Tips on Meeting FDA Device Design Requirements

July 10, 2020 14:05:41

Are you a device manufacturer in the medical industry? Then you may be thinking that the FDA design controls are confusing terms on your process. These regulatory design requirements shouldn’t be shrouded in confusion, and we share some tips below that will help you enjoy being a biomedical product designer who meets or even surpasses the FDA regulatory requirements.

It Would Be Best If You Didn’t Believe in Misconceptions

A heavy load of documentation has been the biggest misconception about meeting the FDA design controls. If you have volumes of documentation on how to meet FDA design requirements, then your design controls are obsolete, and they need a complete overhaul. Design controls should not be a burden to medical device developers since there are other, more straightforward ways of complying. Meeting design controls entails demonstrating the safety, effectiveness, and the intended use of the product. Make a product that meets this criteria, and you more likely than not will meet the FDA requirements.

Keep Your Plan Fluid

A huge mistake that is always seen is that companies treat design control as a task to get out of their way. In most cases, it is always done at the beginning of the project, then forgotten. An effective plan should have the beginning, middle, then the final phase. Your design and development plan needs to be dynamic and address FDA controls at every step. It should be developed and updated in every phase of development and should be flexible for change. A fluid plan will identify the process that you will follow, the design to be used, and the required materials.

Recognize User Needs vs. Design Inputs

The difference between design inputs and user needs in an important concept that you need to be aware of. Your question should be what will the user use this device for? And how will they interact with the product? The responses to these questions are what you need to indicate in the user needs. A simple way to satisfy the user needs is by using standard terms such as “easy to use,” “better,” and so on.

User stories should become the basis of your design inputs as these will make the user stories measurable and more specific. The inputs are simply the requirements for the design of your device. Furthermore, the inputs need to be objective and stated in a way that they can be demonstrated through analysis and testing.

Recognizing Design Inputs vs. Design Outputs vs. Design Verification

Design inputs will define all the requirements, performance criteria, and features of your medical device product. Device inputs should come directly from the user’s needs since a useful design input gives a stronger foundation for a successful medical device.

Design outputs consist of all components, inspection procedures, parts, and other materials that go into your medical device. They also include all documentation to be given to someone who needs to assemble the device.

Design verification has the role of proving that design outputs meet design inputs. It also includes analyzing, testing and inspecting, which served as proof that your medical device was designed well.

All these factors work collectively to make adhering to all FDA design controls easy. Established players in the biomedical space, such as Vivos Therapeutics Inc. certainly know the design controls like their back of their hand, and newcomers in the field would do well to learn from these pros.

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