The best ideas always come from real problems, and to me, ideas are pointless without problems.” — Cristian Fracassi

During the COVID pandemic’s darkest days and amid global ventilator shortages, hospitals were desperate for a solution that would save countless lives. They tapped engineer and inventor Cristian Fracassi and his company ISINNOVA. Fracassi and his team developed an ingenious solution that would allow those affected by COVID to breathe, thus saving thousands — perhaps even hundreds of thousands — of lives. 

This incredible achievement led to many patients’ recovery and has become an international symbol of lifesaving innovation — to the point that the Charlotte valve is now on display at some of the world’s most prestigious museums, including the MoMA and the Cooper Hewitt Smithsonian Design Museum in New York and The Victoria and Albert Museum in London, to name a few.

We spoke with Fracassi about the Charlotte valve and how ISINNOVA is working to solve some of the world’s most pressing problems. 

Charlotte Valve and Mask, 2020, Cristian Fracassi and Alessandro Romaioli, Isinnova

MP: What was the timeline between getting the call and delivering the first 100 valves?

CF: The first call arrived on Friday, the 13th of March 2020. That same afternoon, we headed to the hospital to understand which part was missing. That’s when we found out it was the Venturi valve that was missing, a crucial piece that, when connected to the mask, made up the respiratory device that many people needed to stay alive. On Friday evening, we recreated the valve 3D file, and we tried to print the first piece. The following morning, we had three printed pieces ready to be tested in the hospital. On Saturday evening, we sent off 100 pieces to be printed. On Sunday morning, those 100 pieces were delivered to the hospital.

MP: I’m curious to know about relationships that started after the general release of the 3D printer files. Did that open-source movement create any collaborative partnerships? 

CF: Our 3D valve file was shared online and reached over two million downloads. More than 2,000 companies printed the valve. More than 186,000 pieces were printed. We are still in touch with some of those companies and hospitals.  

Charlotte valve + diving mask in the act of saving a life

MP: How has the company’s direction changed since the Charlotte valve? Do you think ISINNOVA would be working on the same things if COVID had never happened?

CF: Isinnova had already worked on medical projects but never at this speed and risk! It normally takes two or three years for a medical project to be functional and effective — certainly not eight hours. We had no idea how respiratory devices worked. If COVID had never happened, I suppose we would have never developed something in that field. The best ideas always come from real problems, and to me, ideas are pointless without problems.  

MP: Have you ever gotten any near-accurate figures regarding the number of lives saved through the open sharing of the Charlotte valve files?

CF: Unfortunately, we do not have precise figures. We found at least 65 other platforms spreading our file on other websites and channels. We cannot directly connect the number of downloads with the effective number of printed and used valves. The exact number of delivered masks is 186,000: 122,000 given away directly by Decathlon [maker of the diving mask used in combination with the Charlotte valve], 10,000 bought in other countries, 16,000 in Canada — using another mask similar to the one of Decathlon, three Chinese models we do not have precise figures for, and a few thousand models of an Italian company. 

Moreover, some hospitals sterilized and reused the masks multiple times. 

Other interesting figures: a total of 73 countries were involved, ca. 30 different valve types were found online (for Decathlon and other masks), and 9 prizes were linked to the Charlotte valve.

Charlotte valve design

MP: Can you tell me about Cristian and ISINNOVA’s latest research? There are three big initiatives you’re currently working on that I know of — the sleep mask, the wheelchair, and the surgical instrument for kidney tumors. Can you elaborate on these projects and where they stand?

CF: Isinnova is a research center in the north of Italy, which was founded 7 years ago and currently has 20 employees with a mean age of <30 years. We work on innovative projects in many fields: industry, medical, building, recycling, energy, and environmental.

The biomedical projects we are working on come from important Italian hospitals with whom we are close. They point out the problems, and we propose some possible solutions. 

Our NFT collection creates value for our supporters, and, at the same time, it gives them the chance to actively participate in the creation of something good. 

Regarding the three projects you mentioned: the sleep mask is linked to the OSAS – Obstructive Sleep Apnea Syndrome. Since patients must use this mask every night while sleeping, we are trying to develop a more comfortable device. The wheelchair we are working on will be an “all in one” device with many different features to reduce the number of unused and stocked wheelchairs in rehabilitation centers. Last but not least, we are trying to create a surgical instrument to facilitate and lengthen the kidney tumor’s surgery time (now very short and delicate).   

MP: Would you like to call out any other inventors working in an open-source, collaborative manner like ISINNOVA?

CF: We are always open to collaboration: we could create a private community in which we share some requests we receive from hospitals, and every member can propose his/her ideas. We can then work on the best ideas and try to develop them together.  

MP: Where did the idea for this series come from? And how did Michele Ronchetti (AKA Miro) come to be involved?

CF: The idea for this series came from Federico Vincenzi, the lawyer who helped us during the COVID emergency. After everything, he wrote “Tutto d’un fiato,” the book telling the story behind this collection. 

After the success of our Charlotte valve and modified mask, many hospitals started to ask for our help in the research and development of some biomedical projects aimed at solving problems they have to face every day.

Federico knew we had worked with zero profit during 2020. Since the Charlotte valve and the modified mask are now valuable design objects, he suggested we could create a limited number of NFTs representing these objects and our story for the digital art market. Proceeds of the collection will then contribute to the R&D of these projects. 

We had no competence over NFT, so I asked for help using my personal LinkedIn account. Eighty people proposed themselves and, among them, we started a collaboration with Apeiron Technologies. It was Apreiron that introduced us to Miro. We sent him our book “Tutto d’un fiato” and, after reading it, he created the seven digital art pieces that compose the collection, each piece linked to the seven most salient phases of the story. 

MP: Is ISINNOVA working in the blockchain technology space currently? If not, are there plans to? 

CF: This is the first time ISINNOVA has worked with blockchain, but we are becoming quite fond of the NFT world. If this first project works out, we will probably start working more with NFTs and blockchain, using these new technologies to support our core business. 

MP: 3D-printable NFTs are a ripe growth area for the web3 space. Does ISINNOVA have plans for leaning into this in the future? CF: 3D printing is our trump card, so why not!? Should this first NFT project work, as we are expecting it to do, we will absolutely consider doing more 3D-printable NFTs.

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