On 16-17 May 2023, Luxembourg will host the first-ever European Digital HealthTech Hub Conference focused on how to help companies successfully launch new digital medical devices on the market. We spoke to Jean-Philippe Arié, Cluster Manager – HealthTech at Luxinnovation, about why start-ups, companies, national and regional healthtech hubs and policy makers should join the conference.
Dr Arié, why are you organising this event?
Jean-Philippe Arié: An increasing number of European companies are developing digital medical devices – solutions using software, sensors and connectivity to monitor health-related conditions. These solutions have great potential for making the healthcare sector more efficient and accessible to patients.
If we want to fully exploit the capacities of entrepreneurs in Europe and ensure that European patients are among the first to benefit from new digital healthtech innovations, we need to align much better with each other.
However, introducing digital medical devices on the market is a challenge. One reason is the complex regulatory requirements that such devices must fulfil. There is also great variation in how healthcare is organised in different EU countries, as well as in how healthcare costs are covered. A company that wants to introduce its devices all over Europe currently needs to follow 27 different approaches, which consumes a lot of time and resources.
If we want to fully exploit the capacities of entrepreneurs in Europe and ensure that European patients are among the first to benefit from new digital healthtech innovations, we need to align much better with each other. We also need to identify the best ways for companies to proceed in order to bring their devices to the market as quickly, safely and efficiently as possible. This is why we have invited healthtech hubs – organisations which, similarly to Luxinnovation, support digital health ecosystems in their regions and countries – start-up acceleration and incubation experts, opinion leaders, European officials and healthtech start-ups from across Europe to come here and learn from each other.
What do you hope to achieve?
We hope to gain a better understanding of the systems in the different countries and suggest keys to gaining times for entrepreneurs, such as the best places to start the EU market launch and the optimal approach to adopt. We will also look into how to optimise the clinical validation of digital medical devices. We will talk about blockages and pinpoint possible dead-ends.
We are well aware of the value of exchanging experience with other European players and of being inspired by what they do. On behalf of Luxembourg, Luxinnovation will present ourFit 4 Innovation HealthTech Market programme, which we have designed to help companies define their regulatory roadmap to obtain CE marking for their new and innovative digital medical devices and thus accelerate their launch on the European market. We hope that this will spark ideas in other regions, and I’m sure that we will learn much from the 200 or so participants who will join the event.
What topics will the conference focus on?
We will organise interactive sessions on the topics of market access funding, business models and market acceleration programmes, and clinical validation trial design. Healthtech organisations and companies from across Europe will present best practice initiatives and use cases. We will also invite people in the audience to share their own experience. Participants who want to exchange more in depth with each other can then request personalised matchmaking meetings with the people they want to meet.
Healthtech organisations and companies from across Europe will present best practice initiatives and use cases.
In addition to this, high-level keynote speakers will present European initiatives aimed at supporting the development and market uptake of digital medical devices. We are organising the event together with the German healthtech cluster Medical Valley and EIT Health, a knowledge and innovation community of the European Institute of Innovation and Technology, and we are happy to have Jean-Marc Bourez, CEO of EIT Health, as one of the speakers. Jochen Klucken, Chair of Digital Medicine at the University of Luxembourg, will give a keynote address, and I’m pleased to say that representatives of the European Investment Bank, the European Commission and VC companies, as well as ventures that offer digital therapy solutions formally approved for health insurance reimbursement in Germany (so-called DiGAs), have confirmed their presence on stage. The event will be opened by Luxembourg Minister of the Economy Franz Fayot.
What will be the next step after the conference?
Our objective is to pool and document the experience and knowledge from across Europe on how to best help companies bring their digital medical devices to the market.