Christian Fracassi, founder and CEO of Isinnova, an Italian engineering startup, heard the call for help last Friday. The hospital in Chiari, in the Brescia area of northern Italy where the coronavirus pandemic has hit hard, urgently needed valves for its respirators in order to keep patients who required oxygen alive. The manufacturer couldn’t provide them quickly enough and the hospital was desperate.
Fracassi immediately started tinkering with his engineers to reverse-engineer a 3D-printed version of the official part. Called a venturi valve, it connects to a patient’s face mask to deliver oxygen at a fixed concentration. The valves need to be replaced for each patient.
By Saturday evening, Fracassi had a prototype, and, the next day, he brought it to the Chiari hospital for testing. “They told us, ‘It’s good. It works. We need 100,’” says Fracassi, who is 36 and holds a Ph.d. in materials science with a focus on polymers. “We printed 100 of them on Sunday, and we gave all the pieces to the hospital. They are working very well.”
As the coronavirus spreads globally, shortages of medical supplies have become a major problem. Manufacturers simply can’t crank up their production of life-saving medical devices fast enough. The biggest supply crunch is with ventilators, but respirator parts like the ones in Italy and even simple nasopharyngeal swabs for testing are all in short supply. Meanwhile, the technology of 3D printing, which allows digital design of parts and the “printing” of them off a machine that creates them layer by layer, is ideally suited to emergency manufacturing because it is fast, cheap and can be done without a big factory.
But it raises issues, ranging from the quality of the products in a medical situation to the patents held by the original device’s manufacturers. Typically, new 3D-printed parts have to be certified. In Italy, Fracassi says, emergency rules during the coronavirus pandemic allowed that requirement to be waived.
“They said, ‘We know the product you will bring will never be the same,’” says Alessandro Romaioli, Isinnova’s engineer, who designed the 3D-printed valves. Isinnova offered the hospital in Chiari the valves for free; Fracassi says the cost to print them is two or three Euros (or $2-3) apiece. Isinnova now has the capacity to produce around 100 parts per day, and is talking with a second hospital in Italy about sending the valves there, too.
Yet potential legal and medical issues have stopped Fracassi from distributing the digital design file more widely, despite receiving hundreds of requests for the 3D-printed valves. There are complexities because hospitals use a wide variety of respirators, each of which has slightly different technical specs and would require slightly different valves. Then, too, there’s the threat of potential patent litigation, as first raised by Techdirt. “We don’t know if something is patented. We just hope the factory can close its eyes because they cannot produce it in time,” Fracassi says. “It’s only for emergencies.”
Still, in the face of the coronavirus pandemic, 3D printing offers a smart stop-gap solution at least. Davide Sher, the 3D printing analyst who wrote the original story about Isinnova for trade publication 3D Printing Media Network, subsequently created an online Emergency AM Forum to help hospitals, 3D printing companies and inventors share ideas in the fight against COVID-19. As he writes there: “While there are both copyright issues and medical issues that need to be taken into account when 3D printing any medical product, and a critical one such as a venturi valve, in particular, this case has shown that a life-and-death situation could warrant using a 3D-printable replica.”
Fracassi says that Isinnova is now working to design other medical products that hospitals need during the coronavirus pandemic. The first is a mask. The startup created a prototype earlier this week, and sent it to the hospital for testing, he says. “We are waiting for a response, and if it works, we are ready,” Fracassi says. “Then every hospital can make their own masks.”