Senior Director - Medical Devices & Combination Products at Voisin Consulting

Tara Dougal: Is it your first time at Medtec Europe?

Christophe Amiel: No, this is actually the fifth time.

TD: How do you find the show? Why do you attend?

CA: Primarily to meet companies that are really into innovation, most of them being start-ups, SMEs, and companies that are really driving the development of innovative medical devices. We are then able to design the strategy for them to position the product and actually facilitate the placing of it on the market with minimum financial investment and minimum delay in registering these innovative technologies on the international market list.

TD: Have you visited our Start-up academy already? Do you see any interesting companies there?

CA: Not yet, I’m planning to do that actually shortly after this interview, but not quite yet.

TD: Touching on your presentation: you spoke a little bit about implications for European Developers of a forthcoming MDR (Medical Device Reporting), what are the top issues that developers are facing?

CA: Basically, there is a general reinforcement of regulatory constraint because of that medical device regulation but there are dedicated provisions which did not exist before that developers really need to carefully take into account. The key one being the nature of clinical evidence they will have to develop in order to ensure regulatory conformance to the CE marking And be able to reassure the regulator that they are meeting the claims they are making on their mobile application.

TD: You also mentioned about how regulatory is having to keep up with the developments of the industry at the moment – is there anything a developer of a mobile health app can do now to safeguard their product later down the line, should new regulations arise?

CA: I would say that the first step would be to carefully check, in terms of risk analysis, whether all the functionalities are properly set, whether all the safety and performance claims are well defined for this app and to really ensure that non-clinical and clinical evaluation is properly mapped out.

TD: You spoke about apps that are being developed for Diabetes, any other particular treatment areas or conditions that you can see m-health and app development has a lot of potential in?

CA: I would say theoretically that could be applicable to all types of chronic diseases but we saw a push recently toward mental disease and into a smarter way to deliver drugs for patients suffering from pathology and requesting to remain at home so as not to be hospitalized on a weekly basis. So I would say everything will develop with the improvement of this m-health application, in particular the development of implantable discrete sensors that will also allow this technology to generalize and be widely applicable.

TD: You mention sensors, it’s actually something that we’re trying to develop more at Medtec Europe for next year – do you see this as quite a big growth area?

CA: It is certainly for mobile apps because a lot of the adoption by patients will depend again on how discrete and how customizable the sensors will be in order to be worn daily and without raising awareness to the fact that this patient will be monitored for this or that particular pathology. So yes, it’s one of the barriers to product development currently.