sme

Europe is known for its excellent startup ecosystem. Moreover, the medtech industry in Europe is made up of 95% SMEs. If we want the innovation successes of past and present to continue well into the future, it is critical that the bigger medtech players, and the financial and investment ecosystem keep taking the pulse of European medtech startups.
EU Parliament
With the summer holidays well and truly behind us, and temperatures outside gradually dropping, I am sure the temperature inside the EU institutions is rising as the EU machine is picking up steam again. Commission portfolios have been handed out, the Commissioners-designate will soon be vetted, and certain competences are being moved from one Directorate-General to another. Make sure to read on to find out our thoughts on the move. And if that’s not enough ingredients to guarantee an interesting and exciting Q3 and Q4, we have our MedTech Forum that promises to be the biggest, boldest one yet. It’s been a big month for the EU in this year of change—last week Commission President Jean-Claude Juncker officially announced the new College of Commissioners-designate and their respective portfolios. Of particular interest to our industry was the move of the unit for health technology and cosmetics which includes IVDs and medical devices from the Directorate-General for Health and Consumers (DG SANCO) to the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG ENTR) under the Polish Commissioner-designate Elżbieta Bieńkowska. This means that DG ENTR will take over the responsibility for the ongoing revision of the medical devices and in vitro diagnostics Regulations. It seems this move does not sit well with many of our partners in health. I have read articles in both national and European press in which various stakeholders have voiced their concern. As MedTech Europe, EDMA and Eucomed want to be very clear on this issue. Our #1 priority is to provide patients with access to safe, effective and innovative diagnostic and treatment options. Our #1 priority is to provide patients with access to safe, effective and innovative diagnostic and treatment options. Of course, being an SME-driven industry in Europe, these very SMEs are just as critical and...
Where are we again on the MDD and IVDD?
The European Commission released its proposal for the revision of the EU Medical Devices (MDD) and In Vitro Diagnostics Directives (IVDD) in September 2012. The European Parliament weighed in on the file, voting on its final report in a plenary session last October. And in December we heard reps from the 28 EU health ministries voice their views on key issues. The word on the street is that the EU Council is set to reach its final position by June with trialogue discussions (where the Commision, Parliament and Council negotiate a final text) pencilled in for Q4 2014.
I overheard a debate at a breakfast meeting at the World Economic Forum Meeting of the New Champions in Dalian, China that went like this: “The market won’t accept a malaria vaccine that costs more than $.40 a dose.” “But that’s not possible, why can’t we just start solving the technical problem and then figure out how to pay for it?”
Think of innovation in health and many people conjure up images of men and women in white coats - surrounded by coloured test tubes crouched over microscopes in sterile laboratories - developing intricate vaccines or other miracle cures. Yet these tightly controlled, high cost, industrial scale operations are only one end of a very long scale. In the developing world at least, we’re increasingly witnessing some of the more interesting, impactful healthcare innovations coming from lone entrepreneurs and problem solvers. Large multinationals just don’t operate in what can often be seen as the ‘scrappy long tail’ of social innovation. Not only are few present in these markets, many just don’t understand them – or even worse they don’t understand why they need to be in them.
Parliament
Europe’s medical device industry has always agreed that Europe’s regulatory system for devices needs to be improved and has put forward various proposals to achieve this. In the wake of a case of fraud like the PIP breast implant incident, it is clear that we need a safer system that makes sure Europe’s patients continue to have timely access to the latest life-saving and life-enhancing medical technologies.