Imagine it's the year 2040 and you're due for your regular health checkup. Time to schedule your next colonoscopy, Pap smear if you're a woman, and prostate screen if you're a man.
"The evolution of the biological ion transistor technology is a game changer."
But wait, you no longer need any of those, since you recently got one of the new biomed implants – a device that integrates seamlessly with body tissues, because of a watershed breakthrough that happened in the early 2020s. It's an improved biological transistor driven by electrically charged particles that move in and out of your own cells. Like insulin pumps and cardiac pacemakers, the medical implants of the future will go where they are needed, on or inside the body.
But unlike current implants, biological transistors will have a remarkable range of applications. Currently small enough to fit between a patient's hair follicles, the devices could one day enable correction of problems ranging from damaged heart muscle to failing retinas to deficiencies of hormones and enzymes.
Their usefulness raises the prospect of overcorrection to the point of human enhancement, as in the bionic parts that were imagined on the ABC television series The Six Million Dollar Man, which aired in the 1970s.
"The evolution of the biological ion transistor technology is a game changer," says Zoltan Istvan, who ran as a U.S. Presidential candidate in 2016 for the Transhumanist Party and later ran for California governor. Istvan envisions humans becoming faster, stronger, and increasingly more capable by way of technological innovations, especially in the biotechnology realm. "It's a big step forward on how we can improve and upgrade the human body."
How It Works
The new transistors are more like the soft, organic machines that biology has evolved than like traditional transistors built of semiconductors and metal, according to electric engineering expert Dion Khodagholy, one of the leaders of the team at Columbia University that developed the technology.
The key to the advance, notes Khodagholy, is that the transistors will interface seamlessly with tissue, because the electricity will be of the biological type -- transmitted via the flow of ions through liquid, rather than electrons through metal. This will boost the sensitivity of detection and decoding of biological change.
Naturally, such a paradigm change in the world of medical devices raises potential societal and ethical dilemmas.
Known as an ion-gated transistor (IGT), the new class of technology effectively melds electronics with molecules of human skin. That's the current prototype, but ultimately, biological devices will be able to go anywhere in the body. "IGT-based devices hold great promise for development of fully implantable bioelectronic devices that can address key clinical issues for patients with neuropsychiatric disease," says Khodagholy, based on the expectation that future devices could fuse with, measure, and modulate cells of the human nervous system.
Naturally, such a paradigm change in the world of medical devices raises potential societal and ethical dilemmas, starting with who receives the new technology and who pays for it. But, according clinical ethicist and health care attorney David Hoffman, we can gain insight from past experience, such as how society reacted to the invention of kidney dialysis in the mid 20th century.
"Kidney dialysis has been federally funded for all these decades, largely because the who-gets-the-technology question was an issue when the technology entered clinical medicine," says Hoffman, who teaches bioethics at Columbia's College of Physicians and Surgeons as well as at the law school and medical school of Yeshiva University. Just as dialysis became a necessity for many patients, he suggests that the emerging bio-transistors may also become critical life-sustaining devices, prompting discussions about federal coverage.
But unlike dialysis, biological transistors could allow some users to become "better than well," making it more similar to medication for ADHD (attention deficit hyperactivity disorder): People who don't require it can still use it to improve their baseline normal functioning. This raises the classic question: Should society draw a line between treatment and enhancement? And who gets to decide the answer?
If it's strictly a medical use of the technology, should everyone who needs it get to use it, regardless of ability to pay, relying on federal or private insurance coverage? On the other hand, if it's used voluntarily for enhancement, should that option also be available to everyone -- but at an upfront cost?
From a transhumanist viewpoint, getting wrapped up with concerns about the evolution of devices from therapy to enhancement is not worth the trouble.
It seems safe to say that some lively debates and growing pains are on the horizon.
"Even if [the biological ion transistor] is developed only for medical devices that compensate for losses and deficiencies similar to that of a cardiac pacemaker, it will be hard to stop its eventual evolution from compensation to enhancement," says Istvan. "If you use it in a bionic eye to restore vision to the blind, how do you draw the line between replacement of normal function and provision of enhanced function? Do you pass a law placing limits on visual capabilities of a synthetic eye? Transhumanists would oppose such laws, and any restrictions in one country or another would allow another country to gain an advantage by creating their own real-life super human cyborg citizens."
In the same breath though, Istvan admits that biotechnology on a bionic scale is bound to complicate a range of international phenomena, from economic growth and military confrontations to sporting events like the Olympic Games.
The technology is already here, and it's just a matter of time before we see clinically viable, implantable devices. As for how society will react, it seems safe to say that some lively debates and growing pains are on the horizon.
Jessica Ware is obsessed with bugs.
My guest today is a leading researcher on insects, the president of the Entomological Society of America and a curator at the American Museum of Natural History. Learn more about her here.
You may not think that insects and human health go hand-in-hand, but as Jessica makes clear, they’re closely related. A lot of people care about their health, and the health of other creatures on the planet, and the health of the planet itself, but researchers like Jessica are studying another thing we should be focusing on even more: how these seemingly separate areas are deeply entwined. (This is the theme of an upcoming event hosted by Leaps.org and the Aspen Institute.)
Listen to the Episode
Entomologist Jessica Ware
D. Finnin / AMNH
Maybe it feels like a core human instinct to demonize bugs as gross. We seem to try to eradicate them in every way possible, whether that’s with poison, or getting out our blood thirst by stomping them whenever they creep and crawl into sight.
But where did our fear of bugs really come from? Jessica makes a compelling case that a lot of it is cultural, rather than in-born, and we should be following the lead of other cultures that have learned to live with and appreciate bugs.
The truth is that a healthy planet depends on insects. You may feel stung by that news if you hate bugs. Reality bites.
Jessica and I talk about whether learning to live with insects should include eating them and gene editing them so they don’t transmit viruses. She also tells me about her important research into using genomic tools to track bugs in the wild to figure out why and how we’ve lost 50 percent of the insect population since 1970 according to some estimates – bad news because the ecosystems that make up the planet heavily depend on insects. Jessica is leading the way to better understand what’s causing these declines in order to start reversing these trends to save the insects and to save ourselves.
The first thing Jeroen Perk saw after he partially regained his sight nearly a decade ago was the outline of his guide dog Pedro.
“There was a white floor, and the dog was black,” recalls Perk, a 43-year-old investigator for the Dutch customs service. “I was crying. It was a very nice moment.”
Perk was diagnosed with retinitis pigmentosa as a child and had been blind since early adulthood. He has been able to use the implant placed into his retina in 2013 to help identify street crossings, and even ski and pursue archery. A video posted by the company that designed and manufactured the device indicates he’s a good shot.
Less black-and-white has been the journey Perk and others have been on after they were implanted with the Argus II, a second-generation device created by a Los Angeles-based company called Second Sight Medical Devices.
The Argus II uses the implant and a video camera embedded in a special pair of glasses to provide limited vision to those with retinitis pigmentosa, a genetic disease that causes cells in the retina to deteriorate. The camera feeds information to the implant, which sends electrical impulses into the retina to recapitulate what the camera sees. The impulses appear in the Argus II as a 60-pixel grid of blacks, grays and whites in the user’s eye that can render rough outlines of objects and their motion.
Smartphone and computer manufacturers typically stop issuing software upgrades to their devices after two or three years, eventually rendering them bricks. But is the smartphone approach acceptable for a device that helps restore the most crucial sense a human being possesses?
Ross Doerr, a retired disability rights attorney in Maine who received an Argus II in 2019, describes the field of vision as the equivalent of an index card held at arm’s length. Perk often brings objects close to his face to decipher them. Moreover, users must swivel their heads to take in visual data; moving their eyeballs does not work.
Despite its limitations, the Argus II beats the alternative. Perk no longer relies on his guide dog. Doerr was uplifted when he was able to see the outlines of Christmas trees at a holiday show.
“The fairy godmother department sort of reaches out and taps you on the shoulder once in a while,” Doerr says of his implant, which came about purely by chance. A surgeon treating his cataracts was partnered with the son of another surgeon who was implanting the devices, and he was referred.
Doerr had no reason to believe the shower of fairy dust wouldn’t continue. Second Sight held out promises that the Argus II recipients’ vision would gradually improve through upgrades to much higher pixel densities. The ability to recognize individual faces was even touted as a possibility. In the winter of 2020, Doerr was preparing to travel across the U.S. to Second Sight’s headquarters to receive an upgrade. But then COVID-19 descended, and the trip was canceled.
The pandemic also hit Second Sight’s bottom line. Doerr found out about its tribulations only from one of the company’s vision therapists, who told him the entire department was being laid off. Second Sight cut nearly 80% of its workforce in March 2020 and announced it would wind down operations.
Ross Doerr has mostly stopped using his Argus II, the result of combination of fear of losing its assistance from wear and tear and disdain for the company that brought it to market.
Second Sight’s implosion left some 350 Argus recipients in the metaphorical dark about what to do if their implants failed. Skeleton staff seem to have rarely responded to queries from their customers, at least based on the experiences of Perk and Doerr. And some recipients have unfortunately returned to the actual dark as well, as reports have surfaced of Argus II failures due to aging or worn-down parts.
Product support for complex products is remarkably uneven. Although the iconic Ford Mustang ceased production in the late 1960s, its parts market is so robust that it’s theoretically possible to assemble a new vehicle from recently crafted components. Conversely, smartphone and computer manufacturers typically stop issuing software upgrades to their devices after two or three years, eventually rendering them bricks. Consumers have accepted both extremes.
But is the smartphone approach acceptable for a device that helps restore the most crucial sense a human being possesses?
Margaret McLean, a senior fellow at the Markkula Center for Applied Ethics at Santa Clara University in California, notes companies like Second Sight have a greater obligation for product support than other consumer product ventures.
“In this particular case, you have a great deal of risk that is involved in using this device, the implant, and the after care of this device,” she says. “You cannot, like with your car, decide that ‘I don’t like my Mustang anymore,’ and go out and buy a Corvette.”
And, whether the Argus II implant works or not, its physical presence can impact critical medical decisions. Doerr’s doctor wanted him to undergo an MRI to assist in diagnosing attacks of vertigo. But the physician was concerned his implant might interfere. With the latest available manufacturer advisories on his implant nearly a decade old, the procedure was held up. Doerr spent months importuning Second Sight through phone calls, emails and Facebook postings to learn if his implant was contraindicated with MRIs, which he never received. Although the cause of his vertigo was found without an MRI, Doerr was hardly assured.
“Put that into context for a minute. I get into a serious car accident. I end up in the emergency room, and I have a tag saying I have an implanted medical device,” he says. “You can’t do an MRI until you get the proper information from the company. Who’s going to answer the phone?”
Second Sight’s management did answer the call to revamp its business. It netted nearly $78 million through a private stock placement and an initial public offering last year. At the end of 2021, Second Sight had nearly $70 million in cash on hand, according to a recent filing with the Securities and Exchange Commission.
And while the Argus II is still touted at length on Second Sight’s home page, it appears little of its corporate coffers are earmarked toward its support. These days, the company is focused on obtaining federal approvals for Orion, a new implant that would go directly into the recipient’s brain and could be used to remedy blindness from a variety of causes. It obtained a $6.4 million grant from the National Institutes of Health in May 2021 to help develop Orion.
Presented with a list of written questions by email, Second Sight’s spokesperson, Dave Gentry of the investor relations firm Red Chip Companies, copied a subordinate with an abrupt message to “please handle.” That was the only response from a company representative. A call to Second Sight acting chief executive officer Scott Dunbar went unreturned.
Whether or not the Orion succeeds remains to be seen. The company’s SEC filings suggest a viable and FDA-approved device is years away, and that operational losses are expected for the “foreseeable future.” Second Sight reported zero revenue in 2020 or 2021.
Moreover, the experiences of the Argus II recipients could color the reception of future Second Sight products. Doerr notes that his insurer paid nearly $500,000 to implant his device and for training on how to use it.
“What’s the insurance industry going to say the next time this crops up?” Doerr asks, noting that the company’s reputation is “completely shot” with the recipients of its implants.
Perk, who made speeches to praise the Argus II and is still featured in a video on the Second Sight website, says he also no longer supports the company.
Jeroen Perk, an investigator for the Dutch customs service, cried for joy after partially regaining his sight, but he no longer trusts Second Sight, the company that provided his implant.
Nevertheless, Perk remains highly reliant on the technology. When he dropped an external component of his device in late 2020 and it broke, Perk briefly debated whether to remain blind or find a way to get his Argus II working again. Three months later, he was able to revive it by crowdsourcing parts, primarily from surgeons with spare components or other Argus II recipients who no longer use their devices. Perk now has several spare parts in reserve in case of future breakdowns.
Despite the frantic efforts to retain what little sight he has, Perk has no regrets about having the device implanted. And while he no longer trusts Second Sight, he is looking forward to possibly obtaining more advanced implants from companies in the Netherlands and Australia working on their own products.
Doerr suggests that biotech firms whose implants are distributed globally be bound to some sort of international treaty requiring them to service their products in perpetuity. Such treaties are still applied to the salvage rights for ships that sunk centuries ago, he notes.
“I think that in a global tech economy, that would be a good thing,” says McLean, the fellow at Santa Clara, “but I am not optimistic about it in the near term. Business incentives push toward return on share to stockholders, not to patients and other stakeholders. We likely need to rely on some combination of corporately responsibility…and [international] government regulation. It’s tough—the Paris Climate Accord implementation at a slow walk comes to mind.”
Unlike Perk, Doerr has mostly stopped using his Argus II, the result of combination of fear of losing its assistance from wear and tear and disdain for the company that brought it to market. At 70, Doerr says he does not have the time or energy to hold the company more accountable. And with Second Sight having gone through a considerable corporate reorganization, Doerr believes a lawsuit to compel it to better serve its Argus recipients would be nothing but an extremely costly longshot.
“It’s corporate America at its best,” he observes.