Medical Device Link.

IP AND TECHNOLOGY DEVELOPMENT

Return to Article: Panel Discussion: Defining the Product Development Process

FDA’s quality system regulation (QSR) details specific activities that must occur for a new medical device to be made and commercialized in the United States. QSR requirements govern “the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.”¹ Examples of design controls defined by QSR include: design input, design output, verification, and validation. Verification and validation testing are performed to ensure that design output meets design input specifications.

At a general level, the medical device development process can be described by the following five phases.

1. Initiation of the opportunity and risk analysis.
2. Formulation of the concept and feasibility analysis.
3. Design and development, including verification and validation.
4. Final validation and product launch preparation.
5. Product launch and postlaunch assessment.

Each of these phases contains a variety of separate tasks and activities, such as early concept selection, gathering customer feedback, and conducting clinical trials.

A key issue for the InHealth-Stanford study described in the adjoining article is to consider the contrast between the medical device development process described in FDA guidelines and the challenges frequently faced by device companies as they bring new products to market.

The study highlights the differences between an ideal model of medical device development and the iterative nature of medical device design. This comparison is made by first creating a linear or idealized model of device development, and then investigating the iterative loops that commonly occur along the path from concept to commercialization.

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