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. […]
Think shock absorbers for the human body. Moximed could help active and young patients who have osteoarthritis prolong the amount of time before total knee replacement. The Heyward, Calif.-based company’s Kinespring Knee Implant System is a medical device that absorbs part of the load put on the knee, without changing anatomy. The device is positioned […]
While Europe may still provide a faster route to regulatory approval for such devices, post-market requirements are creeping in like an expensive final cheese course served by European regulators and health systems just when companies are feeling most broke and tired. So regulatory approvals may come, but actual, meaningful revenues? Not so fast.
Representing one-third of the global medical device market, the European Union provides a significant opportunity for start-up, medical device companies. But, it can also present costly challenges for the unprepared. Following are a half-dozen cautions drawn from real-world experience that could help you avoid some common commercial pitfalls. 1. Chasing conflicting commercialization objectives. What are […]
