Imagine having an impaired sense restored by an innovative device, only to suddenly lose that function again because the company that developed the device folded, or stopped supporting it and pivoted to other products. Then imagine having no one to turn to — not the company, not the government, and not the medical community — to deal with the aftermath.
That was the experience of the hundreds of people who used Argus II, a retinal implant that restores some aspects of sight for visually impaired people.
Earlier this year, journalists Eliza Strickland and Mark Harris reported in IEEE Spectrum that Second Sight — a company that had for decades been lauded in the press for developing this potentially life-changing device — had abandoned the technology due to the threat of bankruptcy, leaving its patients in the dark. Individuals who had spent hundreds of thousands of dollars to acquire the retinal implant system were left to decide between leaving a now-defunct device attached to their brain or taking on the risk, pain, and cost of having it removed by someone who was not familiar with the particulars of the proprietary implant.
This technology company’s business failure resulted in serious physical, emotional and financial consequences for its users — not to mention their loss of vision. It also presented a drastic example of what might be to come if regulators don’t act fast to protect those who take a chance on cutting-edge medical implants.
Millions of people around the world use implants for treating seizures, improving sound perception, or restoring brain function after strokes or other head injuries. These kinds of medical devices are increasingly being adopted to enhance users’ health or quality of life. To reap the benefits of these tools, individuals often undergo costly, invasive procedures and train their brains and bodies to interpret and coexist with the signals emitted by their implants.
But entanglements between market and medicine have created an environment wherein people who embrace and rely on these new technologies are vulnerable to losing access to the essential functions they come to depend on.
U.S. legislators tend to be reluctant to regulate technologies out of fear of stymying innovation. But the lack of protections in place for those who decide to embrace these potentially life-changing devices makes the cost of adoption extremely high for users. After Second Sight abandoned the Argus II, users not only lost their regained vision but were left with an obsolete device implanted in their brain and forced to decide between the risks of leaving it in, or the risk — and cost — of having it removed.
Yet, despite its irresponsible treatment of those users, last month Second Sight received a new round of funding from the National Institutes of Health to support research and testing of a different neural prosthesis intended to provide artificial vision. If that technology is eventually approved for sale to blind users, who or what will protect them from being abandoned the same way?
The discontinuation of a medical implant is more than a technological failure: It has a significant corporeal and spiritual impact. Medical research and innovation should not be tethered to the whims of the market, and users should not have to fear that devices that support their functions might become permanently discontinued at any point.
Regulators should require that companies developing technologies that become integrated into patients’ bodies and brains have a duty of care and, like medical professionals, should be liable for negligence or malpractice. This would also require them to designate a successor in the event of failure or bankruptcy, so users are ensured indefinite support.
Another related solution is to make public information about proprietary medical devices, either from the start or in the event that bankruptcy or other deviation ensures. With open-source information, a third party would be able to access the information needed to take on the complex responsibilities of supporting implant users in the event of business failure.
Furthermore, as Anders Sandberg of Oxford University’s Future of Humanity Institute argues, potential users of medical implants need to be adequately informed not just about the medical functionality of their implants, but also about the technical and economic implications of taking them on. Otherwise, they stand to face dangerous consequences for their health, finances, and autonomy.
Technologies that have the potential to save or improve users’ lives should remain accessible, even if they become unprofitable. The burden of business failure should not be on the consumer. Individuals should have the ability to consent to life-changing care without having to fear that they might lose access to critical functionality at any time, leaving them in the same place as, or even worse off than, before getting the implant.
As the development and adoption of proprietary medical implants become increasingly common, legislators should work to protect users’ bodies from serving as e-waste repositories for once-useful technologies.
Klaudia Jaźwińska is a research fellow at the Center for Information Technology Policy at Princeton University.