The consequences of implantable technology
What happens to medical tech that's installed, but needs an update... and the company no longer exists
Not only does new technology need to work in its intended environment, but one of the big lessons of technology development is those environments can change over time. For every launch, for every new product, for every widget and gadget, there comes a time when the device will no longer work and needs to enter what product developers call the “end of life.” Here’s a story of technology that reached the end of life (a completely predictable event) and yet somehow had an unanticipated poor outcome.
Retinal and brain implants: Retinal implants are truly miraculous—while still experimental, they’re good enough now (2023) to let profoundly blind people see. While their vision isn’t 20/20 (or even 20/1000), test patients can at least navigate a shadowy, low-res, black-and-white world.
The first commercial retinal implants were placed into experimental patients in 2004. [National Eye Institute; FDA 2013] For those patients that got them, the devices were transformative—they literally let the profoundly blind see once more. The image quality wasn’t perfect high resolution, but it was good enough to let blind people walk around in the world and go about their daily lives once more.
And yet, in 2020, the Los Angeles-based Second Sight, a major maker of retinal implant technology, dropped support for the devices during an economic downturn, causing the patients who had the implants to suddenly lose all tech support. If their device stopped working for any reason, they were out of luck, and suddenly unable to see.
What’s even worse is when medical device companies not only go bankrupt, but also stop answering the phone about their devices. Ross Doerr, a longtime user/wearer/cyborg with a Second Sight implant had his device, the Argus I, implanted in the retina in 2019. But then just a few months later, the company went through a difficult time, dropping all support for the product. They also stopped replying to questions about the implant. A few months later when Doerr needed an MRI to diagnose a possible brain stem tumor, his doctors had to cancel when they couldn’t get any information about the retinal device. Surely those researchers who implanted them into those patients must have known that one day they’d have to be repaired or removed. And they should have known this would prevent CAT scans or MRIs from being taken.
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Could they possibly work around the implant? Was it made of some kind of non-magnetic materials? Someone knows, but they’ve been laid off or just aren’t answering the phone and responding to questions about the Argus I. [Strickland]
But oddly enough in 2019 after Second Sight discontinued its retinal implant, they shifted strategy to focus on a new and different retinal implant device. The second device, the Orion, could potentially help even larger numbers of blind people. Then, in 2020, the firm nearly went out of business and most of its staff were let go, including vision rehabilitation therapists who helped customers use the implants. The Orion continues on in clinical trials, hopefully this time with a plan for the devices’ end-of-life. [Harris, 2023] The Argus I users are just out of luck.
Of course, all devices have a life cycle. They’re made, they deteriorate over time, and eventually they need to be recycled. Sometimes that cycle goes quickly leading to product recalls and updates. In the case of HeartWare’s ventricular assist device (a life-sustaining heart pump), it was taken off the market after years of problems and FDA inaction in the face of multiple complains. While it’s great that the FDA found the problems and eventually forced the company to close, the device was put into the chests of more than 19,000 patients, the majority of whom got it after the FDA learned that the device didn’t meet federal standards. That is, thousands of people are now stuck with it embedded in their hearts with no simple way to repair or recall the gadget. Those who already have the heart pump can’t just get it removed or replaced. The required surgery is typically considered more dangerous than leaving it in place, so guess what recourse the patients have. [Bedi, 2021] [FDA, 2023]
Sometimes bankrupt companies manage to do the right thing. In 2010, NeuroVista, a company that made implantable brain seizure control device that made living with epilepsy much simpler. Rita Leggett had lived with violent, uncontrollable seizures since she was a child. The NeuroVista device gave her advance warning of a seizure and let her squelch it before it became a problem. Yet, when Neurovista went bankrupt in 2013, they demanded that the device be removed—very much against Rita’s wishes. [Bublitz] [Hamzelou]
Researchers on the front lines deal with this every day, and there are calls for medical regulators to take action to be sure such patients receive continuing medical care after the end of life of a device. There are increasing numbers of experimental medical devices being developed that stimulate nerves to treat things like pain and spinal cord injury. These are not trivial conditions for which a device can be implanted and removed like a plug-and-play gadget. [Wilson]
Rule of Thumb: Always think about how your devices will be maintained. Ask yourself, when this thing inevitably breaks, how can I fix it? If the answer is “I don’t really know,” you need to rethink your project. Technology that can’t be maintained—especially medical tech—needs very careful consideration.
Citations
[Harris, Mark] “Second Sight’s Implant Technology Gets a Second Chance “ IEEE Spectrum (15 Aug 2023) https://spectrum.ieee.org/bionic-eye
[Bedi] Bedi, N., Jameel, M. “Get this thing out of my chest” Propublica (Dec, 2021) https://www.propublica.org/article/get-this-thing-out-of-my-chest
[Bublitz] Bublitz, Jan Christoph, and Frederic Gilbert. "Legal aspects of unwanted device explanations: A comment on the patient R case." Brain Stimulation 16.5 (2023): 1425-1429. https://www.sciencedirect.com/science/article/pii/S1935861X23019101
[FDA, 2023] FDA, 2023 – “Medtronic’s HeartWare Recalls” https://www.fda.gov/medical-devices/cardiovascular-devices/recalls-related-hvad-system
[FDA, 2013] "FDA approves first retinal implant for adults with rare genetic eye disease” U.S. Food and Drug Administration. 14 February 2013. https://web.archive.org/web/20130228184045/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm339824.htm (Checked: Aug 5, 2022)
[Hamzelou] Hamzelou, J. “A brain implant changed her life. Then it was removed against her will” MIT Technology Review (May 25, 2023) https://www.technologyreview.com/2023/05/25/1073634/brain-implant-removed-against-her-will/
National Eye Institute. “Funded by National Eye Institute, Makers of Bionic Eye Receive Eight Millionth Patent” https://www.nei.nih.gov/about/news-and-events/news/funded-national-eye-institute-makers-bionic-eye-receive-eight-millionth-patent (checked: Aug 5, 2022)
[Strickland] Strickland, Eliza, and Mark Harris. “Their Bionics Eyes Became Unsupported: Second Sight left users of its retinal implants in the dark." IEEE Spectrum 59.3 (2022): 24-31. https://spectrum.ieee.org/bionic-eye-obsolete (checked: Aug 5, 2022)
[Wilson] Wilson, Claire “Doctors warn about the rise of people with obsolete medical implants” New Scientist (18 Sep 2023) https://www.newscientist.com/article/2392358-doctors-warn-about-the-rise-of-people-with-obsolete-medical-implants/
As you know, you can’t have metal on your person—or IN your person—when getting a CAT scan. The giant scanner magnets would yank the metal suddenly and violently to the surface of the magnet. If your body happens to be the way, that would a painful and sudden metal removal disaster by pulling the metallic bits in a straight line from middle-of-body to the scanner electromagnet.