National innovation agency Luxinnovation is a central player in Luxembourg’s innovation landscape, supporting start-ups and SMEs as well as large international groups in their R&D and innovation activities. In collaboration with the Ministry of the Economy, the agency runs several programmes supporting healthtech firms.

From start-up acceleration to CE marking: entering the European healthtech market

Régis Ciré, Anne Meunier and Lauriane Chuzeville at LuxinnovationOne of them is the internationally renowned start-up acceleration programme Fit 4 Start, which offers start-ups from Luxembourg and abroad coaching, seed funding and access to key networks that can help them succeed with their market launch and growth. Since 2018, it includes a specific track for healthtech companies. “The Fit 4 Start coaches help start-ups acquire an understanding of the European healthtech market and build their business strategies in the most efficient way,” says Anne Meunier, Senior Advisor – Healthtech. The programme also gives them insights into medical device, data protection and other regulations that they need to comply with, so that they can take these into account in their early technology development.

The Fit 4 Start coaches help start-ups understand the European healthtech market and build their business strategies in the most efficient way.

As a next step, the agency has launched Fit 4 Innovation – HealthTech Market to help companies developing digital medical devices obtain the CE marking that is compulsory for commercialisation in the EU. “Receiving the CE marking is a complex process, and many young companies are not capable of defining a clear roadmap for getting there on their own. We give them access to experienced experts from across Europe and beyond that take them through all the steps from defining the class of their medical device to developing a quality management system, conducting the clinical validation, and preparing technical documentation as well as post-market surveillance,” explains Dr Meunier.

Finding the right partners

The clinical validation cannot be done by companies on their own, so the Ministry of the Economy, the Luxembourg National Research Fund and Luxinnovation have launched a joint call for clinical investigation projects involving companies, research centres and hospitals. Luxinnovation notably contributes with a matchmaking platform that helps companies find the right project partners.

Connecting companies with the partners that can help them move forward is an important part of our everyday work.

“Bringing the national healthtech ecosystem together and connecting companies with the partners that can help them move forward is an important part of our everyday work,” says Luxinnovation Healthtech Advisor Lauriane Chuzeville. “In addition, we also collaborate with clusters abroad, such as EIT Health and Medical Valley in Germany, to work on strategic topics.”

In May 2023, Luxinnovation, together with Medical Valley and its digital health application centre DMAC, EIT Health and the Enterprise European Network, organised the first European Digital Healthtech Hub Conference. The event brought together companies, decision makers, researchers, investors and other experts from 15 countries as well as European Commission representatives to discuss funding solutions, business models and clinical validation approaches that facilitate the market access of digital health technologies.

A tailor-made approach

The added value of these instruments is confirmed by Luxinnovation’s Head of International Business Development – Heathtech, Régis Ciré. Since joining the agency in spring 2023, the former entrepreneur has been amazed by the number of international healthtech companies interested in using Luxembourg as their European base and testbed for launching their products on the European market.

Luxembourg is a good place for non-European companies that do not yet know the market here.

“Luxembourg is a good place for non-European companies that do not yet know the market here,” he points out. “As the size of the ecosystem is limited, we know all players very well. We can listen to the needs and expectations of companies and connect them with the right people. There are also initiatives such as the recently organised Luxembourg Healthcare Week to create bridges between businesses and medical professions. Each healthtech company is basically getting tailor-made support.”

Photos: © Luxinnovation/Michel Brumat

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