Reimbursement is the elephant in the room, not FDA or CE Mark.

With the countries around the world looking to control health care costs, payers are looking for evidence to validate medical device and mHealth application value, quality and necessity.

The clinical evidence required for FDA is no longer the highest hurdle required.  The evidence required downstream by health insurance companies and AMA, with which to obtain coverage, coding and pricing from private and public payers and purchasers, is becoming the highest hurdle. 

Just as in the USA, where the Local CMS reimbursement is done on a State and regional basis, each country in Europe requires evidence for reimbursement.  The CE Mark is not a license to sell, just as FDA approval is 'not enough' to sell. Consider, each country's coverage policies are very different, thus the 'value-based' study for reimbursement in one country is not sufficient to address the value proposition questions in another country.

It is important to recognize that FDA Approval and the CE Mark are merely foothills in comparison to the reimbursement data mountain collection.

Data collection for reimbursement takes additional time to validate and receive approval for, resulting in additional delays of at least 1 year, and often two years or even longer.  The longer you wait to plan for reimbursement strategy, the further downstream you will realize ROI.

Europe is leading the practice of 'rationing'. US is not yet rationing, but looking for the immediate value, and even may pay more for a device if the value is proven with evidence…data.

So, is the US in the long run is a better place to bring your device after all?  That is not clear yet. What is clear, regardless which market you pursue, you have to integrate your value proposition questions into your regulatory clinical trials, to minimize the reimbursement delays.

Stay tuned for ClearRoadmap(SM) on-line tool launch, to enable medical device and mHealth navigation through regulatory and reimbursement process. ClearRoadmap(SM) both reduces the time to access the relevant information for hours and days to seconds and minutes, and with sophisticated search increases the reliability of finding the right information.

-- Vizma Carver, Founder and CEO, Carver Global Health Group