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Make sure you develop a reimbursable product.
Are your current decisions optimized for future drug/medical device reimbursement?
Bringing a new product to market requires decision-making under great uncertainty. However, the decisions you make today may impact the odds of obtaining reimbursement in the future. For example:
Product related decisions
a.
Design:
Decisions about the design of the product (e.g., specific features, pressure ranges, type of sensors, etc.) may prevent the possible use of existing reimbursement mechanisms, and make it necessary to develop new reimbursement mechanisms.
b.
Application:
The same product may be used for two different applications, one of which is reimbursed, while the other is not. Knowing this in advance, may help you focus on the right application.
c.
Validation:
Payers, or the entities that will typically pay for your product in the future, may be approached early on in order to obtain their feedback on the design of the product and your clinical development plan. Use this option to avoid unnecessary and costly mistakes.
Regulatory strategy related decisions
a.
Regulatory route:
Will the identified regulatory route interfere with my reimbursement goals?
b.
Intended use:
How can I lower the reimbursement hurdle and expedite commercialization by changing the intended use on my regulatory clearance/approval or by focusing on a different patient population?
Clinical data development decisions
a.
Existing data:
Do I have the necessary clinical data for reimbursement?
b.
Planned data:
Is there any way to validate my clinical development plan in advance, with the entities that are supposed to pay for my product in the future?
b.
Price setting:
How will the price of my product be determined? Is this the optimal price for me?
We help our clients answer these questions early, so they can focus on bringing to market a product that the market is willing to pay for.
Flat fees, concrete timelines, and support through your entire reimbursement process
