Synchron is making tangible progress. In August 2020, the company received an investigational device exemption from the FDA, allowing it to become the first company to conduct clinical trials of a permanently implanted BCI. It took five years and a “huge amount of work” to get to this point, says Oxley. A trial in Australia followed four patients who had been implanted with the device for 12 months and suggested that such prolonged use of the device was safe.
The company is now working on the safety and feasibility part of its tests: finding out if the procedure can be performed on multiple patients without serious side effects. The trials also aim to determine how scalable the implant is, whether it could be implanted in everyone’s brain. Synchron plans to implant the device in 15 patients before the end of 2022.
The next phase will be a fundamental test, in which Synchron will have to demonstrate that the technology significantly improves aspects of its users’ lives. This will involve consulting the patients themselves to find out what they hope to gain or regain from the implant. Provided the test goes according to plan, the company will seek FDA approval and make a case for the device to be available under Medicare, the government-provided health insurance program. Going through Medicare is a key step in making the device as accessible to as many people as possible, Oxley says. He is vague about the price of the implant, saying it will cost “on the order of magnitude of the cost of a car” (although he declined to say what kind of car).
But as the technology increasingly enters the commercial space, there are a number of ethical, legal and social risks. The key ingredient of the device is neural data, which is also a highly sensitive reward. Questions naturally arise: how long should this data be stored, what should it be used for outside of the immediate application on the device, who owns the data, and who can do what with it do you want
“If it’s private corporations with commercial interests in the data, is there anything at risk if they monopolize it in one set of hands?” says Jennifer Chandler, a law professor at the University of Ottawa who studies the intersection of brain science, law and ethics. There are questions about what happens if the company runs out of money and goes under: Can patients keep the device? And if they want to take it out, would the company pay for the move? But the various ethical landmines shouldn’t prohibit the technology from moving forward, Chandler says. “My view would be: be aware of the types of risks, pitfalls, challenges and address them early on and prepare, while also pursuing the benefits of that.”
The growing competition in the BCI space has both positive and negative effects, says Ian Buckhart, who had a BCI implanted a few years after a spinal cord injury left him paralyzed from the chest down. Buckhart helps lead the BCI Pioneers Coalition, a collective of BCI users who share their experiences. The rush to market has made things happen faster and big names like Elon Musk have drawn attention to the field. On the other hand, “you want to make sure things are done the right way,” says Buckhart. “You have to have some good faith in these companies doing things for the right reasons.”
A big concern in the disability community is that all the BCI hype will go nowhere. Another question on Buckhart’s mind is how long the device can safely last in the body. Synchron’s device is permanently implanted, which Oxley says is crucial to making it commercially viable, but is also a factor that Buckhart believes may put some patients off.
Oxley dreams of a million implants a year, which is how many heart stents and pacemakers are implanted annually. This goal is between 15 and 20 years, he estimates. And he appreciates the discourse surrounding technology, even if it bothers him. “What I want the world to understand is that this technology is going to help people,” he says. “There seems to be a theme around the potential downsides of this technology or where it could go, but the reality is that people need this technology and they need it now.”