Scale-up is the last stage prior to full product launch. The following seven Competitive Assessment Tools and Viewpoints used for the Scale-Up stage (Tools 44-50) are focused on obtaining protective IP rights for the commercial product and any easy follow-on approaches competitors might try. Competitive Assessment Tools and Viewpoints tools help visualize how much protection is necessary.
Concerns for entering full commercialization are about whether all major manufacturing and distribution hurdles are cleared, and whether commercialization costs allow for profitable entry into the marketplace. Some strategic questions must still be addressed, including market need and timing. Metrics here address both the strategic and tactical issues.
Scale-up is obviously market and manufacturing oriented. Careful management of commercialization and product costs, timing, and execution are the key issues. Since budgets up to tens to hundreds of millions of dollars may be at stake, program and resource management are paramount.