Product Development versus Design Control

I shared my story of revamping a medical device product development process in “The Language of Product Development” parts 1, 2, and 3. I described a few issues and obstacles we faced with these efforts but did not expand on the biggest obstacle. This obstacle related to the differences and similarities of product development and design control.

Many companies struggle with the similarities and differences between Design Control and Product Development. Many view these as synonyms. There certainly is a relationship between Design Control and Product Development. To quote the FDA Design Control guidance:

Design Controls are an interrelated set of practices that are incorporated into the product development process, i.e. a system of checks and balances. Design Controls make systematic assessment of the design an integral part of development. . . Design Controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.

But Product Development is much more broad than this. Product Development is a holistic business process. Design Controls are deliverables to a Product Development Process. Product Development is cross-functional and also includes deliverables for other areas. Regulatory affairs, marketing, operations, quality assurrance, and other functions all contribute to a Product Development Process.

A Product Development process describes how a company takes an idea from initial concept to product in the marketplace. Design Controls are documented, objective evidence that a medical device will perform as intended, safely and effectively.