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To secure a successful product in today's era of cost containment, manufacturers and developers of new in vitro diagnostic technologies must consider payment issues--coverage and reimbursement by healthcare insurers--as critical market forces that must be addressed in the business plan. Similar to the regulatory hurdles involving 510(k)s and premarket applications, the requirements for payment are related to the unique features of the technology, its costs, and its effect on clinical outcomes. Because cost containment continues to be a driving force for change in healthcare, the business plan must not only include strategies for optimal payment at the product's introduction, but also contain provisions for continuous monitoring of the payment environment throughout the product's life cycle.

A parallel revolution: payment for new in vitro diagnostic technologies