Q&A with Sarah Andries, Regulatory Affairs Manager at genae
Q: Why is it important for manufacturers to focus on the health economics of their device?
A: It' s important to think ahead. During the first stages of the development of a medical device, manufacturers are introduced to the world of market access and health economics.
While the main focus is mostly to prove safety and performance, it is essential that you do not focus solely on the clinical benefits, but also do the necessary research to examine the maximum cost and the appropriate indication for your technology to realize an economic benefit.
Reach out to healthcare and reimbursement providers from the beginning and evaluate in which countries you want to use and sell your device to make sure that you are developing a device that can be reimbursed. By doing this, developers will come across questions early on in development and can address them on time to avoid costs for what otherwise might be duplicate or useless data.
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