Small and medium sized enterprises (SMEs) are the lifeblood of the medical technology industry. Research in the medical technology industry, which typically occurs at the bedside not at the bench, is usually a result of small or micro collaborations between health professionals, academia and SMEs. This research model brings rapid innovation, which quickly tackles current and emerging medical needs. This innovation can only be good news for under-pressure European healthcare systems as there is clear evidence that more effective treatments are capable of delivering clear benefits; reduced hospital stays (with an associated reduction in cost of treatment); better outcomes, and faster rehabilitation and return to society.
Europe is a good place for medical technology SMEs to innovate and grow, but don’t take my word for it. Stephan Rietiker, MD (Senior Advisor to Brown Brothers Harriman’s medical technology M&A advisory practice) said recently that “The U.S. medtech community would do well to consider Europe as the new model for success in funding innovative companies that are developing technology to save lives and enhance the quality of life” We also know from a survey carried out by Prof John Linehan (Northwestern University) and Jan B Pietzsch (Stanford) that 64% of small device and diagnostic companies consider Europe to be the most predictable for regulatory approval (only 8% consider the US to be so).
But, and there’s always a but, much more can be done to protect the innovation potential of the 7,000+ medical technology SMEs in Europe and ensure that all those innovations are available to more and more patients and citizens across Europe. So why should we? Because, besides the health benefits of such innovation, medical technology SMEs also play a pivotal role in developing novel technology which puts them at the heart of competitiveness, growth and future prosperity, not only for the healthcare sector but also for the EU’s competitiveness as a whole. Failing to protect them and address the challenges that they face will ultimately impact Europe at many levels.
Eucomed launched in 2010 an SME Task Force in an effort to understand the needs of medical technology SMEs. As Chair of this group, I am pleased to see that we have achieved some important milestones. The first part of our work was to have a better idea of how many medical technology SMEs there are in Europe and identify the specific challenges and opportunities that they face. We thought that the best way to approach this was to ask all national association members of Eucomed to survey their members. They told us that small but powerful changes would reap rich rewards for Europe’s population, healthcare systems and economic development. The second part of the work (and that is what we are doing now) is to work together with the European Commission to make those small but powerful changes to remove big barriers that hamper the innovation potential of those SMEs.
In order to do so, Eucomed and the national trade associations are ready to work together with the European Commission to jointly conduct a more comprehensive in-depth survey to further map the sector, identify revenue, employment, R&D and priority needs. Having been able to identify those 7,000+ medical technology SMEs with our survey was a significant step in the right direction but we know that there are more out there that need our support and we really need to know who they are.
We also recommended the European Commission to take a number of actions that will without any doubt improve the business environment of all those small businesses. More specifically:
- Establish a coordinated and transparent programme of market surveillance;
- Implement a smarter regulatory process whereby novel technologies can be commercialised faster;
- Set up easier processes for applying for EU R&D funds, and
- Provide information about market access and distribution channels.
The other positive news is that more and more we see that medical technology SMEs are being recognised as important if not vital contributors to – coining a phrase by past EU Commissioner for Health David Byrne – the ‘health and wealth’ of Europe.
And so in response to our survey and report, and as part of our collaborative work with the European Commission, I am delighted to say that I have been invited to sit on the High level Steering Group on the Pilot European Innovation Partnership on Active and Healthy Ageing to represent the views of our SMEs. It is the first time that in Europe all the stakeholders are joining forces at this scale to commit to advancing innovation in active and healthy ageing. This is a very exciting and powerful initiative. The Steering Group has already met once. A number of work streams have been established to discuss and propose actions. The next Steering Group meeting
will take place on 16 September. The priority of the Eucomed SME Task Force is to address the horizontal issues identified in our survey results and I look forward to representing all of you who believe, like me, that the future of the medical technology SME sector can be even bigger and brighter than it currently is and, all of this, for the benefits of European citizens and Europe as a whole.
I look forward to hearing your thoughts on the needs of SMEs, what you would like us to do to support them and of course my attempts at blogging (this is my first so please be kind).
– Sharon Higgins, Chairwoman of the Eucomed SME Task Force
Director of IMDA, the Irish Medical Devices Association
