The outbreak of COVID-19 has caused much-documented shortages of medical supplies around the globe. Countries, states and hospitals have had to scramble as their provisions dwindle in the face of being inundated with patients. Faced with a supply crunch, people have had to resort to various methods to procure supplies and have even been ordered to reuse masks. In Italy, the shortage of a certain respiratory valve sparked a creative solution among a group of volunteers who 3D printed that part. However, this may have gotten the volunteers in trouble on intellectual property grounds as there are reports that they could be in legal trouble with the product’s manufacturer. Some sources have reported that the maker was threatening a lawsuit.
Italy was the global epicenter of the coronavirus outbreak before the United States assumed that title. The health situation in that country continues to be dire, partially due to the advanced age of many Italians along with the country’s poor preparation for the pandemic. Hospitals have literally had to choose who lives and who dies in making treatment decisions.
A Supply Shortage at an Italian Hospital Created a Desperate Situation
One Italian hospital ran out of a critical medical supply that it desperately needed. The breathing machine used by one Italian hospital required a certain valve to function. Media reports differ as to how complicated this part was. Some reports place the cost of this valve at roughly $11,000. However, the company that makes the product denies that the valve itself costs this much. Instead, the company claims that it was a non-complicated part that costs only a few Euros apiece.
Regardless, without this valve, the breathing machine was not able to perform its job. Engineers asked the company for the specification and design of the valve so that they could quickly reverse engineer the part. However, the company, protecting its own intellectual property, refused to provide the designs of the part.
It was at this time that a handful of volunteers took matters into their own hands to try to relieve the critical supply shortage. The volunteers put out a call for a 3D printer so they could set about trying to make the product for themselves. They quickly got their hands on one of these printers through the generosity of an Italian company.
There is some dispute over the valve manufacturer’s reaction at this point. Initial media reports suggested that not only did the maker not provide the specs on request but it also threatened a patent infringement lawsuit. However, the company claims that the part was not intricate and it had no reason to sue the volunteers for trademark violations. Eventually, the engineers clarified that they are not facing the threat of a lawsuit.
The Engineers Acted on Their Own in a Desperate Situation
Regardless, the volunteers took matters into their own hands and did not fear the possible reaction of the company. With their main goal of saving lives, engineers quickly went to work to design their own valves so that the breathing machines could return to saving lives.
Just from studying the valve, the pair of engineers were able to figure out how to design and make their own using a 3D printer. What made the engineers’ feat even more remarkable was that the 3D valves cost roughly $1 each to make. They created three different prototypes of the valves, finding the one that worked best with the breathing machine.
In the meantime, the pair was able to literally save lives through their ingenuity. This was a case of extraordinary people doing what they had to do to get the job done in an emergency and worrying about the consequences later. The engineers had literally figured out the problem within a few hours and had a batch of ten prototypes by the end of the day after someone brought a 3D printer to the hospital. By the next day, they had produced 100 of their own valves.
However, it remains to be seen how well these 3D parts will hold up under the strain of their usage. They are adequate but not perfect and could break down after little usage. However, the situation does not require an exact replica, just one that works.
Other Italian hospitals have contacted the pair seeking to have them produce these 3D valves for them to alleviate parts shortages. The engineers will not release the design themselves because they believe that there needs to be some expertise in producing the part. They still believe that it is best to buy these from the manufacturer, even if they cost more because they produce a safer product. Nonetheless, the two engineers are committed to not making any money from this venture and are only doing this to save lives should they be required to step in and make more valves.
Can 3D Printing and Open-Sources Solutions Help Alleviate Shortages?
There is some hope that the use of 3D technology can help relieve acute supply shortages during the COVID-19 crisis. However, there are legal risks to this. Companies will not simply release the designs to their product. People will then have to reverse engineer the products and hope that they do not end up as the defendant in a lawsuit. The companies that make these medical supplies do have patents and therefore have the legal right to sue.
This invokes some of the policy questions surrounding medical patents. The companies who make these parts invest money in designing them and are compensated through a patent. However, the patent then imposes high costs on society, who ends up paying through sky-high medical device prices. You can see in this example some of the costs involved. A part that many media reports claimed cost $11,000 was 3D printed for just over $1.
Still, this serves as an inspirational example of what some gutsy engineers can do when faced with a dire emergency. There have even now been calls for open-sourced ventilators to help relieve the desperate shortage of these life-saving devices.
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