Medical Devices: Control is Not the Same as Innovation

In the design of medical devices, design controls are not necessarily the same as a product development process. A quality management system requires that a process and controls be in place and be documented. Its intent is to guarantee that product development is documented for traceability and that products are made in a consistent manner. For example, a standard such as ISO 13485:2003 requires that a medical device manufacturer establish and maintain a quality system. In addition to other requirements, ISO 13485 puts more focus on risk management and design control activity during product development without actually dictating the exact nature of that system. Additionally, 21 CFR 820.30 outlines the requirements for design controls without describing the exact form they might take.

Standards describe the need for processes but do not lay out a path to innovative new products. A robust, consistent new product development system, such as a phase-gate process, is an important means to the end of design control, including risk reduction, device history, and traceability. It can form the basis for the design history file from the new product’s inception and contribute to the design master file.  And what the NPD system does especially well is addresses business-related issues that the QMS in not concerned with, such as which new products should move forward (based on the most promising market opportunity) and how to improve customer satisfaction.