Progress is being made. The company was granted an exemption from the FDA in August of 2020. It took five years and a lot of work to get to this point. Four patients who had been implanted with the device for a year were found to be safe.
The company is trying to find out if the procedure can be done on multiple patients with no serious side effects. The trials are trying to figure out if the implant could be put into everyone's brain. The device will be implanted into 15 patients before the end of the century.
Synchron will have to show that the technology improves aspects of its users' lives in the next phase. The patients will be consulted to find out what they want from the implant. The company will apply for FDA approval and make a case for the device to be made available under Medicare once the trial is over. It's important to go through Medicare to make the device accessible to as many people as possible. The price of the implant will be in the order of magnitude of the cost of a car, but he wouldn't say what kind of car.
There are ethical, legal, and social risks when technology enters the commercial space. Neural data is the key ingredient in the device. There are questions about how long the data should be stored, who owns the data, and who gets to do what they want with it.
"If this is private corporations with commercial interests in the data, is there anything kind of risky if it's monopolized in one set of hands?" Do patients get to keep the device if the company runs out of cash? Would the company be responsible for removing it if they wanted to? The technology shouldn't be stopped because of ethical mines. Be aware of the types of risks, pitfalls, challenges and address them early on and prepare, while pursuing the benefits of this as well.
Ian Buckhart, who was paralyzed from the chest down after a spinal cord injury, says that the BCI space is becoming more competitive. The BCI Pioneers Coalition is a group of BCI users who share their experiences. Big names like Musk have drawn attention to the field because of the rush to market. You want to make sure that things are being done the right way. It is important to have good faith in companies that are doing things for the right reason.
The disabled community is worried that the BCI hype won't lead anywhere. How long the device can last in the body is one of the questions Buckhart is pondering. Synchron's device is permanently implanted, which is crucial to making it commercially viable, but it is also a factor that Buckhart thinks may put some patients off.
Oxley would like to see a million implants a year. He thinks it will take about 20 years to reach that goal. Even though he doesn't like it, he appreciates the discourse surrounding the technology. He wants the world to know that technology will help people. The reality is that people need this technology, and they need it now, even though there may be negative aspects to it.