Licence to print25 November 2020
Struggling with unprecedented demand, hospitals the world over have begun printing their own PPE – but with worries from regulators and technical glitches, it’s unclear if 3D printers and open source schematics are ready to become part of the medical mainstream. Andrea Valentino talks to Joshua Pearce, an engineering professor at Michigan Tech; Sam Onukuri, head of Johnson & Johnson’s 3D printing innovation and customer solutions department; and Carmelo De Maria, an assistant professor at the University of Pisa, about the challenges of using open source technology to manufacture medical devices – and how getting it right could have consequences far beyond Covid-19.
By the middle of March 2020, things had become so desperate at the Open Cities Community Health Centre that doctors had to ask the neighbours for help. The clinic, a block from the highway in a normally quiet corner of St Paul, Minnesota, was down to just 74 protective masks – and Covid-19 was causing mayhem in the wards. But rather than concede defeat and close the site, hospital administrators turned to charity, asking regular Minnesotans to donate any masks they had spare.
In the end, Open Cities was able to stay open thanks to Midwestern generosity. But other US hospitals have been less lucky. At one Los Angeles clinic, doctors were given a box of respirator masks, but when they tried to put them on, the elastic bands snapped. Nor is the US alone. In the UK, some NHS workers fashioned makeshift hair nets from plastic bags. In Brescia, Italy, one doctor built a ventilator from a snorkel.
Aside from a truckload of other social ills, then, the Covid-19 pandemic has highlighted the frantic medical demand for kit – for doctors and nurses to get the quality masks, gloves and coats they need to keep themselves and their patients safe. One solution, of course, is to just order in more equipment before the next pandemic hits, but neither manufacturers nor their customers tend to operate with the slack for that extra spending; producing, transporting and buying the surplus equipment necessary for true pandemic preparedness could actually harm normal supply chain operations.
So, what if hospitals could simply buy the materials and print out everything they needed when they needed it? What if they could personalise protection for specific patients? A decade ago, it would have felt like hopeless fantasy – but this is no longer the case. By melding open source schematics with the latest technology, a few pioneers are dreaming of just that – transforming medical life, and quite possibly the infrastructure that supports it, as they go.
Professor Joshua Pearce’s fascination with open source technology began almost by accident. A few years ago, a major piece of equipment in the Michigan Tech engineer’s lab broke down. Apart from being expensive, repairs would have taken all summer – time he could have spent working. Fortunately, Pearce says, he had started “messing around” with open source 3D printing, and so an idea was forged. “Why don’t I just make the equipment I want?” he remembers thinking. That’s what he did, using a 3D printer to build the exact spare parts he needed. More to the point, it soon became clear that not ordering from Amazon had paid off. Apart from being far cheaper than shop-bought alternatives, this homemade equipment actually worked better.
With results that good, you might expect 3D printers and open source handbooks to be in university labs and hospital basements from Munich to Madison. Not quite. According to statistics by Autonomous Manufacturing, a London-based company, 3D printers are currently used in less than 1% of manufacturing worldwide, with a full 71% of companies complaining that they struggle to understand the technology. Nor are open source solutions – built patent-free from blueprints online – doing much better. One study in Journals of Open Hardware found that hospitals worldwide might make savings of up to $222m a year if they stopped relying on traditional manufacturers – and yet they haven’t.
In the US, this unimpressive uptake can be understood in three letters: FDA. From its headquarters in Maryland, the Food and Drug Administration is responsible for the safety of all medical devices from sea to shining sea – and, from its perspective, letting amateurs build potentially faulty equipment at home isn’t likely to do much besides make its fiefdom harder to administer and secure. “Regulatory and reimbursement challenges still need to be addressed for personalised 3D-printed advances to realise their full potential,” says Sam Onukuri, head of Johnson & Johnson’s 3D printing innovation and customer solutions department. He has a point: in an industry like healthcare, where there is such close attention on the minutiae of pricing, it’s hard for manufacturers to give up so much of their leverage by freely sharing trade secrets with amateurs.
Then there is the question of open source itself. Even if 3D printers could print equipment faultlessly seven days a week – and given they break every six months, that’s a while off yet – you first need the right blueprints to build from. Though manufacturers are gradually coming around to the idea of putting their designs online, Pearce admits that “there is definitely still a wide range of opinions” about the next step. Simple masks and syringes are available to print for free, he says, but manufacturers are still closely guarding the patents on more sophisticated designs. A few intrepid scientists are filling the gap and putting technical information online, but their blueprints are often too vague for anyone to repeat – as Pearce puts it, the method section on many open source papers is almost non-existent.
Manufacturing processes that use 3D printing worldwide, with 71% of companies complaining that they struggle to understand the technology itself.
The savings that hospitals worldwide could make over a year if they used open source technology to reduce their reliance on traditional manufacturers.
Journals of Open Hardware
Glance through the pages of HardwareX and one can quickly feel overwhelmed by the number of projects. There are medical devices like defibrillators, bioreactors for stem cells and gadgets to clean hospital wards. Even for laypeople, the papers are written clearly, every image sharp and each measurement precise. This is very much the idea. “What HardwareX is trying to do,” explains Pearce, the journal’s editor-in-chief – a role that emphasises the difference between open source and traditional manufacturing infrastructure – “is make it so that anyone that reads your study should be able to replicate your equipment and then get the exact same result you did. In order to publish with us, you have to include every single detail of the mechanical design, the electrical wiring diagram, how to build and how to calibrate it.”
Impressive work – but really what Pearce has achieved with HardwareX is only a single line of a far longer story. Though some manufacturers and regulators still sniff at the potential of open source, others seem far more relaxed. That is particularly true in the old world. As Carmelo De Maria, an assistant professor at the University of Pisa explains, new EU guidelines state that hospitals have the right to “create and certify devices” that are unavailable in the open market. With colleagues in Italy, in fact, De Maria helped establish Ubora, a competition that encourages open source medical innovations. Announced in June 2020, the most recent winners included a portable ventilator and an oxygen monitoring system for acute patients.
The sense from both Pearce and De Maria is that the immediate impetus for open source medical equipment came not in the past few years, but the past few months. As Covid-19 ravaged the Italian health service, De Maria and his colleagues helped save hospitals thousands of euros by printing out cheap PPE. Some compatriots went even further. In Brescia – the same northern town that hosted the snorkel-wielding doctor – one inventor donated 3D-printed ventilator valves to his local clinic. Even in the US, where the FDA often squashes comparable projects, the drama of 2020 sparked a hurricane of amateur face masks. Pearce casually mentions how his colleagues at Michigan Tech donated a few thousand – even as the FDA balked at homemade nose swabs, despite the chorus of doctors “screaming” for more.
In other words, if the current crisis starts prodding open source medical technology towards the mainstream, Pearce wonders if the next one might push the dial even further. As things stand, he argues that the pandemic simply erupted too suddenly for doctors to fully react. Not that researchers are lying back until the next disaster strikes. Instead, they’re working to prove just how transformative 3D printing and open source can be. At Johnson & Johnson, for instance, Onukuri and his colleagues are building 3D-printed models of patients’ anatomies to help surgeons plan surgeries. “Innovations like these have the potential,” explains Onukuri, “[of reducing] surgical time and [improving] outcomes for a better overall patient experience.”
Take the print
Others are fixing the printers themselves. In work that might finally help the FDA relax, one group of scientists has hooked special cameras to their printer. That means that if there’s a problem, they’re immediately informed of the error and can get it sorted before the whole thing goes up in smoke. At the same time, Pearce is optimistic that manufacturers’ qualms can be soothed too. Though their monopoly on masks – or nose swabs – might be winding down, he argues they’re quite happy focusing on high-grade polymers and other cutting-edge gadgets instead. As Pearce puts it, “Open source is going to push manufacturers that are using a centralised manufacturing model to get more and more sophisticated.”
All the same, the ultimate benefits of open source might be experienced not in swanky labs or boardrooms, but in developing countries. Perhaps 90% of all the medical devices donated to developing nations don’t work properly. Until now, there’s been little the recipients could do about it. But armed with an open source design and a 3D printer, both Pearce and De Maria describe how doctors in Nairobi or Lima might soon print out spare parts for crucial equipment – saving vast sums of money and lives along the way. So, as the world waits for the pandemic’s latest surge to pass, and for the FDA to loosen its shirt, consider those places far from Brescia or the Open Cities clinic in St Paul, which haven’t made Covid headlines but who need open source technology all the same.