Friday, November 18, 2016

Critical feature confirmation: The next big thing in medical device design. Link to MD+DI Article

Ongoing design revisions during development can put stress on a medical device’s go-to-market timeline.

Narrowing the list of critical features in a design is one of the best ways to keep a project on track and on time.

Critical feature confirmation (CFC) is a leading-edge method to figure out which device features are critical and which aren’t. It uses designed experiments to test product and design requirements against key design inputs. The test results indicate which features are critical.

The CFC process helps companies alleviate pain points in getting a product to market in three important ways:

Accelerating reviews: Design and product development review processes now focus only on the few things that matter – features confirmed by the CFC process. This quickens reviews to ensure projects are delivered on time and on budget.

Simplifying the quality control process: Test method development targets only confirmed critical features. This also helps reduce the amount of data that needs to be collected throughout development.

Improving regulatory review: Clean, objective data answers what-if questions, and is better documented for regulatory bodies to review during submissions.

To learn more details about critical feature confirmation and how to apply it for your device, click here  for a link to MD+DI.

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