Covid-inspired 3D printing has not, however, revolutionised the medical device market in the way that seemed possible at the start of the pandemic. As coronavirus began sweeping the world 3D printing was able to meet a very specific need that arose because lockdowns in all corners of the globe meant supply chains instantaneously broke down. They were quick to recover, though, and while 3D printing filled a gap it has not, Gershenson says, stepped in to replace traditional manufacturing.
Part of the reason for that is that, despite allowing manufacturing to be localised, on a large scale 3D printing is not as efficient as traditional manufacturing when large numbers of individual products are required. When it closed its PPE initiative last year, the National 3D Printing Society noted that numerous injection moulding companies had been able to set up across the UK in the preceding two months and that the visors they were producing used a “much more efficient and sustainable method of manufacturing”. “Injection moulding not only produces the visors in larger quantities but also increases product consistency and quality,” the organisation said.
The quality issue is key, particularly for products being created for use in a hospital environment. In August last year a group of academics from Nanyang Technological University in Singapore wrote a paper that highlighted the downsides involved in 3D printing medical devices. Noting that “safeguarding lives and users’ wellbeing remains a priority”, they stressed that “it is paramount that the 3D printing community works in parallel with medical professionals to avoid creating undue risks to public health”.
Gershenson says this became an issue at the start of the pandemic because much of the demand was being met by hobbyists who used low-grade printers and materials and whose products were not therefore able to comply with stringent medical standards. “The problem with 3D printing is that, yes, you can make anything, but that doesn’t mean you should,” he says. “A person with a 3D printer in their garage can make amazing stuff that they need, but that doesn’t mean they can deliver it to a hospital. What’s needed is a quality programme.”
In 2019, Gartner noted in its Hype Curve that regulatory constraints were likely to pose a challenge to the growth of 3D printing in the medical sector. Jacobson says 3D printing was able to fill the void at the beginning of the pandemic because regulators such as the US Food and Drug Administration relaxed their rules in order to meet demand.
“The FDA realised there was a need to become more relaxed and all regulatory bodies were putting out guidance saying ‘you need to be careful but we understand there’s a need for it’,” he says. “In the US they also limited liability, saying if you’re doing anything for Covid you can’t later be sued – pre-Covid, if traditional manufacturers didn’t realise there was something defective but there was a complication they could still be held liable. They can’t do that forever.”
Rules may have been relaxed to allow 3D printing to meet a specific medical need, but Jacobson says new rules will have to be made if 3D printing is ever to meet its full potential. Legislative processes do not move fast, meaning that will “probably take a decade”, he says. “The technology is ready, it’s the laws that are hampering it,” he adds. “Legal systems are always slow to catch up, but now is the time [to do it], when it’s fresh in everyone’s mind.”
In the meantime, 3D printing is still being used to fill supply-chain gaps that have arisen due to the pandemic. Earlier this month Scottish 3D printing company Abergower launched a Covid-19 test in partnership with Heriot-Watt University’s Medical Device Manufacturing Centre and Scottish Enterprise’s Scottish Manufacturing Advisory Service. The project can print up to 25,000 swab kits every day, with the aim being to reduce reliance on imported testing equipment. That such a scenario has become normalised is, for Gershenson, the biggest positive outcome the pandemic has had on the 3D printing industry.
“Before the pandemic hit, when we were trying to explain the model to people they would be like ‘what are you talking about?’,” he says. “The pandemic hit and people started printing PPE and now everyone and their grandmother is like ‘3D printing, local manufacturing, we totally understand it’.”
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