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G_NIUS: Hundred Days to Success. This is the podcast of G_NIUS, the Guichet National de l'Innovation et des Usages en e-Santé. Around Lionel Reichardt, meet e-Health innovators and key experts to help you succeed in your projects.

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Lionel Reichardt: Hello everyone, you're listening to 100 Days to Success, the podcast aimed at innovators and entrepreneurs in digital, healthcare, but also anyone curious about this field. This podcast is produced by G_NIUS, the Guichet National de l'Innovation et des Usages en e-Santé. For this episode devoted to CIC-ITs, Clinical Investigation and Technological Innovation Centers, I'm pleased to welcome Régis Logier, Director of the Lille CIC-IT and Associate Professor of Health Engineering at the University of Lille. Régis Logier, good morning.

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Régis Logier: Hello.

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Lionel Reichardt: First of all, Mr Logier, can you tell us what the CIC-ITs are? How long have they existed and how many are there in France?

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Régis Logier: The CIC-ITs were created in 2008, under the joint impetus of Inserm and the Ministry of Health's DGOS, to meet a particular need for organizing clinical and preclinical trials involving medical devices and, more broadly, healthcare technologies in general. These devices are not medicines, and to carry out clinical trials on them, preclinical trials are required. There are special procedures involved, and this is why the CIC-ITs were created. In France, there are eight CIC-ITs, each with its own special field of technology. Given that healthcare technology is a very broad field, each CIC-IT has its own specialty. For example, all imaging technologies can be found in Nancy. It's important to note that CIC-ITs are housed in university teaching hospitals. At the Nancy CHU, we'll find all the technologies for MRI and imaging in general, while Besançon will have all the micro technologies for healthcare. We'll find all the technologies for augmented medical interventions in Grenoble, biomaterials in Bordeaux, ultrasound in Tours, cardiovascular systems and technologies for the cardiovascular system in Rennes, and everything to do with motor disabilities in Garches. And in Lille, we specialize in biosensors and e-health. I've done a bit of a tour of France's CIC-ITs.

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Lionel Reichardt: Very good. The CIC-IT in Lille specializes in e-health and biosensors. What type of projects are you working on, and what is the framework for these collaborations? Are they partnerships or services?

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Régis Logier: First of all, the mission we've set ourselves is to support project leaders from within the CHU, since we're part of one of Lille's largest CHUs, so we're in constant contact with clinicians. Innovation ideas come from the field, from the day-to-day practice of medicine or surgery. Our first mission is to listen to our clinicians within the CHU and support them in the development of their idea. They come to us with their ideas, and we start by transforming them into prototypes. There will be three phases. Firstly, there's a design phase, which means that we'll use the idea brought to us by the surgeon or practitioner to create what we call a proof of concept. Then, when the answer is yes, we'll make a prototype, so we have all the facilities to be able to make prototypes, and it's the prototype that will then be used in the evaluation phase for clinical trials.

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Régis Logier: In this evaluation phase, and this is why, as I say, the CIC-ITs were created, the evaluation phase for medical devices is quite extensive, since you first have to carry out what we call preclinical trials. In other words, the prototype must first be tested on simulators to test the device's functionality. Then we need to carry out so-called safety tests, electrical safety and electromagnetic compatibility tests, which will be necessary before bringing the prototype to patients. Another very important aspect of preclinical studies is ergonomics and usability. In Lille, we're lucky enough to be associated with ergonomists who do this kind of usability analysis. We will then enter the clinical evaluation phase, where we will of course be involved in setting up the clinical protocol methodology and carrying out the protocol itself. When all this is done, we'll launch the third phase of our work, which we call valorization. We've done the prototype, we've done the clinical evaluations, we've got something that works, that's been proven, then we launch what we call valorization.

00:06:08
Régis Logier: Valorisation in the usual research sense, of course, means speaking at conferences and then producing scientific publications. Above all, we're interested in the possibility of patenting and protecting the innovation, because in these cases, we often work on breakthrough innovations, so there's often the possibility of registering patents. We're not going to shy away from this, we're going to try and register patents, and with these patents, we're going to try and interest industrialists who are already on the market for the technology we've developed, or we're going to try and create a start-up. In Lille, we're lucky enough to be close to a bio-incubator called Santé, and they're going to help us create the start-up and bring the product to market. That's the pathway, if you like, from idea to market for our in-house projects. We are also increasingly able to work with external project leaders, whether clinicians from other hospitals, start-ups or final-year students, who have ideas for innovation, and we will also support them. This support is provided either through services or real partnerships.

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Lionel Reichardt: On the types of projects can you give us a few examples of the projects you've been able to support, in which therapeutic areas, with what purpose in recent years?

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Régis Logier: I'll give you two examples, an internal project and an external project. An internal project involves a visceral surgeon who performs intestinal operations, and then comes to us with a problem. He says that there are certain patients who have undergone small bowel surgery. We have to put them in ostomy pouches. An ostomy pouch is a pouch used to collect the alimentary bolus. These patients remain in an ostomy pouch for several weeks, or even months, before undergoing further surgery to restore continuity to the small intestine. This surgeon comes to see us and says, there's a problem: when we put these patients on an ostomy pouch, they're malnourished. We have to give them parenteral nutrition, which means artificial nutrition, and this leads to liver complications and so on. He says, "I've got an idea: couldn't we replace the ostomy pouch with a pump that would allow us to reinstill intestinal fluid from the upstream segment of the intestine to the downstream segment? He has this idea, and he thinks it's really what's going to save patients. We did it, because we came up with the technology behind the idea.

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Régis Logier: A first pneumatic pump, then a second, then a third. We carried out tests on simulators and so on. Gradually, we were able to prove the concept of the idea. Today, we're in the process of producing a finished prototype. We've set up a start-up company and are about to begin clinical trials on patients. It can take 10 years from the idea to the startup. We began this work in 2013. Today, 2022, we created the startup last year. This is a concrete example of an idea coming from a practitioner who comes knocking at our door. I'll give you another example, someone who works in the biomedical industry and is already used to marketing anesthesia devices. This person comes to us and says, I've got an idea, I've met a lot of anaesthetists and I think we can develop a system that will monitor brain oxygenation during surgery. I think it's important to do this, but he doesn't have the practical means. This person, completely outside the CHU, who came from another region, created his startup, we entered into a partnership and we're developing the system together with CIC-IT engineers and researchers.

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Régis Logier: We're partners, which means we each have our skills, we're going to carry out a project together, we're going to share the costs of this project, but we're also going to share the intellectual property. We'll be co-owners of the patents, if any, and we'll share the profits. In other words, the Lille University Hospital will receive royalties on sales of this product.

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Lionel Reichardt: In Lille, you've set up a CETS, a healthcare technology expertise unit. You're the only CIC-IT, I believe, where this structure exists. What is its role?

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Régis Logier: Why did we set up this healthcare technology expertise unit? It's because we're increasingly approached by project sponsors from outside the CHU, who have very different cultures. There's the surgeon I was talking about earlier, who knows exactly what he wants, knows exactly how to run his clinical trial, but doesn't know how to make a prototype, file a patent or create a start-up. On the other hand, there's the young engineer who's just come out of school, he's done his internship in a biomedical industry, he's got an idea, he's made a prototype, he's filed a patent, he's in the process of creating a start-up and he comes to us saying: "When do we start clinical trials? My idea is good." We're obliged to tell him, "No, that's not how it's done, you need to do preclinical tests, etc." When you're dealing with project leaders from such different cultures, you say to yourself, there's something to be done, we're going to try and create a structure where people can come and present their project. The idea of CETS is to map out their project at a given moment and say to them, "You're where you are today" and give them a roadmap.

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Régis Logier: They're going to talk to experts. The experts are clinicians, intellectual property experts, regulatory experts, clinical trial experts, and we're going to tell them everything they need to know about the path from idea to market launch. We'll give them a roadmap. That's the idea behind CETS. Following this CETS, we can eventually enter into a partnership or service to help them on this or that point.

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Lionel Reichardt: To conclude, Mr. Logier, what advice would you give to an entrepreneur, a healthcare innovator wondering whether they should apply for a CIC-IT?

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Régis Logier: I'd propose going CETS already, and I hope one day CETS can grow to national level. Why would I do this? Because within the CIC-IT, we already have a global knowledge of the innovation cycle. We also know the applicable regulations and standards, both for clinical trials and for CE marking. It's true that CE marking, which means marketing authorization, is very important. We have the capacity to carry out functional tests on simulators, preclinical tests, use tests and safety tests. Then we're able to support the entire clinical trial process. This is very important. Because for a start-up, the big difficulty in medical technologies is clinical trials and CE marking, which are time-consuming and very costly. We can support them in these areas, with the aim of optimizing their time to market.

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Lionel Reichardt: Régis Logier, thank you very much. Our episode is coming to an end. Thank you for listening. Our thanks again to our guest for his availability. Don't hesitate to subscribe to the podcast on your listening platforms. We look forward to seeing you soon for a new episode of 100 Days to Success!

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