What with the medical device tax and regulatory hurdles, there is a lot of medical device startups are contemplating beginning business in Europe. But before you leap, look. Is America or Europe right for your company?
Here are four tips to mull over from two CEOs who lead startups that have a strong European presence.
1. The first step is choosing, and yes, you must choose (for now).
Don’t try to straddle the Atlantic Ocean at first. You aren’t a giant (yet).
If you’re a startup founder to-be, you’re likely strapped for cash and definitely hoping to get the highest ROI possible. So you must make a decision. You don’t want to stretch your cash or your team too thin.
2. Think about where you can secure the best relationships with the best practitioners.
Sidow said Moximed went for European milestones first because of the German market’s long history with tibial osteotomies (and, of course, the US regulatory hurdles). Thought its headquarters is in California, it has fully staffed offices in Zurich, Switzerland. “Set up relationships between key surgeons first before you begin to hire people or go to third party suppliers or agents,” Sidow said. “Once you have developed that relationship you can expand from there.”
3. Organizationally speaking, it’s different. A lot different. It may seem a bit obvious but can’t be stressed enough: Europe is one continent, but many countries.
“Different pricing, different healthcare systems, different languages–as a smaller company that can be quite a headache,” said NeoSurgical CEO Barry Russell. (NeoSurgical is a medical device startup headquartered in Ireland that’s just launched a Chicago office.)
Do you have the manpower and knowledge to navigate such a diverse set of systems at the onset of your business?
4. Conventional wisdom isn’t always wise for your company.
Don’t oversimplify or start renting space in Galway because you’ve heard you’ll get ahead quicker overseas.
While it’s common to hear regulatory hurdles in Europe are “more reasonable” than stateside (and they often are), you have to look in to the nitty gritty of what works for your product and company. The CE mark isn’t always easier to obtain than an FDA nod. Russell said his company was an anomaly, finding the 510(k) route easier than the CE path due to classifications.
Do you have any sage advice for or a question concerning starting a medical device company in Europe? Share it in the comments section below.
I founded a medical imaging software company in Spain, and then opened a US subsidiary in New York (www.kanteron.com). I completely agree with your advice:
- FDA/CE regulation requirements depend on your product classification. But having a certified quality management system in place helps a lot.
- All European markets are very different. Much more different than Latin America, North America or parts of Asia.
- Relationships with practitioners may be important, but eventually you will need a channel (sales, tech support), and that is definitely the key.
- While agreements with other companies (related tech, equipment, etc) may seem promising, they seldom lead to sales (everybody is looking after their own pocket). Use them as a tool to learn and expand your network.