Cetas Healthcare | Market Access Consulting
A global firm specializing in customer insights and strategy for the medical devices industry
Medical Market Research Emerging Markets Business Analytics Desk Research Qualitative Quantitative Competitive Intelligence
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The market for Medical Devices is regulated almost all over the world and access to healthcare providers and patients depends on adequately demonstrating the safety and effectiveness of a Medical Device along locally applicable rules.

Passing the regulatory hurdles however is not the only challenge a novel product faces in obtaining market access. It is equally important to also obtain market acceptance, which is usually rooted in demonstrated value compared to the current standard of care, differentiation over competitive products and techniques, and the preparedness of payers to reimburse the adoption of such novel technology. These crucial components, which may vary for different key markets, determine the commercial success of a Medical Device in the long run more than anything else.
“As the application of Medical Devices is regulated across the globe, you will find restrictions on what you are allowed to state about your medical product’s performance and what buyers are ready to compensate on its demonstrated performance .
Product Claim Management means moving beyond the right to enter a specific market. It means developing a strategy for Market Acceptanceand execute on it. By this way youfocus on those aspects of your product, which truly can make the difference in your selected market space andprove them in compliance with the applicable regulatory rules and reimbursement potential”.

Product Claim Management is our structured approach to ensure Market Access beyond regulatory compliance and to investigate what elements of your product and evidence of their performance are critical success factors to establish market acceptance in specific key markets along their local regulatory rules and requirements.