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Konstantin Slavin is a neurosurgeon at the University of Illinois College of Medicine in Chicago, who contributed to clinical trials of ATI’s cluster-headache device and implanted the spinal-cord stimulator made by Nuvectra. He thinks that anyone given an implanted device as a part of routine clinical care should be able to count on ongoing support. “You expect them to receive essentially lifelong care from the device manufacturer,” he says.

He is not alone in this view — every device user, physician and engineer Nature interviewed thinks that people need to be better protected from the failure of device makers.

“You expect them to receive essentially lifelong care from the device manufacturer.”

One proposal is that neurotechnology companies should ensure that there is money available to support the people using their devices in the event of the company’s closure. How this would best be achieved is uncertain. Suggestions include the company setting up a partner non-profit organization to manage funds to cover this eventuality; putting aside money in an escrow account; being obliged to take out an insurance policy that would support users; paying into a government-supported safety network; or ensuring the people using the devices are high-priority creditors during bankruptcy proceedings.

“Long-term support on the commercial side would be a competitive advantage” — Ronald Triolo

Currently, there is little sign that device makers are taking this kind of action. Asked in July if Realeve had plans in place to protect people should its business go the same way as ATI, Snyder, then chief executive, replied: “There is always the risk that a company may stop operating, but our focus is to be successful in our effort to deliver the Realeve Pulsante therapy to patients”.

Realeve’s interim chief executive Donato thinks that it will take legislation to convince investors or shareholders in companies to take on the expense of a safety net. “Unless, and until, the governments force it on us,” he says, “I’m not sure companies will do it on their own.” But Triolo is optimistic that manufacturers might think differently if the jeopardy faced by device users becomes more widely known, and physicians and prospective patients start to favour companies that do have a safety net in place. “If that is what it takes to have a competitive advantage, maybe that’ll be enlightening for our friends on the commercial side of things,” Triolo says.

Indeed, the failures of various neurotechnology start-ups over the past few years are already causing the surgeons responsible for implanting the devices to be cautious.

“Making patients the victims of bad business practices or a bankruptcy is horrible for them, horrible for the field, and grossly unethical.”

Robert Levy, a neurosurgeon in Boca Raton, Florida, and a former president of the International Neuromodulation Society, was particularly burnt by the demise of Nuvectra. He had been sufficiently impressed with its technology to become chairman of the company’s medical advisory board in August 2016. But in 2019, around five months before Nuvectra filed for bankruptcy, he cut ties after what he and others formerly associated with the firm saw as the company side-lining the needs of people using the implant in its attempt to stay afloat. “All of us who had any association with the company at that time expressed our severe dissatisfaction with such a move, which we felt was unethical,” Levy says.

From now on, Levy requires any new company that asks him to implant its product to send him a letter guaranteeing support for the people who have the surgery should something happen to the business. “If they should not supply such a letter, they’re not going to be included in my practice,” he says.

He plans to write an editorial arguing for this approach in the journal Neuromodulation, of which he is editor-in-chief, to further raise awareness and put pressure on neurotechnology companies. “Patients are suffering terribly,” he says. “Making them the victims of bad business practices or a bankruptcy is horrible for patients, horrible for the field and grossly unethical.”

Parts from cardiac pacemakers have been standardized since the 1990s. Credit: Louise Oligny/BSIP/Alamy

Parts from cardiac pacemakers have been standardized since the 1990s. Credit: Louise Oligny/BSIP/Alamy

Momentum is also building behind another way to protect people with implants: technical standardization. The electrodes, connectors, programmable circuits and power supplies used in implanted neurotechnology are often proprietary or otherwise difficult to source, as Möllmann-Bohle discovered when looking for replacement parts for his stimulator. If components were common across devices, one manufacturer might be able to step in and offer spares when another goes under.

A 2021 survey of surgeons who implant neurostimulators showed that 86% backed standardization of the connectors used by these devices2. Such a move would not be without precedent, says retired neurosurgeon and medical-device engineer Richard North, formerly at Johns Hopkins Medical School in Baltimore, and president of the Institute of Neuromodulation in Chicago, who led the survey. Cardiac pacemakers have included standardized elements since the early 1990s, when manufacturers voluntarily agreed to ensure that any company’s power supply could fuel a pacemaker from any other company. Many of those same companies are now the biggest names in spinal-cord stimulators and DBS systems.

“It’s inevitable that there will be standardization, and I think the companies involved recognize that too.”

North now co-chairs a Connector Standards Committee for the North American Neuromodulation Society, of which the Institute of Neuromodulation is a part, that is promoting the idea. Although the industry has not raced to embrace further standardization, he thinks it is only a matter of time. “It’s inevitable that there will be standardization, and I think the companies involved recognize that too,” he says. As well as making replacement components easier to come by, North thinks that standardization would boost innovation by encouraging companies to develop components that can be used with a wide range of existing systems.

Peckham hopes that the neurotechnology field can go even further — he wants devices to be made open source. Under the auspices of the Institute for Functional Restoration, a non-profit organization that he and his colleagues at Case Western established in 2013, Peckham plans to make the design specifications and supporting documentation of new implantable technologies developed by his team freely available. “Then people can just cut and paste,” he says.

This marks a major departure from the proprietary nature of most current devices. Peckham hopes that other people will build on the technology, and potentially even adapt it for new indications. The benefits for the people using these devices are at the centre of his thinking. “It starts with a commitment to the patients, to the people who can benefit from this,” he says.

It is exactly that sort of commitment that people such as Möllmann-Bohle, White and French want to see — and which they think they are entitled to. A raft of new companies are developing evermore sophisticated neurological implants with the power to transform people’s lives. Should any fail, it is the people using the devices, and their physicians, who will be most affected, says Triolo.

The recent run of commercial casualties demonstrates the human cost of abandoning neurotechnology. “It’s impossible,” Triolo says, “for people not to know that this is becoming a bigger and bigger issue.”


Table of Contents

  1. J. Schoenen et al. Cephalalgia 33, 816–830 (2013). Article
  2. R. B. North et al. Neuromodulation 24, 1299–1306 (2021). Article

Author: Liam Drew

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