Challenges in Design Development: Why Design Controls Make Sense

The time and investment needed to bring an idea for a new medical product successfully to commercial realization can be daunting. In developing new drugs, the costs and timing required to conduct multiple stages of clinical studies, even under the best of circumstances, can be a “non-starter” if the projected long-term revenue and profit potential are not sufficient to justify the cost and risk associated with development. Similarly, the development of software-driven instrumentation products is complex in the extent of interactions among components and the number of areas where a seemingly small problem with one mechanical component, or a mistake in one line of software coding, can lead to catastrophic product system failure. Even the development of “simple” single-use medical devices can involve years of development and millions of dollars in capital investment.