“Our mission from the beginning was to make professional grade technology accessible to the masses. Our whole mission statement is about making this digital manufacturing tool accessible to everyone.”
It’s unlikely Formlabs ever imagined that objective, set out by the 3D printer manufacturer almost a decade ago and reiterated by its Director for Healthcare Gaurav Manchanda during a recent conversation with TCT, would be put to the ultimate test during a global health crisis.
Yet here we are: several months of lockdowns, socially distanced Zoom chats, and an immeasurable number of 3D printed parts later, and Formlabs’ ambitions, realised with an estimated 70,000 stereolithography (SLA) systems installed worldwide, have never felt more relevant.
“Formlabs’ technology has been used by many of the world's leading health systems, hospitals and medical schools for the last three or four years,” Manchanda told TCT. “As a result […] those same physicians were comfortable enough to reach out to us with their supply chain requirements when COVID hit and we worked hand in hand with a number of hospitals to create everything from NP (Nasopharyngeal) swabs to ventilation system components to PPE (Personal Protective Equipment) and other accessories. But it was all physician driven and need-based.”
The emphasis on “need-based” is perhaps key to why the desktop SLA pioneer’s approach to COVID-19 solutions has been so effective. When the World Health Organization declared the crisis a pandemic back in March, supply chains were shaken and crucial parts were suddenly unavailable when and where they were needed most - the kinds of challenges 3D printing had been promising to solve for years. The problem was, there was a lot of noise and mixed messages coupled with good intentions from manufacturers and consortiums rushing to print parts for a demand that wasn’t yet clear – the UK Government, for example, massively scaled back a callout to industry to manufacture 30,000 ventilators after the need proved much smaller than anticipated. Formlabs, a company which began mobilising its community of users very early in the crisis to print low-risk accessories, admits to having learned a few valuable lessons during this unprecedented time.
New York healthcare provider Northwell Health was one of the first companies that made the call to Formlabs for a series of plastic T-shape bi-level positive airway pressure (BiPAP) adapters designed to convert sleep apnoea equipment into mechanical ventilators. Formlabs, with the help of its in-house Regulatory Affairs team, quickly received emergency use authorisation (EUA) from the FDA – something which the association had only ever done a handful of times pre-COVID but has hastened considerably since – to commence production at its Somerville, MA headquarters. This new part went on to be used to support hundreds of COVID-19 patients in New York City but the demand, fortunately, has since fallen due to positive effects of lockdown measures and updates to clinical literature.
“Thankfully, those ventilation system components were not as in high demand as everyone was anticipating early on in the pandemic,” Manchanda shared, confirming a similar pattern to that in the UK. He does however believe that there is a need for these components arising in emerging markets, adding that “there is a really interesting and high impact role that 3D printing can play in more resource limited settings.” Should the need occur, Formlabs has 150 3D printers currently on standby ready to print up to 3,000 of these parts per day.
T-shape adapters printed by Formlabs.
T-shape adapters printed by Formlabs.
Formlabs has since focused its efforts on four high-demand application areas: test swabs, ventilation components, PPE components and diagnostic devices. Here in the UK, Mologic, a rapid diagnostics company specialising in lateral flow technology, employed a Form 2 to prototype test devices for COVID-19.
Adrian Walker, Biomedical Engineer at Mologic said in a Formlabs' blog post: "Mologic currently uses Formlabs 3D printers for the prototyping of all of its test devices for COVID-19 as the system is easy to use, has a wide range of materials, and is quick. The production of high-quality detailed parts is invaluable to speedy device development and the fact we can produce parts in a matter of hours with Formlabs technology enables us to progress quickly with our research."
“We did not come up with concepts in a boardroom or in a Zoom meeting and then start experimenting and posting things on social media,” Manchanda said. “We really answered the phones when we were called by doctors, we reached out to first line responders from the ICU to the ER to the lab and asked what the needs were. Everyone worked very closely together to make sure that these tools were being made safely and responsibly but also meeting a critical, urgent need. That made us very efficient by just focusing on the few things that were being requested over and over again, as opposed to spreading our resources across dozens of applications.”
Read more on the 3D printing industry's response to COVID-19:
- The latest 3D printing efforts against Covid-19
- Xometry CEO: “The impact of COVID-19 on manufacturing will pale in comparison to climate change."
- Is 3D printing a magic bullet for supply chain at the time of COVID-19 pandemic?
Machine sales across the AM industry were hard hit by COVID and as a result, we’ve witnessed many 3D printer manufacturers taking a similar approach and adapting to new service provider business models. While according to a recent report from CONTEXT the shift helped plug a stagnant hardware sales period for some vendors, Manchanda describes the model as a temporary solution to an urgent consumer demand.
“We don't intend to be a manufacturer of medical devices for the long term but we're certainly filling what we see as a very clear gap in the supply chain these days,” he added.
In fact, while COVID has impacted 3D printer hardware sales drastically for some OEMs, Manchanda said Formlabs has seen an upturn in demand with “large and small health systems” reaching out to them proactively to see how 3D printing can help, and current customers exploiting their 3D printing capacities in new ways to keep them afloat.
“We are seeing many new customers,” Manchanda said. “Hospitals and health systems that have never used 3D printing before are now adopting it to de risk their supply chains. They also see a way to use the same machines clinically after things normalise again and after their surgical operations come back online. We're also seeing many of our current customers with machines, pivot and support the response. Everything from medical schools, engineering schools and dental labs to the small audiology lab and medical device manufacturers who have all been affected – either their businesses have been forced to change or they have extra capacity given the nature of things these days. It’s really been a very uplifting community effort.”
3D printed test kit swabs.
That community effort has been reflected in the wider AM industry’s response with a number of what would have been considered competitors teaming together on special projects; SLM Solutions set up its Additive Alliance Against Corona, EOS launched the ‘3D Against Corona’ platform, America Makes set up an online repository to connect manufacturing efforts with healthcare providers, and there are many others like them. Similarly, Formlabs joined forces with Carbon, EnvisionTEC, Origin and several academic institutions to deliver millions of NP Swabs on mass with a network of ISO13485-verified facilities across the U.S. at a rate of up to 4 million per week.
“As soon as the pandemic hit our shores in March, it was a matter of hours until the first group email went out to all of industry and the larger medical associations to ask how we could all work together,” Manchanda explained. “There was extreme transparency with plans, strategies, status updates of various components. We also thought, this is going to be a group effort, a rising tide lifts all boats situation. It was much bigger than just the 3D printing community. [...] It feels like we're in war times, where there are all these collaborations and conversations taking place that wouldn't have taken place in normal times.”
The 3D printing industry has been through its fair share of inflated and failed expectation cycles – we don’t have a 3D printer in every home as postulated by evangelists back in 2014, for example. The COVID crisis has put the spotlight on the industry once again with 3D printed valves and visors grabbing mainstream media attention; the last thing the industry needs is a headline about a faulty 3D printed part used in a critical environment to undo any good work. To that end, Formlabs has split its COVID parts repository into two sections: one for those validated by medical professionals and manufacturers, and the other for community sourced, non-clinical, low-risk components which can be used to help minimise the spread of infection, such as hands-free door openers. The company wants to be crystal clear about the validity of 3D printed alternatives, particularly in the case of N95 respirators, and has published a transparent statement from the Director of a 3D Printing Lab within one of the largest health systems in the U.S., which reads, “While I applaud the maker community for trying to assist the overloaded healthcare system right now, I would caution the fabrication of 'hacked masks'. Unfortunately, the resolution required to create an N95 far outweighs the resolution of 3D printers.” Formlabs is still working closely with several government agencies and clinicians to evaluate and validate potential respirator solutions.
“We see our job as providing all of the information and precautions needed for users to manufacture these devices safely and responsibly,” Manchanda elaborated. “We not only have disclaimers, but we have instructions coming from clinicians, we have warnings from regulatory bodies and medical associations. We want everyone to know the risks involved with printing these devices and, if anything, we've seen a lot of well-intentioned individuals with machines offering to print medical devices that are high risk and really require a medical device manufacturer or a point of care manufacturer to print, test and validate and use those devices.”
However, a lot of good is being done: 3D printer factories are producing face shields in their millions and while the idea of medical equipment being manufactured in a maker’s garage raised eyebrows and concerns in the beginning, the perception of the technology on the frontlines of the pandemic has been largely positive. Could this renewed visibility potentially change perceptions around the technology and accelerate adoption going forward?
“No one was anticipating this,” Manchanda said. “I think we've all seen the value of decentralised or distributed manufacturing and the power of manufacturing being as close to these hard-hit regions as possible. Now the international supply chains of the pre COVID era are being questioned and the risks associated with having a handful of manufacturers serve a global market is coming under scrutiny. We anticipate 3D printing to be adopted at an increasing rate year over year even greater than anyone was anticipating in the pre COVID world.”
Formlabs has launched a new line of BioMed Resins for healthcare applications. (Credit: Formlabs via Twitter)
The crisis has permeated Formlabs’ roadmap in other ways too. The company has launched a new consulting arm, a service which has historically only been offered to large engineering and manufacturing firms, but spurred by recent events is now expanding to the medical space.
"We're really pleased to have that service be available and think it'll be really high value to all those systems that will regrettably need this service as this pandemic stays with us," Manchanda commented.
Last month the company also launched a new collection of proprietary 3D printing resins aimed at engineering, healthcare and dental applications. In its new BioMed range, new BioMed Clear and BioMed Amber have been developed for healthcare applications such as surgical planning, device manufacture and research. The fast-tracking of these materials intends to provide further access to appropriate materials for medical device prototyping, which were previously limited by market restrictions, to accelerate development in the face of future challenges.
“I think we're much better prepared,” Manchanda concluded. “Within the health system, within the government, within the 3D printing industry, we were all caught off guard the first time around. We've all put significant resources towards this for the last four or five months and are very confident that we can be of even greater value if and when required in the future.”
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