Pandemic drives demand for 3D-printed medical parts

Healthcare systems opt for 3D-printed medical supplies

Northwell Health, Tampa General Hospital and USF Health are using the 3D-printed nasal swabs to help increase testing; swabs, as well as the 3D swab design, will be shared with other healthcare organizations across the country in need of swabs for COVID-19 test kits, Manchanda said.

Before moving forward with 3D printing nasal swabs, Formlabs worked closely with Northwell Health and USF Health over the span of one weekend to develop and test a prototype, Manchanda said. The nasal swab prototype received approval from hospitals, as well as Class I Exempt status from the FDA. The FDA has essentially determined that the demand for swabs justifies authorization of emergency use during the COVID-19 public health crisis.

"The FDA is keeping up with the needs of the health system and making exemptions when appropriate," Manchanda said. "A nasal swab is pretty low risk on its own, it's not going all the way inside the body the way an implant might, for example. We're making sure everyone is doing this as safely as possible and getting all the clearances necessary to do this responsibly."

David Lakatos, chief product officer at Formlabs, said the company kept a couple of factors in mind when designing the device: It needed to be safe for human use, meaning it wouldn't break in the nose when inserted, and it needed to be able to collect enough samples from the nose that could actually be tested.

Manchanda said the nasal swabs are printed using a sterilizable autoclavable resin. Even the Formlabs' printing facility in Millbury, Ohio, is a certified medical device facility registered with the FDA as of March 2019.

Although Formlabs has worked with health systems and the FDA to fast track the 3D nasal swabs, Lakatos said it's also working on creating splitter tubes so that one ventilator can support multiple people. Patients with severe COVID-19 symptoms often need breathing support through ventilators, but hospitals are facing ventilator shortages as they deal with an influx of patients during the pandemic.

"There are obvious concerns with supporting multiple people," he said. "But our job is to support the manufacturing of these splitters because there's not going to be an injection molding factory spun up in four days to make these parts. So, we can support the validation process and then, if the validation goes through, we can start printing these and providing instructions on how to retrofit ventilators."

3D-printed medical devices -- opportunity and concern

While Formlabs is juggling multiple requests from healthcare systems for parts, it is far from the only 3D printing company being asked for help.

Jos Burger, CEO of 3D printing company Ultimaker based in the Netherlands, said the company has been overwhelmed by emails and phone calls from health systems asking for assistance printing surgical masks and other products.

In response, Ultimaker started an initiative to connect healthcare systems with nearby 3D printers to print what they need based on available designs.

"All of us in the space are being bombarded by all kinds of people in the healthcare industry who are screaming for 3D printing capacity in order to make stuff like valves and splitters and pieces of protection masks," Burger said. "In these extraordinary times, we are taking responsibility, and that's why we started this program."

Formlabs' Lakatos said many hospitals have their own 3D printers, which he sees as an opportunity for health systems. Health systems and academic medical centers, such as the BJC Institute of Health at the Washington University medical campus, use 3D printers to create surgical models of patients.

"A hospital that has one of our printers can output about 600 of these [nasal swabs] a day, so that could be potentially enough for a hospital to do a kind of self-service," he said.

Despite the momentum around 3D printing parts for healthcare, Chilmark Research analyst Alex Lennox-Miller sounded a word of caution.

"This is a space that has a huge amount to offer healthcare, especially when you're talking about sudden need," Lennox-Miller said. "I think it's a space that really doesn't have the history or the amount of study behind it, and so it makes me a little bit wary when you hear people 3D printing valves, 3D printing components, especially if they're going into what needs to be a clinically secure, sterile machine."

Indeed, 3D printing medical devices like nasal swabs and ventilator tubes is a bad idea, said Jared Crooks, founder and CEO of A.M. ToolBox LLC, a 3D printing consultancy in Powell, Ohio.

3D printing works by building parts layer by layer, regardless of the material used or the particular 3D printing machine. The process leaves a certain amount of porousness or surface grit behind, which can allow a virus or bacteria to adhere or pass through.

"A couple years ago, I was designing functional parts and knobs for the inside of ambulances, so I got a crash course on disinfecting an ambulance after each call," Crooks said. "You have to have almost a glass surface, because with any kind of nook and cranny, a bacteria will get in there and thrive."

It would be more useful to use 3D printing for what it does best: creating prototypes and design iterations for devices such as medical masks, Crooks said.

"You should use 3D printing to do what it's intended to do. For example, you have an idea for a mask that's easier to manufacture than the ones they currently have, you can go ahead and 3D print parts to develop it in a controlled environment," he said. "People can look at the mask and review it, then you can figure out how to improve the mask or face shield design by developing it and testing it out, and then going into maybe a better DFM [design for manufacturing]."

COVID-19 a 'proving ground' for 3D printing in healthcare

Manchanda said Formlabs is "trying our best" to work closely with medical associations and clinical partners during the process -- from creating the first prototype to FDA approval.

We are not looking to get parts out there just for the sake of it. We're going to make sure there's a clinical need and that the health systems are protected, as are we.

"We are not looking to get parts out there just for the sake of it," Manchanda said. "We're going to make sure there's a clinical need and that the health systems are protected, as are we. Formlabs, in particular, has been working with hospitals and medical device companies for several years now. We have an in-house regulatory affairs team and we want to do no harm just like medical professionals do."

Although he has concerns about using 3D-printed parts in healthcare, Lennox-Miller said he doesn't fault healthcare systems looking to make up for shortages in supplies any way they can. He also believes the COVID-19 crisis is an opportunity for 3D printing, and other technologies to demonstrate their capabilities.

"This is going to be a proving ground," Lennox-Miller said. "You're going to see a lot of people saying: 'Here's what we did; here's where it worked; here's where it didn't work; here's where we can improve.'"