The recently established European Diagnostic Clusters Alliance (EDCA) is now registered as an international non-profit organisation under Belgian law and headquartered in Brussels. Could you give us an idea of the strategic aims of this alliance?
The main goal of the EDCA is to bring together the key players in European in vitro-diagnostics (IVD) in order to develop EU competitiveness in the IVD field. The partnership wants to increase European medical diagnostic competitiveness, ease and accelerate access to non-EU markets, promote a major role for medical diagnostics in healthcare practice, structure the EU diagnostic cluster network and provide national and European decision makers with high level expert analyses in this field. But our first goal, of course, is to support SME growth and transform our European cluster into a real commercial cooperation platform.
What are the general criteria for membership of the alliance? And why did you invite Berlin-Brandenburg to become a founding member?
To become a member you have to:
- Be structured as a cluster
- Have a critical mass in IVD
- Implement a mapping of IVD members
- Structure an IVD group within its own cluster
- Contribute to the EDCA initiatives and roadmap
- Subscribe to the EDCA statutes and membership requirements
The Centre for Molecular Diagnostics and Bioanalytics in Berlin-Brandenburg (ZMDB) meets all membership criteria: It is already structured as an IVD cluster, covers the entire value-added chain for in vitro-diagnostics, has a critical mass with more than 80 innovative IVD companies, and has real potential for international development based on its relationships and partnerships worldwide. The ZMDB has been one of the pillars of the EDCA from the start and has given continuous support to the development of EDCA visibility and activities.
We now have ten member clusters with more than 350 IVD companies, and three others have sent us a request to become members.
What are the challenges and obstacles facing SMEs in the field of in vitro-diagnostics when they strive to do more business internationally?
To do more business internationally, an SME has to find a good partner and a good interlocutor. It has to be well aware of market trends abroad, of the regulatory evolution – which can be extremely expensive and time-consuming – and of the competitive environment. These challenges and constraints can slow down an SME’s growth as well as its competitiveness on the global markets (both leading and emerging markets).
IVD SMEs can rely on the EDCA to find a partner, technology and know-how abroad and present its needs to the European community.
To ensure a bottom-up approach and that the needs of individual SMEs are reflected in the EDCA’s activities, one industrial representative per country must be present and active on the EDCA Board.
The EDCA was a co-organiser of the 4th Berlin-Brandenburg Technology Forum on In vitro-Diagnostics and Bioanalysis. What was your impression of the cross-border cooperation between the SMEs?
Several SMEs from different EDCA partners attended the Technology Forum and presented their companies. There is clearly a strong need for SMEs to develop their visibility abroad. Ten countries were represented, and the B-to-B sessions were mainly attended by SMEs. This kind of event is obviously an effective tool to develop European SME cooperation.
Can you already reveal some of your future plans and – in a more immediate perspective – what you will be doing in the coming months?
We finally achieved the EDCA mapping for each region. We now have a database of about 350 IVD SMEs. The next step will be to transform it into an interactive tool for our SMEs on the EDCA website, analyse the synergies between these companies and start fostering the emergence of new transnational collaborative R&D projects.
One of the main constraints for internationalisation of EDCA SMEs is to cope with regulatory changes. This is why we have started to work on the evolution of the EU IVD directive with European partners involved in European IVD, MD and pharmaceuticals regulation in the context of personalised medicine. We will establish a roadmap for this cooperation and, of course, include SMEs in this initiative.
Some months ago, we met a similar IVD association dedicated to major corporations – the European Diagnostic Manufacturers Association (EDMA). The idea is to establish a bridge between SMEs and major companies – keeping in mind the interest of SMEs. The roadmap has not been defined yet, but will be part of our upcoming activities.