After a preliminary review of the design control regulation it may not be obvious to device developers why planning is important to the FDA. After all, the FDA’s purpose is to protect public health, right? Why would they care about how product development is planned? The FDA does not have a significant vested interest in having products launch on time; so why do they care about planning?
Their first priority is to “allow no harm” by establishing regulations and inspecting medical device manufacturers which will encourage safe development and manufacturing. Their second priority is not to be a barrier for devices that may be beneficial to those that are in need of new technology or procedures. So even though the FDA is not necessarily interested in the timely launch of a product, they do understand that effective planning is essential for the development of a safe and effective device.
Essentially the design and developing plan helps manufacturers “think ahead” before just jumping into product development. There are already significant unknown surprises and challenges that are inherent in the development process, planning will help minimize these foreseeable challenges.
Planning allows project managers to identify activities, deliverables, personnel and resources required to develop a device. Management will typically use the plan to allocate personnel and resources to support development. In the absence of a plan, teams may jump into development unprepared, understaffed and underfunded. As a result, milestones will be missed, completion of project deliverables will be rushed, risks will be taken and an ineffective and unsafe device may be developed.