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By Mark Foley – Engineering Manager
If you are involved in the development of medical devices, it’s likely you’ve heard the words ‘design outputs’. Well – What are design outputs? What purpose do they serve? Why should I be concerned about them? These are all just a few questions you will probably ask yourself.
I once asked myself the very same questions. After spending the better part of the last seventeen years in medical device product development, I hope that I can help explain what is often a widely misunderstood part of the process.
I’m sure it’s no surprise that I’m referring to the FDA-regulated process for medical device development known as design controls. The design controls process provides a product development workflow and a set of criteria for which the FDA expects medical devices under development to conform to if a company hopes to receive approval to market their device in the U.S.
As defined by the FDA¹, design controls are procedures that control the design process to ensure that your product meets user needs, intended uses, and specified requirements. After the FDA learned that 44% of voluntary recalls between 1983 and 1989 could have been prevented by adequate design controls, the agency was authorized to add design controls to the current Good Manufacturing Practice (cGMP) requirements for medical devices.
Learn More About Medical Device Regulations
Design outputs are the work produced at the end of design efforts, such as drawings, material specifications, or manufacturing instructions. They are what control your design. They must also meet design input criteria defined in the planning stage of your project during design verification.
I often see little time spent thinking about how design outputs will be verified until after the close of the design effort and the start of the design verification stage. By this time, it’s too late; design outputs need to be considered at the beginning of your work.
You will end up wasting time making updates to outputs that have already been released but don’t have the information needed to verify their inputs. You will also find yourself having to navigate the change control process in a hurry as you try to keep the project on schedule.
I’ve seen projects delayed for months because of things like this. Instead, pay attention to design outputs from the jump and work to make sure they contain the information needed to make verification possible. This will help you work in a more optimized manner and keep your product development schedule on track.
I recommend that during your design stage you create a mechanism to serve as a deliverable that will force you to evaluate each design output against each design input before its release. This is a paper exercise that can often be accomplished in a single document. I like to refer to the document as a technical review.
In this document, capture your input, and the acceptance criteria that you will use in verification, checking that the information or specification is contained in your design output. Time spent performing this exercise before closing your design stage and freezing your design will serve you well.
Changes made after a design freeze can often mean that other activities or assessments will need to happen and these activities are sure to drain time from your schedule and money from your budget, which doesn’t do anyone any good.
Partnering with an industrial design company, all phases in the product development plan can be streamlined to accelerate time to market, reduce waste, and meet regulations.
At Goddard Inc., our team of engineers and designers specialize in medical device development, life sciences and diagnostics, and high-tech consumer and industrial technologies. From product conceptualization to production, our team delivers a competitive difference with an on-site partnership model, commitment to quality, unique collaborative expertise, and in-depth employee development programs.
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