Commercialization Process: Clinical Rationale

Upon completion of this first milestone, the innovator has become aware of the potential risks that might derail a project from achieving commercialization. These risks include intellectual property, ownership of the idea, market size and trends, outside influences (political, social, etc), regulatory issues, revenue limitations (for example, reimbursement), and current and alternative solutions being used by customers. This milestone is an early check and balance to determine if a business opportunity exists and should be accomplished before any product development occurs.

Need and Market Opportunity Analysis asks the innovator to consider the elements of a comprehensive business model. Through this consideration the innovator identifies potential risks and creates a plan to understand, and perhaps overcome, these outside influences.

Awareness of the influences, beyond technical issues, that could derail a successful commercialization effort.