There are quite a few companies trying to connect a computer directly to your brain, but only one gets all the attention right now. That’s because Neuralink is the one run by Elon Musk. Musk’s brain implant startup became the latest to receive FDA approval to begin clinical trials in humans last week. Normally, catching up to the rest of the pack isn’t the kind of story that makes national news, but Musk has a way of making his ideas seem unique. In this case, he’s made a huge sales pitch for his product, tying it to the idea of humans competing with AI — and everyone wonders where exactly he might take it long-term. But in the short term, Neuralink is a window into a different important question: What happens when a tech-style mogul tries to make the leap into health care? The fields are superficially similar — highly profitable, with a hyper-educated workforce and venture-backed idea ecosystem — but health care operates with far more stringent regulatory controls, and requires much deeper reservoirs of consumer trust. The market Neuralink has chosen isn’t exactly easy to enter or compete in. Brain-computer interfaces are built to correct for severe impairments: According to its website, Neuralink is currently intended for people with quadriplegia, meant to give them the ability to control digital devices with their thoughts. Other BCIs are being tested on people with severe paralysis in both upper limbs or neurodegenerative diseases like ALS. Part of the challenge with devices like this is simply time. Musk is known for radically speeding up slow industries like EV carmaking or private space travel. But medical devices move on a timeline of their own, and other firms are already ahead, at least in proving their devices’ safety. Synchron, a Neuralink rival backed by Jeff Bezos and Bill Gates, published a study earlier this year with four severely paralyzed patients and found they could control a computer only through brain activity. That study took almost two years to complete and required follow-up visits and training sessions at home and at a university clinic in Australia. The largest ongoing trial of intracortical BCIs concluded just this year after analyzing over 17 years of safety data from clinical trials. That came from the team behind BrainGate, a multi-institutional effort that began at Brown University. Regulators have made some efforts to speed things up: Last year, the rapid progression of the BCI field prompted the FDA to issue specific recommendations on non-clinical testing for BCIs to make the regulatory process more efficient for its many entrants. But speeding up can only go so far: Since so little data is available on the long-term efficacy and safety of these devices, the FDA recommended a minimum follow-up period of a year after clinical trials are conducted — adding to the total time any clinical trial would take. Of course that is not fast enough for an entrepreneur, and in typical Musk fashion, the CEO reportedly put Neuralink employees under immense pressure to speed up animal trials in order to begin human trials, leading to botched animal experimentation, a Reuters investigation revealed. In December 2022, the USDA’s watchdog, the Office of the Inspector General, launched an investigation into the company for potential animal-welfare violations. The same investigators were also scrutinizing the USDA itself for their past oversight of Neuralink. Neuralink did not respond to a request for comment for this story. In response to allegations of animal abuse, the company released a blog post in February 2022 saying it was “absolutely committed to working with animals in the most humane and ethical way possible” and noted that (as of the time of the post) it had “never received a citation from the USDA inspections of our facilities and animal care program.” That’s not the end of the company’s federal challenges. As recently as February, Neuralink was under investigation again, this time by the U.S. Department of Transportation, for allegedly packaging and transporting contaminated hardware in an unsafe manner back in 2019. All those issues are hurdles you can expect to hit when you move quickly through a super-regulated area like health care. Another one will come at the far end of the process. Right now, Musk is selling Neuralink not just as useful to people in need, but as cooler than the competition: he talks about it in very Silicon Valley terms as the fastest and highest-bandwidth connection being tried. “The constraint on having human interests align with machine interests is bandwidth, especially the output,” said Musk at Wall Street Journal’s CEO Council last week. He was referring to the bit-rate at which people can type or speak into existing digital devices. “With Neuralink, you can increase that by a million, probably.” He veered off the company’s therapeutic message to tease the idea of more sci-fi human enhancement. “How do we even appreciate or understand what the computer is doing? How do we go along for the ride? And if we have a better brain-machine interface that's a million times faster, then we'll go along for the ride a lot better than interfacing with a phone using two slow moving meat sticks.” Musk added. But Neuralink is not — and will not be, for many years — a consumer product like a car, or a social-media platform. Even for the people who need it most, the demand might not be automatic. When the team at BrainGate analyzed their 17 years of safety data on clinical trials, they noted that not everyone might want a device that helped them in this way. Ultimately, they concluded the “potential utility of implanted BCIs will reflect the personal risk/benefit assessment of the people for whom these devices are being developed” — that is to say, each person will have to determine whether the risk of getting a brain implant is worth the potential benefit. The people Musk will ultimately have to convince are risk-averse FDA regulators, and the doctors who will recommend the implant, and the patients who will have it inserted into their most complex organ, and the caregivers who will have to deal with the results — that’s a tall order for any tech company. | 
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