Tom Patzelt and I discuss the first stage in the new era of commercialization and how the "this product will sell itself" delusion that many startups/new product launches believe will not be successful . The point is not to point out failures but to share best practices and how to launch a product in this new era. Commercialization should start 12 month prior to an expected FDA clearance and not 90 days before as is the norm today.