Creating the Requirements – Voice of the Business

Creating the Requirements – VOB (Voice of the Business)

VOB (voice of the business) represents the commercial and other business considerations for the medical device. VOB development must be kept distinct from the activities associated with user needs in order to prevent the corruption of the true user needs.  In developing these distinct needs, every effort should be made to make the statement of these needs as quantifiable as possible, as this will be a critical aspect of the final concept evaluation.  As an example,

The system shall enable a gross margin of 65%

This statement represents a quantifiable business need that can be easily used to evaluate concepts for the medical device.  The following rules apply to the development of VOB:

• The statement should be quantifiable – this will drive better evaluations in subsequent steps.
• The statement must have universal acceptance – it should be agreed upon throughout the business
• The statement must prompt a course of action – statements such as “it must be more aesthetically pleasing” will not define a course of action.
• The statement itself shall not confound the way it or other statements are prioritized – be careful that the statements do not overlap.

These rules represent a subset of the rules for customer input, with the business representing the customer.

Key to the development of VOB is the concept that the statement should be quantifiable.  Business needs, as a result of being closely associated with the development, can drive a number of qualitative needs.  These should be avoided, as these needs often represent the business interpreting customer needs.  By focusing on the quantifiable, VOB can be focused on true business needs.

With the development of VOB as well as VOC, the basic elements required to begin concept selection are in place.