Market volume estimates play into how you manufacture your device. Estimate it wrong, and you could be stuck with a manufacturing process that doesn't fit. "It plays into your business models," Murdeshwar says.
You need to figure out the right price for the device, or even how you are going to sell it.
And then there is the need to make sure the health providers can be reimbursed for the device after they buy it from you.
Reimbursement has become a huge issue, Murdeshwar says. No codes yet for the procedure you are proposing? It could add on years to your project. Says Murdeshwar: "It takes years to get a code, which is one of the main reasons that people don't come up with these crazily innovative devices, unless they know what's going to happen with reimbursement."
[Image courtesy of amy gizienski on Flickr, per Creative Commons 2.0 license]