Sometimes the dividing line between regulation and flexibility can be unclear. Somewhere in the middle of the life cycle for new innovations, there exists a period of time when innovation slows and a crystallization of consistent customer expectations takes over. In effect, those expectations from the customer provide a de facto standard for that type of product. In a Darwinian sort of way, a natural balance exists until a new innovation eclipses the old, upsetting that balance and ushering in a new de facto standard for customer expectations.
Standards (in their written, regulatory form) are, in my opinion, necessary when either that natural balance is never achieved or if the balance fails to provide an adequate level of safety. The latter could be true even if individual instances of products are considered safe, but when taken as a full category of products, they fall short. This is the benefit that I see in standards development; it provides a forum to bring together all the affected parties. We can talk openly about trends and adverse data affecting our products, and we can arrive at a consensus to change (or not). In the end, a product conforming to a written standard provides a customer the ability to expect a certain level of performance from a product category; he can thus focus his attention elsewhere without worry of the performance he can expect.
Edwin Burnard is associate director of innovation R&D at B. Braun Medical Inc. He is involved in AAMI standards work related to reservoir connectors for intravascular applications.