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Thursday, October 4, 2007
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Design Controls Are Worth the Effort
It has been 10 years since the quality system regulation went into effect, which means that it has been 10 years since medical device manufacturers have been required to perform design controls. To some, this was a foreign concept when first mandated. But now it is a commonly accepted practice, and medical device design is better for it.
Compliance-Alliance LLC (Arlington, VA) recently conducted a survey to measure the effects that the design-controls requirement has had on the device industry. Compliance-Alliance president Nancy Singer, a member of MD&DI’s Editorial Advisory Board, analyzed the results and solicited the feedback of David R. Jones, a quality assurance director for Philips Consumer Healthcare Solutions (Andover, MA). They in turn shared their perspectives with MD&DI, and the results can be found in this month’s issue.
The regulation appears to be well-understood and well-regarded 10 years out. More than 80% of the survey’s respondents believe the regulation takes the correct approach, and a similar number believe that FDA inspectors understand the regulation and go into the appropriate depth during the inspection. It has particularly come in handy, Jones argues, to firms that rely on a platform-based approach to product design. This is because the design-controls process allows firms to leverage the benefits of prior products when designing add-on products.
Similarly, 86% of respondents felt that design controls have contributed positively to the medical device development process. It has made product design a more disciplined process. By requiring certain things to be considered up front, the regulation has perhaps contributed to a reduction in unpleasant surprises once a final design has been submitted for FDA review or gone to market.
Packaging
The State of Unique Device Identification
By Laura Bix and Robb Clarke
Unique device identification could mean a uniform tracking system for all medical devices.
Validation
Exploring Summative Usability Testing
By Michael Wiklund
Manufacturers must ensure that their devices can be used without causing harm to the user or patient.
Design
The Rise of Human Factors Principles
By Erik Swain
More device companies are incorporating human factors into their product development processes, but some are still holding out.
Precision Technology
Understanding Screw Thread Technology
By Jim Speck
The geometry, inspection, and control of medical component screw threads are crucial to staying competitive.
Diagnostics
Automated Cap Inspection
By Andrew Zosel and Neils Wartenberg
Cap inspection systems can help streamline diagnostics automation and limit mistakes.
More from this issue of MD&DI
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