The focus on medical device strategy has often compared FDA approval to CE Mark, with FDA requiring both safety and efficacy. As a result, the trend in recent years has been to move "First-in-Man" and initial commercialization to European markets.
But the FDA and CE Mark are only the foothills to the mountain rage of reimbursement and market penetration. As I mentioned in my previous blog Reimbursement is the elephant in the room, not FDA or CE Mark.
For medical technologies to successfully enter the market (both medical devices and mobile health technologies), it's more like mountaineering the Alps. Since the Alps range across many countries, each has their own summit to conquer: Aiguille Verte in France, Weisshorn in Germany, The Dom in Switzerland, Gran Paradiso in Italy, and some share peaks such as Mont Blanc and Matterhorn.
Similarly, though the EU currency and CE Mark span across Europe, each country has their individual medical device reimbursement approval processes and evidence based criteria by which to demonstrate value for their population.
54million are 15+ years old, of which 12 million are65+
- Technical Assessment: Clinical Requirements HAS (Fig 8) HAS-CNEDiMTS
- Reimbursement CEPS singe use medical device Tariffs, UNCAM-CHAMP
70million are 15+ years old, of which 17million are 65+
Additionally, in the:
53million are 15+ years old, of which 11million are 65+
Compared to USA:
258million are 15+ years old, of which 48milllion are 65+
Multiple options to receive coverage and penetrate the market:
- Private - Direct sales to hospitals and patients
- Government - CMS – Local Coverage (65 over, disabled, low income families)
- Government – CMS - National coverage, one decision across the nation 'Yes or No'.
In the end, the effort required to demonstrate 'value' for reimbursement coverage relative to the larger market size, and generally higher rates in the USA, the FDAs safety and efficacy study becomes a foothill.
Stay tuned for ClearRoadmap(SM) on-line tool launch, to enable medical device and mHealth navigation through US regulatory and reimbursement process.
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-- Vizma Carver, Founder and CEO,
Carver Global Health Group LLC | firstname.lastname@example.org