This question is part of the following Ask The Expert session:
I do not think there is one answer to this question – there are a variety of factors that will determine if a product is ultimately successful in the market including its positioning (i.e. what market segment or sub-segment you are targeting), competition, reimbursement, pricing as well as a host of other factors. Beyond the obvious need to demonstrate safety and efficacy, a lot will depend on the market dynamics – what I mean by this is will your product replace one that is currently on the market or is it a “me too” product? If you are targeting a specific sub-set of a patient population and your product will be used as a combination therapy, a lower price point will be necessary as insurers will have to reimburse for your product as well as others (mispricing a product can have devastating results and is often hard to fully recover from).
The best advice I can give is to be sure to plan ahead. I would encourage you to talk to the end user, be it physicians, specialists or other point of care providers and ask how your product will benefit their daily practice and how they will incorporate it, if at all. Talk to insurers about reimbursement and make sure to understand what they will need to see in order to reimbursement your product – don’t wait for the product to be on the market to think about this (it is too late by then).