Update, March 18th 5:30PM ET: A group of Italian volunteers distributed 3D-printed versions of a vital medical device — but it doesn’t appear that the original manufacturer threatened a legal crackdown. As we reported earlier, Cristian Fracassi and Alessandro Romaioli used their 3D printer to create unofficial copies of a patented valve, which was in short supply at Italian hospitals. Business Insider Italia quoted Massimo Temporelli, the Italian professor who recruited the pair, saying that the device maker threatened them with an infringement claim.
But in an interview with The Verge, Romaioli denied they’d received threats. He said the company had simply refused to release design files, forcing them to reverse-engineer the valve. “I talked to an operator who told me he couldn’t give me the files, but after that we didn’t receive anything from the original company — so I can assure you we didn’t get any threat,” he said. “They said they couldn’t give us the file because it’s company property, but that’s all.” While earlier reporting said the original valve cost over $10,000, Fracassi also told Fast Company that this number was inaccurate.
Temporelli gave The Verge a more ambiguous account of the call, which he says he wasn’t directly involved in. “The group we asked for the files refused and said it was illegal” to copy the valves, he said. He stopped short of calling the statement a threat. “Let’s say the risk to be sued exists since they bypassed a patent, but that’s it.”
Manufacturing company Intersurgical says it had no intention of making a threat. Managing director Charles Bellm issued a statement to The Verge:
Just to confirm that recent reports from Italy are totally incorrect, we were contacted at the end of last week for manufacturing details of a valve accessory but could not supply these due to medical manufacturing regulations, we have categorically not threatened to sue anyone involved. The valve is an accessory supplied as part of a CPAP Hood system which alone costs a few euros.
Our Italian company has been doing their utmost to supply the hospitals at this time and have been supplying these free of charge in many cases to use with the CPAP Hoods. It is very disappointing that in the current climate this incorrect information is circulating, our focus as a company is to be able to supply the hospitals that require these and many other vital products and we are making every effort to ensure we can do so.
Romaioli and Temporelli have emphasized that both devices serve a purpose: the official product is the better long-term solution, but for now, hospitals can use this printed alternative to fulfill a sudden, drastic demand.
The original article follows below.
A medical device manufacturer has threatened to sue a group of volunteers in Italy that 3D printed a valve used for life-saving coronavirus treatments. The valve typically costs about $11,000 from the medical device manufacturer, but the volunteers were able to print replicas for about $1 (via Techdirt).
A hospital in Italy was in need of the valves after running out while treating patients for COVID-19. The hospital’s usual supplier said they could not make the valves in time to treat the patients, according to Metro. That launched a search for a way to 3D print a replica part, and Cristian Fracassi and Alessandro Romaioli, who work at Italian startup Isinnova, offered their company’s printer for the job, reports Business Insider.
However, when the pair asked the manufacturer of the valves for blueprints they could use to print replicas, the company declined and threatened to sue for patent infringement, according to Business Insider Italia. Fracassi and Romaioli moved ahead anyway by measuring the valves and 3D printing three different versions of them.
So far, the valves they made have worked on 10 patients as of March 14th, according to Massimo Temporelli, the founder of Italian manufacturing solutions company FabLab who helped recruit Fracassi and Romaioli to print the replica valves.
“[The patients] were people in danger of life, and we acted. Period,” said Fracassi in a Facebook post. He also said that “we have no intention of profit on this situation, we are not going to use the designs or product beyond the strict need for us forced to act, we are not going to spread the drawing.”
Here’s a good look at the valves, shared by Italy’s Minister of Technological Innovation Paola Pisano on Twitter.
Italy has more than 31,500 confirmed infections of COVID-19, the disease caused by the novel coronavirus, and more than 2,500 confirmed deaths. Both figures trail only China.