The Medical Device Development Process

IP AND TECHNOLOGY DEVELOPMENT

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

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

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 frequentlyfaced 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.

References

1. “Quality System Regulation,” Code of Federal Regulations 21 CFR 820 (1996, rev. ed. 2006); available from Internet: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.1.

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