Do changes to your device warrant a new 510(k) submission? There are several elements to consider, such as design controls compliance, risk analysis and postmarket surveillance data.
In order for your product to succeed, everyone needs to be paid. Be proactive for you and your customers by making reimbursement a part of your development timeline, and by investing in the collection of data.
Challenges have created new areas for opportunity, and this requires you to broaden your understanding of the commercialization chain. Two opportune areas for consideration: delivery of care and manufacturing techniques.
Headed to NASS 2016?
Prepare with our NASS articles and other spine-centric content:
A manufacturer that does not measure and manage its "costs to serve" customers puts itself at a competitive disadvantage, leaving an opening that can be exploited by both customers and competitors.
