Product Claimscan be described as “factual statements on the safety and performance characteristics of your Medical Device within its Intended Use”. Ideally such claims should be differentiating, which means that they are suitable to highlight why a target customer, be it a physician,payer or patient, would prefer a specific product over other market alternatives.
Identifying the right Claim Space for your target customer group requires to identify the key drivers and obstacles, which are relevant for the application of a Medical Devices within the specific context of its usage and under the circumstances of a local market.
To be able to differentiate in this Claim Space often also requires the calibration and comparison towards an explicit or implicit Standard of Care against which all market or treatment alternatives can be benchmarked.
A thorough analysis of current local reimbursement patterns and a strategy to gain access to a sustainable compensation of your novel device in a specific healthcare market is also a critical factor to be commercially successful after market entry.
Our support in Market Access blends our partner’s knowledge on local rules, regulation and reimbursement patterns to a guidance on how to effectively demonstrate the safety and performance of your device.
Our support in Clinical Intelligence offers to identify the relevant categories within a given Standard of Care which allow for a strong differentiation.
Product ClaimManagerTM is our structural approach to allow making informed choices and select technical, clinical and economical claims on their differentiating impact and substantiation costs.
The support Product ClaimManager offerstherefore blends
to enablea differentiating positioning of your Medical Device in compliance with the applicable Regulatory Rules.
Product ClaimManagerTM is offered in partnership with and is a trademark of MD squared B.V., The Netherlands