|
Originally Published MX Supplement July/August 2007 IP AND TECHNOLOGY DEVELOPMENT
The Medical Device 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.
- Initiation of the opportunity and risk analysis.
- Formulation of the concept and feasibility analysis.
- Design and development, including verification and validation.
- Final validation and product launch preparation.
- 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.
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.
Copyright ©2007 MX
|
