|Successful product development requires the orchestration |
of multiple complex systems and processes, sometimes
requiring worldwide coordination.
by Lisa Weeks, Communications Specialist, MasterControl
Having a great product does not guarantee success. The road from concept initiation to commercial release is a long and arduous one. Success depends upon not only understanding the new product development process, but also the FDA submission process, and the complex interplay between the two. Many companies underestimate the value of a carefully thought-out submission strategy. They focus solely on product development and treat the approval process as an afterthought. Others are so eager to get their product to market, they rush the design and testing processes and end up with a product that’s dogged by costly delays or, worse, unmarketable.
Successful product development requires the orchestration of multiple complex systems and processes, including design control, compliance management, and risk analysis/assessment and design and process validation. Is your company’s new product development program equipped to handle all of these elements in an environment that’s constantly changing due to new technologies, regulations and competitive activity? Few are.