What is 12Clip and how does it work?
Our project is based on the insertion, under appropriate conditions, of the peripheral venous catheter. he peripheral venous catheter is by far the most widely used catheter in medicine: In Spain, for example, more than 30,000,000 catheters a year. In the USA, more than 300 million per year. According to the World Health Organisation’s recommendations for inserting these types of catheters, non-sterile gloves can be used. In turn, these recommendations state that the catheter should be inserted in an aseptic manner, but it is metaphysically impossible to fulfil both recommendations at the same time, because, when handling the catheter during insertion, the catheter becomes contaminated with bacteria. These bacteria can enter the bloodstream, can cause complications such as local infection, phlebitis (inflammation that is very painful for the patient and that up to 15% of patients develop at the site of catheter insertion)… And also, if the bacteria pass into the blood, they can cause disseminated infection, endocarditis, brain abscesses, infection of the vertebrae, etc. To avoid this, we have designed and patented a device that allows the insertion of the catheter in aseptic conditions without manipulating this proximal part. This device is then removed and the catheter is inserted into the patient’s vein without any manipulation.
What is the goal?
The ultimate goal is to be able to commercialise this device and benefit patients, as it would reduce the risk of phlebitis at the insertion site and the risk of developing potentially very serious and very costly infections for the national health system: it is estimated that each episode of bacteraemia costs up to 11,000 euros and globally, taking into account the number of infections that occur in Spain associated with vascular access catheters, we are talking about hundreds of billions of euros that could be saved by avoiding this type of infection.
How did the idea come about?
I work in infectious diseases and I am very aware of this issue, because every day I see this type of serious complications and infections that develop because of a catheter: the patient comes to the hospital for another reason and ends up developing an infection related to the catheter that was not the reason for his or her admission. So from daily practice, from seeing these kinds of infections on the one hand and from seeing how catheters are inserted on the other, the idea arose that something had to be done so that the healthcare staff inserting the catheter would not have to manipulate in this proximal area and try not to contaminate the catheter at the time of insertion.
But if you ask me about the eureka moment, this literally started with the design of a drawing on a napkin and I honestly believe that I wouldn’t have got much further on my own if it hadn’t been for the help of the Innovation Unit of the Research Institute of the Hospital 12 Octubre.
Why did you decide to participate in the Fundación para el Conocimiento madri+d programme to promote the creation of technological start-ups in the healthcare sector?
As I said, thanks to the hospital’s Innovation Unit, we have been making progress with the project: we have received public and private subsidies with which we have managed to start developing patents. We already have a patent for an initial device in 2016. Then we have also progressed with the help of the PRODINTEC institute, thanks to which we have managed to develop a more advanced device and start the patent process again. Once we had the technological development practically finished, we wanted to try to commercialise it and try to set up a company or make a business plan. And in this sense, the Innovation Unit proposed that we participate in the healthstart madrimasd programme and the truth is that the experience could not have been more satisfactory.
What has it meant for you to have been chosen as one of the most innovative initiatives in the health sector in our region?
I am deeply grateful for this recognition because it has opened up a new perspective for us, a completely new field, and has allowed us to reach a level of development that I honestly didn’t think we could reach. We had the technological development, the patent was already in place, but we were missing that step towards society, so that society could benefit from it and that there would also be a commercial or business development of the project. The healthstart programme has allowed us to take a giant step forward in this sense.
What is the current status of the project and what are the next steps? What is the current status of the project and what are the next steps?
We have just received very positive news in terms of the patentability of the device and the international development of the patent. So we are right now with the device already well protected with a robust patent, and we are just at that point where we could take the leap to try to make a commercial or business development of the device. One of the possibilities would be in the form of a spin-off from the Instituto de Investigación del Hospital 12 Octubre to launch ourselves into the market: Thanks also to the support received from the healthstart programme, we plan to start initially in the Community of Madrid and then move on to a national development, then to a European level and, subsequently, even to an international level.
What have been the main difficulties you have encountered during these months of work?
Participating in healthstart was an opportunity that we had to take advantage of, but the truth is that it is a world that is in some ways completely unknown to me. I work in the clinic, seeing patients, and when they talked about business plans, balance sheets, laws, how to insure it… It was completely alien to me. So we had to make a big effort to get up to speed, but I think it was worth it, especially because it has set us some objectives, it has taken us to a level of development of the project that, frankly, a year ago we didn’t have at all.
And the greatest achievement?
I would say that the greatest achievement has been to be able to launch ourselves in the market. Our participation in healthstart has been a real boost to the project. It is true that our project was practically finished from the point of view of technological development and, well, the fact that the Community of Madrid encourages the work developed in the research institutes of its hospitals to take this step to the market, which is where many technological projects come to a standstill, has really been very important for us. I always say, half jokingly and half seriously, that the day I need a catheter, I would like it to be inserted with my device, so I am the first one interested in making it available. I would not like my project to remain simply an academic patent, which is all very well for my CV, but honestly I need people to be able to benefit from it and, for this to happen, we need to develop the project as a business, which, of course, without the help of healthstart at the moment, I think would have been impossible or would have taken much longer.