Localized Manufacturing In Hospitals: Point-Of-Care 3D Printing Before, During, and After COVID-19
May 26, 2020. Desktop 3D printing is designed for affordable and accessible rapid prototyping, iteration, and small-batch production of customized models to provide bespoke solutions quickly. Hospitals are a perfect fit for this technology, where for the past few years it has been used for pre-surgical models typically based on CT or MRI data, surgical guides for individual operations, and training aids for complex procedures. COVID-19 brought new challenges and opportunities for 3D printing in hospitals, and after their 3D labs were able to assist in making needed PPE, no one will ever look at point-of-care manufacturing the same way again.
3D printers became quite public during the COVID-19 crisis. A severe national shortage of proper PPE caused the medical community to get scrappy and come up with other solutions. Hospitals with 3D printers and trained staff already in-house were able to quickly pivot to 3D printing items like no-contact door handles and face shields for emergency response. There was no downtime to re-tool, no need to purchase additional equipment and wait for it to arrive, no learning curve, and no dependence on outside sources to provide PPE that could be 3D printed. The very nature of digital manufacturing is made for emergency response – internal or external. It’s made for the pivot. Just download a new file and you are ready to solve a new problem.
Three leaders in this revolution are Sarah Flora at Geisinger Health System, Nicole Wake at Montefiore Medical Center, and Amy Alexander at Mayo Clinic. All three run 3D imaging and 3D printing labs, and have spoken at length about their applications at industry events around the world.
Amy Alexander, MS Senior Biomedical Engineer at Anatomic Modeling Laboratories in the Department of Radiology at Mayo Clinic, is very passionate about point-of-care (POC) 3D printing, and speaks about its benefits at conferences around the world.
For surgeons, these models provide a better understanding of spatial relationships and scale, which can lead to a more streamlined, multi-disciplinary approach to developing a patient-specific treatment plan. Their lab provides customized, affordable task trainers for surgical practice and training, as well as custom surgical cutting guides. On the patient side, 3D printed models help doctors to explain complex treatment plans to visual and tactile learners, and promote more informed consent. Models can ease the minds of scared families sending their kids into surgeries when they actually see and understand the procedure.
Craniofacial surgery accounts for ~60% of clinical casework at Mayo Clinic, including Oral-maxillofacial Surgery (OMFS), Otorhinolaryngology Surgery (ENT), Plastic Reconstructive Surgery, and Prosthodontics. In fact over 200 craniofacial reconstruction cases have been 3D planned and carried out since 2016. It has also been used for Pediatric scoliosis correction planning and Spine Surgery Planning (SSP).
Then COVID-19 hit.
“I feel like we’ve been activated as a point-of-care manufacturing facility,” explains Alexander.
The 3D printing community on Twitter quickly started publishing STLs for masks and ventilator parts in response to the pandemic, but Alexander was concerned.
“I came up with the hashtag #PrintResonsibly because, while it was great to see everyone getting excited to help, medical devices need to be tested and produced in a safe and effective way,” Alexander says.
When the NIH rolled out their 3D Print Exchange in partnership with the VA, FDA, and America Makes, things got a lot easier. The community had a pathway to have their models reviewed for safety and efficacy, and hospitals who didn’t have time to research and develop their own solutions had a place to pull STLs which had already been proven effective and start printing.
Then the question became what makes sense to 3D print, and what could – and should – be fabricated traditionally. Alexander worked with an advisory group including staff from engineering, microbiology, pathology, respiratory therapy, infectious diseases, and supply chain to determine what was needed and what was safe to produce internally.
Mayo Clinic was able to reassign Radiology staff who had time to help as many patient appointments were canceled to hand-build PPE with transparencies and foam by the thousands as an alternative to the 3D printed version. Alexander and the team started running their 3D printers 24/7 – stacking ear savers by the hundreds on their Ultimaker 3D printers using PLA between layers of PVA support material to maximize production when the ear saver was backordered in the supply chain.
The lab found itself moving from custom fabrication of one or two models meant for specific patient cases, to getting requests for thousands of ear savers and face shield bands. Rather than individually responding to endless email requests, they partnered directly with Mayo Clinic’s supply chain to better understand what shipments were being delayed, what was needed where, and then use existing processes and workflows to fabricate and distribute. When parts were needed in the hundreds of thousands, the Division of Engineering worked to procure traditionally manufactured items.
“Without realizing it, we were building a new, internal, small-batch manufacturing workflow of identifying a need, designing, testing, and mass producing in-house solutions” says Alexander. “We are also very grateful for the donations that supplemented our own in-house production. Groups like MatterHackers Maker Response Hub, HP, Ultimaker, Materialise, and so many others stepped up to help.”
Nasopharyngeal swabs for COVID-19 testing were another huge supply chain gap that made sense to fill with 3D printing on Formlabs resin printers, after their regular overseas swab manufacturer was severely impacted by the pandemic. After joining a national IRB and running several test rounds internally,, Mayo Clinic was able to run batches of over 300 at a time on inexpensive equipment using surgical guide resin. These swabs are crucial for bringing furloughed staff back to work, and for expanding surgical capabilities, as both staff and patents need to be regularly tested inside the hospital, and at local external testing centers before they are admitted.
In addition to filling supply chain gaps for mass-produced PPE and testing swabs, there was an uptick in custom modeling for patient care.
“The only surgeries that were allowed were non-elective, complex, life-threatening procedures, which is what we are most used for,” says Alexander. “So in addition to figuring out how we were going to keep our staff and patients safe, suddenly the requests for complex models that used to come in at a regular pace started coming in – and still are – with intense frequency.”
As the world starts to open up again, hospitals like Mayo Clinic are faced with extraordinary challenges. They need to make staff and patients feel safe (and actually be safe) as they come back to work and begin to schedule elective surgeries, with no way to predict the volume of COVID-19 cases to come, or the impact of asymptomatic spread.
For the future, Alexander hopes that they will be able to go back to fabricating patient-specific educational models, tools, and guides, and that the small-batch manufacturing for internal problem solving will be taken on by the engineering division.
“3D printing has gotten more internal exposure because of COVID-19 response than ever before.” Alexander says. “Our engineering division has been there for over a century, focused on complex projects that take years to complete, and having them potentially shift to providing inventory solutions could be very interesting. Regardless of what happens with the future of supply chain, the leadership at Mayo Clinic recognizes that in-house additive manufacturing can be a very effective, affordable, and immediately actionable backup. I don’t think anyone realized the combined capabilities of the engineers, scientists, and physicians we have here when all eyes are set to a common task.”
Sarah Flora is the Program Director of 3D imaging and 3D printing in Radiology at Geisinger Health System. Geisinger’s 3D Imaging Lab was established in 2012 in the Radiology department. They purchased their first FDM 3D printer in 2015, and have since added SLA, binder jetting, material jetting, and surface scanning to serve staff and patient needs. The 3D lab fabricates models for pre-surgical planning, surgical simulation, staff/resident and patient education, as well as custom surgical aids and tools.
When COVID-19 flooded their hospitals, Flora immediately saw a need for assistive devices and designed a touchless door-pull for staff to keep in their pockets in order to minimize contact points throughout their shift. It was the first time that a model needed to be produced at such a scale. She reached out to the MatterHackers Maker Response Hub to help, and volunteers at 3DPPGH – a local Pittsburgh makerspace – were able to quickly provide additional 3D printing capacity.
With a shortage of N95 masks, her staff were reusing the same ones for weeks, but the elastic straps would wear and break. Flora wanted to design 3D printable replacement straps, and again reached out to MatterHackers for help. Applications Engineer Scott Cahoon responded with a viable design so that Sarah and a few volunteers from Maker Response Hub could produce them quickly and get them to those in harm’s way.
“We are currently in a grey area and are still producing PPE for outstanding internal needs and projecting for a second surge, but also re-opening for outpatients and surgeries.” explains Flora “People are asking if we’re still 3D printing surgical models on top of all of this!”
Now that supply chain understands that the 3D lab can design custom solutions and even move into small-batch production in the same day, Flora is in daily discussions with the head of supply chain and facilities to explore in-house fabrication possibilities instead of trying to outsource.
“There will be a different normal for 3D printing in hospitals.” Flora predicts “Our Ultimakers were ridiculously productive to have in-house – even our little Ultimaker 2 was dragged out as a workhorse. The Ultimaker S5 I have at home is crazy! I love the bigger build platform, and using Cura Connect via WiFi so that I can be printing at home and checking on it while I’m at work helps with capacity. I even got the Air Manager so that I know I’m printing safely.”
Moving forward, Flora sees more opportunities for in-house custom design and production.
“We are prototyping replacement parts for MRI machines through Geisinger’s LLC ISS Solutions, and designing custom tools for surgeons,” she says “And while the OB loves the current design for face shields, they are too long for OR, who have asked if we could customize glasses frames instead. So we prototype for a few hours, do some small-batch production, and we’re good to go. 3D printing is so easy and accessible for things that need a fast turnaround.”
But no one can do this alone.
“We’ve really been taken aback by the overwhelming variety of community support.” says Flora. “From the 3D printing community and response teams like MatterHackers Maker Response Hub donating PPE, to local restaurants supplying frontline workers with food, and even Facebook friends donating transparency sheets. Healthcare workers go through this all the time, so to be recognized and see people coming together…is a lot. I have to step back sometimes to think about it – it’s really remarkable.”
Nicole Wake, PhD is Director of the 3D Imaging Lab in the Department of Radiology at Montefiore Medical Center in New York City. Dr. Wake specializes in creating 3D images from radiological imaging data. Specifically, she has coupled MRI data with a range of 3D printing, augmented reality, and virtual reality technologies to create individualized anatomically precise anatomic models for pre-operative planning. She is using these models to guide patient management and is investigating the added value of 3D modeling in personalized medical care.
The 3D imaging lab at Montefiore focuses on digital images and representation of MRI data. 3D printing has become an extension of that, used to fabricate pre-surgical anatomical models for surgical planning, education for patients, and internal training. They have one Ultimaker S5 and a second one on loan from the Department of Radiology’s Radiochemistry Lab located at the Albert Einstein College of Medicine. Dr. Wake is also able to print from home on nights and weekends using two donated Ultimaker S5 printers and her own Prusa 3D printer.
“Like all hospitals, we saw a need for 3D printed face shields. We were able to prototype and trial a few different designs quickly to get feedback.” explains Dr. Wake. “Initially we were printing Prusa and Budman designs. We also liked the 3DVerkstan models which were donated by MatterHackers Maker Response Hub and other organizations, so we switched to those in-house as well.”
Seeing the different designs possible, people developed preferences based on their own comfort and application.
“Now some people request different colors or plastics for their shields,” says Dr. Wake.
Mask prototypes can be difficult because everyone’s fit-to-face is actually different, but a few varieties of shields is something that hospitals could consider bringing in-house. It could also help to prepare for a possible second wave, or other future supply chain interruptions.
“This pandemic has brought out the best in a lot of people,” explains Dr. Wake. “Helping to produce PE in-house was an amazing pivot for me and allowed me to help out during this time in ways that were tangible and important.”
While the COVID-19 pandemic has been extraordinarily trying and tragic for the healthcare community, hospitals and first responders have shown incredible resilience and determination to get as much learning out of this terrible turn of events as possible. 3D printing has certainly been one of the bright spots in finding solutions to unforeseen problems, and these lessons can really be applied to any industry. We thank everyone who contributed to this article for taking the time to share their story, and all who put their own lives on the line every day to protect the rest of us.
Courtesy of MatterHackers