“As medical printing technologies become more ubiquitous, how do we stop criminals flooding the market with low-quality knock-offs?”
More than 60 years after the world’s first successful transplant, there is still no answer to the desperate global shortage of human organs. In the UK, around 49,000 people have languished on the transplant list in the past decade. More than 6,000 of those people, including children, have died waiting.
The dearth of organs for transplant is an international crisis, and one that has produced some grisly makeshift solutions. After exposing China’s state-sponsored system of harvesting organs from prisoners in 2007, human rights lawyer David Matas and activist David Kilgour recently updated their incendiary report to claim that the practice continues to this day, despite the state’s claims to the contrary.
In India, the Mohan Foundation – an NGO set up to spread awareness of the illicit organ trade – receives frequent enquiries from would-be donors who see a ‘spare’ kidney as their path out of poverty. In Iran, the only country in the world with an official organ-selling program, the result has been a state-sanctioned flow of kidneys up the socioeconomic ladder from the desperate and poor to the desperate and rich.
But for patients unwilling to enter the black market as ‘transplant tourists’, there is a glimmer of hope in the promise of printed organs and medical devices.
‘Bioprinting’ – the use of specialist 3D printers to construct cellular scaffolds on which further cells can be grown – is being used to produce hearts, livers, kidneys and other types of human tissue in laboratories. Traditional 3D-printing is being used to create prototypes of everything from wheelchairs to exoskeletons.
But as medical printing technologies become more ubiquitous and the barriers to entry become lower, a familiar question arises: how do we make sure criminals don’t start filling gaps in the market with low-cost, low-quality knock-offs?
“The issue will not be whether these technologies can solve [medical problems], or whether it’s affordable or whether it’s disruptive enough,” Dr. Bertalan Mesko, medical futurist and author of My Health Upgraded: Revolutionary Technologies to Bring A Healthier Future told WIRED. “The question is how the bad guys will find ways to use [these technologies] in unsafe, unregulated ways.”
Mesko is a self-described optimist on the subject of medical printing. His concern lies in the languorous workings of today’s medical regulatory bodies. If 3D-printing technologies arrive and are disseminated quickly, then healthcare providers will flood the market with affordable (and potentially miraculous) treatments. If they arrive in fits and starts, other interests will try to plug the gap.
“Like always, there are illegal ways of getting organs to people in need,” Mesko says. “And when bioprinting becomes mainstream practice in medicine, then again, the bad guys might come up with solutions themselves.
“If bioprinting becomes a mainstream method, then actually anyone could have access to the technology for quite a good price. If you can print out organs based on that patient’s own stem cells in a short amount of time, it will become a normal element of healthcare, and then there’s no reason to print [organs] in a criminal way.”
Mesko acknowledges that in the West, where the majority of people have access to at least relatively comprehensive healthcare, patients are less likely to take risks by turning to organised crime or black-market organs. A more “reasonable scenario,” he says, is that printed knock-offs of medical devices, in particular, will start to appear in poorer countries, in the same way counterfeit drugs today are predominantly (though not exclusively) a third-world problem.
“If you’re in a wheelchair in the West, then you might turn to an insurance company to get you an exoskeleton – a robotic structure around your limbs that helps you walk again,” says Mesko. “But an exoskeleton costs [around ten] thousand dollars right now. The reason why is that these devices have to be approved; they have to be safe and regulated. But there might be some criminal gangs who will use a cheap 3D printer to print out parts of the exoskeleton and create something that might do almost the same, functionally, but without it being regulated.
“Patients who have no good insurance plan or have no access to these innovations in poorer countries might turn to these guys. They want to walk again, but they cannot afford the [approved] methods… There is a niche for criminal gangs.”
Printing medical devices – let alone human tissue – is still a hugely daunting, specialist process. For the near future, the technical hurdles will buy regulatory authorities time to decide what, how and when to best make these disruptive technologies available.
But, says Mesko, unless these technologies are affordable and widely distributed they will “not be disruptive enough.” If patients in poorer countries learn there are treatments available elsewhere, but that those treatments are prohibitively expensive, that’s when criminal alternatives might start to look appealing.
“[An imperfect solution] is better than nothing at all,” says Mesko. “But when it comes to your own health, you won’t like risking it if you know there are fairly good, affordable solutions out there. Today, the reason why some patients risk their lives with the illegal organ market is because they either get it this way, or they die. That’s quite a clear choice.
“The majority of us will get access to these technologies through traditional healthcare systems if regular frameworks are fast enough. But for the rest, they will [always] try to find a solution.”