Michael Wilke wants to ease market access for Medtech companies to do business in Europe.
The CEO of Munich-based inspiring-health GmbH says that because the reimbursement approval processes in Europe change frequently, early development of a strategy is “key to the future.” Therefore, companies need to know the expectations and plan their development accordingly.
Data requirements differ between France, the UK, and Germany, he says, so it’s important to keep up with those differences or companies could lose years of work if their data are not satisfactory.
Wilke recommends that early-stage companies understand their time frames. Tackle the CE certification first, he advises, then “map out the pathway to reimbursement by ease.” Go to the country with the easiest access first is the inspiring-health CEO’s advice.
He also advises companies seeking entry to the European market to be very clear about the type of patients they plan to treat. A narrow indication strategy makes it easier to generate the right data, Wilke says.