#26: Your validation plans and/or clinical trials need to include and validate all the attributes (Outcomes, Cost and Access) that you intend to claim.

#27: You might not have the customer intimacy and the experience (e.g. FDA and CMS) to make the relevant decision and trade-offs early in the product development cycle. Allocating extra budgets early in the design process to in-source or outsource this effort will give you a competitive edge when executing your U.S. market entry.