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G_NIUS: 100 days to success is the podcast from G_NIUS, the Guichet national de l'innovation et des usages en e-santé. With 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 at 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 the importance and difficulty of including regulatory skills in your healthcare innovation project, I'm pleased to welcome Claire Nassiet, Education Project Manager at EIT Health, a network of excellence for patient health in Europe, co-funded by the European Union. Hello Claire Nassiet.

00:00:57
Claire Nassiet: Hello.

00:00:58
Lionel REICHARDT: When we think of start-ups and human resources, we often think of Tech profiles or those around data, but rarely regulatory profiles. And yet, innovating in the healthcare sector generally involves mastering a number of regulatory aspects. Why is regulation the poor relation of this team vision to innovate in healthcare?

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Claire Nassiet: Mainly because the profession suffers from an image flaw. It's not known, and when it is known, it's not sexy, so to speak. It suffers from an image of a niche profession, too technical, too technocratic. And yet, regulatory profiles play a key role in start-ups and corporate healthcare innovation, and the need for them has been growing for years. It's very difficult to attract and recruit these profiles, whether for start-ups, SMEs, major groups or notified bodies. In all EU countries, it's very difficult to attract and recruit them.

00:01:56
Claire Nassiet: Let me go back to the European regulations. The MDR, or Medical Device Regulation, which has often been presented in a somewhat restrictive light, meaning that it adds a whole set of constraints, but the spirit of this new regulation was really patient safety and ensuring that products and solutions or innovations in healthcare, which ultimately affect us all, have a positive medical benefit.

00:02:23
Claire Nassiet: In any case, this regulation has further increased the need for regulatory skills for all players in the sector and it has multiplied the type of requirement and it has changed the profile and skills of regulatory profiles a little.

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Lionel REICHARDT: Just mentioning these regulatory profiles, what are they today? What are the professions that are linked to regulation, that are indispensable to healthcare entrepreneurs?

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Claire Nassiet: What emerges from our discussions with the ecosystem is that regulatory affairs professionals need to be both technically competent to be able to understand the specifics of healthcare solutions, products or innovations, and they need to be extremely aware of the various regulations and above all their interpretation. It's a landscape that's evolving very rapidly, so you have to keep constantly up to date with the different interpretations and their application, and how that can impact the innovation you can work on in a startup or company.

00:03:21
Claire Nassiet: It's also very important to have specialized regulatory resources when developing a digital health solution. We have teams of developers who have their own roadmap or their own IT development roadmap and who aren't necessarily used to asking themselves questions around regulatory issues, and this can come very late and far too late in the development if we don't have someone in-house in the company who will be able to make them ask themselves the right questions at the outset.

00:03:55
Claire Nassiet: One of the key skills also for all these profiles, is this multidisciplinary work it's really a team effort. The regulatory profile has a central role in the startup because it's going to be the connector or bridge between different teams and it has to be able to speak, understand different languages and make everyone understand the different regulatory issues.

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Lionel REICHARDT: The ideal regulator must be both business-oriented, understand technology and make his or her business sexy enough to get the whole company on board. It's quite a challenge. There's a lot of talk about the talent crunch in many fields, and we're hearing a lot about what you mentioned earlier, the regulatory bottlenecks in the context of the MDR, the new European regulation for medical devices. I guess regulatory profiles are in high demand.

00:04:51
Lionel REICHARDT: How can we attract them, recruit them, keep them and how, in the long run, can we combat this shortage?

00:04:57
Claire Nassiet: Actually, it's not a simple profile. First, there's the first level. The first level is the communication problem we talked about at the very beginning. Very little is known about the business. There's a problem with marketing the regulatory profession. The sector needs to learn how to better talk about and market this profession, particularly to young people, but also to healthcare professionals who have a number of years' experience in the sector and who could be helped to develop their regulatory skills.

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Claire Nassiet: The second issue that makes it difficult to recruit regulatory teams, is also that often in startups, in companies, entrepreneurs tend to see the regulatory colleague a bit as a constraint, a bit as the one who slows things down, the one who can complicate access to markets. This is a real change, a revolution in the mindset, in the way we see this profession and its place within the startup and the company. It's a key role.

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Claire Nassiet: He's really there to support product development, both on the compliance side, but also to contribute his expertise on clinical benefits, and really inform the development roadmap. He's not just there to slow things down and impose constraints. From the outset, you have to integrate regulatory aspects into these different roadmaps, whether it's fundraising, development, access to market or reimbursement.

00:06:41
Claire Nassiet: I think with this change, a bit of mindset, it makes the regulatory medico First Leeds job, Chief Medical Officer, whatever it's called in different start-ups. It makes this strategic job really central to the success and growth of the start-up.

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Lionel REICHARDT: How, in the long run, do we combat this shortage of skills, of regulatory resources?

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Claire Nassiet: There's a big long-term training issue too. This is an area that has been under-invested for years in the various countries of the European Union. The French government is investing 80 million euros to train 200 professionals over the next five years, starting in 2022. The European Union is also investing heavily in regulatory issues, but there isn't yet enough degree-granting training aimed at students that would come onto the market to become a regulatory affairs profile.

00:07:39
Claire Nassiet: This subject of continuing education is essential. As I said before, it's quite difficult to be young in regulatory affairs. Someone else in the ecosystem told us that. It's hard to come out of engineering school at 23 or 24 and become a regulatory affairs consultant. Maybe you know the theory, but you don't yet have the practical, interpretive baggage.

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Claire Nassiet: There's also support work to be done on the retraining of professionals who have been in this sector for a while, whether as clinicians, developers, or Leed business people, to provide them with a regulatory layer and enable them to upskill themselves and their start-ups.

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Lionel REICHARDT: That has the merit of being clear. Is regulation in an innovative healthcare company the prerogative of an individual or a team, or how can it be better taken into account within an innovative healthcare company?

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Claire Nassiet: It's really a strategic role. It's not just one person, and if it is just one person, he or she needs to have a champion or ambassador role to instill these regulatory issues in all the teams and enable the start-up to have a regulatory by design mindset, like we can think of interoperability by design, to really have this regulatory reflex that affects all the teams. Otherwise, there are two possible choices for a start-up when it comes to recruiting or integrating a regulatory skill, there's a first choice which is outsourced.

00:09:12
Claire Nassiet: We look for expertise outside the start-up, whether with consulting firms or other types of players. What emerges from our discussions with the ecosystem is that it can be interesting in the early stages, especially when things are a bit tight financially, which is understandable, but you need to develop a relationship with your service provider to make sure that the regulatory issues are well adapted to your solution, your product, your innovation. So that it's not just a one-stop shop, I have a service provider to whom I'm going to turn for advice in the very short term.

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Claire Nassiet: The second scenario, the second choice, is to have in-house expertise to really integrate regulatory issues and instill them in all the different teams. This can be a difficult choice to make, especially in the early stages of a start-up's development, but it requires a certain investment. As we've said, these are not easy profiles to find; they're people with fairly complex skills. To find them, it can be interesting to rely on players specialized in recruitment.

00:10:12
Claire Nassiet: Here again, it's an investment. It's a cost for entrepreneurs and start-ups, but in the long term, it's a cost that can be extremely profitable.

00:10:21
Lionel REICHARDT: To conclude, Claire Nassiet, what advice could you give to a healthcare entrepreneur or innovator who would like to better integrate the regulatory skills needed to carry out their project?

00:10:31
Claire Nassiet: Think about it as early as possible. Don't think of regulation as something you'll do afterwards, once you've raised the first financing and recruited the CTO and CEO, and find that profile who can really help the other teams to become more competent in regulatory issues. The other piece of advice is to look at regulatory issues differently. It's a central role, just like the Chief Data Officer or the Chief Technical Officer in a healthcare start-up.

00:11:13
Lionel REICHARDT: Claire Nassiet, 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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