Europe is the second largest MedTech market in the world, so it’s unsurprising that many companies outside of it want a slice of the action. And, there seems to be a belief that Europe is an easier place to commercialize a new device before attempting to do the same in places like the US. But, size isn’t everything, and things aren’t often as straightforward as they seem. Here are three things MedTech companies must be aware of if they’re to be successful in Europe…
1. Market acceptance isn’t as straightforward as you may first think
Firstly, there’s no doubt that obtaining CE Mark status is an awful lot easier than securing FDA approval. However, while it may be relatively straightforward to secure a CE Mark, MedTech companies will need to overcome other market acceptance issues if they’re going to be successful in Europe. For example, time-to-market is a hurdle that Medtech companies are often surprised by when entering Europe, so they must be prepared for a process that can take just as long as those in the US, if not longer. Also, while a company might readily secure CE Mark status, it won’t count for much if they haven’t focused on payers.
2. Europe is not a single market
Secondly, companies operating outside of Europe would be forgiven for thinking that the European market is a single market. After all, we’ve all heard a great deal about the Single Market provisions of the EU (allowing for the free movement of people, goods and services across the 27 states) as a result of the Brexit conversations that are ongoing. But, that doesn’t mean non-EU companies can adopt a ‘one size fits all’ approach.
While the single market allows for a single regulatory process for the entire region, each country has its own national and regional characteristics. This makes the EU market more of a ‘patchwork quilt’ than a homogenous market. Moreover, medical systems are funded differently throughout each of the member states, which can mean a MedTech company would need to establish 27 legal entities in order to gain access to all of these markets.
3. You may face issues with payers across multiple countries
Payers are another obstacle to a Medtech company’s success in Europe. Echoing the fact that the European market is not a realty a single market, payers in different European countries take very different approaches for the same product. For example, you may find that Germany approves the use of a particular drug, while France limits its use to a narrower population through a different set of circumstances. A non-European MedTech company will need to be anticipate how different payers are going to behave if they want to sell into various European countries successfully.
As you can see, Europe can be a difficult place to ‘crack’. But, with 27 countries to sell to, it would be a shame to avoid it altogether. That’s why MedTech companies would be best served by working with a firm of life science consultants who know the specifics of working in the European market. For instance, Alacrita consulting is comprised of consultants who specialize in both US and EU biotech and pharmaceutical consulting (originating in the UK), with a wealth of experience assisting entities operating in the USA and mainland Europe. This makes the the consulting firm one that MedTech companies should be speaking to if they want to bolster their chances of success.