must be informed of the possibility of stopping the study and that they will be assigned to the treatment or control group of the study.
Second, participants must be notified of the conditions under which the study will be terminated.
Third, participants must be provided with resources for other treatments that meet accepted standards of care.
Of course, in addition to the problem of premature termination of the trial, there is a nuance with the fate of the implant when the trial reaches its natural conclusion. In this situation, study participants are usually asked to remove the device. In the US, this occurs after researchers contact health insurance companies to find out will they cover the costs . There are currently no clear recommendations regarding whether the implant remains or is removed.
The collapse of neurotech companies
It was expected that by 2026 the global neuroimplant market would reach US$17.1 billion. However, this does not guarantee that the companies producing these products will remain afloat. NeuroVista isn't the only company that has closed its doors to customers.
Autonomic Technologies (ATI) went out of business in 2019 after successful placebo-controlled trials of a stimulant that treats cluster headaches. The company closed due to regulatory fraud, but the result for more than 700 There was only one person using the device:
People were unable to access the software needed to calibrate it and maintain the effectiveness of the neuroimplant. The conflict, so to speak, is on the level of Sony and Helldivers. Luckily Unity HA acquired ATI intellectual property and in 2022 received from the FDA breakthrough device status.
Nuvectra, manufacturer of a spinal cord stimulator for the treatment of chronic pain, filed for bankruptcy in 2019. That same year, artificial vision implant company Second Sight began losing money and advised manufacturers stop production retinal implants to focus on brain implants that restore vision. At the beginning of 2020, the CEO and R&D director suddenly quit, most of the employees were laid off, and the company began auctioning off its physical assets, causing the approximately 350 people equipped with Second Sight implants to become a little nervous.
Shortly after this incident, the company merged with Nano Precision Medicine (NPM). And in mid-2020, another manufacturer of spinal cord stimulators, Stimware, recalled all of its devices and filed for bankruptcy in 2022. At the same time, Stentrode, which produces neuroimplants to combat paralysis feels overall confident.
When companies like these go out of business, the implants usually remain in place. In most cases, explantation is considered too expensive, too risky, or simply unnecessary. And people with neurological diseases roll back in their condition, albeit with additional useless equipment.
With luck, customers may be able to find a replacement device, but this is unlikely. According to an article published in Nature magazine in 2022, replacing older implants such as the Nuvectra spinal cord stimulator requires surgery with a recovery time of several weeks. Plus, it's expensive. The surgery and replacement of the device will cost approximately $40,000. And this is provided that a replacement implant has already been purchased separately.
Device durability: to remove or not to remove
As mentioned, neuroimplants that are considered cutting-edge today may be obsolete tomorrow. These devices have an expiration date after which their operation is impossible without ongoing maintenance and support.
In the summer of 2020, Elon Musk shared information about the progress of work on the Neuralink implant. Describing the device as “a Fitbit in your skull,” Musk is optimistic when describing the installation process. Considering that a neuroimplant can help people with quadriplegia.
Essentially, you are losing an extremely small portion of your skull. We remove a fragment of the skull about the size of a coin, and then the robot inserts the electrodes… After installing the electrodes, the device replaces the removed part of the skull. And we, in fact, go over the top with superglue, which is used to stitch up many wounds. And immediately after the procedure you can safely go for a walk, which is pretty cool.
Elon Musk
Yeah cool. But no less interesting is the section of the presentation dedicated to Dorothy the pig, who used to have Neuralink. Musk said removing Dorothy's implant demonstrated the “reversibility” of the device.
The Dorothy example shows that you can plug in a Neuralink, use it, remove the implant, and be happy, healthy, and indistinguishable from the rest of your species.
Elon Musk.
That's all Musk said regarding the removal of the device. And nothing about risks.
Musk's brain implant company has since abandoned pigs and begun recruiting subjects for its first human experiment. But first he had to fight the FDA for approval. In 2023 Reuters said the FDA rejected an application to approve the trial on patient safety grounds, citing, among other things, serious concerns about how the device could be removed without damaging brain tissue. However Musk has already received approvalso the FDA is generally satisfied.
It's hard to find expert commentary on whether removing a Neuralink – or other brain implant – will damage the brain or not. If we try to look at the situation objectively, now is the time when we are operating only with assumptions. But if installing a device like Neuralink carries the risk of damaging brain tissue, it stands to reason that removing it also carries risks.
Brain neuroimplants and legal aspect. What is “implanted neurological device refusal”?
The researchers reviewed articles on cases of neuroimplant failure before reaching consensus on an appropriate definition. They propose combining the following criteria to formulate a justified refusal of a neuroimplant:
Failure to provide information regarding the presence or absence of medical, technical and/or financial liability plans as fundamental aspects of patient consent during and after a clinical trial.
Failure to meet reasonable responsibility for providing medical, technical and/or financial support until the end of the implantable device's stated life.
Failure to meet any immediate needs, such as troubleshooting or reprogramming an implant. Which may lead to safety issues and/or poor performance of the device.
A failed clinical trial if or when (1) informed consent did not provide ongoing access to and control of the implanted device as stated above and/or other devices that can be demonstrated to have equal or greater therapeutic value in the future and (2) those responsible for the study failed to make reasonable efforts to ensure continued access to the device and support for patients who would benefit from the device.
The issues raised in this article make it clear that more precise and consistent guidelines are needed in this rapidly evolving field to protect patients and their physicians.
What's the result?
Personally, I see this as “settling down the neuroimplant market.” The previous wave of hype could not last forever and extrapolation from Moore, now deceased, will not work here. Bold expectations and ambitions gave rise to startups and projects. But when the technology moved beyond the laboratory, it was forced to face realities.
In simple words: some companies will leave the market, some startups will close, and inevitably there will be people who will suffer from this. But does this mean that the entire field of neurotechnology will collapse? Of course not. What is happening with neuroimplants today is a childhood disease of any technology related to health and productivity. And, personally, I believe in the scenario that in 15-20 years someone will read this article using only volitional effort and a neural interface.
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