Nature asks a question that doesn’t have an easy answer. Medical implants – especially newer ones that interface directly with your brain – are designed for the long term, to give as close to a lifetime of service as possible. But they’re made, mostly, by tech startups. And those companies are, more and more often, designed to rise up, get a product to market, and then get shuttered by their VC investors who are there to maximize their returns with the next big thing. So if you’ve got a life-changing piece of brain hardware that’s aging and needs a tune-up, who do you go to once the inventors have gone belly up?:
Developed by the start-up Autonomic Technologies (known as ATI) in San Francisco, California, the device had passed a series of placebo-controlled clinical trials with flying colours. “It worked remarkably well,” says Arne May, a neurologist at the University of Hamburg in Germany who led some of those trials on behalf of the start-up. In most people, stimulation reduced the pain of an attack, made attacks less frequent, or both1. Side effects were rare. In February 2012, while US trials continued, the European Medicines Agency granted the company approval to market the device across Europe.
[Markus] Möllmann-Bohle contacted May, and travelled from his home near Düsseldorf, Germany, to meet him. Filled with hope that this might alleviate his suffering, Möllmann-Bohle underwent surgery to have the device fitted in 2013.
The implant was a revelation. After the pattern and strength of the stimulation had been tailored to Möllmann-Bohle’s needs, around an hour’s use five or six times a day was enough to prevent attacks from becoming debilitating. “I was reborn,” he says.
But, by the end of 2019, ATI had collapsed. The company’s closure left Möllmann-Bohle and more than 700 other people alone with a complex implanted medical device. People using the stimulator and their physicians could no longer access the proprietary software needed to recalibrate the device and maintain its effectiveness. Möllmann-Bohle and his fellow users now faced the prospect of the battery in the hand-held remote wearing out, robbing them of the relief that they had found. “I was left standing in the rain,” Möllmann-Bohle says.
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For example, in 2013, the US Food and Drug Administration approved a closed-loop system for people with epilepsy. The device detects signs of neural activity that could indicate a seizure and stimulates the brain to suppress it. Some researchers are aiming to treat depression by creating analogous devices that can track signals related to mood. And systems that allow people who have quadriplegia to control computers and prosthetic limbs using only their thoughts are also in development and attracting substantial funding.
The market for neurotechnology is predicted to expand by around 75% by 2026, to US$17.1 billion. But as commercial investment grows, so too do the instances of neurotechnology companies giving up on products or going out of business, abandoning the people who have come to depend on their devices.
Shortly after the demise of ATI, a company called Nuvectra, which was based in Plano, Texas, filed for bankruptcy in 2019. Its device — a new kind of spinal-cord stimulator for chronic pain — had been implanted in at least 3,000 people. In 2020, artificial-vision company Second Sight, in Sylmar, California, laid off most of its workforce, ending support for the 350 or so people who were using its much heralded retinal implant to see. And in June, another manufacturer of spinal-cord stimulators — Stimwave in Pompano Beach, Florida — filed for bankruptcy. The firm has been bought by a credit-management company and is now embroiled in a legal battle with its former chief executive. Thousands of people with the stimulator, and their physicians, are watching on in the hope that the company will continue to operate.
When the makers of implanted devices go under, the implants themselves are typically left in place — surgery to remove them is often too expensive or risky, or simply deemed unnecessary. But without ongoing technical support from the manufacturer, it is only a matter of time before the programming needs to be adjusted or a snagged wire or depleted battery renders the implant unusable.
People are then left searching for another way to manage their condition, but with the added difficulty of a non-functional implant that can be an obstacle both to medical imaging and future implants. For some people, including Möllmann-Bohle, no clear alternative exists.
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A greater challenge arises when no ready replacement is available. The stimulator made by ATI that Möllmann-Bohle and White have was the first of its kind. When the manufacturer closed its doors, there was no other implant on the market that they could use to manage their cluster headaches.
Left to fend for themselves, White and Möllmann-Bohle each leant on their own professional expertise. White drew on his medical training and found a drug, developed for treating migraines, that suppresses his headaches. But he must take triple the recommended dose, and worries about potential long-term side effects.
Möllmann-Bohle, meanwhile, turned to skills he developed as an electrical engineer. In the past three years, he has repaired a faulty charging port on the hand-held portion of his device and replaced its inbuilt battery several times. This battery was never intended to be accessible to the user, and it turned out to be unusual. Möllmann-Bohle scoured the Internet and eventually found suitable replacements made by a firm in the United States. When he returned for more, however, he learnt that the company had stopped making them. His most recent replacement came from a Chinese company that custom made what he needed.
His tinkering brought him into conflict with his insurers, who initially advised him not to tamper with the device, but eventually agreed to foot the bill for the replacement parts, after he convinced them he was suitably qualified. “They put really big obstacles in my way, or at least they tried to,” Möllmann-Bohle says. But although his repairs have been successful so far, he knows that he does not have the tools or skills to fix everything that could go wrong.