Navigating the Nuances of Europe’s MedTech Industry

Podcast, Videos


Richard Houlihan, CEO of EirMed, sat down with me to explore topics related to EUDAMED–the European Databank for Medical Devices–including the key pain points and concerns MedTech companies frequently encounter when working on their submissions.

Here is a sneak peek of our conversation:

Q: Tell me a little bit about your company EirMed. What exactly are you doing and how is your business model revolving around your EUDAMED and what are you doing with that whole area?

A: We’re doing absolutely everything to do with EUDAMED. When I left the Commission and started talking to companies; when I realized that they didn’t have a clue, despite what the Commission believed, then we had to put training in place – I’m not a trainer, never wanted to be a trainer – but yet, we’ve ended up building up the training side.

We had a meeting within the Commission in January 2019 regarding what level of support companies are going to be given. At that point, it was only going to be a couple of people behind the functional mailbox and if the developers had time, they might fix the book which absolutely appalled me coming from the IT industry. I thought, “Okay, two people and the way the Commission answer questions, they’re not going to be able to support companies.” So, we started heavily providing support.

My original plan which we have actually implemented was actually created software to help companies. We have two different types of software – one beast that installs on your own servers and another SAAS version. One of them can be managed from spreadsheet templates that they upload and we do the XML and all that. But what we found with the SAAS one is an awful lot of companies that just didn’t want to touch EUDAMED. They had no problem putting the data into the templates, so we ended up having to create a make-it-go-away service. They email us the spreadsheets, we do everything else. If there are errors, we get them to fix them, and then we will submit the data to EUDAMED, etc.

Our whole raison d’etre is to make life easier on you. The MedTech industry is never going to make money out of this. This is always going to be an expense. One of the things you mentioned at the very beginning about disruptors, that’s the space that I see us in for this. There were existing companies doing the uploads to the FDA, etc. but they charge some amount of money. There’s got to be over 18,000 companies in this. There is a lot of money to be made in there but not at the expense of taking advantage of companies. What we’ve come in and done is we’ve kept the costs down. We built the correct software, we make it a lot easier for people, but everything around EUDAMED, anything people have an issue with, we can help them.

For more of our discussion, you can watch the whole Fireside Chat with Richard Houlihan, or listen to the podcast version, below.

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